21 CFR PART 56 IRB

21 CFR 56 Subpart B

Organization and personnel

21 CFR 56 Subpart C

IRB functions and operations

21 CFR 56 Subpart D

Records and Reports

21 CFR 56 Subpart E

Administrative Actions for Noncompliance

Name two main safegaurds for human subjects

Institutional Review Boards
Informed consent process

What does IRB stand for

Institutional Review Boards

Define an IRB

Any board, committee or group formally designated by an institution to review, approve the initiation of and to conduct periodic review of biomedical researach involving human subjects. Primary purpose of such review is to assure the protection of the rights and welfare of human subjects.

What does a study require before it can start

IRB approval

Who is responsible for interacting and asking for approval from an IRB

The investigator- not the pharmaceutical company sponsoring the research

What are the two types of IRB's

Local IRB's - affiliated with a particular institution
Independent, Central and National IRB's - unaffiliated with an institution

Who can use an local IRB?

Investigators who are affiliated with the institution that the IRB governs

Who can use an Independent,central or national IRB?

Any researcher who is not contrained by institutional policy to the use of a particular IRB.

What is Emergent Use as described in 21 CFR part 56

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

Define IRB approval

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 and by other institutional and Federal requirements

What are IRB requirements?

Must have at least 5 members with varied backgrounds
Must be atleast 1 member who is not affiliated with the institution
Must be 1 member whose interest/background are non-scientific (layperson)
Must have at least 1 member who is a physician

Why is IRB membership strict with diversity?

To assure appropriate diversity including representation by multiple professions, multiple ethnic backgrounds, both genders, and both scientific and nonscientific representation.

What is the primary responsibility of an IRB

To protect the rights and welfare of human subjects participating in clinical research

To fulfil the respsonsiblity of protecting human subjects rights and welfare what two questions must an IRB answer?

Should the study be done at all?
If so,k what constitutes adequate informed consent?

Why does the IRB need to determine Risks vs Benefits?

An IRB must determine whether the anticipated benefit to subjects and the overall knowledge to be gained from the research compares favorably to the risks.

When will the IRB consider consent form submissions?

When the IRB determines that the benefits outweigh the risks and that it is acceptable to do the study

Who are considered vulnerable subjects?

Children, pregnant women, prisoners, handicapped or mentally disabled people, people with acute or severe mental illness, economically or educatonally disadvantaged and those who are vulnerable because they are institutionalized.

What CFR protects vulnerable subjects?

45 CFR 46 regarding research in various vulnerable populations and 21 CFR 50 subpart D Additional Safegaurds for Children

IRB submission for review documents from an investigators must include?

Current CV (includes qualifications/education)
Study Protocol
Investigator Brochure/Package Insert
Proposed Informed Consent (containg all appropriate elements)
All subject Advertisements/Recruitment Procedures
Grant Application (for federally funded research)
Application form and ny other specific forms/materials required by the IRB

What does a PROTOCOL have to contain before submitting to the IRB for review

Title of Study
Purpose of Study (including expected benefits)
Sponsor of Study
Results from previous related research
Subject inclusioni/exclusion criteria
Study design (discussion of research methods)
Description of scheduleof procedures to be done
Provisions for managing AE's
Payment to subjects for their participation
Compensation for injuries to research subjects
Provisions for protecting subject privacy
Extra costs to subjects for participationi in the study
Extra costs to third party payers because of a subjects participation

What does the IRB protocol review process contain

IRB will meet to decide whether or not to approve research after reviewing all required submitted documents. The IRB can approve, request changes or ask for additional informationi in order to approve or disapprove a research request

Can oral confirmation of IRB approval justify the okay to start a clinical investigation

NO. The IRB MUST notify the investigator in writing that the study is approved. In most cases, sponsors will NOT ship drup until an approval letter is received.

What happens if the IRB disapproves a submission for research

The IRB will notify the investigator in writing of its action and its reasons for disapproving the study. The IRB must allow the investigator to address the IRB concerning the decision either in writing or in person.

How often does an IRB review research studies

At least annually. Although may require updates on a more frequent basis based on the degree of risk to subjects.

What categores are EXEMPT from IRB requirement

ANY investigation commenced before July 27, 1981 and remains subject for IRB reviews, and that meets the FDA requirement in effect before July 27, 1981
ANY investigation commenced before July 27, 1981, not subject to IRB requirements under the FDA before that date
EMERGENCY use of a test article provided that the emergent use is reported to the IRB within 5 working days
Taste/Food quality evaluations and consumer studies.