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Policy ____ [''Number from Table of Contents'']
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Policy 209
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== Introduction ==
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== Purpose ==
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Appalachian State University has a responsibility and a requirement to maintain a specified level of confidentiality, and in some instances, total anonymity, in research involving the use of human subjects.  In addition, it is important to maintain appropriate business practices in payments to these subjects.  The University has set practices for handling various types of payments and the Internal Revenue Service (IRS) may require reporting of these payments.  Payment is defined as any type of remuneration including, but not limited to: cash, gift certificates, or other items of value.
+
 
−
+
This policy provides authority to the Institutional Review Board (hereinafter “IRB”) to provide ethical
−
The University must obtain the subject’s name, Social Security number/Banner ID and address in order to conform to certain IRS reporting requirements.  The informed consent document and process for research studies involving payment to human subjects must provide information to the subject regarding the need to disclose name, Social Security number/Banner ID, and address to the University for payment purposes.
+
and regulatory oversight for research involving human subjects conducted by Appalachian State
 +
University, its faculty, staff, students and visitors.
  
 
== Scope ==
 
== 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  ==
 
== Definitions  ==
  
−
=== Definition phrase or word ===
+
=== Anonymity ===
−
: Definition summary
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: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  ==
 
== Policy and Procedure Statements  ==
−
=== Methods of Payment ===
 
−
 
−
Cash is one method for making payments of less than $100 to human subjects. Another option is the Research Subject Payment Form (XLS 25K). This method results in a check written through Accounts Payable. Due to the administrative costs of processing a check, this method can be chosen when payment amounts exceed $25, but is required for payments of $100 or more. The P-Card should not be used to purchase gift cards to pay human subjects. If gift cards are chosen as the method of payment for small amounts, they should be purchased through the normal Procurement Form process.
 
−
 
−
Rather than using personal funds, a cash advance by procurement up to $1000 is the preferred method to fund cash payments to subjects. (Procurements > $1000 must receive prior approval and should be submitted to Amy Roberts, Special Funds Accounting.) No more than 2 cash advances can be “open” at any time. Any remaining cash after the project is complete must be deposited within 24 hours to the Cashiers Office. If you are traveling for the project, the 24 hour period begins when you return. A cash advance clearing form must be submitted to Special Funds within 30 days along with Stipend Log #1 (portrait (DOC 32K)) or (landscape (DOC 36K)), or Stipend Log #2 (4 slips to a page (DOC 25K)).
 
−
 
−
=== Catagory 1:  Confidential Studies ===
 
−
 
−
For studies where the University guarantees confidentiality and human subjects will be compensated, the University must obtain informed consent from the prospective research subject. The informed consent process would provide the prospective subject with information related to the reason for the need to provide the University with their name, Social Security number/Banner ID and address. Subjects who do not wish to have their confidential information shared with the University could have the option to waive receipt of any payment if they still wish to enroll in the study. If waiving receipt of payment violates the subject inclusion criteria for the study, the investigator may amend the form so that subjects who choose not to provide their name, Social Security number/Banner ID and address to the university may not enroll in the study.
 
−
 
−
=== Category 2: Total Anonymity ===
 
−
 
−
Some studies require total anonymity. The Principal Investigator (PI) must indicate to the Institutional Review Board (IRB) in the protocol application that subjects will be paid a nominal amount, how many subjects will be paid and why is it is important that total anonymity be maintained. In these instances, do not collect names or any other identifiers. The IRB will authorize payment using a form with the information that a certain dollar amount can be paid for a specified number of subjects and the period of time. This signed form should accompany all cash advance requests or reimbursements sent to Accounts Payable. (Only payments of less than $100 per occurrence may be made in cash to a human subject requiring anonymity. The total payments to any individual during a calendar year cannot exceed $599).
 
  
−
== Additional References ==
+
=== Roles and Responsibilities ===
  
−
== Authority ==
+
==== 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.
  
−
== Contact Information ==
+
==== Members of IRB ====
 +
4.1.3.1 The IRB shall report to the IO and consist of a minimum of five members, including:
 +
# One member from a scientific area; and
 +
# One member from a nonscientific area; and
 +
# One member unaffiliated with the University; and
 +
# 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
 +
# The IRB Administrator, as an ex officio non-voting member.
 +
4.1.3.2 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:
  
−
== Effective Date ==
+
# Developing procedures to facilitate the review of human subjects research and to maintain compliance with federal regulations related to the protection of human subjects,
 +
# Developing procedures and guidelines for the IRB and University community related to the protection of human subjects under this policy,
 +
# Providing federal and state regulatory updates to the IRB and University Community, and
 +
# Acting as liaison with federal regulators when necessary.
 +
 
 +
=== IRB Oversight ===
 +
4.2.1  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.
 +
 
 +
4.2.2 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 ===
 +
4.3.1 The IRB shall only approve research protocols that satisfy all of the following requirements:
 +
# Any risk(s) to human subjects are minimal and reasonable in relation to anticipated benefits of the research;
 +
# Selection of subjects is equitable given the purposes and the setting of the research;
 +
# 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);
 +
# The research plan makes appropriate provision for monitoring the data collected to ensure the safety of subjects;
 +
# 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.
 +
 
 +
4.3.2 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.
 +
 
 +
4.3.3  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.
 +
 
 +
4.3.4  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.
 +
 
 +
=== Levels of Review ===
 +
 
 +
==== Exempt Research and Limited Review ====
 +
4.4.1.1 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.
 +
 
 +
4.4.1.2  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
 +
# The deception of the human subject without prospective agreement by the subject.
 +
 
 +
==== Expedited Review ====
 +
4.4.2.1  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.
 +
 
 +
4.4.2.2  Classified research involving human subjects cannot be subject to an Expedited Review.
 +
 
 +
==== 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.
 +
 
 +
=== Full IRB Reviews ===
 +
4.5.1 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.
 +
 
 +
4.5.2  Members may participate and be counted toward quorum in meetings via teleconferencing technology.
 +
 
 +
4.5.3  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.
 +
 
 +
4.5.4  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.
 +
 
 +
4.5.5  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.
 +
 
 +
=== Informed Consent ===
 +
==== 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.
 +
 
 +
==== 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.
 +
 
 +
==== Content of Consent Forms ====
 +
For research that is not exempt from IRB review, Informed Consent forms shall include at a minimum the
 +
following information:
 +
 
 +
# 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;
 +
# A description of any reasonably foreseeable risks or discomforts to the subject;
 +
# A description of any benefits to the subject or to others that may reasonably be expected from the research; and
 +
# A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
 +
# A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
 +
# 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;
 +
# 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;
 +
# 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
 +
# One of the following statements about any research that involves the collection of identifiable private information or identifiable bio-specimens:
 +
## 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
 +
## 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.
 +
 
 +
==== Federal, State and Local Law Requirements ====
 +
Informed Consents shall also conform to all requirements of applicable federal, state, or local laws which require information to be disclosed in order to be legally effective. The consent form shall document that the subject understands the information contained therein, and has had an opportunity to have any of their questions answered prior to, during and after participation in the research.
 +
 
 +
==== Alternation(s) of Informed Consent ====
 +
The IRB may approve a consent procedure which does not include, or which alters some or all of the elements of Informed Consent set forth above, or waives requirements to obtain Informed Consent if the IRB determines the following:
 +
# The research involves no more than minimal risk to the subjects;
 +
# The waiver or alteration will not adversely affect the rights and welfare of the human subjects;
 +
# The research could not practicably be carried out without the waiver or alteration; and
 +
# Whenever appropriate, the researcher will provide the human subjects with additional pertinent information after participation.
 +
 
 +
==== Signed Consent Form(s) ====
 +
When an Informed Consent form requires the signatures of research subjects and/or their parents or legally authorized representative (LAR), a copy of the signed form must be given to the subject/parent/LAR and a copy must be retained by the Principal Investigator for a minimum of three years after completion of the project.
 +
 
 +
==== Waiver to Obtain Signed Consent Form ====
 +
The IRB may waive the requirement for the Principal Investigator to obtain a signed consent form for some or all subjects if the IRB determines the following:
 +
 
 +
# That the only record linking the human subject and the research would be the Informed Consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the human subject wants documentation linking the human subject with the research, and the subject's wishes will govern;
 +
# That the research presents no more than minimal risk of harm to human subjects and involves no procedures for which written consent is normally required outside of the research context; or
 +
# If the human subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to human subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
 +
 
 +
==== Written Statement ====
 +
In cases in which the Informed Consent requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
 +
 
 +
=== Continuing Review and Post-Approval Monitoring ===
 +
4.7.1  Continuing review will generally not be requested for minimal risk research unless the IRB documents the justification for continuing review within local practices or regulatory requirements.
 +
 
 +
4.7.2  If continuing review is required, IRB approval may be for a maximum one-year period. The Principal Investigator (“PI”) is responsible for requesting continuing review prior to the expiration of the approval period. Failure of the PI to initiate this annual review prior to the expiration date of the approval may result in termination of the IRB approval.
 +
 
 +
4.7.3  The IRB may conduct for cause and not for cause post approval monitoring of approved IRB research protocols in the following situations:
 +
# For cause monitoring may be the result of noncompliance, a reported incident, or other cause of concern identified by the IRB.
 +
# Not for cause monitoring will be regular, ongoing and randomly selected from all active, non-exempt studies.
 +
# Post approval monitoring may consist of record review, observing the consent process, or observing study procedures. One or more members of the IRB may participate in a monitoring event.
 +
 
 +
=== Payments to Human Subjects ===
 +
4.8.1 The Office of Research Protections, in conjunction with the Contracts and Grants Accounting, is responsible for maintaining procedures related to human subject research and compensation.
 +
 
 +
=== Noncompliance and Reportable Event ===
 +
4.9.1 If at any time, the IRB becomes aware of unanticipated problems involving risks to human subjects, serious or continuing noncompliance with federal requirements, or terminations of the IRB, including ongoing human subject research which has not been reviewed by the IRB, the IRB shall request a meeting with the PI and suspend the research until the problem can be further evaluated.
 +
 
 +
4.9.2  In the event the IRB becomes aware of such noncompliance, the IO shall be notified of the situation immediately, and advised of any further sanctions subsequently recommended by the IRB.
 +
 
 +
4.9.3  Possible sanctions the IRB may impose for noncompliance include, but are not limited to, suspending the Principal Investigator’s right to conduct or supervise research involving human subjects, taking possession of the data collected by the non-compliant PI, withholding or revoking academic credit to a student PI, and recommending discipline of a faculty or staff member to the Provost & Executive Vice Chancellor.
 +
 
 +
4.9.4  Principal Investigators will receive notice of any such sanction within 3 business days of the determination by the IRB, and such sanction shall be final.
 +
 
 +
4.9.5  As required by federal regulations, any decision of the IRB with respect to research involving human subjects is final. However, the convened IRB may review an investigator’s request for reconsideration to a determination regarding noncompliance and/or corrective actions as warranted by the presentation of new information or unusual circumstances. All investigator petitions must be made within 30 days of the investigator’s notification of the IRB’s sanction. The IRB will review an investigator’s request within 30 days, and the investigator will be notified in writing of the IRB’s decision within 14 days of the review.
 +
 
 +
== Related University Policies ==
 +
:[[Human Subject Research Recruitment|Appalachian State University’s Human Subject Research Recruitment Policy]]
 +
 
 +
== Additional References ==
 +
:[https://www.govinfo.gov/content/pkg/USCODE-2011-title42/html/USCODE-2011-title42.htm Code of Federal Regulations, Title 42, Chapter 6(a) Public Health Service, Subchapter III Part H]
 +
:[https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html Code of Federal Regulations, Title 45, Part 46 (Protection of Human Subjects)]
 +
:[https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs U.S. Food and Drug Administration Regulations, Title 21, Parts 50, 56, 312, 812]
 +
:[https://www.ncleg.net/enactedlegislation/statutes/html/bychapter/chapter_90.html North Carolina Statute on Practice of Medicine]
 +
:[https://researchprotections.appstate.edu/human-subjects Appalachian State University's Federal-wide Assurance]
 +
:[https://researchprotections.appstate.edu/human-subjects-irb/irb-policies-and-guidelines Appalachian State University's Standard Operating Procedures for Human Subjects Research]
 +
 
 +
== Contact Information ==
 +
:Vice Provost for Research, (828) 262-7459, irb@appstate.edu, [https://research.appstate.edu/ Office of Research]
 +
 
 +
== Original Effective Date ==
 +
:May 18, 2010
  
 
== Revision Dates ==
 
== Revision Dates ==
 +
:April 29, 2019
 +
:December 1, 2021
 +
:March 8, 2024
 +
 +
[[Category:Contents]]
 +
[[Category:Academic Affairs]]

Latest revision as of 19:31, 8 March 2024

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

4.1.3.1 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.

4.1.3.2 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

4.2.1 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.

4.2.2 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

4.3.1 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.

4.3.2 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.

4.3.3 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.

4.3.4 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 Exempt Research and Limited Review

4.4.1.1 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.

4.4.1.2 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

4.4.2.1 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.

4.4.2.2 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

4.5.1 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.

4.5.2 Members may participate and be counted toward quorum in meetings via teleconferencing technology.

4.5.3 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.

4.5.4 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.

4.5.5 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.

4.6.4 Federal, State and Local Law Requirements

Informed Consents shall also conform to all requirements of applicable federal, state, or local laws which require information to be disclosed in order to be legally effective. The consent form shall document that the subject understands the information contained therein, and has had an opportunity to have any of their questions answered prior to, during and after participation in the research.

4.6.5 Alternation(s) of Informed Consent

The IRB may approve a consent procedure which does not include, or which alters some or all of the elements of Informed Consent set forth above, or waives requirements to obtain Informed Consent if the IRB determines the following:

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the human subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the researcher will provide the human subjects with additional pertinent information after participation.

4.6.6 Signed Consent Form(s)

When an Informed Consent form requires the signatures of research subjects and/or their parents or legally authorized representative (LAR), a copy of the signed form must be given to the subject/parent/LAR and a copy must be retained by the Principal Investigator for a minimum of three years after completion of the project.

4.6.7 Waiver to Obtain Signed Consent Form

The IRB may waive the requirement for the Principal Investigator to obtain a signed consent form for some or all subjects if the IRB determines the following:

  1. That the only record linking the human subject and the research would be the Informed Consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the human subject wants documentation linking the human subject with the research, and the subject's wishes will govern;
  2. That the research presents no more than minimal risk of harm to human subjects and involves no procedures for which written consent is normally required outside of the research context; or
  3. If the human subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to human subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

4.6.8 Written Statement

In cases in which the Informed Consent requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

4.7 Continuing Review and Post-Approval Monitoring

4.7.1 Continuing review will generally not be requested for minimal risk research unless the IRB documents the justification for continuing review within local practices or regulatory requirements.

4.7.2 If continuing review is required, IRB approval may be for a maximum one-year period. The Principal Investigator (“PI”) is responsible for requesting continuing review prior to the expiration of the approval period. Failure of the PI to initiate this annual review prior to the expiration date of the approval may result in termination of the IRB approval.

4.7.3 The IRB may conduct for cause and not for cause post approval monitoring of approved IRB research protocols in the following situations:

  1. For cause monitoring may be the result of noncompliance, a reported incident, or other cause of concern identified by the IRB.
  2. Not for cause monitoring will be regular, ongoing and randomly selected from all active, non-exempt studies.
  3. Post approval monitoring may consist of record review, observing the consent process, or observing study procedures. One or more members of the IRB may participate in a monitoring event.

4.8 Payments to Human Subjects

4.8.1 The Office of Research Protections, in conjunction with the Contracts and Grants Accounting, is responsible for maintaining procedures related to human subject research and compensation.

4.9 Noncompliance and Reportable Event

4.9.1 If at any time, the IRB becomes aware of unanticipated problems involving risks to human subjects, serious or continuing noncompliance with federal requirements, or terminations of the IRB, including ongoing human subject research which has not been reviewed by the IRB, the IRB shall request a meeting with the PI and suspend the research until the problem can be further evaluated.

4.9.2 In the event the IRB becomes aware of such noncompliance, the IO shall be notified of the situation immediately, and advised of any further sanctions subsequently recommended by the IRB.

4.9.3 Possible sanctions the IRB may impose for noncompliance include, but are not limited to, suspending the Principal Investigator’s right to conduct or supervise research involving human subjects, taking possession of the data collected by the non-compliant PI, withholding or revoking academic credit to a student PI, and recommending discipline of a faculty or staff member to the Provost & Executive Vice Chancellor.

4.9.4 Principal Investigators will receive notice of any such sanction within 3 business days of the determination by the IRB, and such sanction shall be final.

4.9.5 As required by federal regulations, any decision of the IRB with respect to research involving human subjects is final. However, the convened IRB may review an investigator’s request for reconsideration to a determination regarding noncompliance and/or corrective actions as warranted by the presentation of new information or unusual circumstances. All investigator petitions must be made within 30 days of the investigator’s notification of the IRB’s sanction. The IRB will review an investigator’s request within 30 days, and the investigator will be notified in writing of the IRB’s decision within 14 days of the review.

5 Related University Policies

Appalachian State University’s Human Subject Research Recruitment Policy

6 Additional References

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
North Carolina Statute on Practice of Medicine
Appalachian State University's Federal-wide Assurance
Appalachian State University's Standard Operating Procedures for Human Subjects Research

7 Contact Information

Vice Provost for Research, (828) 262-7459, irb@appstate.edu, Office of Research

8 Original Effective Date

May 18, 2010

9 Revision Dates

April 29, 2019
December 1, 2021
March 8, 2024
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