Research Involving Human Subjects

Policy 209

Purpose

This policy provides authority to the Institutional Review Board (hereinafter “IRB”) to provide ethical and regulatory oversight for research involving human subjects conducted by Appalachian State University, its faculty, staff, students and visitors.

Scope

This policy applies to all faculty, staff, students and any other individual engaged in research involving human subjects on the campus of the University, through funding provided by the University, on behalf of the University or in conjunction with University employees or students.

Definitions

Anonymity

means that the identity of subjects cannot be matched to their responses either directly through identifiers or by "linked" or "coded" responses.

Confidentiality

means not disclosing individually identifiable information received from a human subject to others in a manner inconsistent with the understanding of the original Informed Consent agreement.

Data Collection

means any research procedure that is intended to elicit from or record the actions, reactions, attitudes, and/or behavioral manifestations of human subjects participating in a research project.

Exempt Research

means human subject research activities which are minimal risk in nature and fall into one or more of the federally defined exempt research categories.

Expedited Review

means a review by the IRB Chair or designee of research proposals which involve minimal risk or no-risk.

Full IRB Review

means the review of proposals conducted during a convened IRB meeting at which a quorum has been established.

Human Subject

means a living individual about whom a researcher (whether professional or student) conducting research that (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable bio-specimens.

Informed Consent

means the voluntary agreement by an individual or an individual's legally authorized representative to participate in a particular study without any element of force, fraud, deceit, duress, or any other form of constraint or coercion. Valid consent requires voluntary action, competence, informed decision, and comprehension of terminology.

IRB

means the University’s institutional review board.

Minimal Risk

means that the probability and magnitude of harm(s) or discomfort(s) anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations.

Research

means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

University

means Appalachian State University

Vulnerable Populations

means human subjects that are children, prisoners, pregnant persons, or any population that may be relatively or absolutely incapable of protecting their interests through the informed consent process.

Policy and Procedure Statements

Roles and Responsibilities

Protection of Research Subjects

The primary responsibility for the responsible conduct of research shall reside with the investigators who are conducting the research. However, other persons not involved directly share in the responsibility to establish and maintain an atmosphere where respect for the rights of individuals and compliance with applicable regulations is the standard.

Vice Provost for Research

The Chancellor has designated the University’s Vice Provost for Research ("VPR") as the authorized Institutional Officer ("IO") with responsibility for the University’s program for the protection of human subjects.

Members of IRB

• The IRB shall report to the IO and consist of a minimum of five members, including:
  1. One member from a scientific area; and
  2. One member from a nonscientific area; and
  3. One member unaffiliated with the University; and
  4. Other additional members to provide expertise in research areas commonly employing human subjects, or expertise with unique or vulnerable populations to ensure ethical treatment of subjects; and
  5. The IRB Administrator, as an ex officio non-voting member.
• The Chancellor shall appoint all members of the IRB for a term of one to three years and shall designate a Chair.

Office of Research Protections

The Office of Research Protections provides administrative support and leadership to the IRB, and is responsible for the interpretation and implementation of this policy, as well as addressing non-compliance with this policy. The Office of Research Protection is responsible for:

1. Developing procedures to facilitate the review of human subjects research and to maintain compliance with federal regulations related to the protection of human subjects,
2. Developing procedures and guidelines for the IRB and University community related to the protection of human subjects under this policy,
3. Providing federal and state regulatory updates to the IRB and University Community, and
4. Acting as liaison with federal regulators when necessary.

IRB Oversight

• Any research involving human subjects, including internally funded, externally funded or unfunded research that involves University faculty, staff or students or is supported by or conducted on the University campus; must be reviewed and approved by the IRB prior to soliciting human subject participants or collecting any data from any human subject.
• The IO has the authority to rely on another institution’s IRB approval for collaborative activities where human subject protections are the responsibility of the collaborating intuition’s human subjects program.

Review Requirements

1. The IRB shall only approve research protocols that satisfy all of the following requirements:
   1. Any risk(s) to human subjects are minimal and reasonable in relation to anticipated benefits of the research;
   2. Selection of subjects is equitable given the purposes and the setting of the research;
   3. Researchers will seek Informed Consent appropriate to the research from each subject or the subject's legally authorized representative, and such consent will be appropriately documented (see Informed Consent Guidelines below);
   4. The research plan makes appropriate provision for monitoring the data collected to ensure the safety of subjects;
   5. Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data; and
   6. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included to protect the rights and welfare of these subjects.

Additional References

Appalachian State University’s Federal-wide Assurance

Appalachian State University’s Standard Operating Procedures for Human Subjects Research

Appalachian State University’s Human Subject Research Recruitment Policy

North Carolina Statute on Practice of Medicine

Authority

Code of Federal Regulations, Title 42, Chapter 6(a) Public Health Service, Subchapter III Part H

Code of Federal Regulations, Title 45, Part 46 (Protection of Human Subjects)

U.S. Food and Drug Administration Regulations, Title 21, Parts 50, 56, 312, 812

The UNC Policy Manual 100.1, Section 502

Contact Information

Office of Research Protections, (828) 262-7459 office, (828) 262-7459 fax, [email protected]

Original Effective Date

May 18, 2010

Revision Dates

April 29, 2019