IRB Frequently Asked Questions

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 the same 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 Hospitals are in compliance with the Federal requirements for the protection of human subjects. For details on the University's FWA, please visit the University Research Administration's website.

The University of Chicago currently has five independent IRBs: 1 Social and Behavioral Sciences 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.

The Biological Sciences Division (BSD) Institutional Review Boards are administered by the Office of Research Services. The BSD IRBs are responsible for all biological or medical research conducted at the University of Chicago and/or the University of Chicago Hospitals. 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).

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 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). These quality assurance activities would therefore not be research and would not require review by the IRB.

“Human Subject” is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Interventions may be physical procedures by which data is 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 “which the individual can reasonably expect will not be made public (for example, 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.

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 because HIPAA regulations still apply.

Investigators pursuing a research project involving solely deceased individuals should fill out a request on the New Submission Forms page for “Request for Research on Decedents.”

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 be research.

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 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.

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.

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.”

Again, 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 a “Claim of Exemption” to the IRB detailing the proposed study (available on the Forms and Guidelines page). You should be notified within a week of the status of your exemption.

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

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 Hospitals 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 would 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 must be sought from the individual whose information is being disclosed. The subject must sign a consent form (or 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 must 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. In addition, the activity should be considered “research” once the potential publication involves reporting on more than a single case.

I'm planning a chart review. What do I need to do?

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 obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” [45 CFR 46.102(f)]

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 2006, 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 as “January 1, 2006 through December 31, 2006.”

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 approved. Thus, if you expect approval on March 17, 2006, the endpoint of data collection must be on or before March 16, 2006. Investigators are advised to submit supplemental form W to request a waiver of consent for the retrospective review of medical records. Note that the decision to grant a waiver of consent is the 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. 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 form be prepared to prospectively collect data from medical records.

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 2006 to examine information from March 2005 to February 2006. Eventually, you will also want to examine the charts from March 2006 to February 2007. Rather than submit an amendment in a year, if you know now that you will want the 2006-2007 data, this request should be included in your current proposal.

Continuing reviews: Remember, since you are obtaining private information, you are considered to be studying human subjects. Consequently, when the IRB asks for the number of subjects you have enrolled in the past year, they are asking for the number of charts of individual subjects that you have studied.

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.

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. Janice Phillips, Nurse Researcher, in the University of Chicago Hospital at 2-6084.

When the IRB asks for number of subjects to be enrolled, what does this mean? What if I need to enroll more subjects?

In order to clarify the discrepancies in reporting numbers of subjects enrolled, the IRB has split the question of “how many subjects are to be enrolled onto this study” into two questions, as follows.

For studies that are not clinical trials, such as chart reviews, the number to be evaluated will often be the same as the number to be identified for participation, since there are unlikely to be drop outs or screen failures. For survey studies, the number to be contacted or approached will likely be more than the number that are expected to participate. For example, 500 surveys might be sent out in order to generate 250 responses (the desired number of responses being 250; 250 is the “evaluable” number).

During continuing review, investigators are asked to provide the number of subjects enrolled and the number taken through the consent process (or otherwise identified as possible participants) to date. Investigators are also asked to provide the number of subjects the study is approved to enroll. This is the number of evaluable subjects, that is, the number expected to complete all study procedures.

When submitting an amendment, the investigator is asked whether subjects are being added to increase the number of evaluable subjects or to increase the number taken through the consent proves in order to obtain the original number of evaluable subjects approved for the study. An increase in the first number often necessitates an increase in the second number as well.

How long will it take for my new protocol submission to be approved? What happens between submission and approval?

The IRB office has two deadlines per month for the submission of new protocols. Studies submitted prior to a deadline date will generally be held until the deadline and all submissions for that period are processed at once. If you have submitted a protocol for expedited review, be advised that it may not be reviewed until after the deadline. Deadlines occur approximately one month before the scheduled meeting.

After a study is submitted, the IRB administrators conduct a pre-review before sending it to the IRB Committee for review. This pre-review usually occurs within the two weeks following the deadline, depending on volume of submissions and other factors. 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.

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 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 PI of your study will receive a letter detailing the outstanding issues after the meeting, usually within the following 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.

I received a pending-conditional letter a month ago for my new protocol. Today I received a “30 day” notice. What is this? I thought I had 60 days to respond.

Pending and deferred new protocol submissions and amendments are given 60 days to respond to the conditions outlined in the pending conditional or deferral letter. If 30 days have passed from the date the letter was issued and the IRB has not yet received a response, we may send you a reminder notice, the “30 day” notice, to let you know that you now have only 30 days to respond to the letter before the study will be automatically withdrawn from further consideration by the IRB.

The reminder notice is a courtesy; should you fail to receive your 30 days reminder notice for any reason, note that your protocol may still be withdrawn after 60 days have passed without response.

I submitted a protocol for expedited review. Why haven’t I received an approval letter yet?

Deadlines are the same for full review and expedited protocols. If you have submitted a protocol for expedited review, be advised that it may not be reviewed until after the next deadline date, regardless of the day it was submitted. During a pre-review, the IRB administrators and IRB chair will determine if they believe your study can be expedited. The majority of studies are not expeditable, and 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.

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.

Ideally, a PI should always be well informed of the literature relating to his/her 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. 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).

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 his or her 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.

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.

My study is closed to enrollment. Do I still need to perform a literature search?

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 is not 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.)

I just had an amendment approved. Do I still need to submit a continuing review for that study?

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. If an amendment is approved after you have submitted your continuing review documents but before renewal approval, you will need to update your continuing review documents to reflect any changes made with the amendment. Conversely, if your consent form is revised during the time of continuing review, you will need to submit a revised consent form for any pending amendment as well.

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.

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.

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.

Again, 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.

My study was finally approved 5 months ago. Why is the IRB already sending me reminder notices about renewing the study?

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. 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 IRB staff sends out renewal reminders approximately 3 months before studies expire. A deadline is given 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.

If any study procedures are ongoing, the study should be renewed. This includes studies with subjects still on study treatment, 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 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.

An adverse event occurred on a different study and my sponsor is asking me to report it for my study. What do I do?

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 external events; the investigator should determine whether the event was serious, unexpected, and related/possibly related to the study drug/device/procedure. If the event meets those conditions, it should be reported to the IRB using the “External Adverse Event” form. A memo should be attached to the form stating that the event did not occur in a subject enrolled on the study for which it is being reported.

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

My sponsor is requesting that certain language be put in the consent form regarding research-related injury. Now the IRB is asking me to remove this language. Why?

Please see the IRB policy on "Sponsor Statements Regarding Research-Related Injury" on the Policies and Procedures page.

My sponsor is requesting that I have my consent form stamped “approved.” How do I get my consent form stamped?

Due to the large volume of consent forms processed by the IRB, the IRB office is no longer able to stamp consent forms “approved.”

The IRB original approval and amendment approval letters have been reformatted and now include the most current version and date of the consent form in the approval letter. Please reference your most recent approval letter to find the approved version of the consent form.

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:

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 must be re-consented using the new consent form version before they may continue they 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 his or her own 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 require 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 a subject for whom someone else has given proxy consent regains the ability to consent for his or herself, 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 him or herself did not originally participate in a consent process, this circumstance does require that a subject who had previously been enrolled may only continue his or her participation after another consent process has taken place.

I would like to recruit more subjects and want to increase the potential compensation amount for my study. Can I mention the amount that subjects will be paid in my study advertisment?

Yes, the compensation amount can be stated. However, it should not be put in large type or emphasized in any way. For more on what should and should not be included in a study advertisement, please see the IRB webpage on Advertisements.

I would like to recruit subjects through a temporary employment agency. Will this be acceptable to the IRB?

Several IRBs have been asked to review protocols that propose to recruit subjects though temporary employment agencies. Per our Institutional Official, 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.

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 for his/herself (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.

The IRB suggests that all new researchers complete the “Human Subjects Protections” training, either by checking out the videotape from the IRB or attending a training session. The BSD/UCH IRB training videotape is available in the IRB office (contact James Lynch at 4-1613). However, this training is not mandatory for IRB submission. Note that human subject protection training is mandatory for research staff on any NIH-funded project. The NIH provides an on-line training program to fulfill this requirement (http://phrp.nihtraining.com/users/login.php), or you can check out the videotape from the IRB office.

There is also a required training program for new principal investigators conducted by the Office of Clinical Research (OCR). Please contact Linda DeSouza in the OCR at 5-7421 or ldesouza@delphi.bsd.uchicago.edu for more information. The IRB will verify training with the OCR at the time of new protocol submission by a new investigator.

The BSD/UCH IRB recently reviewed several protocols that include healthy children as volunteers. During the review of these protocols, it became apparent that the IRB has occasionally approved research projects falling within a special category of research that requires additional review by the Office of Human Research Protections (OHRP) before subjects may be enrolled (known as Subpart D under 45 CFR 46). In response to this finding, the IRB halted enrollment onto these studies. Official notification of this noncompliance issue has been sent to the Office of Human Research Protections. In addition, the following corrective action plans are currently being implemented.

Corrective Actions and Required Training:

The BSD/UCH IRB has implemented a revised Supplemental Form C that is mandatory for all protocols involving children. This form is available on the Forms page and should be used immediately. In addition, the IRB staff and committee members have been trained regarding the regulations governing research with children.

The University and the IRB have also determined that training is necessary for all investigators who conduct research with pediatric populations. We asked Dr. Lainie Ross, Associate Professor, Department of Pediatrics and an expert in research involving children, to conduct two training sessions for faculty on this topic. Dr. Ross’s training is now available on videotape and DVD so that if you did not attend a live session, a taped version is available in the IRB offices.

Effective September 1, 2005, all faculty listed on protocols that include pediatric populations must have completed the pediatric research training.

In addition, new faculty should complete the pediatric training (either by viewing the videotape or attending a training session) prior to the approval of any research protocols involving children.

We also strongly recommend that all staff involved in research protocols that enroll children receive training on this topic.

Successful implementation of this new training requirement will require a strong partnership between the faculty, departments and the IRB. We thank you for working together to make changes and improvements to our systems. Please feel free to contact the IRB staff for further information.

The IRB has instituted "Brown Bag" training sessions 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. Please see the Training page for more information about these sessions.

In addition, researchers with specific training topics in mind may contact James Lynch, Assistant Director of Education/Quality Assurance for Human Subjects in the Office of Research Services, 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 .