Difference between revisions of "Research Involving Human Subjects"

Revision as of 17:03, 1 December 2021

Policy 209

1 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.

2 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.

3 Definitions

3.1 Anonymity

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

3.2 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.

3.3 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.

3.4 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.

3.5 Expedited Review

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

3.6 Full IRB Review

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

3.7 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.

3.8 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.

3.9 IRB

means the University’s institutional review board.

3.10 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.

3.11 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.

3.12 University

means Appalachian State University

3.13 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.

4 Policy and Procedure Statements

4.1 Roles and Responsibilities

4.1.1 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.

4.1.2 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.

4.1.3 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.

4.1.4 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.

4.2 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.

4.3 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.
2. All proposals for research with human subjects will be processed by the IRB through an exemption letter, Expedited Review or Full Review. The IRB shall determine in its sole discretion which form of review is appropriate for each research protocol.
3. In reviewing research proposals, the IRB has the authority to approve as written, require modifications, defer review to a later date, disapprove or terminate any research involving human subjects conducted.
4. Research proposals approved by the IRB may be subject to further review by University officials as appropriate. However, those officials may not approve the research if it has not been approved by the IRB.

4.4 Levels of Review

4.4.1 Except Research and Limited Review

1. Certain categories of research protocols may be exempt from IRB review or may require limited IRB review. Research Protections staff, in consultation with the IRB Chair when necessary, shall make a determination regarding exemption or limited IRB review.
2. Research protocols involving the following will not be considered exempt from IRB review:
   1. Prisoners as a specifically recruited population;
   2. Children when the exemption category prohibits children as subjects;
   3. Research which requires oversight by other federal regulations (e.g., HIPAA, FDA) where exemption is not permitted;
   4. Research techniques which expose human subjects to more than minimal risk; or
   5. The deception of the human subject without prospective agreement by the subject.

4.4.2 Expedited Review

• Federal regulations permit an expedited review procedure for research protocols that meet certain eligibility requirements. Such reviews may be carried out by the Chair of the IRB or by one or more experienced reviewers from among the members of the Board. In performing expedited reviews, reviewers may exercise all of the authorities of the IRB with the exception of disapproval. A research project may be disapproved only after a Full Review by the IRB. The IRB shall be informed of all expedited reviews at its next full meeting.
• Classified research involving human subjects cannot be subject to an Expedited Review.

4.4.3 Full IRB Review

Full IRB Review must take place for all protocols that do not qualify for an Exempt or Expedited Review or as otherwise specified by the IRB.

4.5 Full IRB Reviews

• The IRB shall engage in initial and continuing reviews of research protocols at their scheduled meetings. In order to conduct business, a majority of the members must be present, including at least one member who represents the nonscientific community. This constitutes a quorum.
• Members may participate and be counted toward quorum in meetings via teleconferencing technology.
• Approval of research protocols shall be via a majority vote of the quorum. Should a quorum be lost during a meeting, the IRB may not take further action or vote until the quorum is restored.
• Minutes of each IRB meeting shall document the deliberations, actions, and votes for each research protocol whether undergoing initial or continuing review. IRB Chair shall record votes as the number of “For,” “Opposed,” and/or “Abstaining.” Minutes shall include notation and explanation of any unusual degree of risk or an approval period less than one year for any research protocol.
• IRB shall retain all records of its meetings and research protocols for at least three years after completion of the research or in accordance with the UNC System Record Retention Policy, whichever is longer.

4.6 Informed Consent

4.6.1 Informed Consent

Obtaining the Informed Consent of a potential human subject (or the subject’s legally authorized representative) for participation in non-exempt research is a federally mandated safeguard to ensure the protection of the rights and welfare of all human subjects.

4.6.2 Complex Informed Consent

For complex Informed Consent forms, the investigator must provide a concise statement of the possible risks and other key information regarding the research protocol to assist a prospective human subject or their legally authorized representative to make an informed determination to participate or not in the research.

4.6.3 Content of Consent Forms

For research that is not exempt from IRB review, Informed Consent forms shall include at a minimum the following information:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research; and
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable bio-specimens:
   1. A statement that identifiers might be removed from the identifiable private information or identifiable bio-specimens and that, after such removal, the information or bio-specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative; or
   2. A statement that the subject’s information or bio-specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

5 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

6 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

7 Contact Information

Office of Research Protections, (828) 262-7459 office, (828) 262-7459 fax, irb@appstate.edu

8 Original Effective Date

May 18, 2010

9 Revision Dates

April 29, 2019