Protecting Human Subjects in Research at UNH
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Application Materials, Resource Materials, and Sample Forms *Updated 8/13/2008*
Frequently Asked Questions
Levels of IRB Review
Education about Protecting Human Subjects *Updated 8/4/2008*
IRB Submission Deadlines and Meeting Schedule *Updated 5/7/2008*
IRB Functions and Membership
Regulatory and Background Information
National Institutes of Health (NIH) Required Human Subjects Protections Education
Regulations Governing Use/Disclosure of Personally Identifiable Health Information
The University of New Hampshire (UNH) Institutional Review Board (IRB) for the Protection of Human Subjects in Research is a standing committee responsible for protecting the rights and welfare of people who are subjects of UNH research activities. The UNH IRB Procedures Manual (updated August, 2008) sets forth the IRB’s basic operational procedures.
UNH’s Policy regarding the use of human subjects in research states
All UNH research activities proposing to involve human subjects must be reviewed and receive written, unconditional approval from the IRB before commencing.
This policy applies to ALL research, including that in the humanities, and behavioral and social sciences regardless of whether it is funded .
The IRB meets twice a month during the academic year and once each month during the summer to review studies qualifying for Full Board review. Studies qualifying for Exempt or Expedited level review are reviewed on an ongoing basis. The IRB, not the researcher, determines the review level.
All applications for review and correspondence with the IRB should be directed to the Research Conduct and Compliance Services (RCCS) office in the Office of Sponsored Research (OSR), the IRB's administrative office. For forms, application information, study submission deadlines, administrative concerns, and general inquiries, see additional information below, or contact
Research Conduct & Compliance Services |
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Julie Simpson, Manager |
603-862-2003 |
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Kathleen Stilwell, Assistant |
603-862-3536 |
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Faculty, staff, and students who would like assistance in developing research protocols, or would like to discuss any issues related to their research studies, should contact the RCCS Manager. The RCCS Manager is also available to talk to classes or groups of faculty, staff, or students about protecting human subjects in research and the IRB. Please contact her as indicated above.
IRB Application Materials, Resource Materials, and Sample Forms
Studies submitted to the IRB for review must comprise an application form and a complete research protocol. The application form must be signed and forwarded with the research protocol and any other supporting materials to RCCS in OSR. If you experience trouble successfully downloading any of the documents below, please contact either or .
IMPORTANT! If the researcher is a student, the faculty advisor must sign the application form and attach a letter of support for the research stating the student’s experience and the level of supervision to be provided.
Resource Materials |
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IRB Guide for Researchers (updated August, 2008) |
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Activities Involving Human Subjects and IRB Approval |
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Responsibilities of Directors of Research Studies Involving Human Subjects |
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Guidelines for Developing a Research Protocol |
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Information Individuals in New Hampshire are Legally Required to Report |
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Informed Consent Format and Checklist |
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Tips for Writing Easy-to-Read Informed Consent Documents |
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Child Assent Guidelines |
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Confidentiality Guidelines |
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Guidelines for Special Populations |
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Guidelines for Conducting Web-Based Survey Research |
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Requesting a Modification to a Previously Approved Protocol |
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Below are templates for different consent form formats. Choose the format that you feel most effectively conveys consent information to prospective subjects and that you are most comfortable working with in your study. Please make sure when using a template that you customize the information to address the specifics of your study.
Sample Consent Forms |
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Informed Consent Document |
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Informed Consent Letter |
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Informed Consent Form |
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Levels of Institutional Review Board (IRB) Review
To qualify for Exempt level review, the research study must fall into any of six (6) categories delineated in the federal regulations. Exempt DOES NOT mean the study is exempt from IRB review. The categories represent studies that present minimal risk to subjects. Risk is reduced through anonymity of responses, use of data from human subjects that is existing or publicly available, or through the use of non-invasive paradigms that will not harm subjects.
Exempt level reviews are conducted by one IRB member. Common examples of Exempt level research at UNH are
- Anonymous surveys,
- Educational tests,
- Studies using human subjects data or information that is publicly available (such as that from a data repository or purchasable data set), or
- Observation of public behavior that does not put subjects at risk.
Special guidelines apply to children included in research classified as Exempt. Please contact the RCCS staff for more information.
For reviews of certain Exempt level studies (involving no greater than minimal risk) in the departments of Psychology and Sociology, contact the respective Department Chair.
To qualify for Expedited level review, research must fall into any of nine (9) regulated categories. Expedited categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.
Expedited level reviews are conducted by two IRB members. Common examples of Expedited research at UNH are
- Studies including blood samples taken from healthy volunteers,
- Studies involving moderate exercise by healthy volunteers,
- Analyses of data collected via recordings (such as those taken in the investigation of speech defects),
- Studies of existing data or pathological specimens that include identifying information,
- Linguistic and ethnographic studies, or
- Studies involving focus groups.
Proposed research studies involving human subjects that do not qualify for Exempt or Expedited level review must be reviewed by the IRB at a convened meeting (Full Board level review ). Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations, such as children, prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimer patients).
Full Board studies are reviewed on a first come, first served basis by the IRB. Common examples of research reviewed at the Full Board level at UNH are studies that include:
- Maximal exercise (VO2 Max) by healthy volunteers,
- Institutionalized persons (e.g., prisoners, patients in long term care facilities)
- Persons who lack capacity to consent (e.g., persons with severe mental disabilities or developmental delays), or
- Sensitive topics (e.g., criminal behavior, sexuality).
Education about Protecting Human Subjects
While the IRB currently does not require researchers complete any specific training program in human subjects protections in order to conduct studies involving human subjects, the IRB strongly encourages all researchers, particularly novices and students, to become knowledgeable about key issues presented when involving human subjects in their studies. These include, but are not limited to:
- The ethical principles for protecting human subjects in research,
- Key issues in human subjects research, including minimizing risk, recruitment, informed consent, confidentiality and privacy, and involvement of vulnerable populations, and
- The primary responsibilities of researchers conducting studies that involve human subjects
To assist researchers with gaining familiarity with this information, UNH has developed an interactive, self-contained Web-based training module on the use of human subjects in research. This module may be completed according to an individual’s own timeframe. Allow approximately 30 minutes to complete the module.
Institutional Review Board (IRB) Meeting Schedule
UNH faculty, staff, and students who plan to conduct research involving human subjects must submit applications for IRB review prior to commencing the study. Applicants must receive written, unconditional IRB approval before starting their study.
Studies qualifying for Exempt or Expedited level review are reviewed by the IRB as they are received, usually within two (2) weeks (allow 3 weeks in the summer). Studies requiring Full Board level review must be submitted according to the following schedule:
Meeting Date |
Deadline for Receipt of Applications Requiring Full Board Review |
May 21, 2008 |
May 7, 2008 |
June 11, 2008 |
May 28 , 2008 |
July 16, 2008 |
July 2, 2008 |
August 27, 2008 |
August 13, 2008 |
Please note that this schedule is subject to change. Contact RCCS staff (603-862-3536 or Kathy.Stilwell@unh.edu) to confirm receipt deadlines and meeting dates.
Institutional Review Board (IRB) Functions and Membership
At UNH, the primary purpose of the IRB is to protect the rights and welfare of human research subjects by ensuring that physical, psychological, legal, and/or social risks to subjects are minimized, and when present, justified by the importance of the research, and agreed to by subjects (informed consent).
Secondly, the IRB seeks to protect UNH and researchers from possible adverse consequences of research with human subjects, by assisting researcher with the design of their studies so they comply with federal regulations and UNH requirements.
- Research is defined as "a systematic investigation (including research development, testing, and evaluation), designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)].
- Human subjects are defined as "living individual(s) about whom a researcher (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information" [45 CFR 46.102(f)].
All research conducted by UNH agents (faculty, students, and staff) at UNH or elsewhere, or by researchers of other institutions conducting research at UNH, using living humans as research subjects, or using samples or data obtained from living subjects, directly or indirectly, with or without the subjects’ consent, must be reviewed by the UNH IRB prior to commencing.
Review and approval by another IRB does not negate the requirement for review and approval by the UNH IRB.
The UNH IRB:
- Reviews all research studies involving human subjects,
- Reviews and addresses concerns involving the use of human subjects in research,
- Advises faculty, staff and students on the ethical conduct of research involving people,
- Conducts appropriate reviews of the University's program and develops guidelines to ensure compliance with federal and state regulations,
- Participates in developing, reviewing, and providing educational opportunities for the UNH community on the use and protection of human subjects in research, and
- Serves in an advisory capacity to the Vice President for Research.
Per federal regulations, the IRB cannot approve a research study ex post facto. Conducting research with human subjects at UNH without IRB approval is a violation of UNH policy. Researchers conducting studies without IRB approval are subject to the sanctions administered by the Vice President for Research.
The IRB is constituted according to federal regulations. Current IRB members are
Dina Bock, Community Member
Grant Cioffi, Education - Chair
Kurk Dorsey, History
John Limber, Psychology
Gladi Porsche, Physician, UNH Health Services
Julie Simpson, Office of Sponsored Research
Neil Vroman, Kinesiology - Vice Chair
Wendy Walsh, Family Research Laboratory
Melissa Wells, Social Work
Kathryn Cataneo, Office of Sponsored Research*
*Ex-Officio Non-Voting Member
Regulatory and Background Information on Human Subjects in Research
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UNH Federalwide Assurance for the Protection of Human Subjects |
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Information |
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National Institutes of Health (NIH) Certificates of Confidentiality Kiosk |
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Research Involving Individuals with Questionable Capacity to Consent: Points to Consider (NIH) |
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Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens |
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Office for Human Research Protections (OHRP) International Compilation of Human Subject Research Protections |
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Ethical Issues in Research Involving Human Subjects: Bibliography (National Library of Medicine) |
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Timeline of Laws Related to the Protection of Human Subjects (National Institutes of Health) |
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Ethical Issues in Qualitative Research on Internet Communities (British Medical Journal Article) |
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American Geriatrics Society Position Statement on Research Involving the Elderly |
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Bioethics Resources on the Web (National Institutes of Health) |
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Links |
Food and Drug Administration (FDA) Information Sheets for IRBs and Clinical Investigators |
Secretary's Advisory Committee on Human Research Protections (SACHRP) |
National Institutes of Health (NIH) Mandates Training in Human Subjects Protections for all Key Personnel
All NIH grant and contract awards that involve human subjects issued after October 1, 2000, require signed institutional documentation that all key personnel on a given award have received education/training in the protection of human subjects. This new rule was issued by NIH on June 5, 2000, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
This requirement falls under the NIH "just in time" procedures, meaning that the required training does not have to be completed by the time of proposal submission; rather, the training must be completed and certified by the institution BEFORE an award can be made. For further clarification, see "Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects" http://grants.nih.gov/grants/policy/hs_educ_faq.htm.
UNH has chosen to meet this policy by requiring the completion of two education components, listed below. Researchers and key personnel are responsible for ensuring they complete both components within the timeframe stipulated by NIH.
Each researcher and person identified as key personnel must take the on-line UNH Web-based training module on the use of human subjects in research. This can be accessed at http://www.unh.edu/rcr/HumSubj-Title.htm. Allow approximately 30 minutes to complete the module. Individuals must certify completion of the module as instructed at the end of the module.
Each researcher and person identified as key personnel must attend a seminar on human subjects protections. Please contact Julie Simpson at 603-862-2003 or for seminar information.
Upon completion of these two components, the RCCS Manager will issue individuals with a certificate of completion of continuing education in human subjects protections. Researchers should forward this documentation to NIH as proof of meeting the human subjects protections education requirement. Certificates will not be issued unless both components have been completed.
For more information please contact Julie Simpson, RCCS Manager at 603-862-2003 or .
