FREQUENTLY ASKED QUESTIONS
Who must apply for review by the Institutional Review Board (IRB)?
What is research?
If I'm not applying for funding for my research, do I still have to apply for IRB review?
What's the worst that can happen if I don't get IRB approval?
Where do I get an IRB Application for Review?
If I'm working with other researchers, how should I fill out the application form?
Where do I send my completed application?
What happens after I submit my form?
I need to plan data collection around IRB approval. How long does review take?
How often does the IRB meet?
What does the IRB look for in an application?
How do I know the IRB will understand my proposed research?
Do I have to attend the IRB meeting when my study is reviewed?
How do I know when my study has been approved?
I'm conducting all or part of my research off-site (at a non-UNH site). Should I apply for study approval through the other site's IRB and the UNH IRB?
How do I modify an approved study?
How do I extend the study beyond the approval period?
I still have questions, who can help?
Who must apply for review by the Institutional Review Board (IRB)?
Anyone who intends to conduct research that involves people must apply for and receive unconditional IRB approval (approval without contingency) before beginning the research. This applies to ALL research involving people, not just clinical research. Social science, behavioral, historic, linguistic and marketing research studies must be reviewed by, and receive approval from, the IRB (this is a representation of likely studies, and not an exhaustive list). Check with RCCS staff if in doubt about the need for IRB review (603-862-2003).
What is research?
Research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge, or investigation designed to test a hypothesis.
If I'm not applying for funding for my research, do I still have to apply for IRB review?
Yes. Any research study involving human subjects must be submitted to the IRB for review, regardless of funding source.
What's the worst that can happen if I don't get IRB approval?Aside from potential ethical implications for the subjects and for the researcher, bypassing IRB review brings other risks:
Students
~ Funding may be withheld - IRB approval is required for UROP, IROP, McNair and other grant programs. These programs will not release funds without IRB approval.~ Credit may be withheld - UNH may, at its discretion, refuse to grant students course credit for research conducted without IRB approval.
~Dissertation or thesis work will not be accepted - Graduate students must present to the Graduate School evidence of IRB approval for their studies involving human subjects. Thesis or dissertation work will not be accepted without it. Degrees will not be awarded for work based on non-IRB-reviewed studies.
~ Articles may not be published - Most professional journals require evidence of IRB approval when considering articles for publication.
Faculty and Staff
~ Funding may be withheld - Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission. Some sponsors will not release funds to UNH for the researcher's use without IRB approval. OSR will not set up accounts for studies lacking necessary IRB approval.~ Articles may not be published - Many professional journals require evidence of IRB approval when considering articles for publication.
~ The University will not support unapproved research - Liability issues arising from unapproved research become the responsibility of the researcher. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by UNH. UNH will not, therefore, provide a researcher of an unapproved study the resources to answer a liability complaint.
Where do I get an IRB Application for Review?
In Person
Applications are available from RCCS staff (Room 102 or 103, second floor, Service Building)
Via the Web
Human subjects information and application materials are available at http://www.unh.edu/osr/compliance/irb.html
By Phone
You may call 603-862-2003 or 603-862-3536 to request an application form or ask questions about the IRB application process.
By Email
or to request an application form or ask questions about the IRB application and review process.
If I'm working with other researchers, how should I fill out the application form?
The IRB will want to know the name and background of each person on the study (see application instructions), but only one person should be listed on the application form as project director. If necessary, submit affiliated staff information on an additional sheet of paper.
Where do I send my completed application?
Return your completed application to Research Conduct and Compliance Services, Office of Sponsored Research, Service Building. You may fax your completed application to 603-862-3564. If you're mailing your application from off-campus, the mailing address is:
University of New Hampshire
Office of Sponsored Research - IRB
51 College Road, Service Building
Durham, NH 03824-3585
What happens after I submit my form?
Once the application is received, it is assigned a number and is routed for IRB review. There are three levels of IRB review. Researchers are notified as soon as possible, in writing, of the IRB's decision.
I need to plan data collection around IRB approval. How long does review take?
PLEASE NOTE! You may not begin your research until the IRB has given your research study written unconditional approval.
Review of Exempt or Expedited studies usually takes about 10 working days (allow 15 in the summer). The review process for studies submitted for Full Board review can take up to a month or longer to complete.
You should include sufficient time in your research plan as allowance for any IRB-required changes to the research study. Many revisions can be considered by the RCCS Manager alone, or by a subcommittee of the IRB. Substantive revisions usually return to the Full Board for review at a convened meeting.
How often does the IRB meet?
The IRB generally meets twice each month during the academic year (September through May) and once a month during the summer. A quorum of the IRB must be present for decisions to be "official."
What does the IRB look for in an application?
The IRB seeks
- Research design that's sound, given the proposed use of human subjects in the study,
- Equitable selection of subjects,
- Balanced risks and benefits, and
- A thoughtful and comprehensive informed consent process.
How do I know the IRB will understand my proposed research?The IRB is a standing faculty committee of at least five individuals, including researchers and members of the community at large. Individual experiences and interests cross diverse areas.
When review of a study requires expertise beyond that available on the IRB, the IRB seeks assistance from qualified persons outside its membership. While outside experts may inform the IRB's decisions, they do not vote on UNH research studies presented for review.
Do I have to attend the IRB meeting when my study is reviewed?
Generally speaking, no. If the IRB has several questions, or believes the researcher(s) could provide valuable insight for review, the IRB will set a mutually convenient time to meet with the researcher(s) to discuss the study.
How do I know when my study has been approved?
You will receive written notification of the status of your study following IRB review, usually by email. The IRB will also identify any required revisions at that time.
I'm conducting all or part of my research off-site (at a non-UNH site). Should I apply for study approval through the other site's IRB and the UNH IRB?
If the other site has an IRB
Yes. Many hospitals, universities and other institutions have their own IRBs. If the site of your research has an IRB, the site IRB and the UNH IRB must both approve your study before you start. You may submit your study for review to UNH at the same time you submit your study to the other institution's IRB for review, or you may submit the study after the other institution's review is completed. Remember that review and approval requirements may vary among institutions, so you should familiarize yourself with each IRB's policies. You should also plan your research chronology accordingly.
If the other site doesn't have an IRB
Elementary schools, nursing homes and community centers often serve as non-UNH research sites, and rarely have IRBs. You should ask appropriate personnel (e.g., school principal, director of nursing home, community center director) at the research site to provide a letter indicating that (s)he has read your research study, and that you, the researcher, have permission to conduct your research at his or her facility. Alternatively, appropriate personnel may co-sign, with you, an invitation-to-participate letter to indicate institutional permission for you to conduct your research on-site. The UNH IRB requires evidence of site permission for its review and approval of your study.
How do I modify an approved study?
Changes to a research study must be reviewed and approved by the IRB prior to implementation. To submit proposed changes for IRB review, send a cover letter (be sure to include the IRB study number from your approval letter) with a summary of modifications you wish to make. Attach new or revised instruments, measures, consent documents, etc., as appropriate. Requests for modifications are reviewed at the same level as the original study, i.e., Full Board modifications are reviewed by the IRB at a convened meeting.
How do I extend the study beyond the approval period?
Any study in good standing may be extended. If your study will continue beyond the "approval expiration" date on your approval letter, complete the Annual Continuing Review Questionnaire when you receive it (60 days prior to study approval expiration), and attach a letter requesting a time extension for your study and a brief summary of findings to-date. If you are proposing changes to your study along with the extension, include appropriate materials as you would for a modification.
Submit your extension request to the IRB. Requests for time extensions and annual renewals are reviewed at the same level as the original study - i.e., "Full Board" renewals are reviewed by the full IRB. You should plan accordingly to avoid disruption in data collection.
I still have questions, who can help?
Email or call RCCS at 603-862-2003 or 603-862-3536 for assistance.
