Human Subjects in Research (IRB)

Keene State College Human Subject Research Policy and Procedures
Submission Guidelines
Human Subjects Training
Instructions for Extramural Researchers
Meeting Dates and Submission Deadlines
The KSC IRB Committee
Sample Informed Consent Forms (Templates)
Types of Review
Is Your Project Human Subjects Research?
Levels of Review

Keene State College Human Subject Research Policy and Procedures

Keene State recognizes the need for investigations in which human beings serve as research subjects. The College is also cognizant of its responsibility for ensuring that the privacy, safety, health, and welfare of subjects are adequately protected. An Institutional Review Board (IRB) has been established to review and approve the adequacy of human subject protection. Additionally, the College has established a Federal Wide Assurance with regard to the conduct of human subjects research.

The policies of the College, with respect to research involving human subjects are guided by The Belmont Report, a federal government document that charges each investigator who is conducting human subject research with the responsibility of demonstrating respect for persons, beneficence (maximizing benefits minimizing risks), and justice.

The policies are based on the following principles:

Participation in any research project must be voluntary;
The risks of participation must be acceptable when measured against the possible benefits to the participant or by the importance of the knowledge gained,
Research and training activities involving human subjects must be supervised by a qualified person,
All research programs that involve human subjects must be reviewed and approved by the IRB prior to initiation of the protocol.
Per Federal Regulations, continuing research may be required on an annual basis.
This applies to all research involving humans, not just clinical research and regardless of whether or not the research is funded.

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

Submission Guidelines

Investigators need to select and submit the appropriate document electronically to the IRB at irb@keene.edu.

Additionally, each IRB protocol submission must be accompanied by proof of satisfactory completion of the UNH Human Subjects IRB training (a certificate is generated upon completion-please include this with your materials). Per Keene State College policy, no IRB protocol can be approved without proof of training. For instructions on completing the training please visit https://rit.sr.unh.edu/training/rcr-training/human-subjects.html.

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.

Human Subjects Training

As of November 1, 2021 Keene State no longer has a contract with CITI for human subjects research training. Any student, faculty, or staff in need of training to conduct research with human subjects must complete the UNH web-based training on human subjects protections: https://rit.sr.unh.edu/training/rcr-training/human-subjects.html.

The training module takes approximately 30 minutes. Individuals who certify their completion of the module at the end will receive an email that is the documentation/certification of completion of the training to be submitted as part of the IRB application. The training is designed to assist researchers with gaining familiarity with key issues in conducting research involving human subjects. Please contact the Keene State IRB at irb@keene.edu with general questions. Contact Melissa McGee (603) 862-2005, Susan Jalbert (603) 862-3536, or Julie Simpson (603) 862-2003 in UNH Research Integrity Services with any questions about the documentation/certification of completion of training.

All researchers with current CITI certificates do not need to complete the UNH training until the CITI certificate expires.

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

The IRB Committee typically meets monthly during the fall and spring semesters, and on an as-needed basis during the summer. Timeline for Receiving Initial and Ongoing Approval Note: You must not begin your research until the IRB has given your research protocol full approval. The review process for protocols submitted for full board review can take up to a month or longer to complete.

Anticipated Timeline for Academic Year 2023/2024:

Protocol Submission Deadline is one week prior to Convened Meeting	Convened Meeting Date	Outcome of Review Communicated to Applicant is 1 week following Convened Meeting
September 22, 2023	September 29, 2023	October 6, 2023
October 20, 2023	October 27, 2023	November 3, 2023
November 24, 2023	December 1, 2023	December 8, 2023
January 12, 2024	January 19, 2024	January 26, 2024
February 9, 2024	February 16, 2024	February 23, 2024
March 8, 2024.	March 15, 2024	March 22, 2024
April 12, 2024	April 19, 2024	April 20, 2024
May 10, 2024	May 17, 2024	May 24, 2024

* 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.

What happens to my protocol, once I submit it?

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
Lito Amit, Member, Occupational Safety and Health
Paul Fowler, Member, Sustainable Product Design and Architecture
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:

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
All 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?

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Levels of Review