IRB

What is IRB and what is its purpose?

Institutional Review Board - Human subject research ethics

Which government entity audits IRB processes?

The FDA (Food & Drug Administration)

Nuremburg Code of 1947

A code that resulted from the Nuremburg Trials in 1946. Outlined a research ethics code including informed consent, etc.

National Research Act of 1974

Created the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (NCPHSBBR)

The Belmont Report of 1979

Three parts:
1) Respect for persons (consent, full disclosure)
2) Beneficence (risk & benefits)
3) Justice (civil rights, not harming communities)

The "Common Rule" of 1991

45 CFR 46 - codifies requirements for ethical research conduct. Three parts:
a) Protection of Human Research Subjects
b) Additional Protections for Pregnant Women, Fetuses, Prisoners, and Children
c) Registration of IRBs

CITI

Collaborative Institutional Training Initiative. Established in 2000, CITI Program's mission is to provide educational content that promotes the quality of and public trust in the research enterprise.

What is an FWA, and which government entity does your institution file with?

Federalwide Assurance - Institution's commitment to comply with HHS regs for the protection of human subjects.
DHHS

IAA

IRB Authorization Agreement - An IAA is a joint
review arrangement where one IRB relies upon the review of another qualified IRB to avoid
duplication of effort.

What does the FDA do?

Food & Drug Administration
-protects the public health re: drugs, biological products, medical services, food supply, cosmetics, and radioactive products.
-speeds innovations that make medicines more effective/affordable/safe
-regulates tobacco
-counterterrorism (security of food supply, medical products, health threats)

What are the three IRB review options?

1) Exempt review - no risk (using past data, etc)
2) Expedited review - not exempt, but minimal risk
3) Full Panel review

Who must be on an IRB?
What if a prisoner is involved?

At least 5 members: faculty, non-scientists, community member. If prisoners are involved: one member must be a prisoner, a majority of the panel should have no association with the prison.

OHRP

Office for Human Research Protections (part of DHHS)

How long is your IRB approval valid?

One year

Which entities negotiatate and approve remuneration given to human subject participants?

Negotiated with the sponsor, approved by the IRB.

The IRB is responsible for deciding the amount of remuneration, which cannot unduly influence a person to participate.

What is allowed to be reimbursed to human subject participants? Is the reimbursement taxable?

transportation
parking
meals
hotel stays

(receipts required)

Non-taxable income

When is an incentive payment taxable as income?

These payments become taxable income and are reportable to the IRS when the amount exceeds $600 (the current IRS rate) in a single calendar year.