21 CFR Part 56 Flashcards
what does 21 CFR Part 56 cover?
general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB)
emergency use
use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and there is not sufficient time to obtain IRB approval.
IRB approval
the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB
When is IRB review required?
any clinical investigation which must meet the requirements for prior submission to the FDA shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB.
Exemption from IRB requirement
(4 conditions)
- Any investigation which started before July 27, 1981 and was subject to IRB review
- Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review
- Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days.
- Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe,
Waiver of IRB requirement
On the application of a sponsor or sponsor-investigator, the FDA may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific activities
IRB registration- who must register?
Each IRB in the US that reviews clinical investigations regulated by FDA and each IRB in the US that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products must register at a site maintained by the DHHS.
*An individual authorized to act on the IRB’s behalf must submit the registration information.
What information must an IRB register?
- Name, mailing address, street address of the institution operating the IRB & the name, mailing address, phone #, fax #, and email the senior officer of that institution who is responsible for overseeing activities performed by the IRB;
- The IRB’s name, mailing address, street address, phone #, fax #, and email address; each IRB chairperson’s name, phone #, and email address; and the name, mailing address, phone #, fax #, and email of the contact person providing the registration information.
- The approximate #of active protocols involving FDA-regulated products reviewed.
- A description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in the protocols that the IRB reviews.
When must an IRB register?
Each IRB must renew its registration every 3 years
Where can an IRB register?
online at OHRP
How does an IRB revise its registration information?
If an IRB’s contact or chair person information changes, the IRB must revise its registration information by submitting any changes in that information within 90 days of the change.
IRB membership
(6 conditions)
- IRB shall have at least 5 members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
- Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of 1 sex or race or profession.
- Each IRB shall include at least 1member whose primary concerns are in the scientific area and at least 1 member whose primary concerns are in nonscientific areas.
- Each IRB shall include at least one member who is not affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
- No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest.
- IRB may invite individuals with competence in special areas to assist in the review of complex issues These individuals may not vote with the IRB.
IRB functions and operations
- Follow written procedures:
- For conducting its initial and continuing review of research and reporting its findings and actions to the investigator and institution;
- determining which projects require review more often than annually and which projects
- ensuring prompt reporting to the IRB of changes in research activity;
- ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review
- Follow written procedures for ensuring prompt reporting to the IRB, officials, and the FDA of:
- unanticipated problems involving risks to human subjects or others;
- any instance of serious or continuing noncompliance with these regulations
- any suspension or termination of IRB approval.
- review proposed research at convened meetings at which a majority of the members of the IRB are present,
IRB review of research
(8)
- An IRB shall review and have authority to approve, require modifications or disapprove all research activities covered by these regulations.
- An IRB shall require that information given to subjects as part of informed consent is in accordance with
- An IRB shall require documentation of informed consent
- In cases where the documentation requirement is waived the IRB may require the investigator to provide subjects with a written statement regarding the research.
- An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
- An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year,
- An IRB shall provide in writing to the sponsor of research involving an exception to informed consent
- When some or all of the subjects in a study are children, an IRB must determine that the research study is in compliance
Expedited review procedures
The FDA has established, and published in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure.
-An IRB may use the expedited review procedure to review either or both of the following:
- Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
- minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized.
