Frequently Asked Questions
Updated January 2009
Q . What constitutes the identification of a subject in a set of data?
A . Certainly, the subject's name and/or social security account number (SSAN) identifies the subject, as described in the definition of a "record" in the Privacy Act, paragraph (a)(4). In addition, a subject may be identified by small group affiliation plus other demographic information. The subject is probably identifiable if the following or similar information is recorded:
- Name and/or SSAN and/or other specific identifier such as drivers license number, and/or
- Small group membership, and
- Age, or
- Gender, or
- Race and/or ethnicity, or
- Rank, or
- Partial identifer, such as the last four digits of the SSAN.
Q. What happens if I conduct human research without IRB approval?
A . You will place USAFA out of compliance with Federal requirements for human subjects research. This can result in Federal or USAF actions that will prevent you, your Department or USAFA from conducting human subjects research and will jeopardize the USAFA human research certification from the Air Force Surgeon General.
Q. How may I safeguard private information?
A . Paper records and removable computer storage media (e.g., CDs, tapes) that hold private information should be secured such that the data are available only to researchers involved in the specific project. Similarly, when private data are stored on non-removable computer storage media (e.g., hard disks, servers), they should be protected with passwords or similar mechanisms such that the data are available only to researchers involved in the specific project.
Q. How do I amend a protocol, for example, to add or delete investigators or measurement instruments?
A . The preferred method is to re-submit the amended, original protocol with the changes clearly marked. The amendment must be approved and signed again, as shown in the present protocol template. It may also be acceptable to write a memo to the IRB describing very simple changes, such as the addition of an investigator.
Q. Are Pilot Studies considered Research?
The module “What is research?” in the CITI Training module clearly states that pilot studies, such as giving a survey instrument to a few subjects in order to refine the questions, meets the definition of research in 32 CFR 219.102(d) and therefore is subject to IRB oversight. Researchers considering running pilot studies should submit a protocol for the study to the IRB for review, using the appropriate template for their study (e.g. exempt or full board review). Researchers should clearly state that the study is a pilot study in explaining the design of the research, particularly the sample size.
Q. If my survey/questionnaire/subjective ratings protocol is going to receive expedited review, how will I acquire a survey control number from XPA?
A . The IRB Chair intiates expedited review. Request in the cover memo for the protocol that the Chair include XPA as part of the expedited review process so that a SCN may be assigned in a timely manner.
Q. If no officer or civilian instructor will remain in the room when informed consent is being considered and given, who will be available to answer questions when informed consent is being considered?
A . The fundamental idea is to preclude undue instructor/officer influence while allowing the information phase of the consent process to take place. 32 CFR 219 states that the IRB must ensure that:
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Generally speaking, investigators should be present and available to answer questions during the informed consent process. In the event that there is concern that the principal investigator may exert undue influence over the subject’s decision to participate (such as an instructor-student or superior-subordinate relationship), then it may be appropriate to have an associate investigator (such as a cadet assistant) administer the informed consent. Because cadets are considered vulnerable subjects (due to their position in the military hierarchy at USAFA and their status as students), it is important that they have adequate time to consider participation in a non-coercive atmosphere. The board usually recommends the following safeguards: adequate time between the recruitment/information phase and enrollment/consent phase of the study, during which potential subjects have the opportunity to consider participation and pose questions; instructors refrain from recruiting their own students; and cadet nvestigators refrain from recruiting potential subjects within their squadron chains of command. Investigators are reminded to be mindful of the vulnerable status of cadets as subjects and to create a respectful and non-coercive environment in which cadets may choose whether or not to consent to participate in a given study.
Q. What is the purpose of a witness signature on an Informed Consent Document? Is it to document who administers the consent?
A . I'd suggest moving away from the concept of there being a single person who "administers" "the consent." I prefer to think in terms of there being an adequate body of information available and an adequate means to deliver it, and consent comes after this information is delivered and evaluated by the prospective subject (consent is most assuredly NOT the piece of paper). Part of this is semantic guerilla warfare, but there are real reasons, too. For some studies, the PI may be the most appropriate informant; for other studies, the PI may have conflicts that make it inappropriate that s/he be involved in the consent process; for some studies (e.g. organ transplantation), the information may be so multifaceted that a team approach makes far more sense than a single informant. Making a blanket policy seems unwise. In the federal regs, a witness signature is only required when the witness is attesting to the adequacy of process. At least two federal officials have told me that this is their assumption when they see a line labeled "witness" with no explanation. I once polled an IRB panel to see what their understanding would be as to what the "witness" signature meant. There were six distinct interpretations, among this group of people who ought to be savvy about it. Then, just to be nasty, I posed the question to a couple of co-operative group offices --- one hadn't a clue, promised to get back to me and never did. The other said that "of course" it was a witness to the signature of the subject. So, what's the use of a witness signature if nobody knows what it means? We advise investigators to identify their witness lines functionally, so they at least are understood similarly by different people seeing them. "Witness to signature." or "Consent process monitored by..." or whatever. (From the Medical College of Wisconsin's IRB Discussion Group.)