Human Subjects in Research (IRB)

1. Submission Guidelines
2. Human Subjects Training
3. Instructions for Extramural Researchers
4. Meeting Dates and Submission Deadlines
5. The KSC IRB Committee
6. Types of Review
7. Is Your Project Human Subjects Research?
8. Helpful links
9. I still have questions. Whom can I contact?

Keene State College’s full IRB policy and procedure manual is available here.

Submission Guidelines

Investigators must use Cayuse to electronically submit new research studies for review and approval, course approvals, continuing research requests, amendments to approved research studies, and incident reports.

Additionally, each IRB protocol submission must include a certificate of completion of the CITI Human Subjects IRB training. A certificate is required for each researcher on the proposed study. Per Keene State College policy, no IRB protocol can be approved without proof of training. See the Human Subjects Training section below for more details and instructions.

If the research involves children (under 18), vulnerable populations (e.g. prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons), sensitive questions, deception, or potentially harmful interventions, a full board review will likely be required. For children, the consent form must have a signature line for the child’s assent and the parent’s consent.

If the research qualifies as minimal risk, involves adults (age 18 or older), secondary data analysis, non-sensitive questions, or routine educational or cognitive tests, an expedited review is possible, handled by the IRB chair or his/her designee, without need of a full review. See the Types of Review section below for more information.

Human Subjects Training

Any student, faculty, or staff in need of human subjects research training must complete a CITI Human Subjects research module. The training is designed to familiarize researchers with key issues in conducting research on human subjects. Researchers will receive a certificate documenting their successful completion of the training module(s).

This certificate is to be submitted as part of IRB applications on Cayuse. Researchers will need to retake the CITI training after their current certificate expires. Researchers with active UNH human subjects training certificates do not need to complete the CITI training until their UNH certificate expires.

To complete the CITI training, follow the steps below.

1. Navigate to https://about.citiprogram.org.
2. Click on “Register” in the top-right corner.
3. Click the heading “Log in Through My Organization.”
4. In the search field provided, start typing “University System of New Hampshire” and select the “University System of New Hampshire” option. Then click “Continue To SSO Login / Instructions.”
5. If you are not enrolled in any courses for the institution, select “Add a Course.”
6. Scroll down and answer the series of nine (9) questions to help determine which CITI courses are appropriate for you to take. You will likely require the “Human Subjects Research for Social-Behavioral-Educational Researchers” or “Human Subjects Research for Biomedical Researchers” (if conducting biomedical research).
7. CITI will then guide you through the training modules relevant to your research.
8. After completing the module, you will receive your CITI certificate. Save this certificate, as it will be submitted to Cayuse as proof of your training in your IRB applications.

Contact Susan Jalbert, Melissa McGee, or Julie Simpson at research.integrity@unh.edu with any questions about CITI training.

Instructions for Extramural Researchers

Extramural investigators desiring to conduct human subject research at Keene State College, either by using the College’s facilities or by recruiting members of the College’s community as participants, are expected to demonstrate compliance with all relevant federal and state human subject regulations, including review and approval by their sponsoring or affiliated IRBs.

To demonstrate said compliance, extramural researchers should submit a copy of the protocol submitted to their IRB along with a copy of the IRB’s Record of Review indicating that the protocol was approved. Submit these items electronically to the Keene State College IRB at this address (irb@keene.edu). Approval by an extramural IRB does not necessarily replace review by Keene State College’s IRB, however, which may elect to do its own full review of the protocol.

Members of the Keene State College IRB are expected to keep all information and documentation disclosed during the IRB review process confidential. These confidentiality requirements continue indefinitely.

Meeting Dates and Submission Deadlines

If your proposed research required a full board review (see Submission Guidelines section above), it will be reviewed during an IRB Committee meeting. The IRB Committee typically meets monthly during the fall and spring semesters, and on an as-needed basis during the summer.

The review process for protocols submitted for full board review can take up to a month or longer to complete. Research proposals not requiring full board review will be reviewed on a rolling basis. In any case, you must not begin your research until the IRB has given your research protocol full approval.

Anticipated Timeline for Academic Year 2024/2025

Protocol Submission Deadline for Full Board Reviews	IRB Meeting Date	IRB Protocol Decision Date
September 20, 2024	September 27, 2024	October 4, 2024
October 18, 2024	October 25, 2024	November 1, 2024
November 15, 2024	November 22, 2024	November 29, 2024
December 6, 2024	December 13, 2024	December 20, 2024
January 24, 2025	January 31, 2025	February 7, 2025
February 21, 2025	February 28, 2025	March 7, 2025
March 21, 2025	March 28, 2025	April 4, 2025
April 18, 2025	April 25, 2025	May 2, 2025
May 16, 2025	May 23, 2025	May 30, 2025

• Note, protocols may be submitted at any time. If they are eligible for expedited review, they will be processed and reviewed on a rolling basis. The above dates, however, give you an idea of the timeline to expect in instances where full board review is required. Please be aware that protocols that result in questions during the review process that must be addressed with the investigator may take longer to resolve.

You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol. Minor revisions may be reviewed by the chair alone, or by a subcommittee of the full IRB. Substantive revisions usually return to the full board for review at a regularly scheduled meeting.

Per federal regulations, some ongoing projects (normally those NOT previously approved via expedited review) must seek re-approval at least annually. It is the investigator’s responsibility to submit renewal protocols in a timely fashion. No human subjects research may be conducted without a current IRB approval in place.

The KSC IRB Committee

Harlan Fichtenholtz, Co-Chair, Psychology
John Hart, Co-Chair, Music
Margaret Henning, Member, Health Sciences
Shailee Woodard, Member, Psychology
Wren Fournier, Member, non-affiliated community member

Sample Informed Consent Forms (Templates) Below you will find three templates for consent forms; two for adults (one with template including instructions and one template only) and one for children.

• Informed Consent Form for Adults - Template with Guidance
• Informed Consent Form for Adults - Template Only
• Informed Consent Form for Children
• IRB Broad Consent Form

Types of Review

There are three levels of IRB review. See the Levels of Review Chart for an overview of each of these levels. The levels of review are described in more detail below.

1. Exempt

“Exempt” means a protocol does not require extensive initial regulatory review. It does not mean the protocol is exempt from IRB review. To qualify as exempt, research must fall into any of eight (8) regulated exemption categories. The categories represent a low potential for risk to subjects.

Risk is reduced through anonymity of responses, use of existing or publicly available data, or through the use of non-invasive paradigms that will not harm subjects. Exempt reviews are conducted by designees of the full IRB. Some common examples of Exempt research:

• Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or the observation of public behavior, unless: a. information is recorded in such a manner that human subjects can be identified b. any disclosure of the human subjects responses outside the research could place subjects at risk of criminal or civil liability, or be damaging to the subject’s financial standing, employability, or reputation.
• Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met and the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.

Important: The likelihood that a proposal of this kind will be found exempt does not relieve you of the responsibility to submit your proposal to the IRB chair and have him or her decide if the proposal is in fact exempt.

For more information see the full IRB Policy and Procedure Manual.

2. Expedited

To qualify for expedited review, research must fall into one of the regulated expedited 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 reviews are conducted by a subcommittee of the full IRB. Some common examples of expedited research:

• Studies including blood samples taken from healthy volunteers
• Studies including moderate exercise by healthy volunteers
• Analyses of voice recordings (such as those taken in the investigation of speech defects)
• Studies of existing data or pathological specimens that include patient identifiers

For more information see the full IRB Policy and Procedure Manual.

3. Full Board

Proposed human subject research that does not qualify for exemption or expedited review must be reviewed by the full IRB. Protocols sent to the full board represent more than minimal risk to subjects, and are, therefore, reviewed rigorously for compliance with all applicable federal, state, local and university regulations. Some common examples of research requiring full IRB review:

• Research on Substance Abuse
• Research on Sexual and Physical Abuse
• Research on Depression and Suicide
• Some research involving Children and Adolescents
• Research on Sexuality and Gender
• Research involving subjects with Impaired Decision-Making Ability
• Research involving Prisoners

For more information see the full IRB Policy and Procedure Manual.

Is Your Project Human Subjects Research?

View document

Helpful links

• UNH Cayuse Information and Help
• USNH Support Team for the Administration of Research (STAR)
• Office of Human Research Protections (OHRP)
• OHRP Database for Registered IORGs and IRBs, and Approved FWAs (including Keene State College)
• Information Individuals in New Hampshire are Legally Required to Report

I still have questions. Whom can I contact?

IRB Administrator
IRB@keene.edu

IRB Co-Chairs

• Dr. Harlan Fichtenholtz 603-358-2705
• Dr. John Hart
  603-358-2193