Definitions and Regulations

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Research – 45 CFR 46.102(I)  

 A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to general knowledge. 

• Systematic investigation: A structured and organized method of inquiry involving data collection and analysis. 
• Generalizable knowledge: Information intended to be applied beyond the immediate study sample (e.g., publications, presentations, or policy development). 

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Human Subject – (45 CFR 46.102(e)(1))  

A living individual about whom an investigator conducting research obtains: 

• Data through intervention or interaction, or 
• Identifiable private information. 
• Intervention: Physical procedures (e.g., blood draws) or manipulations of the subject’s environment. 
• Interaction: Communication or interpersonal contact (e.g., interviews, surveys). 
• Identifiable private information: Data that can be directly or indirectly linked to an individual. 

Human Research Protection Training

OHRP offers this comprehensive training on human research protections based on the requirements of the revised Common Rule (or 2018 Requirements). A printable completion certificate is available at the conclusion of each lesson. Note that OHRP does not collect information about who accesses or completes this training.

Institutional Review Committee

Purpose of the Institutional Review Committee:

The Jackson College Institutional Review Committee shall protect the rights and welfare of human subjects involved in research activities at Jackson College or under its auspices.

The committee shall:

• Advise investigators in designing research projects in a manner that minimizes potential harm to human subjects.
• Review all planned research involving human subjects prior to the research being conducted.
• Ensure adherence to the criteria for IRC approval as listed in 45 CFR 46.111 and 21 CFR 56.111. [may not apply – see exemptions in 45 CFR 46.101(b)]
• Monitor approved research to ascertain that human subjects are indeed protected.
• Provide support and guidance to the research community at Jackson College, as well as ongoing support and advice on issues that arise during the conduct of research.

Decision-Making Context and Scope:

• The IRC shall review and have authority to exempt, approve, require modifications, or deny, any human subject research carried out at Jackson College or under its auspices.
• The Institutional Review Committee shall use a consensus based decision-making method when possible. If the body is unable to reach consensus, a simple majority vote may be used. Opposing views shall be documented in the record of the meeting.
• The Institutional Review Committee provides recommendations and input to the President and the Board of Trustees.

Defined Goals, Monitoring, Reporting, and Accountability:

• Protect the rights of human subjects who participate in research.
• Assess the risks and benefits of proposed research, and ensure that risks to human subjects are kept to an absolute minimum and are justified by potential benefits of the research.
• Ensure the confidentiality of information obtained from research subjects to the extent allowed by law.
• Create a cooperative process, encouraging dialogue with researchers.
• Comply with all applicable state and federal laws.

Identification of Key Customers/Stakeholders and their requirements

Key Customers/Stakeholders	Input Methods
The JC Board of Trustees	Board Monitoring Report feedback
The President’s Office	Inquiry, policy feedback/approval
Students Researchers/Research participants	45 CFR 46.111 and 21 CFR 56.111Department of Health and Human Services
Faculty, Staff, and Administrators	Best practices

Membership

• The IRC shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
• The IRC shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas.
• No IRC member may participate in the IRC’s initial or continuing review of any project in which the member has a conflicting interest.
• The IRC may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRC. These individuals may not vote with the IRC.

Roles and Responsibilities:

• Chairperson- Prepares the agenda, runs the meeting and maintains order, serves as the point of contact for the IRC; is accountable for representing the IRC at the College’s Leadership Council and making reports on behalf of the IRC.

Meetings:

• The IRC will meet minimally on a semester basis, or as necessary to review IRC proposals.

Reporting:

• IRC work shall be summarized in timely written reports to the President, the Jackson College Leadership Council, and the Board of Trustees (as directed by the President).