SOCRA CCRP Exam - IRB/IEC Roles and Responsibilities

True or False: The primary goal of the IRB is to protect the right and safety of human subjects

True

What is the term used for IRB for countries outside of the United States?

Ethics review committee

IRB definition

Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.

True or False: IRBs and be part of an institution or centralized

True

Responsibilities of an IRB/IEC

-Review, approve, or disapprove all research activities under its jurisdiction
-Conduct continuing review of research activities at least once per year
-Oversee informed consent process and all subject-facing documents
-Determine when informed consent is required or waived
-Evaluate amount and method of payment to avoid coercion
-Monitor protocol deviations or safety hazards
-Terminate research not being conducted to regulations or research that causes unexpected serious harm
-Report significant issues to appropriate agencies
-Maintain compliance

Criteria that the IRB must find when approving a study:

1. Risks are minimal
2. Risks are reasonable for anticipated benefits
3. Selection of subjects is equitable
4. Informed consent will be sought and documented
5. Research plan includes monitoring data to ensure subject safety
6. Privacy of subjects and confidentiality
7. Vulnerable population safeguards

Additional IRB for study approval:

1. Valid scientific rationale
2. Appropriate PI/Co-PI
3. Qualified staff, facilities, resources
4. Sufficient study population

IRBs must follow:

SOPs

How many members should an IRB have?

5

IRB Membership criteria

-Different backgrounds, experience, expertise
-Must include persons knowledgeable in terms of regulations, laws etc
-Both genders
-At least one member who has scientific expertise
-One member who is not scientific
-One member not affiliated with the institution