Wright-Patterson Air Force Base   Right Corner Banner
Join the Air Force

Library > Fact Sheets > IRB Frequently Asked Questions

IRB FREQUENTLY ASKED QUESTIONS

Posted 6/5/2008 Printable Fact Sheet

FAQs 

What are all of these regulations?
What happens to my protocol when I submit it to the IRB?
Once I submit a protocol, how long will it take to get approved? 
How will I know if my protocol has to go to SGRC for review? 
Once the IRB has approved my protocol, when can I start recruiting and enrolling subjects and collecting data? 
What should I do if I suspect an adverse event has occurred? 
What if I am only a day late for the protocol submission deadline? 
What documents do I need to have on file for a quality assurance visit? 
I have an international research protocol to submit; what special considerations should I make and what can I expect? 
What should I do when I get comments from the SGHARP regarding my protocol? 
What are the 3 different levels of review conducted by an IRB? 
Who determines if my research protocol is exempt, expedited or requires full board review? 
What if my research is exempt; am I finished? 
What if my research is reviewed by expedited procedures, do the same requirements apply as a full board review? 
Are there any additional requirements for survey research? 
I don't understand how to address comments and changes requested by the IRB? 
What if I do not get all the required materials for continued review submitted on time? 
Is my proposed project even human research? 
How often is human subjects training required for investigators? 
Are there any rules or guidelines on how subjects can be recruited?


What are all of these regulations? Which ones do I need to know?

There are 5 main regulations that you should be familiar with and need to follow when using human subjects in research:
  • 32 CFR 219, Protection of Human Subjects (Federal Level)
  • DoDD 3216.2, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (DoD Level)
  • AFI 40-402, Protection of Human Subjects in Biomedical and Behavioral Research (Air Force Level)
  • 10 USC 980, Limitation on Use of Humans as Experimental Subjects
  • AFRLI 40-402, Using Human Subjects in Research, Development, Test, and Evaluation (AFRL policy on human subjects)
Two other commonly used regulations are 21 CFR 50 and 21 CFR 56, which are FDA regulations that apply primarly when conducting new drug or new medical device research.

What happens to my protocol when I submit it to the IRB?
Formal review of your protocol will not occur until all submission requirements have been received by the IRB. All new protocols are first read by the IRB administrator and chairperson. The protocol will then be sent back to you for revision before it is sent to all of the IRB members; Suggested or required changes will be in the form of comments in the right margin and changes tracked. Please address all comments and accept changes if you agree with them. Discussion of changes with the chairperson is encouraged as it is important that you understand why certain changes are being required. Your protocol will then be sent to all of the IRB members one week prior to the meeting. If your protocol is reviewed through expedited procedures, it will be processed for approval once you have adequately addressed comments and questions.

Once I submit a protocol, how long will it take to get approved? 
For a protocol that requires review by the Air Force Surgeon General's office of Research Compliance (SGRC) you can generally expect to wait 4-6 weeks after IRB approval for full approval of your research (see below for information on when you can begin collecting data). After IRB approval, the protocol is reviewed by our legal office and signed off on by the AFRL Institutional Official (IO). It is then forwarded to SGRC for review and approval. Changes to your protocol may be requested by both the IRB and SGRC. Your timeliness in completing these changes will impact the overall review time for your protocol.

How will I know if my protocol has to go to SGRC for review?
All protocols are reviewed by SGRC. If it is a greater-than-minimal risk protocol, or you have an Assurance of Compliance that requires approval, your protocol will have to be sent to SGRC for approval. In addition, international research and non-lethal weapons research must also be approved by SGRC.

Once the IRB has approved my protocol, when can I start recruiting and enrolling subjects and collecting data?
If it is a minimal risk protocol, research may begin once you receive written approval from the IRB. If your protocol requires an Assurance of Compliance, it must be approved by SGRC before the IRB can provide approval. If it is a greater-than-minimal risk protocol, you must have full SGRC written approval in addition to written IRB approval prior to starting.

What should I do if I suspect an adverse event has occurred?
Refer to the guidelines for reporting adverse events on the AFRL IRB home page. Do not hesitate to contact the medical monitor listed on the protocol or the IRB chairperson to discuss details regarding a suspected adverse event.

What if I am only a day late for the protocol submission deadline? 
Any protocols submitted after the close of business four weeks prior to the IRB meeting will be added to the following month's agenda. There are exceptions to this rule for "just in time" research or extenuating circumstances.

What documents do I need to have on file for a quality assurance visit?
  • Approved version of your protocol
  • A disk or CD with an electronic, read-only copy of your final approved protocol
  • SGRC approval letter
  • IRB approval letter
  • Approved assurance of compliance (if applicable)
  • Approved informed consent document (ICD)
  • All signed ICDs
  • CITI (or equivalent) training certificate of all primary and associate investigators Recruitment measures/advertising
  • Subject screening forms (if applicable)
  • Research data questionnaires (if applicable)
I have an international research protocol to submit. What special considerations should I make and what can I expect? 
When writing the protocol several issues should be considered. The important factors to consider are local culture and community, primary language of the subjects, and ensuring that there is a local advocate for research subjects to contact. The protocol must be reviewed and approved by a local IRB (or other ethics committee) where the research is to be conducted. The WRS IRB also requires that the ICD be written in the local language and that an English translation be provided.

The rest of the requirements, as outlined in the Submission Checklist are the same. As such, an Assurance of Compliance must be completed for the institutions engaged in research, and a Research Review Agreement must be completed by the institution, where a local IRB is designated.

Research that may be considered "exempt" in the United States may not be considered as such in overseas settings or by overseas IRBs. It is important to have approval of exemption from an IRB or equivalent in the country where your research will take place when submitting an overseas request for exemption to our IRB. 

What should I do when I get comments from the SGHARP regarding my protocol?
After your protocol is approved as a greater-than-minimal risk study by the IRB, it is forwarded to the Surgeon General's Human and Animal Research Protections Committee (SGHARP) for review. SGHARP is part of SGRC. You may receive an email from the IRB administrator after your protocol has been reviewed by the SGHARP. Please respond in writing (email) to each of the comments made by the SGHARP. If, in the process of addressing concerns from the SGHARP, you amend or change your protocol, please attach it to your email response.
 
What are the 3 different levels of review conducted by an IRB?
Exempt, Expedited and Full Board Review. 

Who determines if my research protocol is exempt, expedited or requires full board review?
This determination is made by the IRB chair or administrator upon submission of your research protocol. First, your proposal must be considered minimal risk to qualify for exemption or expedited review. There are certain additional criteria that your research must meet to be considered exempt or to qualify for expedited review. The rules for exempt research are delineated in 32 CFR 219.101(b). The criteria for research that qualifies for expedited review can be found on the OHRP web site at: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

What if my research is exempt; am I finished?
It depends; once you receive a letter from the IRB that approves your request for exemption from human use regulations, there are no further requirements unless there is a change in the research that affects human subjects. Your proposal is still considered to be human research and you have an obligation to protect human subjects' rights and minimize risks. You must notify the IRB if there is a change in the design of your experiment that affects human subjects, otherwise no further reports or actions are required. 

What if my research is reviewed by expedited procedures, do the same requirements apply as a full board review?
Yes. The only difference between expedited and full board review is that your protocol is reviewed by only one person versus the entire convened IRB. Typically, but not always, these reviews take less time to approve since they are conducted in a rolling fashion (as soon as we receive your protocol and all submission requirements, we review it). All of the same rules and regulations for full board reviewed research apply to expedited research.
 
Are there any additional requirements for survey research?
Yes. In addition to IRB approval, your survey must be routed through AFPC and be assigned a Survey Control Number (SCN). This process can sometimes take several months. A SCN will not be required for IRB submission, but WILL BE REQUIRED for final IRB approval unless your proposal is exempt. Therefore, you can submit your survey to the IRB for exemption or review while you are awaiting a SCN from AFPC. If your proposal is considered exempt, a SCN will not be required by the IRB. However, you still need to obtain approval for your survey/interview from AFPC per AFI 36-2601 Air Force Personnel Survey Program. Please note that these reviews are completely separate functions.
 
I don't understand how to address comments and changes requested by the IRB?
Reviewing a revised protocol from the IRB will require a working knowledge of the reviewing functions in Microsoft Word, specifically Comments and Tracking Changes. Comments can be viewed in the right margin of the revised protocol that is sent back to you. These comments are usually in the form of a question or a requirement for additional information. You can answer these by adding another comment or simply inserting the answers directly into the protocol where required and tracking your changes so that the IRB can view your response. Suggested changes entered by the IRB must either be accepted or declined by you. If you agree with the change, simply right click on it and choose "accept insertion." If you disagree with the change then provide a justification for why in the form of an inserted comment. Tracked changes will be colored and underlined. 

What if I do not get all the required materials for continued review submitted on time?
Any approved protocol must be reviewed by the IRB at least every 365 days. If continued review and IRB approval is not conducted and documented within this timeframe, IRB approval of the protocol will be suspended and all subject recruitment, enrollment, data collection and analysis must stop. Research can only be resumed after written IRB approval is obtained. In order to prevent this from happening as much as possible, we review protocols on an 11 month cycle.

Is my proposed project even human research?
In order for a project to be considered human research it must meet the definition of both "research" and "human subject" as defined below from 32 CFR 219.102:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
How often is human subjects training required for investigators?
Annually. If investigator training is not completed on an annual basis it may result in the suspension of IRB approval for current research or inability to submit new research to the IRB. 

Are there any rules or guidelines on how subjects can be recruited?
Federal regulations consider direct advertising for study subjects to be the start of the informed consent and subject selection process. All advertising must be reviewed and approved by the IRB as part of the package for initial review. The IRB reviews the information contained in the recruiting material (ads, flyers, emails, briefings, etc.) and the mode of its communication to determine that the recruiting procedures are not coercive. The protocol should contain sufficient detail on the recruiting procedures - who will do the recruiting, when and how it will be done -to allow this determination to be made. 

Special attention to preventing coercion must be addressed in the protocol when recruiting military subjects. It must be made clear that commanders and supervisors will not be involved in the recruiting process in any way. Personnel in a position of authority should not promote participation or be present during subject recruiting briefings nor should they be made aware of who does and does not volunteer.

Generally, any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. The AFRL Wright Site IRB therefore requires that advertisements be limited to the following information:
  • The name and address of the clinical investigator and/or research facility.
  • The condition under study and/or the purpose of the research.
  • In summary form, the criteria that will be used to determine eligibility for the study.
  • A brief list of participation benefits, if any (e.g., a no-cost health examination).
  • The time or other commitment required of the subjects.
  • The location of the research and the person or office to contact for further information.
When reimbursement will be provided to subjects, it can be stated in the advertisement that subjects will be compensated for time, travel and inconvenience. However, dollar amounts are not permitted in the advertising/recruiting material.

____________________________________________________________________________







 Inside WPAFB

ima cornerSearch

ima cornerSpecial Topics

 




Site Map      Contact Us     Questions     USA.gov     Security and Privacy notice     E-publishing  
Suicide Prevention    SAPR   IG   EEO   Accessibility/Section 508   No FEAR Act