Human Subjects in Research (IRB)
Announcement, December 20, 2021
As of January 1, 2022, the Keene State IRB will no longer review expedited protocols on a rolling basis. All protocols will be reviewed at monthly meetings. The meeting schedule (and required submission date to be reviewed by that meeting date) are as follows:
Beginning Jan 01, 2022, all protocols will be reviewed at monthly meetings. Harlan will assign a “primary” reviewer to each protocol and that person will lead the discussion of the assigned protocol at the full-board meeting. Spring 2022 dates are as follows:
Full IRB Committee receives materials for review 2 weeks prior to Convened Meeting (for Full Board) and a minimum of 1 week for expedited reviews:
Must receive materials by / To be reviewed at Convened Meeting on:
- January 10, 2022 / - January 21, 2022
- February 7, 2022 / - February 18, 2022
- March 7, 2022 / - March 11, 2022 (moved up for Spring Break)
- April 4, 2022 / - April 15, 2022
- May 9, 2022 / - May 20, 2022
Please also pay attention to the below announcement outlining changes in CITI human subjects training.
Announcement, November 2021
As of November 1, 2021 Keene State will no longer have 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 firstname.lastname@example.org 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.
- Keene State College Human Subject Research Policy and Procedures
- Submission Guidelines
- 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.
Investigators need to select and submit the appropriate document electronically to the IRB at this address (email@example.com).
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.
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 (firstname.lastname@example.org). 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 2021/2022:
|Protocol Submission Deadline is 2 weeks prior to Convened Meeting||Full IRB Committee receives materials for review is 1 week prior to Convened Meeting||Convened Meeting Date||Outcome of Review Communicated to Applicant is 1 week following Convened Meeting|
|January 10, 2022||January 17, 2022||January 21, 2022||January 28, 2022|
|February 7, 2022||February 14, 2022||February 18, 2022||February 25, 2022|
|February 28, 2022||March 7, 2022||March 11, 2022||March 18, 2022|
|April 4, 2022||April 11, 2022||April 15, 2022||April 22, 2022|
|May 9, 2022||May 16, 2022||May 20, 2022||MAY 27, 2022|
*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 “lengthiest” review 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, Chair, Psychology
Angela Barlow, Member, Sociology/Anthropology/Criminology
Fitni Destani, Member, Physical Education
Christopher Parsons, Member, English, (non-scientist)
John Hart, Member, Music, (non-scientist)
Lito Amit, Member, Occupational Safety and Health 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:
“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.
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?
Levels of Review
I still have questions. Whom can I contact?
Dr. Angela Barlow
Dr. Harlan Fichtenholtz