IRB Policies

This document is to serve as a guide for Edgewood College faculty, staff, and students engaged in research projects involving human participants. These guidelines have been prepared with the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR Part 46), known as the "Common Rule," as a guide. These guidelines provide for and direct the activities of the Edgewood College Institutional Review Board (IRB). The guidelines are housed in the Edgewood College Oscar Rennebohm Library, can be obtained from the IRB Chairperson, or can be found at https://www.edgewood.edu/irb.

The Edgewood College Institutional Review Board (IRB) will be responsible for reviewing all Edgewood College research proposals involving the use of human participants. The IRB shall review, approve or disapprove, and/or request changes in submitted projects brought before it based on the policies stated herein.

1. The Human Participants Review Board (HPRB)

A. Members

The Edgewood College IRB shall be composed of individuals that will credibly represent the varying perspectives of participants, investigators, and society at large. The Human Participants Review Board shall strive to include diverse membership. The Edgewood College IRB will be composed of at least 6 members (5 active and 1 alternate [1]; including the IRB Chair and IRB Administrator) who have exhibited the professional competencies necessary to review human research proposals. The IRB Chair and IRB Administrator will be appointed by the Vice President for Academic Affairs and will have expertise in research methods and ethical guidelines. Members will have demonstrated knowledge, expertise and competency in quantitative and/or qualitative methodologies, disciplines and perspectives. The IRB members will include, but not be limited to: one faculty member teaching in a graduate program, one faculty member teaching in an undergraduate program, one member external to the Edgewood College community [2], one member whose main concerns are nonscientific areas, one member who is a Edgewood College student, and two members at large from the Edgewood College community.

The non-affiliated member(s) of the IRB will be drawn from the local community-at-large. The person(s) selected should be knowledgeable about their own local community and be willing to discuss issues and research from that perspective. Consideration will be given to the type of community from which the institution will draw its research participants. Ad hoc members with expertise in special populations (e.g., the incarcerated, the elderly, the mentally ill, pregnant women, and children) may also be appointed and consulted as needed.

Affiliated IRB committee members will meet the rules set forth in The Common Rule (45 CFR Part 46) and serve staggered two or three year terms as appointed by the VPAA.

IRB members will complete or have completed appropriate training in the legal and ethical standards for the conduct of human subject research.

B. Responsibilities

The Edgewood College IRB will review, approve or disapprove, and/or recommend changes in submitted protocols based on the criteria outlined in these “Guidelines For Research Involving Human Participants,” their experience and expertise, and in accordance with all applicable laws, regulations, and institutional policies. Research involving human participants must come before the IRB in accordance with the policies stated herein. In addition, the IRB has the authority to conduct audits, investigate complaints about, place restrictions on, suspend or terminate approval of a research study that is not being conducted in accordance with applicable law or institutional policies or that has been associated with unexpected serious harm to subjects.

C. Records/Reports

1. The IRB will keep the following records for at least three (3) years after closure of the research study:

1. Copies of research study proposals, informed consent documents, and progress reports;

2. Copies of correspondence between the IRB and principal investigators;

3. Adverse reaction reports.

2. IRB will permanently maintain IRB membership records, IRB policies and procedures, and minutes of IRB meetings.

3. The work of the Board and appropriate supporting documents will be submitted to the Vice President of Academic Affairs at the end of each semester.

4. The IRB Chair will promptly provide written notice of suspension or early termination of the IRB’s approval of a research study to the investigator, the Vice President of Academic Affairs and, if appropriate, the Department of Health and Human Services (DHHS), the head of any supporting federal agency and the Office of Human Research Protections (OHRP).

5. If the IRB becomes aware of any unanticipated problems involving risks to participants or any serious or continuing noncompliance with the federal regulations governing research, the IRB Chair will notify the head of the appropriate supporting federal agency and, if appropriate, OHRP. A copy of the report will be simultaneously delivered to the Vice President of Academic Affairs and to the investigator.

6. The IRB Chair will report to the Office for Research Integrity any occurrence of scientific misconduct in a Public Health Service-sponsored research study that involves fabrication, plagiarism or other practices that are not accepted within the scientific community for proposing, conducting or reporting research.

[1] Any IRB member who has a conflicting interest with a specific proposal must recuse him/herself from the Board during deliberation of the specific proposal. The alternate will attend all meetings but will not vote unless a permanent member recuses him/herself.

[2] The IRB member from the community will not be affiliated with Edgewood College and must be qualified to review proposals and be knowledgeable regarding the context of the community.

IRB Policies

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