Who must apply for review by the Institutional Review Board (IRB)?
What is research?
What is a human subject? 
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?
If I'm applying for external funding for my study, when should I submit my application to the IRB?
Where do I obtain IRB application materials?
If I'm working with other researchers, how should I fill out the application form?
If I'm conducting a quality improvement study, do I need to obtain IRB approval?
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?
If I closed my IRB protocol and then want to re-open it, what do I need to do?
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 Research Integrity Services (RIS) staff if in doubt about the need for IRB review (Julie Simpson, 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.

What is a human subject?

Federal regulations (45 CFR 46) provide the following definitions:

Human subjects: "Living individual(s) 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." 

Private information: “Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”

Using this definition of human subjects, all activities involving prospective collection of information about individuals via intervention/interaction are considered using human subjects and require UNH IRB approval before commencing.

When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]), UNH IRB approval is NOT needed to use such data for research purposes if the secondary/existing data do not contain private information.  Some common examples of secondary/existing data that are not considered private information include, but are not limited to:

Some information on the Internet - comments on TripAdvisor; content of public tweets and blogs; information on public Facebook pages; census information; freely-available datasets (whether or not anonymous)

Archives - identifiable information about individuals in a public archive

      Datasets - anonymous datasets, whether privately held or publicly available

Researchers should be aware that not all information on the Internet is considered publicly available and not all datasets that are characterized as anonymous actually are.  Examples include, but are not limited to: Comments on a non-public chatroom or listserv; restricted-access datasets; or privately held datasets where individuals may be identified, either directly, through a code associated with a name, or through a combination of variables.  As the UNH IRB DOES NOT give post-hoc approval, researchers must be certain that the secondary/existing data do not contain private information before use.  Further, some journals require proof of IRB approval for research projects that the UNH IRB may not consider to involve human subjects (e.g., use of anonymous datasets).  Researchers should check journal requirements before conducting the project and contact the IRB with any questions. 

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. SPA 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.

If I'm applying for external funding for my study, when should I submit my application to the IRB?

You should check the sponsor requirements for the specific grant/fellowship/contract for which you are applying to see what the requirements are for timing of obtaining IRB approval. Most sponsors do not require evidence of IRB approval at the time of proposal submission. Many sponsors require evidence of IRB approval before releasing funds to UNH. Even if the sponsor does not specify requirements for IRB approval, UNH Sponsored Programs Administration (SPA) will not set up any accounts for research projects involving human subjects until IRB approval is obtained. With these facts in mind, you should probably plan on submitting your application to the IRB as soon as you have learned that your proposal has been funded.

Where do I obtain IRB application materials?

• Via the Web ~ Human subjects information and application materials are available at http://www.unh.edu/research/human-subjects
• By email ~ Email Julie Simpson or Kathy Stilwell in RIS to request application materials or ask questions about the IRB application review process
• By phone ~ You may call 603-862-2003 or 603-862-3536 to request application materials or ask questions about the IRB application process.
• In person ~ Applications are available from RIS staff (Room 102 or 103, second floor, Service Building)

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.

If I'm conducting a quality improvement study, do I need to obtain IRB approval?

Quality improvement studies do not automatically qualify as research and therefore may not need to be reviewed by the IRB. To ascertain whether your proposed quality improvement activity also qualifies as research (thus requiring IRB review), consult the Office of Human Research Protections (OHRP) guidance on quality improvement activities.

Where do I send my completed application?

• By email ~ Email your completed (and signed) application materials to Julie Simpson or Kathy Stilwell.
• By fax ~ Fax your completed application materials to 603-862-3564.
• In person ~ Bring your application to the RIS staff (Room 102 or 103, second floor, Service Building)
• By mail ~ from off-campus, mail your application materials to:

University of New Hampshire
Research Integrity Services - 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 RIS Director 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 to review applications that require Full Board review.   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. For some studies, UNH and the other institution may enter into a formal agreement for UNH to rely on the other institution's IRB review, obviating the need for both IRBs to review the study. Contact UNH's IRB administrator for more information about this possibility. Please 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 research sites, and rarely have IRBs. You should ask the appropriate person in charge at the site (e.g., school principal, director of nursing home, community center director) to provide a letter indicating that (s)he has read your research proposal and giving you, the researcher, permission to conduct your research at the site. Alternatively, the person in charge may co-sign with you an invitation-to-participate letter to indicate institutional permission for you to conduct your research at the 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 request changes to an existing study, submit a request to RIS following the outline delinated in the document, Requesting a Modification to a Previously Approved Protocol. 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.

If I closed my IRB protocol and then want to re-open it, what do I need to do?

If you closed your IRB file, either by returning the Annual Continuing Review Questionnaire indicating that the study is no longer active, or you let your IRB approval expire, you need to submit a new application to the IRB in order to re-open the file. The IRB no longer keeps paper copies of closed files.

I still have questions, who can help?

Email Julie Simpson or call RIS at 603-862-2003 or 603-862-3536 for assistance.