OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY
INSTITUTIONAL REVIEW BOARD
Frequently Asked Questions
- See DHHS/OHRP for additional FAQs
- What is research?
- Research is defined as "any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Activities which meet this definition constitute "research" for the IRB, whether or not they are considered research in other contexts.
From the Belmont Report: "It is important to distinguish between biomedical and behavioral research, on one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects. ... For the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. ... By contrast, the term "research" designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge."
The review of patient charts to evaluate the effectiveness of various currently approved treatments, or other similar activities, may or may not be considered research depending on unique circumstances that may exist. Discussion with the IRB staff should be an early and important step prior to initiating the proposed study.
- What is the most important guide to the design and execution of a research project involving human subjects?
- Beyond adherence to the policies and regulations of the Center's IRB and the various governmental agencies overseeing the use of human subjects in research, a thorough knowledge and understanding of and ongoing reference throughout the duration of the study to the three basic ethical principles as presented in the Belmont Report — respect for persons, beneficence and justice — is absolutely essential.
- Do I need IRB approval to do a retrospective chart review?
- A retrospective chart review does not constitute research (see above) if the data are collected for quality assurance or other purposes. If the chart review falls under the definition of research, it may be exempt from IRB review "if the information is recorded by the investigator in such manner that subjects cannot be identified, directly or through identifiers linked to the subjects" [45CFR46.101(b)(4)] — see "If the study is clearly exempt, why is IRB approval required" below.
If the chart review is done for research purposes and the information is recorded with identifiers (e.g., name, medical record number, date of birth, social security number, or initials), IRB review and approval is required — see "How do I have my protocol application reviewed in an expedited manner" below.
- If the study is clearly "exempt," why is IRB approval required?
- IRB approval is not required for a study that is exempt under Federal regulations. However, the IRB is responsible for making the determination whether the study is or is not exempt. The IRB is responsible for interpreting and implementing Federal regulations, specifically those contained in 45CFR46.
- How do I have my protocol application reviewed in an expedited manner?
- The categories of new studies, continuing reviews and amendments eligible for expedited review are described in the Federal regulations [specifically in 45CFR46.110 and in the publication of November 9, 1998 Categories of research That May Be Reviewed by the IRB Through an Expedited Review Procedure]. Copies of both are available in the IRB Office, BSB 2-71E.
- Who can conduct research?
- The principal investigator of a research study involving the use of human subjects must be a member of the faculty of Downstate Medical Center. Students doing human subject related studies must have a member of the faculty serve as principal investigator. The principal investigator will assume full responsibility for the study.
- What constitutes a "conflict of interest" when carrying out industry sponsored clinical research?
- In addition to adhering to the requirements of the Center's Conflict of Interest policy, there are circumstances, creating potential conflicts of interest, that may require disclosure to the potential study subjects through the Informed Consent process. Investigators should discuss with the IRB staff any potential conflict of interest issues before a protocol is prepared and submitted. While every possible situation cannot be identified and evaluated in advance, there are a few situations, listed below, that occur more frequently than others which must be disclosed.
- investigator has a relationship (e.g., as consultant, advisor, owner or shareholder) with a company sponsoring the investigator's study
- investigator receives payment/reimbursement for travel or other expenses for which there is no scientific value (e.g., trip to the Bahamas vs. trip to a scientific conference)
- investigator receives direct payments for study subject recruitment
- How frequently must the protocol be reviewed and reapproved by the IRB?
- The IRB may approve a study for a period of up to 12 months. A Continuing Review Progress Report must be submitted to the IRB in time for the Board to review and approve the protocol before the end of the current approval period. If approval is not received, for whatever reason, the study will be administratively suspended — patient accrual will not be permitted and any data generated during the period of the suspension may not be used for research purposes.
- Are the approvals granted by the IRB always for one year?
- The IRB may approve a study for any period of time up to 12 months. The IRB determines each time whether the study may be approved for the maximum period or for less time. Factors such as risk generally guide this decision.
- Will the IRB Office remind me of the need to apply for continuing review of my study(s)?
- The IRB Office usually sends our a reminder notice 60 days before the expiration date and a second notice 30 days before. However, it is the investigator's responsibility to remember to renew the study. The lack of a reminder notice is not an acceptable excuse when the renewal requirement is not met.
- How do I communicate external adverse events in the case of a multi-center study?
- The IRB Office provides forms to communicate external adverse events. All questions on the form must be answered. The form should be accompanied with the reports sent to the investigator by the study sponsor and with a typed summary of the event(s) and its (their) significance.
- What is required to "close" the study?
- A Continuing Review Progress Report, with the Final Report block checked, must be submitted to the IRB. The report should include a summary of the findings of the study, the numbers of subjects entered into the study and other information as may be required or appropriate.
Additional "frequently asked questions" regarding the use of human subjects in research will be added to this list as relevant and appropriate issues arise.