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(Policy and Procedure Statements)
(Review Requirements)
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## Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data; and
 
## Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data; and
 
## 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.
 
## 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.
 +
# 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.
 +
# 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.
 +
# 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.
 +
 +
=== Levels of Review ===
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==== Except Research and Limited Review ====
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# 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.
 +
# Research protocols involving the following will not be considered exempt from IRB review:
 +
## Prisoners as a specifically recruited population;
 +
## Children when the exemption category prohibits children as subjects;
 +
## Research which requires oversight by other federal regulations (e.g., HIPAA, FDA) where exemption is not permitted;
 +
## Research techniques which expose human subjects to more than minimal risk; or
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## The deception of the human subject without prospective agreement by the subject.
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 +
==== Expedited Review ====
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* 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.
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* Classified research involving human subjects cannot be subject to an Expedited Review.
 +
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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.
  
 
== Additional References ==
 
== Additional References ==

Revision as of 16:51, 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.

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.

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