FAQ: What is an IRB?
What is an IRB?
- The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects.
- The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
- The purpose of the Institutional Review Board (IRB) is to protect human subjects involved in research. After review by the Research Review Committee (RRC), each protocol involving human subjects is initially reviewed by the IRB and, if approved, is reviewed on a continuing basis. A progress report and updated consent form are submitted to and reviewed by the IRB at least annually and more frequently if needed.
What research has to be reviewed by the IRB?
The IRB reviews and monitors human subjects research conducted by Fox Chase faculty and staff or at Fox Chase or Fox Chase Partner facilities.
What is research?
- Research contributes to generalizable knowledge.
- Research is designed in advance.
- Research utilizes a systematic approach.
What is a human subject?
A human subject is defined by Federal Regulations 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))
What kinds of IRB review are there?
- There are three levels of IRB Review (full board, expedited and exempt), determined by the nature of the protocol, level of potential risk to human subjects, and the subject population.
- The determination of level of review applicable to a particular study is made by the IRB.
- Regardless of the kind of review, all applications use the same submission form.
Full Board IRB review
- Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk.
- The Fox Chase IRBs meet bi-monthly.
- Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study.
Expedited IRB review
- Only research involving no more than minimal risk to subjects may be considered for expedited review.
- An expedited review is conducted by the Chairperson, rather than going to the full board.
- Federal guidelines provide categories for expedited review. Examples of categories include:
- blood sampling in minimal amounts
- review of records collected for non-research purposes (such as chart reviews)
- survey research
Exempt from continuing IRB review
- Research with very minimal risk to human subjects as determined by regulatory guidelines may be granted exempt status at the discretion of the IRB.
- An exemption is granted by the IRB upon review of the application.
How to apply
The Fox Chase Cancer Center Research Review Committee (RRC) generally meets three times per month to evaluate the scientific merit, general methodology, and statistical analysis of clinical research protocols prior to submission to the Institutional Review Board (IRB). To submit a protocol for review, an original and 25 copies (stapled) must be forwarded to the Research Review Coordinator in the Protocol Office. Written comments are usually available within 48 hours of the RRC meeting. Approved studies are forwarded to the IRB for a human subjects review.
What is the required ethics education?
Yes, Fox Chase requires certification in human subjects protection.
Is consent from research participants necessary?
- The informed consent process gives potential subjects a description of the study that is clear and complete enough for the individual to judge whether she or he wants to participate.
- The standard expectation is that all subjects will sign a document containing all the elements of informed consent.
Does Fox Chase have a consent form template?
What about HIPAA?
- HIPAA stands for Health Insurance Portability and Accountability Act of 1996.
- HIPAA regulations are focused on privacy and security protections for individuals’ health care information: “protected health information” (PHI).
- PHI includes individually identifiable health and health care payment information, including the demographic data that is a potential identifier of the individual, maintained in the records of health care providers.
- If a research study either uses or creates PHI, documentation of the subject’s authorization to use such information is required.
What are requirements for Waiver of HIPAA Authorization?
- Use or disclosure of protected health information (PHI) involves no more than minimal risk to the subject.
- there is an adequate plan to protect the identifiers from improper use and disclosure;
- there is an adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers;
- adequate written assurances from the researcher that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted to this subject.
- The research could not practicably be conducted without a waiver or alteration.
- The research could not practicably be conducted without access to and use of the PHI.
What happens after submission?
- Your study will be assigned an IRB number that should be used on all correspondence relating to the study until the study is terminated.
- The IRB will determine the level of review.
To discuss problems, concerns and/or questions please use the contact information below:
Fox Chase Cancer Center
Institutional Review Board
50 Huntingdon Pike
Rockledge, PA 19046