Institutional Review Board - Adams State University

Forms

Mission Statement of IRB

The Adams State University Institutional Review Board (IRB) serves the entire Adams State community by protecting human research participants and supporting the design and conduct of sound research.

Primary Function

The primary function of the Institutional Review Board (IRB) is to ensure protection of the rights of all human participants who participate in research endeavors conducted by Adams State faculty, professional staff, and/or students. The policies and regulations of the IRB are guided by federal rules and regulations, and are based on the Protection of Human Subjects Code of Federal Regulation, and the Belmont Report. According to 45CFR 46 – Protection of Human Subjects, at institutions receiving federal funds, all research involving human participants must be reviewed and approved by an IRB. Any research not approved by the IRB and not subject to the exceptions to IRB oversight may not be conducted on Adams State campus.

Role of the Review Process

Assess and identify the risks associated with the research, as distinguished from the risks the participants face in everyday life.
Determine if the foreseeable risks to human participants are minimal.
Determine if the risks of the research are within the level of accepted risks for human participants.
Identify the probable benefits of the research and who the beneficiaries of these benefits may be.
Determine if the risks are reasonable when weighed against the benefits of the research.
Assure that human participants are fully informed of all risks of the research, all benefits of the research, and what protections will be afforded to them should they select to take part in the research.
Identify and enact a reasonable period of review and ensure that collected data is stored and destroyed in an appropriate manner.

Application Types

Exempt Review
In accordance with 45 CFR 46.104(d)(3) and 45 CFR 46.111(a)(7), certain studies qualify for exemption form IRB review. Visit https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html#c2 to verify if your study qualified for exempt review.
Expedited Review
Studies involving no more than minimal risk that fall under a specific set of research categories can be reviewed through an accelerated review process.
Full Board Review
Studies involving more than minimal risk or that involve participants with diminished autonomy or involve deception go through review in front of the entire board.

Required Application Sections

In Reviewing Research Proposals, the IRB will not…

Render judgment on the quality of the research that has been proposed so long as that quality does not cause a risk to the human participants.
Advocate for or against specific research projects because of departmental, political, or personal interests.
Grant retroactive approval

Members of the IRB are expected to protect the integrity of the IRB process when conducting these duties. Faculty, professional staff, and students of Adams State are expected to protect the integrity of the IRB process when conducting research affiliated with Adams State.

Expected Review Timelines

Full-board reviews: 4-8 weeks
Expedited reviews: 2-4 weeks
Exempt reviews: 1 week

Membership

An Institutional Review Board (IRB) committee member represents a distinct area of research. Each member serves as the contact person for his or her respective area of research. Prior to initiating research at Adams State University, faculty members, professional staff members, and students are required to first determine which discipline their research would be categorized. Once the area of research is determined, the researchers should consult the appropriate IRB member for all questions and submissions to the IRB.

Note: If a conflict of interest exists with the IRB member who represents your discipline or if the research being planned is outside of any of the disciplines represented on the committee, researchers should direct all questions and submissions to the Chair of the committee:

Dr. Neil Rigsbee, Counselor Education (Interim Chair)
Dr. Jeff Elison, Psychology
Dr. Terry Dupler, Kinesiology
Dr. Alice Burch, Nursing
Dr. Michelle Mann, Education
Dr. Alex Vernon, Business

Legal Framework for Human Research Protection

The Institutional Review Board (IRB) operates within a comprehensive legal framework designed to protect human research participants. This framework is primarily based on federal regulations, commonly known as the “Common Rule,” which are codified in the Code of Federal Regulations (CFR) and published in the Federal Register. The following sections outline key regulations and policies that govern human subjects research.

U.S. Department of Health and Human Services (HHS) Regulations

45 CFR Part 46: Policy for the Protection of Human Research Subjects
45 CFR Parts 160 & 164 (subparts A & E): Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
Federalwide Assurance (FWA) for the Protection of Human Subjects – Outlines institutional commitments to comply with 45 CFR Part 46

Food and Drug Administration (FDA) Regulations

Department of Defense (DoD) Regulations

Data Protection Regulations

Family Educational Rights and Privacy Act (FERPA) – U.S. Department of Education policy that safeguards the privacy of student education records and establishes guidelines for accessing these records.
General Data Protection Regulation (GDPR) – European Union regulation that sets standards for handling personal data of EU residents and non-EU citizens located within the EU.