ABAC Section 13.2 – Human Subjects Research Policy
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Policy Statement
It is Abraham Baldwin Agricultural College (ABAC) policy that no research involving human subjects may be undertaken until approval has been granted by the Institutional Review Board (IRB). This includes research conducted or involving ABAC faculty, staff, and students from all instructional sites.
Guiding Principles and Regulations
In order to protect the rights of all human participants involved in research at ABAC, the college operates its human participant research programs under Federalwide Assurance (FWA) with the Office of Human Research Protection (OHRP) within the Department of Health and Human Services. The FWA represents a fundamental commitment to the protection of human participants and applies to all ABAC research involving human participants, regardless of the location of the research or its sources of funding, be they governmental agencies, nonprofit organizations, industry, or college funds. In addition, the FWA applies to all research that is conducted at ABAC or using ABAC resources regardless of who is conducting the research. As part of its mission, ABAC maintains a Human Research Protection Program that adheres to the principles outlined in the Belmont Report, as well as with the federal regulations, outlined in 45 CFR 46 and 21 CFR 56, including their subparts, as applicable. In addition, the college complies with other ABAC and University System of Georgia policies and procedures concerning the use of human participants in research.
Definitions
RESEARCH refers to a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A SYSTEMATIC INVESTIGATION is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
A HUMAN SUBJECT a living individual about whom an investigator conducting research 1) Obtains information or biospecimens through intervention or interaction with the individual,
and uses, studies, or analyzes the information or biospecimens; or 2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Responsibilities
The Provost and Vice President for Academic Affairs shall be responsible for the uniform application and enforcement of this policy.
Applicability
The ABAC Human Subjects Research Policy applies to all individuals engaged in scientific and scholarly research involving human subjects, including scientists, faculty, graduate and professional students, technicians, and other staff members. This policy applies to undergraduate students employed in research or working on federally sponsored research, fellows, guest researchers, visiting faculty or staff, faculty or staff on sabbatical leave, adjunct faculty when performing college work, and faculty or staff on leave without pay.
Administrative Actions constituting misconduct as defined herein, or in subsequent procedures, shall not be grievable through any existing or future grievance process.
The ABAC Institutional Review Board Policy complies with regulations applicable to the Public Health Service and the National Science Foundation. However, the application of this Policy shall not be limited to human subjects research arising out of federally funded research. It applies to all research involving human subjects, funded or not.
Procedures
A comprehensive set of procedures shall be drafted and maintained by the Provost and Vice President for Academic Affairs. These shall include:
- This policy, incorporated by reference
- Definitions
- Safeguards to privacy, meeting or exceeding the terms of this policy
- Safeguards to protect data, including student records and research records
- FERPA, HIPAA and other Federal requirements for student data privacy
- FWA and IRB registrations
- IRB member terms of service
- IRB member training requirements
- IRB member conflicts of interest and indemnification
- IRB Chair selection, term, and duties
- IRB Meetings, minutes, and recordkeeping
- Reliance agreements
- Training Requirements for all researchers/applicants, whether paid or unpaid
- Qualifications of researchers
- Researcher application process, systems and forms
- IRB review process and timeframe
- Research Determinations for exempt, expedited and full board review
- Faculty Advisors and sponsors
- Research subject recruitment and participation
- Informed consent, assent, and other participant permissions
- Cooperative, international and internet-based research
- Vulnerable populations and additional requirements
- Community or participatory research
- Genetic materials
- Amendments and changes to approved protocols
- Continuing review
- Project closure
- Policy or procedure(s) non-compliance
- Unanticipated problems
- Administrative actions, including suspension and/or termination
- Record Retention and destruction, consistent with this policy
- Periodic IRB assessment, evaluation and audit
- Parameters for communication, including public website presence
- Notifications and reporting required by Sponsor(s)
- NIH, NSF, FDA and other Federal requirements, as appropriate
- Other considerations not envisioned by this policy or working Procedures
- Policy and/or procedure change notification and training
Procedures shall be reviewed every two years. Minor procedure changes, such as updated web links or forms, may be completed by the VP for Academic Affairs without prior authorization. Substantive changes and new procedures will be brought to the full IRB for their review and approval. If the Board determines it is warranted, further review by the Cabinet and President may be required.
Membership
Members, including the Chair, are appointed by the Provost. The Board shall : 1) have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects; 2) have at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas; 3) have at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution; 4) not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. Membership will be reviewed by the Chair and Provost annually.
Administrative Actions
The Institutional Review Board will notify applicants of Administrative Actions, including but not limited to approval, denial, need for further review or closure, within 10 business days of its vote on said action.
The Institutional Review Board may suspend or terminate human subjects research it determines to be in violation of this policy and will notify local, state and Federal agencies as prescribed in their regulations and charters. Further, the IRB will notify and refer such matters to the Policy Owner for their consideration and action per existing disciplinary structures.
Record Retention
ABAC requires researchers to maintain, in a specified location that ensures security, privacy and confidentiality, all records pertaining to human subjects research conducted. Records may be kept in hardcopy, electronic, or other media form. While most federal regulations require IRB records be retained for at least three (3) years beyond program expiration, researchers should be familiar with and follow the requirements of the USG Records Retention Manual. Also, there may be additional record retention requirements indicated by the sponsor, funding agency, or regulatory authority that must be followed.
For example, “Projects of major national or international significance, interest, or controversy, or where the principal investigator has a widely acknowledged influence on the area of scholarship: PERMANENT; Projects that are not of major significance but there are potential long-term affects [sic]: Retain 70 years after completion of project; Projects that are not of major significance and where the research does not have potential long term affects: 3 years after completion of research project.” BOR 0472-09-004
All research records must be accessible for inspection and copying/reproduction by authorized representative (e.g. IRB, HHS, FDA, Sponsors) at reasonable times and in a reasonable manner. If the researcher should leave the college prior to the end of the record retention period, the researcher is responsible for initiating a mutually satisfactory arrangement with the department and the college administration as to the disposition of the executed subject consent documents and research related files. If a protocol is cancelled without participant enrollment, IRB records must be maintained for at least three (3) years after cancellation.
References and Related Information
https://www.usg.edu/policymanual/section8/C224/#p8.2.18_personnel_conduct
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
https://www.usg.edu/records_management/schedules
Contact Information
Vice President for Academic Affairs and Provost: Tift Hall Administrative suite, 229.391.4783.