FWA Policy Overview / Outline
Any institution receiving federal funds for non-exempt human subjects research will need to have an institutional policy on the protection of human subjects.
E&I regularly receives questions about the content of such a policy. No one policy will accommodate all situations. Below we have the skeleton of an outline. Put it in your own institutional format and make it appropriate for your institutional mission, culture and document format.
NOTE: This is a very basic outline. Your institution – small as it might be – should have the super-structure to support research. It may be small but it should be well thought out and should fit within your other policies.
ALSO: It is likely you already have some or all of these policies. Your new Human Subjects Protection Policy (HRPP) could easily be an institutional commitment and a page of compiled references.
YOUR INSTITUTIONAL POLICY (Sample / Template)
PROTECTION OF HUMAN SUBJECTS
I. YOUR INSTITUTIONAL COMMITMENT
This section should explain what your institution is committed to, such as the protection of subjects in all of your studies as well as anything else appropriate.
This institution has created an institutional HRPP – Human Research Protection Program.
The major HRPP functions include:
- Compliance requirements
- Education requirements
- IRB review
- Organizational structure
- Legal agreements with sponsors, district agreements
- Contract / MUA
The major institutional units affected by the HRPP include:
- Clinical lab
- Legal, Contracts & Grants, etc.
- School district
- Sub-contractor relations
This policy is adopted and disseminated from the very highest level of this organization. Protection of subjects is an important part of our culture.
This institution will use the federal requirements found in 45 CFR 46 Subpart A (“The Common Rule”) for all federally funded) research. (What was promised in question 4 of the FWA? Does this institution want to adopt a stricter standard than what was officially promised?
Optional unless checked on the FWA: This institution will use the federal requirements found in 45 CFR 46 Subpart B (Pregnant women/Fetuses/Neonates), Subpart C (Prisoners), and Subpart D (Children) for all only federally funded research
What is human subjects research? Define the words and give examples from your discipline. Perhaps some of your studies are not “research”. Perhaps they are but the humans are anonymous so there are no human subjects.
Include to whom this applies. Who is covered, and not covered, under this policy?
II. ADMINISTRATIVE HIERARCHY
The Institutional official:
Duties: Set policy and establish culture of conscience/compliance (more?)
The Human Subject Protection Administrator:
Duties: tracking company studies and IRB reviews
Subject complaint handling
Organization Chart attached illustrating functional units responsible for the HRPP.
III. COMMITMENTS TO SUBJECTS
A. Financial: It is the policy of this company that:
- no subject should be financially harmed as a result of participation in one of our studies.
- we may argue with investigators and insurers over payment but that subjects with a righteous claim will not be burdened with knowledge of these disagreements.
- we will carry insurance sufficient to cover direct and liability costs for related to injuries to subjects.
- etc. policy on...
- compensation for direct expenses (e.g. additional office visits)
- compensation for indirect expenses (e.g. childcare, transportation)
B. Timely Results / Significant new information
C. Adverse Events
D. New Information – If we learn about a risk after the study is done, do we tell the prior subjects?
E. Rights – Compliance
IV. COMMITMENT TO INVESTIGATORS
A. Support & resources
B. Freedom from Conflicts of Interest?
D. Publication rights?
A. Monitoring of institutional records
B. Monitoring of investigator site
C. Monitoring of IRB
What baseline requirements does this institution have?
A. Education of institutional Officials
Baseline: Completion of OHRP modules
Additional: GCP courses? Web courses?
B. Education of Investigator and staff
Baseline: Completion of course (you decide on best site for your company needs and ideals. (Consider Citiprogram.org)
Additional: GCP courses? Web courses?
VII. IRB REVIEW AND RELATIONSHIPS
A. Business relationships
FWA - Initial review
A copy of this policy will be sent to the company providing the IRB service.
FWA – E&I Continuing Review
B. Review relationship
The IRB and the Investigator have the primary relationship; this institution will assist the investigator in the preparation of materials and provision of whatever else is needed.
C. Use of external IRBs
E&I may be your “internal” IRB of record but some of your studies may be conducted at institutions with their own IRB. Will the institution agree to accept the determination of that IRB (and thus list it on the FWA) or will duplicative review be needed?
THINK about the kinds of relationships your company has with other companies. How will they be handled?
- Intellectual property
- Getting results from sponsor especially if negative
- Must be signed by institutional officer (not PI) to be effective
This document has been accepted as an official policy of this (named) institution.
Highest person: (signature) (printed name) (date)