Pitfalls to Avoid in Preparing Your Single Project Assurance
Office for Protection from Research Risks

The following are the most common problems that result in OPRR-requested revisions to SPA documents and a delay in approval:

1. The first page of the SPA is not on institutional letterhead.

2. The "Date of IRB Approval" (see beginning of Part 3) is a date more than 12 months prior to submission of the SPA.

3. The individual signing as the "Authorized Official of the Institution Providing This Assurance" (item I, Part 3) is not the CEO, President, Director, or equivalent for the institution. The Chairman of a Department within the institution should not be signing as the Authorized Official.

4. The individual signing as the "Authorized Official of the Institution with the IRB" (item II, Part 3) is not the CEO, President, Director, or equivalent for the institution. The Chairman of a Department within the institution should not be signing as the Authorized Official.

5. The IRB Chairperson (item III, Part 3) is also the Authorized Official in items I or II. The Authorized Official of the Institution should not be the IRB Chairperson because of potential conflicts of interest.

6. The Date of the IRB Chairperson’s signature precedes the "Date of IRB Approval" noted in Part 3. The IRB Chairperson should only sign the SPA on or after the date of IRB approval.

7. Original signatures are not provided on the SPA document.

8. Failure to consult with OPRR prior to using another institution’s IRB.

9. The IRB membership roster fails to include each of the following: at least one member whose primary interests are scientific; at least one member whose primary interests are non-scientific; and at least one member who is not affiliated with the institution with the IRB.

10. The IRB roster includes a member who is also involved in the research project being reviewed, and the roster fails to indicate that this person was absent from the IRB meeting during the deliberations and vote on the project (such an individual may only be invited by the IRB to be present to answer questions about the project; otherwise, that person should be excluded from the meeting).

11. The consent form does not contain all of the elements of consent required by 45 CFR 46.116. Common problems include: failure to completely describe all procedures that subjects will be asked to undergo as part of the research; failure to clearly state alternative procedures or courses of treatment, if any, that may be advantageous to the subject; and failure to include the name of a contact person for questions about "research subjects’ rights" and name of whom to contact in the event of "research-related injury" (contacts for these issues should include someone who is not a member of the research team; a member of the IRB is good contact to include in the consent form).

revised 2/5/98

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Updated June 23, 2000