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IRB Frequently Asked Questions (FAQs) and Submission Guidance

If your question is not addressed below, please contact the BSD/UCMC IRB staff for more information.

All IRB submissions must be submitted in AURA, the University-wide electronic submission system. Please access AURA IRB through the AURA website (http://aura.uchicago.edu).  If you have any questions regarding how to fill out AURA submission forms, please contact the AURA help desk at AURA-Help@uchicago.edu . 

Quick Links

New Submission Guidance

All submissions should be routed using the University-wide IRB system, AURA. Please log in to the IRB module in AURA through the AURA website, http://aura.uchicago.edu

Many new protocols require a full review, but if you believe your new research project qualifies for expedited review, please complete the Expedited Review section on the electronic submission form.

Alternatively, if you believe your study can be exempted from review, request "Exempt" review and fill out only those sections of the electronic submission form that appear in AURA. Please also upload any necessary documentation (e.g. a copy of the survey). The IRB office will then notify you if indeed your study qualifies as exempt or if you will need to complete the entire protocol submission form.

The IRB will make the final decision regarding level of review.

Incomplete submissions will not be reviewed until all necessary materials have been received regardless of the date the initial submission was received.

The BSD/UCMC IRBs require a protocol document to be submitted with all non-exempt new submissions. A sponsor protocol document used by multiple sites can be submitted, or, for a single-site study, the investigator should prepare a local protocol document. The protocol document, "protocol narrative," or "protocol" is submitted with the original submission of the protocol and revised versions, as necessary, with amendments. There is no required format, but the document must be sufficiently detailed to permit the IRB to evaluate the soundness of the procedures proposed and the potential risks and benefits to research subjects. The sample protocol narrative outline prepared by the IRB office demonstrates content that is generally requested by the IRB.

Protocol narrative outline

 

The OCR has more detailed templates posted on the "Tools and Templates" page. 

For non-interventional studies, such as chart reviews and specimen repositories, a sample template is also provided below:

Non Interventional Protocol Document

What is Protected Health Information (PHI)?

Protected health information (“PHI”) is any information that might directly or indirectly identify an individual, including

  • Physical or mental health information
  • Past, present, or future information
  • Information collected, created or received
  • Information in any medium: electronic, paper, oral 

Inclusion of any of the below listed items, alone or in combination, is considered use of protected health information.

  • Name – including the use of initials
  • Address – All geographical identifiers smaller than a state, except for the initial three digits of a zip code
  • Names of relative(s)
  • Names of employer(s)
  • Dates – any specific date, including date of discharge and date of birth, and including year‐month combinations (year of event alone, without month or day, is not PHI)
  • Telephone number
  • Fax number
  • E-mail address
  • Social Security number
  • Medical record number
  • Health Plan or Account number
  • Certificate or license number
  • Vehicle or device serial number
  • Web URL
  • IP Address
  • Voiceprints
  • Fingerprints
  • Photographs ‐ full face
  • Code
  • Any other unique identifying number, characteristic, or code

The IRB must make the final determination regarding exemption status. Never commence any study procedures until receiving notification of exemption or approval from the IRB. Investigators should submit an exemption request through AURA with enough detail to determine whether the protocol meets exemption requirements. You should be notified within a week of the status of your exemption.

If you make changes to an existing study that has previously been determined to be exempt, a new request for exemption should be submitted, as research activities may have changed such that the exempt requirements are no longer met.

Please contact the IRB staff for further information regarding specific studies that may be exempt from IRB review.

In addition, if you have received approval or exemption from a non-University of Chicago IRB, please contact the U of C IRB office to determine approval or exemption procedures at our site.

Consent Guidance

The Department of Health and Human Services issued revisions to the existing Common Rule, the regulations governing human subjects research, including consent process and documentation. The effective date for the revised Common Rule was January 21, 2019.

As it is recognized that research consent forms are often lengthy and complex, under the revised Common Rule consent forms will now be required to begin with a “concise and focused” presentation of the key information that will likely help someone considering research participation to make a decision about whether or not to participate in a study. As a result of this and other additional requirements, the IRB office has prepared a new consent form template. This template has been revised as of December 2018 and updated in November 2019.

The requirement for a concise and focused presentation of key information is mandatory for any federally funded research newly reviewed by the IRB. New submissions to the IRB should use the new template.

The revised Common Rule requires at 45CFR 46.116(h) that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form must be posted on a publicly available federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit (as required by the protocol) by any subject.  The consent form must have been used in enrolling participants in order to satisfy this new provision. 

"Clinical Trial" is defined in the revised Common Rule as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes."

Currently, two publicly available federal websites will satisfy the clinical trial consent form posting requirement:

  • ClinicalTrials.gov and
  • a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).   

Please see OHRP’s website for specific instructions as to how documents can be posted on those two sites.

https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html

 

DHHS regulations require certain elements be present in a consent form. Additional elements are required for more than minimal risk research and FDA-regulated research.

Required Elements for Informed Consent (2018 Common Rule requirements)

The 2018 Common Rule requires a concise and focused presentation of key information at the beginning of the consent form. The IRB office has prepared several sample "Key Information" sections, based on study type. Please use these samples as a guide to drafting your study-specific consent form.

Under the HIPAA regulations, the following elements must be included and/or described in an authorization form in language understandable to a subject.

  • The Protected Health Information (PHI) to be used or disclosed, described in a specific or meaningful way
  • Who will use or disclose the PHI
  • To whom the PHI will be disclosed
  • A description of each purpose of the requested use or disclosure
  • An expiration date/expiration event that relates to the purpose of the use or disclosure
  • A statement of the individual's right to revoke the authorization in writing and the exceptions to the right to revoke, together with a description of how the individual may revoke the authorization
  • A statement that information used may be subject to re-disclosure by the recipient and no longer be protected by this rule [HIPAA]
  • Signature of the individual and date, and if the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual
  • Statement of the consequences to the individual of a refusal to sign

The authorization must be written in plain language.

A signed copy must go to the individual.

For studies that involve a foreseeable risk of harm, federal regulations (45 CFR 46.116) require that the consent process include “an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained.” As the wording in consent forms is intended to inform subjects about studies, not to limit liability, the University of Chicago Biological Sciences Division IRB has set the following policy to ensure that all compensation for injury statements meet both Federal and Institutional standards.

A. COMMERCIAL SPONSOR STATEMENTS
It is the policy of the University of Chicago and the Medical Center that commercial sponsors of clinical research at the Medical Center must agree to pay for treatment of injuries that are the direct result of the administration of a study drug or device, or any study procedure required to be performed in the study. This obligation of commercial sponsors is limited to research protocols designed or supplied by the commercial sponsor. The University and the Medical Center’s obligations for treatment of research injuries, as expressed in the language below and in Medical Center’s Policy on Research-Related Injuries, will be secondary to the commercial sponsor’s obligations under the clinical trial or other sponsored research agreement. University Research Administration is responsible for implementation of this requirement in commercially-sponsored research agreements.

The obligations of commercial sponsors to subjects who suffer a research-related injury must be expressed in the “What Are the Costs” section of the written consent form using the following language, which should immediately precede the applicable statement concerning the Medical Center’s obligations discussed in Part B. below:

The sponsor of the study, [insert sponsor name], has agreed to pay for the care of certain injuries directly resulting from this research. If you think that you have suffered a research-related injury, you must contact [insert PI/study doctor name] right away. The study doctor can help you obtain more information about the sponsor’s agreement to pay for research-related injuries.

Exceptions to this consent form language may be considered by the IRB, in consultation with legal counsel, on a case by case basis if requested by the commercial sponsor, but are not looked on favorably, and must satisfy the requirements of the Medical Center’s Policy on Research-Related Injuries.

B. UNIVERSITY/MEDICAL CENTER STATEMENTS
One of the following University of Chicago BSD/ University of Chicago Hospitals statements must be included (without any modifications) in the “What Are the Costs” section of the written consent form, immediately following the commercial sponsor statement describe in A. above (if applicable). The appropriate statement should be chosen based upon the subject population being recruited. The IRB recognizes that for studies that recruit both individuals with a disorder and condition and healthy controls, the use of both statements may be required. However, a separate consent form should be drafted for each of the populations with the appropriate costs statement included.

1. For studies with therapeutic intent for the subject (including Phase I and II trials):
If you suffer an unanticipated injury as a direct result of this research and require emergency medical treatment, the University of Chicago Medical Center will provide such treatment at the University of Chicago Medical Center at no cost to you. You must notify ___________ [insert PI/study doctor name] as promptly as possible after your injury in order to receive this care. An injury is “unanticipated” if it is not one of the known effects of a study drug, medical device or procedure, and is not the result of your disease or condition. The costs of any non-emergency care for such an injury will be billed to you, your insurance [or the study sponsor*] in the ordinary manner. If you think that you have suffered a research-related injury, you must let ____________ [insert PI/study doctor name] know right away.

* Include only if study is commercially sponsored and the sponsor designed or supplied the protocol.

2. For studies involving healthy volunteers:
If you suffer an unanticipated injury as a direct result of this research and require emergency medical treatment, the University of Chicago Medical Center will provide such treatment at the University of Chicago Medical Center at no cost to you. Costs of related non-emergency care for an unanticipated research injury will be covered if that care is provided at the University of Chicago Medical Center. You must notify ___________[insert PI/study doctor name] as promptly as possible after your injury in order to receive this care. An injury is “unanticipated” if it is not one of the known effects of a study drug, medical device or procedure. If you think that you have suffered a research-related injury, you must let __________ [insert PI/study doctor name] know right away.
 

Conducting studies in situations where the patient is unable to consent to participation in a research project present challenges to the traditional consent process. Such situations include many protocols in the Intensive Care Unit, the Emergency Department, the Psychiatry Department, and those involving patients with dementia. Amendments to the Health Care Surrogate Act and the Medical Patient Rights Act provide a legal basis in the State of Illinois for the use of proxy consent in research.

Proxy consent should involve all the same considerations that informed consent from a competent patient involves. It also involves identifying the proper surrogate and ensuring that the research decision reflects the wishes of the subject, if known or, if not known, the best interests of the subject. In addition, the IRB will be concerned about whether the research could be accomplished in situations involving the consent of a competent patient, and will consider whether the intervention is likely to offer therapeutic benefit to the subject of the study. The IRB will always view these considerations as paramount.

The University of Chicago believes in the importance of the informed consent process and believes that subjects should be given every opportunity to provide their consent. Understanding, however, that medical circumstances may preclude a subject from participating in the consent process, the following procedures are in place to consider requests for surrogate consent in keeping with the Medical Patient Right Act and the Health Care Surrogate Act.

A. Protocol submission and review:

  1. Researchers wishing to utilize surrogate consent will be asked to provide additional information regarding this population in addition to completing the IRB Protocol Submission Form in full.
  2. The IRB will utilize the prioritized listing of surrogates in the Health Care Surrogate Act in evaluating protocols requesting to use surrogate consent. The priority order specified by the Act is as follows: 1) subject's guardian; 2) subject's spouse; 3) any adult son or daughter of the subject; 4) either parent of the subject; 5) any adult brother or sister of the subject; 6) any adult grandchild of the subject; 7) a close friend of the subject; and 8) the subject’s guardian of the estate.
  3. In determining whether to approve the use of surrogate consent in a particular protocol, the IRB will consider such factors as whether the research could be done without using surrogate consent or whether the proposed intervention offers direct benefit to the subjects of the research.

B. Procedures for Surrogate Consent:

  1. The attending physician must determine that the subject lacks decisional capacity.
  2. An attempt should be made to determine whether there is an operable and unrevoked living will, durable power of attorney for health care, or declaration for mental health treatment ("Advance Directive") which is applicable to the subject's decision about whether to participate in the research. Surrogate consent should be invoked only in cases when, after reasonable inquiry, no Advance Directive applies or, despite efforts to contact the person authorized in an Advance Directive, that person is unavailable.
  3. The researcher must attempt to identify a surrogate of the highest priority. (Note: If there is more than one surrogate of the highest priority and there is a disagreement between them, majority rules. If there is disagreement and no majority, consult with the Ethics Consult Service or the Office of Medical Legal Affairs.)
  4. The University of Chicago/UCMC Health Care Surrogate Act Certification Concerning Research must be used in all instances of surrogate consent. The certification shall be placed in the subject's medical record and a copy attached to the research consent form or, if written consent is not required, kept with the subject research records.
  5. The consent process with the surrogate should include a discussion with the attending physician and an inquiry into the extent to which the surrogate is able to speak for the subject. Following the requirements of the Health Care Surrogate Act, this discussion should emphasize the surrogate's ability to make a decision that would conform as closely as possible to what the subject would have done or intended under the circumstances. The surrogate should take into account evidence that includes the subject's personal, philosophical, religious, and moral beliefs and ethical values relative to the purpose of life, sickness, medical procedures, suffering and death.
  6. In circumstances in which the subject's wishes are unknown after reasonable efforts to discern them, the decision shall be made on the basis of the subject's best interests as determined by the surrogate decision maker. In determining the subject's best interests, the surrogate shall weigh the burdens and benefits of the proposed research and shall take into account any other information, including the views of family and friends, that the surrogate decision maker believes the patient would have considered if able to act for self.
  7. The surrogate should express a decision to the researcher in the presence of an adult witness (at least 18 years of age.)
  8. The University of Chicago/UCMC Health Care Surrogate Act Certification Concerning Research attached to the consent form should document the surrogate decision making process described in points 5, 6 and 7.
  9. The subject should be made aware of the research and the identity of the surrogate as soon as feasible. If the subject objects and the surrogate is not a court-appointed guardian, the subject should be withdrawn from the research.
  10. The surrogate will have the same rights as the subject to receive information on the research, to withdraw consent for further participation, etc.

 

The following form should be completed and attached to the consent form when enrolling subjects using a proxy consent process. Prior approval by the IRB to enroll decisionally-impaired subject(s) is required prior to use.

Health Care Surrogate Act Certification Concerning Research

OCR has prepared a checklist to aid in documenting the consent process for the research file.

Checklist for Investigators to Aid in Obtaining Informed Consent

The regulations do not define required elements for an assent process or assent form. It is expected that pertinent information will be presented to child subjects. The following form has been prepared as an example of simplified language that can be used when documenting assent of a child subject. 

Assent form template

FAQs: About the IRB and IRB Review

Federal regulations require an Institutional Review Board (IRB) to review research on human subjects if the research involves federal funding. The University of Chicago has determined that all research undertaken at this institution, or by those persons affiliated with this institution, must undergo a similar level of review as research that falls under federal regulations. The University has obtained a Federalwide Assurance (FWA), which signifies that the University and the University of Chicago Medical Center are in compliance with the Federal requirements for the protection of human subjects. For details on the University's FWA, please visit the FWA page or the University Research Administration's website.

The University of Chicago currently has five IRBs: 1 Social and Behavioral Sciences Division IRB, 1 Social Service Administration IRB, and 3 Biological Sciences Division IRBs (known as Committees A, B, and C). Each IRB is fully constituted with the appropriate number of scientific and non-scientific, affiliated and non-University-affiliated members, as well as members from different genders and ethnic backgrounds, as required by federal regulations. For current BSD IRB rosters, please see the FWA page.

The Biological Sciences Division (BSD) Institutional Review Boards are administered by the Office of Clinical Research. The BSD IRBs are responsible for all biological or medical research conducted at the University of Chicago and/or the University of Chicago Medical Center and all human subjects research conducted by UCMC faculty. If you are a BSD faculty member, the IRB submission system, AURA, will automatically route your submission to the BSD IRBs for review, regardless of the nature of the research and/or subject population. For more information on the Social Service Administration IRB or Social and Behavioral Sciences IRB, please follow the links above.

Research is defined by the Department of Health and Human Services as “a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR46.102(l)). 

Research studies may involve a variety of invasive or non-invasive procedures, including removal of body tissues or fluids, administration of drugs, exposure to various forms of radiation, alteration of diet or environment, interviews, surveys, simple observation, administration of questionnaires, or review of records.

Note that research is systematic, and thus the writing up of a single case report would typically not be considered "research." On the other hand, some quality improvement and quality assurance activities are systematic, but are not designed to contribute to generalizable knowledge (that is, those overseeing the project are not planning to share results outside this institution or results are not generalizable to larger group). These quality assurance activities would therefore not be research and would not require review by the IRB.

Please see the following topics in this section for further information.

Human Subject  is defined as of January 21, 2019 as “a living individual about whom an investigator (whether professional or student) conducting research (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” (45CFR46.102(e)(1)).

Interventions may be physical procedures by which data are gathered or manipulations of the subject or the subject's environment that are performed for research purposes. Obtaining identifiable private information may include a review of medical records or collection of data from surveys or from existing databases. 45 CFR 46 clarifies that “private information” includes “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place” and information “that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. a medical record).”

If an investigator obtains data about a living individual in such a way that she or he has no identifiable private information about the subject, then the project is not considered to involve human subjects. In this case, the data must be coded or anonymous, and the investigator conducting the research, as well as the entire research team, must have no access to any code which links the information or material used in the research back to specific individuals.

If investigators have created the code between identifiable information and study data or will have access to the code, the project may qualify for an exemption from IRB review. However, it is still considered human subjects research and some type of submission to the IRB is necessary in this case.

The regulations for the protection of human subjects in research at 45 CFR 46 do not apply to research on deceased individuals. Similarly, BSD/UCMC policies typically do not apply to research on deceased individuals. However, while most regulations concerning humans in research refer to “living” individuals, the HIPAA regulations at 45 CFR 164 apply to all persons, whether living or no longer living. As a result, activities that may not be subject to full IRB review because all subjects are deceased may still require a minimal submission process to the IRB office because HIPAA regulations still apply. The IRB at the University of Chicago is designated to perform this HIPAA-related function.

Investigators pursuing a research project involving solely deceased individuals should fill out the form for a “Request for Research on Decedents.”

The Office of Clinical Research maintains an email mailing list for IRB contacts through University IT Services. This mailing list will allow researchers and support staff to receive information on upcoming IRB training and meeting dates. Researchers and support staff will also be updated on new or revised policies, forms, or procedures for submitting to the IRB through this mailing list. 

As you sign up for the list yourself, you have the freedom to remove yourself from this list at any time.

To sign up for the list, please go to this website:
https://lists.uchicago.edu/web/info/irbcontacts

Once you sign up at this website, you will receive an email to confirm your subscription.

If you have a specific question about a submission in process, please contact the person listed as the "IRB Administrator" on the workspace for that submission in AURA. Contact information for IRB administrators can be found here on the IRB Contacts page. 

If you have a general question or are unsure whom to contact, you can contact the IRB administrator on call for the day according to the monthly schedule posted at the above address. (Click on the link to "On Call Schedule" for that month)

The BSD/UCMC IRB office has also established a general email address to which questions or comments may be sent by the research community. The email address is: bsdirb@bsd.uchicago.edu

Emails sent to this address will be answered within 1-3 business days. If you have a general question about IRB policies, questions about a planned IRB submission, or a question about other IRB-related issues, please consider contacting this email address. If you do not know the specific IRB administrator to contact about a particular submission, you can also use this address and your email will be directed to the appropriate person to respond.

If you have a question about IRB Reliance Agreements and/or single IRB of record, please email IRBReliance@bsd.uchicago.edu

FAQs: Training

In order to ensure that human subjects are adequately protected from research risk, both the University of Chicago and certain funding agencies set requirements for the training of investigators and their research staff. This training generally involves education on some combination of aspects of federal regulations, ethical principles, and university-specific policies. Training is usually required for investigators both upon beginning work in research at this institution and on an ongoing basis as new guidance, regulations, and areas of concern in research emerge.

The BSD requires training for all researchers per policy “Faculty and Staff Training Requirements for the Conduct of Clinical Research.” Training is required every 3 years.

The IRB suggests the CITI website (www.citiprogram.org) to complete this training requirement.

Note that human subject protection training is also mandatory for research staff on any NIH-funded project.

The IRB has "Brown Bag" training sessions available which are designed to provide researchers with guidance on IRB processes and provide an opportunity to have specific questions answered. We also hope to develop a stronger interactive relationship between the IRB staff and researchers. Research groups are encouraged to attend these sessions.

In addition, researchers with specific training topics in mind may contact James Lynch, Associate Director of Education/Quality Assurance for Human Subjects in the Office of Clinical Research, to determine if applicable training might already be scheduled or planned or if such a session could be provided. He can be reached at 773-834-1613 or via email to jlynch@bsd.uchicago.edu.

The OCR hosts monthly workshops during the academic year on a variety of research topics. If you are interested in a topic that could be of value to the larger research community, suggestions for workshop sessions are welcomed. Please contact Margaret Wieczorek at 773-834-2860 or via email at mwieczor@bsd.uchicago.edu with suggestions for topics and/or presenters.

As of April 10, 2015, you will need to use your University CNet ID and password to log into CITI and affiliate with University of Chicago. If you do not have a CNet ID, a UCHAD ID and password may be used. If you are an incoming faculty member and do not yet have a CNet or UCHAD ID, please contact University Research Administrator for assistance in early access to University resources. If you are not affiliated with the University of Chicago as an employee or student, you will not be able to use the U of C access to CITI. In this case, other training can be obtained.

Be sure to select the University of Chicago as your “Participating Institution,” select a username/password, and fill out all other necessary registry information. Once this is completed you will be required to complete 4 enrollment questions. This will determine the modules you will need to complete.

The new CITI training also offers modules on Good Clinical Practices (GCP). Researchers have the opportunity to complete these modules for sponsors who require that this training be completed.

If you previously completed CITI training at another institution, be sure to log back into CITI using your existing account and affiliate with The University of Chicago. You will receive credit for courses you have completed in the past if they are the same courses the U of C requires.

In summer 2009, the Clinical Research Policy Board approved the Medical Center policy (link below), “Faculty and Staff Training Requirements for the Conduct of Clinical Research.” This policy applies to all faculty and staff involved in the conduct of clinical research. Faculty and staff will be expected to complete on-going training with acceptable documentation every three years.

The Research Training Program Options document (link below) provides the various options for completing the training requirement. The OCR encourages the use of the online CITI training program to complete this requirement. Collaborative Institutional Training Initiative (CITI) is an on-line training program. CITI is not only a national standard, but also allows the Office of Clinical Research to easily monitor compliance. CITI home page: www.citiprogram.org

Full IRB approval of any clinical research project after 6/30/10 will be contingent on all investigators and staff involved in the research completing the training.

Training Policy

Research Training Program Options (initial training)
Refresher Training Options

In order to comply with HIPAA requirements, the IRB must determine if PHI will be used or disclosed as part of a research study. A disclosure occurs when PHI is accessed by anyone outside the “covered entity.” At UChicago, the HIPAA “covered entity” is called the "UC OHCA" or "UC Organized Health Care Arrangement." The components of the OHCA are:
• the University of Chicago Medical Center, including its nurses, residents, other staff, and volunteers,
• the University of Chicago Biological Sciences Division and other portions of the University of Chicago in both cases that supports the activities of Health Care including its physicians, nurses, students, volunteers, and other staff, and
• UCM Community Physicians
• the UCM Care Network Medical Group

The OHCA does not include other divisions on campus and does not include undergraduate students.

If an individual is not listed as affiliated with the BSD or UCMC in the personnel record in AURA, and PHI will be accessed on study, the BSD IRB office will need additional confirmation for that individual for ONE of the following options prior to approving that individual as a member of the research team.

1) Please confirm that individual will not access PHI on this study.
2) Please provide this individual’s current job or student title and confirm that this individual is part of the OHCA. We recognize that the affiliation listed in AURA may not be the most current and may require updating by the AURA team to reflect BSD affiliation.
3) Alternatively, anyone who is performing work “supporting health care functions,” whether or not they are part of the hospital or BSD, might be considered part of the covered entity. In this case, please confirm that the individual is performing the role of “supporting health care functions” AND that this individual has completed the UCMC HIPAA training.
-or-
4) Please confirm that written consent/authorization will be obtained from subjects to disclose PHI to this individual, and that the consent/authorization form has been submitted to the IRB.

If you believe your personnel record in AURA is incorrect, please contact the AURA help desk at aura-help@uchicago.edu to request that it be updated.

FAQs: Submitting New Proposals

IRBs review research that involves human subjects. The types of research that are covered include clinical trials, behavioral research, epidemiological and survey research, outcomes research, anthropological research, educational research, field and international research, oral histories, and psychological research. Research can range from a clinical trial to the use of human cell lines. In addition, quality assurance activities may or may not also be considered to be research activities. 

How the results will be used affects whether or not a project is research. If there is any intent to publish or otherwise make known the results, the project likely should be submitted to the IRB. For example, if the project is being undertaken with the notion that a paper or journal article may be published, or that a poster or paper may be presented at a conference or community gathering, the project most likely will qualify as research and thus is subject to review by the Institutional Review Board.

If you are unsure about your project, please check with the IRB staff to help you determine if it is “research” involving “human subjects” as defined by the institution and federal regulations.

Certain types of human subjects research may qualify as exempt from IRB review. In order to be exempt, research must meet specific, federally-designed criteria, including that the research involve only minimal risk to human subjects. Exempt research under the purview of the BSD IRB cannot involve either sensitive data (data linked to specific individuals that may be painful or embarrassing to reveal) or certain special populations (such as prisoners). Research involving children may be exempted under certain circumstances.

Per University policy, the IRB must make the final determination regarding exemption. Investigators should not begin any human subjects research until the IRB has determined that it is (1) approved or (2) exempt from IRB review.

In addition, if you have received approval from a non-University of Chicago IRB, please contact the U of C IRB office to determine approval procedures at our site.

Minimal risk is defined in the federal regulations as situations wherein “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45CFR46.102(j)).

Federal regulations define research as “a systematic investigation … designed to develop or contribute to generalizable knowledge.” Research is usually designed with the intent to publish the results of a research hypothesis being tested.

However, physicians at the University of Chicago Medical Center occasionally come across a patient who presents with a unique condition or whose stay at the hospital presents an interesting discrepancy from the normal course of treatment or reaction to treatment. In these instances, a physician may wish to publish a case report on this one patient in order to contribute to medical knowledge. 

Although this case reporting does involve the intent to publish results, it does not involve the intent to ask or answer a specific research question. Consequently, the wish to publish a single case report is not considered to be research and the IRB does not require the submission of a protocol in order to publish the case report.

If more than one case occurs of the specific condition or medical anomaly, or the investigators begin to formulate a hypothesis or attempt to gather further information on cases of this type with the intent to publish, activities cross into what could be considered “research” and it becomes necessary to submit a research proposal to the IRB.

Although publishing a case report may not require submission to the IRB, investigators should be aware of the use of individually identifiable health information in their publications. Under HIPAA, the disclosure of an individual’s protected health information must be authorized by that individual. In other words, if a case report contains any identifiers as defined by the HIPAA regulations, authorization to disclose this information in a publication should be sought from the individual whose information is being disclosed. The subject or a designated representative should sign a consent form (HIPAA authorization) to disclose this information.

It should be noted that case reports often involve reporting on a rare disorder, condition, or course of treatment. In such cases, individuals may be more easily identified as being the subject of a publication than individuals with a more common disease or condition. Consequently, this rare disorder may fall under the category of “any other unique identifying characteristic” under the HIPAA regulations, and thus be considered Protected Health Information. Physicians and other researchers should then obtain a subject’s authorization before publishing a report, even when no other identifiers are being disclosed, because the subject may be able to be identified by their disorder. 

When deciding whether or not to submit a proposal to the IRB, it is important to consider the intent of the potential publication. Medical or educational activities are not considered to be research. However, once medical activities become methodical evaluation, “designed to develop or contribute to generalizable knowledge,” this is research as defined by the federal regulations.

Identifiable data can fall under two categories – PHI and PII.

 

PHI stands for “Protected Health Information,” and under the HIPAA Privacy Rule, includes elements such as:

Name

Dates (including dates of birth)

Medical record numbers

Ages over 89

Address

Telephone/Fax numbers

E-Mail addresses

Social security numbers

Health plan beneficiary numbers

Account numbers

Certificate/License numbers

Device identifiers/Serial numbers

Full-face photographic images/any comparable images

Web universal resource locators (URLs)

Internet protocol (IP) address numbers

Biometric identifiers (including fingerprints and voiceprints)

Vehicle identifiers and serial numbers (including license plate numbers)

Any other unique identifying number, characteristic, or code (unless otherwise permitted by the Privacy Rule for re-identification)

 

PII stands for “Personally Identifiable Information”, which refers to information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual.

Identifiable data is study data that contains PHI or PII.

Coded data is study data that is separated from identifiers but CAN be linked back using a code (words, letters, figures, symbols, or a combination that is NOT derived from/related to the personal information)3. With this data, a spreadsheet or similar is created that links the code to identifiers (i.e. a “key”). This is the most typical method of collecting data/samples.

De-identified data is study data that does not contain PHI or PII and can never be linked back to a subject.

 

These are definitions to keep in mind when filling out the AURA submission form, figuring out what data will be shared with sponsors, and/or deciding what information to share with collaborators.

  • What identifiers do I need to use in order to conduct my research? Keep in mind, this includes using identifiers to access medical records. 
  • Are these identifiers needed throughout my entire study? Can they be deleted at a certain point (i.e. can data be removed or “stripped” of identifiers at the end of the study?)?
  • Is there a way for me to keep these identifiers separate from the data/samples that I want to collect?
  • If I am sharing data with others who are not a part of my institution, how will the data be transferred? Will I send identifiers to the collaborating institution?

Sometimes, you can have more than one type of data to be used for your study. This is typically in the event that data/specimens are shared with collaborators. When this is the case, it is helpful to make the distinction for how the data/specimens will be shared. For example, the data that you collect may be identifiable or coded, but how will the researchers at the collaborating institution receive this data? Will the researchers at the collaborating institution receive coded data as well? De-identified? Depending on how this data/specimens are shared and if there is a contract, it is possible that a Data Usage Agreement (DUA)/Materials Transfer Agreement (MTA) may need to be executed.

For more information/any questions about your study, please feel free to contact a BSD IRB administrator. You can find our staff, along with the IRB Administrator on call, here: https://biologicalsciences.uchicago.edu/irb-contact-us

 

Sources:

  1. https://hhs.gov/answers/hipaa/what-is-phi/index.html
  2. https://www.gsa.gov/reference/gsa-privacy-program/rules-and-policies-protecting-pii-privacy-act
  3. Derived from http://orrp.osu.edu/knowledge-base/what-is-the-difference-between-the-terms-coded-de-identified-and-anonymous/
  4. https://ura.uchicago.edu/page/data-sharing-agreements
  5. https://ura.uchicago.edu/page/material-transfer-agreement

The University has recently updated its policy on payments to research subjects. This includes clarification on when gift cards rather than checks may be used as payment.

See University policy at
http://finserv.uchicago.edu/payroll/independent/subjects.shtml

Highlights:

  • Payments to subjects over $100 per occurrence must be paid directly to the individual via University check. Gift cards, gift certificates or in-kind payments over $100 per occurrence are not permitted as remuneration for participation in a research study.
  • Payments $100 and under per occurrence can be processed via University check or other methods including petty cash, gift cards or in-kind payments.
  • Reimbursement for parking, meals, and/or transportation to and from study visits are not taxable. Reimbursement may be made only if a receipt for the expense is provided by the subject. Reimbursements for subjects’ time are taxable. 

Note, if subjects will be entered in a raffle/drawing to win a gift with value of at least $100, the researchers need to record the name of the individual receiving the gift.

If total amount of payment may exceed $600, the University will need to issue a W9, and therefore name and social security number will need to be collected. If total amount is expected to be less than $600, researchers should maintain a log of payments, including name of payee.

Questions? Contact University of Chicago Financial Services Office.
Questions about petty cash? Contact cash-management@uchicago.edu.

Please describe any planned payment/compensation for research subjects in the AURA IRB submission form.

The IRB is charged with the protection of human subjects in research. In order to fulfill that responsibility, the IRB must ensure that research studies comply with applicable federal, state, local, and institutional regulations and policies, as well as with the IRB Committee’s own ethical guidelines. At the federal level, the regulations the IRB must follow are mainly codified at 45CFR46 (DHHS), 21CFR11, 50 and 56 (FDA), and 45CFR164 (HIPAA).

The University of Chicago IRBs must abide by Illinois state laws applicable to research as well as by any city or local rules. Examples of applicable state law include the IL Health Care Surrogate Act and Medical Patient Rights Act (concerning those who cannot consent for themselves), IL Genetic Information Privacy Act, and IL AIDS Confidentiality Act. Examples of city or other local regulations include the requirements for approval or acknowledgement of research when conducting research at specific sites, such as those required from the Friend Family Health Center and the Chicago Public Schools.

These federal, state, and other requirements are addressed by the IRB mainly through the protocol submission form. Many of the submission form questions employ language taken directly from the federal regulations. Other questions address University of Chicago/Biological Sciences Division/UCMC requirements.  One example of an institutional requirement is the need for CTRC review of any study involving cancer patients. At the U of C, there is also a UCMC requirement that the treating physician to be consulted prior to approaching a patient for participation in a research study. 

Thus it is to your advantage to fill out these forms as completely as possible when submitting to the IRB, as additional information may be requested if there is insufficient justification or description provided for the IRB to make a required finding.

Chart reviews are a common method of gathering information on a specific medical condition or set of patient characteristics. Although chart reviews do not involve direct interaction with subjects, chart reviews fall under IRB review because they involve obtaining private information about human subjects. Federal regulations define a human subject as “a living individual about whom an investigator … conducting research (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)(1)]

When submitting a chart review proposal to the IRB, a protocol narrative is needed. This narrative may be brief, but should include a defined purpose for the data collection. The narrative must also include the beginning and end dates of collection. For example, if you plan to review the medical record of every asthma patient seen in clinic in 2017, you should state exactly what information you are obtaining about the patients, explain the data you hope to find, and specify the beginning and end dates of data collection. These dates are the dates during which the data were originally recorded, such as “January 1, 2017 through December 31, 2017.”

Chart reviews may be prospective or retrospective, or a combination of the two. To qualify as retrospective, all information must be collected from a time period prior to the date the study is reviewed. Thus, if you expect IRB review on March 17, 2017, the endpoint of data collection must be on or before March 16, 2017 in order to be considered "retrospective." Investigators are advised to provide justification for a waiver of consent for the retrospective review of medical records. Note that the decision to grant a waiver of consent is the IRB Committee’s; in certain cases, the Committee may require that an attempt be made to obtain written consent from potential subjects, even if the information was previously collected in the chart and no prospective collection is anticipated.

In general, prospective collection of information from medical records will require written consent/authorization. Ethical guidelines indicate that if it is possible to obtain consent from potential subjects, the attempt should be made to do so. The IRB Committee will usually require that a written consent/authorization form be prepared to prospectively collect data from medical records. This includes outcomes data that has not yet occurred (e.g. you want to record 1 year follow up data on a surgery that occurred yesterday).

The Committee is also mindful of “protocol creep.” In other words, amending the protocol in the future to include information that would be retrospective then but is prospective now is not generally allowed. For example, your original protocol is approved in March 2016 to examine information from March 2015 to February 2016. Eventually, you will also want to examine the charts from March 2016 to February 2017. Rather than submit an amendment in a year, if you know now that you will want the 2016-2017 data, this request should be included in your current proposal. 

CRDW: Use of data from the CRDW may or may not require IRB review. If data are provided in a de-identified format, and the research team will not be accessing medical records for additional information, the research may not require IRB review. However, if the research team will receive ANY identifying information from the CRDW and/or will access medical records directly to supplement CRDW data, then IRB review will likely be needed.

Most studies involving cancer patients or their data must be reviewed by the Clinical Trials Review Committee (CTRC). Please note that protocols must be reviewed by the CTRC before they are reviewed by the IRB. For more information on the CTRC submission process or to find out if your protocol requires CTRC review, please contact Amber Burnett in the Cancer Research Center at 4-0357 or aburnett@medicine.bsd.uchicago.edu.

If the study uses existing materials (“on the shelf”), review by the Pathology Biospecimen Utilization Committee (PBUC) review is sufficient and additional review by the CTRC is not required.  On the other hand, for any study with cancer related objectives proposing to obtain prospective tissue samples, the study would require CTRC review in addition to PBUC review. 

Nurse investigators wishing to implement clinical research involving nursing staff and/or nursing care are required to obtain approval from the Nursing Research Committee (NRC) as well as from the IRB before proceeding with their study. Nurses who are hired to do research and collect data for physicians' research or those hired as Clinical Research Associates are not required to submit proposals to the NRC. Nurses who are doing research independent of this are required to submit their proposal to the NRC. NRC approval must be obtained prior to submitting a proposal to the IRB, and a copy of the NRC approval should accompany the IRB submission.

For more information on the NRC submission process or to find out if your protocol requires NRC review, please contact Dr. Cynthia LaFond, Nurse Educator, in the University of Chicago Medical Center at 4-9184.

In order for a new submission to be accepted for IRB processing, certain elements must be included as noted in the Accepted for IRB Processing Checklist.

Within a week after a study is accepted for IRB processing, the IRB administrators conduct a pre-review. Often, this pre-review will result in a request for additional information or documentation. Certain documents are required before the Committee can review a protocol and the IRB administrators will inform you as soon as possible if your submission is missing any such required elements. The submission will not be reviewed by the Committee until all required elements are received, regardless of the date of the original submission.  Please see the Ready for Review Checklist. If you do not wish to respond to certain comments, or if you would like to provide an alternative response, please document this when submitting back to the IRB so that the IRB is aware of any issues that should be considered during its review.

Administrators will also make other suggestions for revisions. While you are not required to submit these other revisions prior to the Committee meeting, it has been the IRB’s experience that Committee members generally incorporate administrator suggestions into their own review by including these suggestions in the pending conditions for study approval. For this reason, we recommend responding to all pre-review comments prior to the IRB meeting in order to reduce the time necessary for review and approval of your study.

If, at the meeting, the Committee feels that further information or documentation is needed before approval can be granted, the protocol will be given “deferred” or “pending-conditional” status.  The Principal Investigator will receive a letter detailing the outstanding issues after the meeting, usually within the following one to two weeks. If a protocol is deferred, it must be reviewed again at a scheduled meeting. Additional information may still be required after the second meeting, and a second deferral or a pending-conditional letter may be sent. Pending-conditional studies can be approved without returning to a meeting once all pending issues have been appropriately addressed, although the Committee may review a pending-conditional response at another meeting at its discretion. 

Generally, non-expeditable studies require at least one month from day of submission to approval. Two months is the average timespan from submission to approval. If a study is deferred, or pending comments are not adequately addressed, approval can take several months or more. Studies that can be expedited generally require about 2-3 weeks.

During a pre-review, the IRB administrators and IRB reviewer will determine if they believe your study can be expedited. Many studies are not granted expedited review even when it is requested. The IRB, not the investigator, has the final decision on whether a study can be expedited.

In addition, expedited review is determined not by a need for quick approval but rather by the minimal level of risk. Only studies of minimal risk falling into one of the federally-defined, IRB-approved categories are eligible to be expedited. 

The following may be a reason why you have not received approval:

  • the study has not been accepted for IRB processing. Your submission may be missing a required documentation element.
  • your study is not eligible for expedited review. The IRB staff will notify you at the time of pre-review if this is the case.
  • the IRB staff or chair has requested further information, which has not yet been received. Check with other members of the study team to see if they are working on a response.

The IRB staff makes every effort to expedite qualifying protocols as quickly as possible. However, due to the large volume of protocols, we are not always able to immediately process expedites. If you submit a study you believe qualifies for expedited review, and you do not hear anything after two weeks, please contact one of the IRB administrators to check on the status of your protocol.

FAQs: Funding

Protocols without an external funding source are considered to be “internally funded.” While internal funds may consist of a departmental award or private funding, the term “internally funded” also refers to the University’s compensation for the researcher’s time spent performing the research. Since salaries are paid by the University, any time spent on research that does not have an external funding source is paid for by the University. Therefore, for studies without any external funding, investigators should check “internal funding” on the submission form. 

If your protocol will be funded by a grant awarded to another university, in many cases some portion of the funds from that grant will be awarded to the University of Chicago as a subaward. If the grant at the other site is providing any funds to our site in a subaward, researchers should submit a copy of the final subaward application to the IRB and indicate that the project is funded by a grant to another institution on the External Funding page of the submission. A copy of the IRB approval letter from the other institution should be uploaded to the submission.

If the University of Chicago is not receiving any funds from a grant that has been awarded to another site, the project is considered to be “internally funded.” No additional documentation is required for “internally funded” protocols.

If the grant for which you have applied has not been awarded and you are not certain it will be awarded, the IRB submission is considered to be “internally funded” until such time as a grant is awarded. The procedures for internally funded projects should be followed. If your protocol has previously been approved with internal funding and you have now been awarded a grant that will be funding the project, a complete copy of the final version of the grant should be submitted to the IRB as an amendment to the protocol approximately 4 to 6 weeks prior to an anticipated award.

Pending grants are not required to be submitted to the IRB. However, if you have received a  favorable score or other indicator that your research is likely to be funded, the grant should be submitted to the IRB at that time and details regarding the external funding should be included on the submission form in the "Funding" section.  By submitting your grant for certification prior to “Just-In-Time” or award acceptance, you may avoid delays or restrictions on your award. Again, this only applies to grants that are likely to be funded.

FAQs: Continuing Review and Amendments

If any study procedures are ongoing, the study should be renewed if the study is FDA regulated. This includes studies with subjects still on study drug(s), undergoing study procedures, or being followed, or studies for which data is still being collected or analyzed. Even if the subject’s own involvement in the study is finished, if you are still working with identifiable subject data IRB approval is needed. You should submit continuing review documents at the appropriate time.

If all study-related procedures are complete, and you are not planning to do any further data analysis, then the study can be terminated. If data analysis will be done at another site, and this site has completed all study procedures, the study can be terminated at this site, unless you feel that the sponsor may request additional data from your site. If you still need to look at subjects’ medical records for information to report to the sponsor, you will need to keep the study active. 

If your study is not FDA-regulated, and the IRB has determined that continuing review is not required, you will be formally notified by the IRB during the approval process that continuing review is not required. If you are not certain whether your approval letter indicates that continuing review is required, please contact the IRB office. 

Federal regulations require that studies be reviewed by the IRB at least once every year. This means that the IRB has one year from the date a protocol is reviewed at a convened meeting, or in the case of expedited reviews, the day the expedited approval is reviewed and approved, to review the study again, either at a convened meeting or through expedited review procedures.

If your protocol was last reviewed at a meeting in March, but did not get final approval until September, it must still be reviewed prior to one year from the day in March it was reviewed at a meeting.

Researchers should check the IRB website for renewal deadlines posted on the Meeting Dates page.

Note that for studies that cannot be expedited, it is imperative to meet renewal deadlines, as renewal forms must be reviewed at a convened meeting. If there is no meeting scheduled before your study’s expiration date, it will expire. 

The AURA-IRB system sends out renewal reminders approximately 3 months before studies expire. These are sent to the email address on the "Profile" page for the PI and primary contact. Posted deadlines on the IRB website give a deadline for 2 months before the expiration date in order to review the studies at the meeting 1 month before the expiration. If any problems arise during the review or revised documents are requested, the PI thus has time to respond before the protocol’s expiration date. Note that the IRB makes every effort to notify investigators prior to study expiration regarding the need for renewal; however, the principal investigator is ultimately responsible for ensuring a protocol's continued approval.

To be accepted for processing, all questions on the continuing review (CR) form should be completed and any applicable documentation uploaded, including any relevant data monitoring committee reports. Please see the Checklist below for the necessary materials to be accepted for processing:

CRs: Accepted for Processing Checklist

 

After a CR has been submitted, the IRB administrative team will review the submission and determine if any information is missing or if more information or documentation is needed. The IRB administrative team uses a "pre-review checklist" to document the administrative review. Any outstanding items or issues noted in this pre-review will be communicated to the study team via email. The administrative pre-review checklist is provided below for your reference:

CR Pre-review Administrative Checklist

 

Ideally, a PI should always be well informed of the literature relating to the particular field of study and should be conducting reviews of the available literature on a regular basis. The need for a literature search to assess the risk level and alternatives to participation of each study was given additional emphasis following the federally-imposed halt on research at Johns Hopkins University in 2001. A volunteer on a Hopkins research study died after being exposed to a drug for which the government determined that risk information had not been adequately researched. 

Consequently, the federal agencies governing research have heightened their emphasis on the need for a thorough review of available applicable literature both before research is started and as an ongoing process throughout the research. The University of Chicago BSD IRB therefore requires that a literature search be conducted and the results presented to the IRB at the time of original submission as well as at each continuing review (renewal).  During the original submission, references in a written protocol may suffice in lieu of a literature search.

PIs should search on one or more web-based search engines for articles relating to 1) the condition being studied and 2) the specific drug/device/process being studied. For example, for studies of a new drug for IBD, PIs should not only search for articles on the risk of that drug, but should also search for articles on new treatments for IBD that would present available alternatives to study procedures. The Committee is also concerned with the applicability of the proposed research; that is, if a literature search reveals that the study being proposed replicates studies that have already been completed with definite results, the PI should consider whether the study is likely to yield new information and if not, if the study should be performed. 

While the IRB has faith that investigators are responsibly conducting research, the IRB does not accept merely a statement that a literature search has been performed. The Committee requests that PIs provide the IRB with the name of the search engine that is used, the search strategy (keywords), and the results of the search, along with a description of the results’ impact on the risk level and/or alternatives to participation of the research.

Example of an acceptable literature search for a renewal: 

SEARCH ENGINE: PubMed 
SEARCH TERMS: Drug Name (generic), Drug Name (brand), Disorder Name 
RESULTS: 1200 articles. 
SUMMARY: Most of the articles were not applicable to the study at hand as they dealt with the risks of or descriptions of standard of care drugs for this disorder. Searching on the drug itself yielded only a few results having to do with animal studies; these are already covered in the investigator’s brochure. One article, “DRUG XYZ in Disease Y” by A. Jones, indicated a possible new alternative therapy, but this is still in Phase I development. Overall, there is nothing in the literature to indicate any new information on the risks or benefits of this study. Risks found in the literature are already covered in the protocol and consent form for this project.

If your study is still enrolling subjects OR if enrollment is closed, but subjects are still actively participating in study procedures or receiving study drug, then a literature review should be submitted. 

If your study is permanently closed to enrollment and all subjects have completed all research-related interventions, then a literature review may not be required. However, the IRB does require that you provide a justification for not providing a literature search. (“Not applicable” is not considered a sufficient justification. Please explain why a search is not applicable.) Also, the IRB may determine that a literature search is needed to ensure that there is no new information that should be provided to subjects in follow up, e.g. new safety information about the drug tested in the study. Please contact the IRB staff for more guidance on your specific protocol, if needed.

Any change to an approved study, including changes to the consent form, advertisement, recruitment procedures, study personnel, or protocol design, should be submitted as an amendment to the protocol. Minor changes can be approved through expedited procedures, but still must be submitted for approval. All requested changes should be described in detail on the amendment submission form, which must be electronically signed by the PI and submitted along with any documents that are being changed.

No change should be implemented until it is approved by the IRB.
Amendments cannot be processed on protocols that have not yet been approved. Changes to protocols that have not yet been approved should be addressed through memos or responses to the IRB Committee.

Study activities should NOT deviate in any way from the protocol that is approved by the IRB unless a change is  necessary to eliminate immediate hazard to an individual. The investigator should notify the IRB as soon as possible after a change is made to eliminate hazard(s) to subjects or others, and a formal amendment should follow within 5 working days of implementation of the change.

Studies for which continuing review is not required are still required to submit amendments prior to initiating changes to approved study procedures. 

The BSD/UCMC IRB does not have a protocol “exception” policy. Accordingly, when any revision to an approved research protocol is desired, including a change in research design or eligibility criteria, for one subject or multiple subjects, the investigator must submit an amendment. The amendment form should explain what changes are desired and provide a rationale for those changes. A revised copy of the pertinent original documents (e.g. protocol, consent form, etc.) should also be submitted with the changes identified.

Amendments to approved protocols may not be initiated until IRB approval has been obtained, except where necessary to eliminate apparent immediate hazards to the subject, in which case the IRB should be notified as soon as possible. Eliminating immediate hazards to a subject should be considered in the light of treatment rather than research. If it is in the best interests of the patient/subject to be given or removed from study drug/procedures, then this should be done regardless of the approved protocol or the need for an amendment. The appropriate paperwork may be completed later.

In other words, treatment decisions should be made separately from research decisions. An investigator/ physician may believe that the best treatment for a patient is an experimental drug. However, as an investigator, that same physician should note that if a treatment decision for a particular patient does not fit within or differs from approved research procedures, the patient may not be able to remain on or be enrolled in the research.

The IRB is often informed that “treatment” may be delayed if an amendment is not approved immediately. In practice, treatment decisions must be made by the treating physician regardless of a research opportunity. Participation on a research study is often not a patient’s only treatment option. Alternative approved drugs/procedures or other drugs given off label may represent other treatment options for a potential patient for a study or a subject already enrolled on a study.

When a PI makes a decision as to whether to treat a person and/or to keep that person on a research study, there may be other entities involved in the decision regarding this person, including the study sponsor and IRB. A sponsor may or may not allow the patient to remain on study if procedures for that patient will differ from study procedures. In addition, this event would require reporting to the IRB as an unanticipated problem if the PI has not requested prior approval for the change to approved study procedures. The IRB may then determine that using data from that patient/subject is not appropriate on the study. Again, this does not affect the treatment decision; it only affects the research.

An IRB is required by federal regulations to ensure prompt reporting of serious or continuing noncompliance with regulations or noncompliance with the IRB’s own requirements/ determinations. Deviations from the approved protocol, i.e., changes made without prior IRB approval, fall under the category of noncompliance. Deviations must be reported to the IRB. Once reported, the IRB can make a decision regarding appropriate response or remedial action, or determine that no remedial action is necessary. Remedial actions may include asking an investigator to exclude data that was obtained inappropriately or outside approved study parameters.

A protocol deviation occurs when the study departs from the IRB-approved protocol in any way, including use of a non-approved or outdated document (consent, advertisement, etc.), change in procedures (drug dosing, scheduling of study visits, re-ordering of study activities), change in personnel conducting study procedures, and inclusion of a subject not meeting eligibility criteria.

It is the expectation of the IRB that all approved protocol procedures are being followed without alteration unless the IRB has been informed of a protocol change (through an amendment) or deviation (through an Unanticipated Problem report or continuing review update).

Example #1:
Patient A was screened for a research study. All the necessary screening labs were done as well as a medical history review. Inclusion/exclusion criteria were verified by the PI and the patient was found to be eligible and started on study. Later, it was discovered that Patient A had a condition diagnosed at an outside facility that was not recorded in the medical history. This condition is among the protocol exclusion criteria. The study physician would like to keep Patient A on study.

Potential issues arising from this example:
1) If this is a sponsored study, the sponsor should be informed that a subject was enrolled who was ineligible. The sponsor must decide whether this person may continue on study.
2) If there are immediate health or safety issues that would require that this person remain on study (e.g drug is only available as part of the research and there may be consequences to abrupt withdrawal of drug, etc.), then to protect the safety of the subject that person should remain on study drug, if possible. This should be documented in the research file, the medical chart, and in an unanticipated problem report.
3) An unanticipated problem should be reported in any case as soon as possible. The IRB will consider whether to protect human subject(s), this subject should continue to be on study or whether the subject should be taken off study, if the subject has not already been removed from the study.

Example #2:
Patient A is an otherwise-eligible 70 year old. The protocol inclusion criteria for this drug trial states that persons ages 18-69 may be enrolled. The study physician feels that Patient A may benefit from the drug and would like to enroll the patient on the study. Patient A is coming to the hospital for a clinical care visit tomorrow. The PI wants to approach Patient A to participate in the study at that visit.

Potential issues arising from this example:
1)If this is a sponsored study, the sponsor should be queried as to whether an exception to eligibility criteria would be allowed. The sponsor must decide whether this person may be enrolled on study and if allowed, should provide documentation to the PI to that effect.
2) As this is a change to the approved research design, IRB approval should be requested prior to enrollment of this individual. As noted above, approval is needed whether this change applies only to this one individual or whether eligibility criteria are expanded for all future potential subjects.
3) It is unlikely that the IRB will be able to approve an amendment prior to the scheduled clinical care visit. The PI may wish to reschedule or explore other appointment options or opportunities with this patient.

The IRB receives multiple requests for amendments to be processed more quickly due to patients waiting. Note that due to the volume of amendments requiring processing and the limited availability of IRB reviewers, the IRB cannot accommodate all requests for quicker processing. Note, too, that if an amendment qualifies for expedited review the IRB will likely expedite it regardless of whether or not expedited review was requested. If it does not qualify for expedited review, it will require review at the nearest convened meeting for which a reviewer is able to review it. If possible and upon request, the IRB may be able to review the amendment at an earlier meeting than the one for which deadline it was submitted. Please contact the IRB office for such a request. Please copy the PI on all such requests.

If a proposed change involves re-consenting of all subjects, it is unlikely that the amendment will receive expedited review.

If you have an IRB-approved consent form and enrollment has not been halted for safety or other concerns, you are free to enroll subjects using that approved consent form. If, however, in the PI’s opinion a change described in an upcoming amendment is a change that potential subjects should be aware of due to safety or other concerns that might affect a subject’s willingness to participate, the subject should not be enrolled until he/she can be informed appropriately and with an approved consent form that adequately reflects approved study procedures.

Yes. Amendments deal with changes to the approved study. Approval of an amendment indicates specific approval of that change. Once approved, an amendment becomes a part of the approved study. On the other hand, a continuing review is a review of the entire study, including all amendments up to that date, to evaluate whether the study continues to meet all requirements for approval.

You can, although the submission of overlapping documents for both can be tricky. Remember that the continuing review is a review of the approved study and your submitted amendment has not yet been approved or may never be approved. If an amendment is approved after you have submitted your continuing review documents but before renewal approval, you may need to update your continuing review submission to reflect any changes made with the amendment. Conversely, if your consent form is revised during the time of continuing review, you may need to submit a revised consent form for any pending amendment to incorporate renewal changes with amendment changes to the consent form. 

Especially with consent forms, be aware of whichever version is approved last. It becomes the approved version. Amendment changes are nullified if the renewal consent form, approved after the amendment, does not reflect the amendment changes. Another amendment must then be submitted to approve the revised consent form before it can be used.

FAQs: Adverse Events/Unanticipated Problems

Occasionally, a sponsor will request that an external adverse event be reported for a study on which the event did not occur. For example, an adverse event of side effects from a certain drug may be reported on several studies involving that drug, even if the adverse event occurred in a subject enrolled on only one specific study. In this case, the non-study adverse event should be reported to the IRB in the same manner as other events; the investigator should determine whether the event represents an Unanticipated Problem according to the IRB definition. If the event meets the reporting requirements, it should be reported to the IRB using the “Unanticipated Problem Report” form in AURA.

If the event does not meet reporting requirements, it may be included in the summary of events reported at the time of continuing review for this study.

If the adverse event does not meet IRB reporting requirements and it is submitted to the IRB office, it may be returned to you. Please see the Policies and Procedures page for the University of Chicago unanticipated problem reporting policy.

If the PI determines that an adverse event (internal or external) does not meet the IRB Unanticipated Problem reporting criteria, it should not be submitted to the IRB for review as an unanticipated problem. Please note that the BSD/UCMC IRB reporting criteria may differ from sponsor or other reporting criteria. Any adverse event that does not meet the IRB reporting criteria will be returned.

All AEs that do not meet UP reporting criteria can be summarized at the time of continuing review.  Any sponsor that insists that an AE that does not meet our reporting criteria be submitted should be notified of the IRB’s Unanticipated Problem reporting policy.

If the adverse event lists contain AEs that do meet the U of C Unanticipated Problem reporting criteria, these AEs should be submitted to the IRB on an individual basis as unanticipated problems. All other AEs that do not meet the IRB reporting criteria should be summarized at the time of continuing review. Any packet or list of AEs not meeting individual reporting criteria that are submitted to the IRB at a time other than during the continuing review process will be returned to the PI, as per the above.

As these AEs do not represent a change to the approved study, they should not be submitted with an amendment. An amendment is only needed if AEs require a change in the protocol (such as a consent form change) and thus an amendment would only be expected to report an AE if the AE meet the criteria for a UP report.

For studies involving an experimental drug, device, or other intervention, it is probable that events will have occurred on study that are expected safety events and/or events that do not suggest that the research places subjects or others at a risk of unknown harm or addition/increased frequency of harms. These are events that do not meet the criteria for reporting as an Unanticipated Problem. However, it is the expectation of the IRB that these events will be reported to the IRB; reporting of these events should be done at the time of continuing review.

With a continuing review submission, researchers are expected to report all safety events that have occurred in the prior year, regardless of whether they met the criteria for reporting as an unanticipated problem and regardless of whether a sponsor deemed the event “serious.” A summary of events should be provided on the AURA continuing review form. Detailed lists of these events can be uploaded to the continuing review form in addition to providing the summary. Researchers are expected to report both internal events that occurred with UChicago subjects and, for multisite studies, external events.

  1. In response to question #4 on view 1.1 of the continuing review submission, “Have any of the following occurred during the last IRB approval Period? (Check all that apply),” researchers should select “Minor Protocol Deviation/Violation, adverse event, Safety Report, or other event that did not meet Unanticipated Problem Reporting Criteria.”  View 1.5 of the continuing review form will then be available to complete.
  2. In view 1.5, question 1 asks the researcher to report any deviations that have occurred. Question 2 asks the researcher to report other events, as follows: “Other Reporting:  Please summarize other problems or safety concerns that occurred in the past year at all sites (including UChicago), including those that have not been previously reported due to not meeting reporting requirements.” The “not meeting reporting requirements” in this sentence refers to not meeting “Unanticipated Problem” reporting requirements. Please provide a summary of all problems and safety concerns/events that have occurred at all sites since the previous continuing review, or, if this is the first continuing review submission, since the original approval of the protocol.
  3. If applicable, a detailed list of events can be uploaded in view 1.8 of the continuing review form in addition to providing the summary.

Clinical guidance suggests that should any participant indicate either verbally or in writing an intent to harm oneself or others, it is imperative for the investigator to get the person to the ER for an assessment of risk.  This can be done either voluntarily by the participant, with the investigator accompanying the participant to the ER, or better, the researchers contact Security and indicate that they need an escort to the ER for a person indicating risk.  The researchers can also page the Psychiatrist on call who will guide them in this process.

FAQs: Recruitment and Consent

Yes, the compensation amount can be stated. However, it should not be put in large type or emphasized in any way.

Advertisements submitted to the University of Chicago BSD/UCMC Institutional Review Board should include:

  • The purpose of the research
  • Summary of eligibility criteria
  • Estimated time commitment
  • Name of the PI
  • Location of the research
  • Contact information
  • Identification as advertisement for "research"

but 

  • NOT Promise free medical care or free medications
  • NOT Emphasize payment or amount to be paid by such means as larger or bold type
  • NOT Name unapproved study drugs by name
  • NOT Contain therapeutic claims

Please also see the FDA Information Sheet on “Recruiting Study Subjects” at http://www.fda.gov

Several IRBs have been asked to review protocols that propose to recruit subjects though temporary employment agencies. Per University Research Administration, this method of recruitment is inherently problematic. Temporary employment agencies are intended for employment opportunities, while participation as a human volunteer in a research project is NOT considered an employment opportunity. Employment agencies have access to disadvantaged populations, who may feel compelled to accept assignments to research projects either for the financial incentive alone or in order to maintain their relationship with a temporary employment agency to secure future placements. Thus, temporary employment agencies should not be used as a recruitment resource for research projects.

Research-related injury language is generally negotiated with the sponsor during the contract negotiations. The University of Chicago provides consent form language concerning research-related injury that is expected to be used unless the IRB is notified otherwise by the U of C contract team.

For more information, please see the above FAQ, "Policy on Research-related Injury."

Over the course of conducting a research study, investigators may find that changes to the protocol are indicated, whether due to newly discovered risks, a change in protocol design, or some other factor. Whatever the change, it may require re-obtaining consent from previously consented subjects in order to continue their participation in the study.

The need to re-consent derives from the federal regulations governing research, which require that subjects be informed of significant new information that may affect their continued willingness to participate. This new information may include the following:

  • increase in study length
  • increased number of study visits
  • a change in study venue(s)
  • increased risks to subjects
  • decreased benefit to subjects revealed than previously believed to be present

Therefore, investigators should evaluate the need for re-consenting previously enrolled subjects when such types of changes occur, or other changes that may affect willingness to participate.

In addition, if a study is terminated or expires while subjects are still on study, subjects will need to be informed of the study termination or expiration and study procedures must be halted. Study procedures may only continue on a terminated study if immediate withholding of study drug or procedures from subjects would affect their health or welfare. In that case, the IRB must be kept informed of subjects’ welfare and a new protocol submitted as soon as possible in order to keep subjects on study. In any case of study termination or expiration, if investigators wish to continue study procedures a new protocol and consent form will be required by the IRB. This new protocol and consent must be approved by the IRB and subjects should be re-consented using the new consent form version before they continue their participation. 

The decision to re-consent subjects on an active protocol should be made by the principal investigator during the time of amendment submission. When amending the protocol to include the new information, the investigator will be asked to provide an assessment of whether re-consenting is required, and to submit a revised consent form as applicable. However, even if an investigator feels that re-consenting is not required, the IRB retains the final judgment concerning re-consenting and may request that it be done if the IRB feels that subjects’ decisions regarding participation may be affected by this new information. 

In a related situation, investigators with protocols involving the use of proxy consent may also need to obtain the consent of previously-consented subjects. In this case, if and when subjects for whom someone else has given proxy consent regain the ability to consent for themselves, the investigator must obtain the consent of that subject directly in order for the subject to continue on the study. While not technically “re-consenting,” as the subject did not originally participate in a consent process, this circumstance does require that a subject who had previously been enrolled may only continue participation after another consent process has taken place. 

Optional consent forms should contain all required elements of informed consent. Since the decision to participate is optional and is made outside the decision to participate in the “main” study, it is an independent consent form and process and thus all required elements should be included.

Addendum consent forms that are used to provide new information about an existing agreement to consent could contain sections with text to “refer to main consent” or similar. For example, a consent form for dosing beyond disease progression is an agreement to continue participation in the main study despite new information (i.e. progression of disease). Therefore, it would fall in this category and it could refer a subject back to the main consent form for information such as the dosing schedule or confidentiality protections, as long as those were not altered by the disease progression.

For any type of consent, the AURA submission form should be clear about when each consent process will occur. For example, consent to dosing beyond disease progression would not be expected to occur until a subject had actually progressed, and therefore it would be expected that the consent discussion would occur at a later time point than the main consent discussion. It would also be expected that there would be some kind of “refresher” discussion and/or reference to the main consent form contents when discussing the agreement to continue on study beyond disease progression. In other words, the addendum consent form would be used in conjunction with the main consent form that had already been signed.  

For research in which investigators expect to enroll non-English speaking subjects, a consent form translated into the native language of the subjects to be enrolled must be provided to the IRB with the original submission or, if this study population is being added, with the amendment. A certified translator should perform the translation and proof of certification should be provided to the IRB along with the translated consent form. 

Any recruitment materials (flyers, radio advertisements, etc.) that have been translated should also be provided to the IRB. In addition, investigators should translate all study materials that will be distributed to non-English-speaking subjects, such as surveys or questionnaires, and submit these to the IRB when the translated consent is submitted. 

The translated documents must be approved by the IRB before non-English speaking subjects can be enrolled into the study. 

Note that the exclusion criteria in certain protocols may specifically exclude non-English-speaking subjects from participating. Check your full written protocol for inclusion/ exclusion criteria before enrolling non-English speaking subjects.  

In some cases, a non-English speaker may be eligible for a study for which there is no translated consent document, and for which the study investigators could not have foreseen enrollment of a potential subject who speaks that language. In this case, investigators may choose to enroll the potential subject using a "short form" consent that has been translated into the subject's native language. 

The consent process must involve a translator who can verbally translate the information in the full written informed consent into the subject's native language. This translator must sign the full written informed consent as well as the short form consent to document participation in the consent process and that the subject has been fully informed regarding the study. A witness to the translation must also sign the consent form; the translator may function as the witness. 

If PHI will be used and/or disclosed as part of the research, the subject should also sign a HIPAA authorization for this use/disclosure written in a language understandable to the subject. Please contact the HIPAA Program Office or see their website for more information on translated HIPAA authorization forms: http://hipaa.bsd.uchicago.edu
A general authorization in Spanish for use/disclosure of PHI is available on that website.

Like the translated full written consent document, the IRB must approve the translated short form consent prior to its use. However, expedited review of an amendment to approve a translated short form consent is possible if the IRB has previously approved both the protocol in question and the protocol's full English-language informed consent document. 

The IRB has approved a short form consent document and has had this consent translated into several languages. Several translations have also been provided by the Cancer Clinical Trials Office (CCTO) (thanks to the CCTO for allowing the IRB office to share these). For the languages listed below, please contact the IRB for a copy of the translated document when submitting an amendment to use the short form consent.

For any language not listed below, the investigator is responsible for obtaining a certified translation.  The English language short form is available below for download:

Short form consent (English) - study was approved under 1991 Common Rule requirements

Short form consent (English) - study was approved under 2018 Common Rule requirements
 

1991 Common Rule versions available from the IRB office include Spanish, Arabic, Bosnian-Serbian, Bulgarian, Cantonese, Greek, Hebrew, Hindi, Korean, Macedonian, Mandarin, Polish, Portuguese, Romanian, Russian

A person who speaks and understands English, but does not read and write, can be enrolled in a study by “making their mark” on the consent document.

If you wish to enroll a person who can understand and comprehend spoken English, but is physically unable to talk or write, or a person who cannot read the consent form (e.g. illiterate persons), you may do so as long as the person is competent and able to indicate approval or disapproval by other means. The person must:

  1. retain the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and
  2. be able to indicate approval or disapproval to study entry.

The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.

Note that for any study for which enrollment of illiterate persons is expected, this should be clearly indicated during the time of original protocol submission. If an approved study now wishes to enroll an illiterate person or persons, an amendment will need to be submitted to request approval for a change in eligibility criteria and describe the consent process for this individual or individuals and how it will differ from the approved consent process.