Research Involving Human Subjects: Difference between revisions

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Policy 209
University Policy 209
== Purpose ==


This policy provides authority to the Institutional Review Board (hereinafter “IRB”) to provide ethical
== 1. Purpose ==
and regulatory oversight for research involving human subjects conducted by Appalachian State
University, its faculty, staff, students and visitors.


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


This policy applies to all faculty, staff, students and any other individual engaged in research involving
== 2. Scope ==
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  ==
All research involving human subjects that is conducted by University researchers – regardless of funding or funding source – must be reviewed and approved by IRB for the use of human subjects in research. This policy applies to all Appalachian faculty, staff, students and any other individual engaged in cooperative research with University that involves human subjects.


=== Anonymity ===
== 3. General Principles ==
:means that the identity of subjects cannot be matched to their responses either directly through identifiers or by "linked" or "coded" responses.


=== Confidentiality ===
All University researchers must adhere to ethical standards for the use of human subjects in their research. These principles and standards exist to protect the basic rights and welfare of humans participating in research. The Belmont Report establishes the principles of beneficence, justice, and respect for persons as core values in human subjects’ research. The ethical principles found in the Belmont Report are incorporated in 45.CFR.46.111 as criteria for IRB approval of research. Any research that departs from the spirit or practice of these principles and standards violates University policy and/or the federal regulation 45.CFR.46.
: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 ===
== 4. Definitions ==
: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 ===
'''4.1 Adverse Events'''
: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 any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered “related” to the subject’s participation in the research. Adverse events encompass both physical and psychological harms.
:means a review by the IRB Chair or designee of research proposals which involve minimal risk or no-risk.


=== Full IRB Review ===
'''4.2 Anonymity'''
:means the review of proposals conducted during a convened IRB meeting at which a quorum has been established.


=== Human Subject ===
Means that the identity of a subject cannot be matched to their responses, either directly through identifiers or by "linked" or "coded" responses.
: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 ===
'''4.3 Clinical Trial'''
: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 a research study in which one or more human subjects is prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes.
:means the University’s institutional review board.
 
'''4.4 Confidentiality'''
=== 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.
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.
 
'''4.5 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.
 
'''4.6 De-Identified Data'''
 
De-identified data refers to the dataset that an investigator has created when they initially generated identifiable data and then removed all direct and indirect identifiers from the data set. The investigator at one time had access to identifiable/indirectly identifiable data, but they have removed the ID/code from the dataset or destroyed the linkage file and thus, the data can no longer be linked back to any individual subject in the study.
 
'''4.7 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.
 
'''4.8 Expedited Review'''
 
Means a review by the IRB Chair or designee of research proposals which involve minimal risk.
 
'''4.9 Full IRB Review'''
 
Means the review of proposals conducted during a convened IRB meeting at which a quorum has been established.
 
'''4.10 Human Subject'''
 
Means a living individual about whom a researcher 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.
 
'''4.11 Identifiable biospecimen'''
 
Means a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen (see 45 CFR 46 (e)(1)).
 
'''4.12 Identifiable private information'''
 
Means private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. This includes re-identification of the subject due to access, expertise, use of technology, and consideration of all data and information available.
 
'''4.13 Interactions'''
 
Means communication or interpersonal contact between the investigator and subject.
 
'''4.14 Intervention'''
 
Means both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
 
'''4.15 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.
 
'''4.16 IRB'''
 
Means the University’s institutional review board.
 
'''4.17 IRB Approval'''
 
Means the determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirements.
 
'''4.18 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.
 
'''4.19 Non-compliance'''
 
Failure of an investigator to follow the applicable laws, regulations, or institutional policies governing the protection of human subjects in research, or the requirements or determinations of the IRB, whether the failure is intentional or not.
 
'''4.20 Personally Identifiable Information (PII)'''
 
Means information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Whether certain information is considered PII requires a case-by-case assessment of the specific risk that an individual can be identified. In performing this assessment, researchers should recognize that non-PII can become PII whenever additional information is made publicly available — in any medium and from any source — that, when combined with other available information, could be used to identify an individual.
 
'''4.21 Private information'''
 
Means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place.  Private information also means information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record, smartphone data, web browser history).
 
'''4.22 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.
 
'''4.23 Terms of Assurance'''
 
An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by the Secretary of Health and Human Services (HHS). Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45.CFR.46. The Federal wide Assurance (FWA) is the only type of assurance of compliance accepted and approved by the Office of Human Research Protections.
 
'''4.24 University'''
 
Means Appalachian State University.
 
'''4.25 Unanticipated problems:'''
 
Means any incident, experience, or outcome that meets all of the following criteria (as determined by the IRB):
 
:4.25.1. The problem is unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied;
:4.25.2. The problem is related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
:4.25.3. The problem suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
 
'''4.26 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. Other examples of vulnerable populations include people who are situationally vulnerable due to their status such as employee, student, student-athlete, or people who are marginalized due to their individual identity or demographics.
 
== 5. Policy and Procedure Statements ==
 
'''5.1 Roles and Responsibilities'''
 
'''5.1.1 Research Investigators'''
 
The primary responsibility for the ethical and compliant conduct of research shall reside with the investigators who are conducting the research. This includes but is not limited to responsible and compliant research design, implementation, and the seeking of appropriate research protocol approvals. When student work is submitted to the IRB for review and approval, a University faculty member must serve as the primary investigator and as the student’s advisor, and must assume responsibility for the conduct of the student’s research under their direction.
 
'''5.1.2 Institutional Official'''
 
The Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the FWA. The IO is a Chancellor appointed individual of sufficient rank who has the authority to ensure that all obligations of the HRPP are carried out effectively and efficiently.
 
'''5.1.3 The IRB Chair'''
 
The IRB Chair promotes a culture consistent with the objectives of University’s HRPP, with special emphasis on the respect for and protection of individuals participating in research at the University. The IRB Chair presides over meetings of the fully convened IRB and ensures that the IRB carries out its duly authorized responsibilities as required by federal regulations, ethical principles, state laws, and University policy. The IRB Chair works closely with the IRB Office Staff and the IO to ensure that policies and procedures are current, research with human subjects, regardless of level of review, meet all necessary standards or criteria for approval.
 
'''5.1.4 The IRB Full Board'''
 
The IRB Full Board is made up of a diverse group of people proposed by the IRB Chair and the IO.  The IRB Full Board must be composed of people who are scientists, non-scientists, unaffiliated with the University in any other way, and experts in research areas commonly employing human subjects at University, and those with expertise with unique or vulnerable populations. The IRB Full Board is responsible for reviewing and approving research with human subjects to ensure compliance and ethical treatment of participants. A convened IRB Full Board is the only authority that can “disapprove” a study.
 
'''5.1.5 Office of Research Protections'''
 
The Office of Research Protections provides administrative support and leadership to the IRB Office.
 
'''5.1.6 The IRB Office Staff'''
 
The IRB office is made up of administrative staff who are tasked with managing the daily operations for facilitating the review and approval for research with human subjects completed by Appalachian State University faculty, staff, and students. The IRB office, in conjunction with the IRB Full Board, is responsible for the interpretation and implementation of this Policy and all subsequent unit standards and operating procedures.
 
'''5.2 IRB Oversight'''
 
5.2.1 Any research involving human subjects, regardless of funding or funding source, where University faculty, staff or students are engaged in the project as research personnel, must be reviewed and approved by the IRB prior to implementation of any research procedures including recruitment and consent, implementation of intervention, interaction with participants, manipulation of participant’s environment, or access to private identifiable data.
 
'''5.3 Protocol Submission, Review, and Approval'''
 
'''5.3.1 Protocol Submission'''
 
5.3.1.1. University researchers are expected to complete thorough and internally consistent IRB applications adhering to all applicable laws, policies, regulations, and unit standards.
 
5.3.1.2. The IRB accepts IRB applications via an online electronic application system. This system allows researchers to submit an IRB application and related study materials to the IRB for review and approval. The online application system is accessible via University’s IRB Website.
 
5.3.1.3. A student may complete the IRB application and provide related materials. However the application itself must be formally submitted to the IRB by the student’s faculty advisor (FA), designated as the primary investigator (PI) in the application and all supporting documents. After ensuring all aspects of the application are complete, the FA may then certify the application and supporting documents for review by the IRB.
 
'''5.3.2 Protocol Review'''
 
Once the IRB application has been completed and all study materials have been uploaded into the electronic IRB application system, the IRB will review the application. There are four types of review for projects submitted to the IRB. Determination of the type of review will be made by the IRB office (in conjunction with the IRB Chair as appropriate) upon consideration of the submitted application and study materials. 
 
5.3.2.1. Administrative review leading to an Exemption Determination
 
The federal regulations governing research with human subjects (45.CFR.46.104) detail categories of research involving human subjects that are deemed “exempt from the requirements of the regulation.” At University, the IRB office makes this determination, the researcher does not. This means that when a researcher submits an application to the IRB for review, that the IRB office will review the protocol and determine its eligibility for exemption. These studies are beholden to ethical standards and applicable federal, state, and local laws. 
 
5.3.2.2. Limited review leading to an Exemption Determination
 
The federal regulations governing research with human subjects (45.CFR.46.104) detail categories of research involving human subjects that are deemed “exempt from the requirements of the regulation.” When a human subjects research protocol is minimal risk, fits into the regulatorily defined exemption categories, and the IRB completes a “Limited Review,” studies that may have required an Expedited review due to privacy and confidentiality concerns, may instead be eligible for exemption. A Limited review is completed by the IRB and ensures that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of their data.
 
5.3.2.3. Expedited Review
 
[https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46#46.110 Expedited review] consists of a review of a research protocol involving human subjects by the IRB chairperson or by an experienced reviewer designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. A study is eligible for Expedited review when the proposed research poses no more than minimal risk to participants and study procedures involve only one (or several) of the categories of research outlined by 45.CFR.46 and supplemental guidance. These [https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html categories] will be maintained by HHS, updated as appropriate, and posted as a notice in the Federal Register. Studies undergoing Expedited review are subject to all aspects of [https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46#46.111 45.CFR.46.111].
 
5.3.2.4. Full Board Review
 
Studies requiring Full Board review and approval are studies that are considered “more than minimal risk,” testing a medical device for safety or efficacy, investigating a drug or biologic, or a study that is “minimal risk” but it does not fit into any eligible Expedited review categories.  Studies requiring Full Board review are subject to all regulations set forth in [https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46#46.111 45.CFR.46] and the study may only be approved at a convened Full Board meeting with quorum.
 
5.3.2.5. Amendment Requests
 
Any changes to the research procedures or study documents in an IRB approved protocol - regardless of level or review - an Amendment Request must be submitted to the IRB office via the electronic IRB application system before any changes are implemented. No changes to the approved study protocol may be implemented until the Amendment Request is processed and approved by the IRB.
 
5.3.2.6. Annual Approval Renewal
 
All studies reviewed via the Full Board, some studies reviewed via Expedited procedures, or studies contractually obligated to do so, must undergo Annual Approval Review.
 
'''5.3.3 Protocol Approval'''
 
5.3.3.1. Approved
 
The study protocol was approved by the IRB, and research with human subjects as described in the approved protocol may commence.
 
5.3.3.1.a. For all non-exempt studies, in order for a study to be considered approved, the IRB must find that the study has met the criteria for approval as defined in the federal regulation 45.CFR.46.111.  


=== Research ===
5.3.3.1.b. For all studies resulting in an Exemption Determination from the IRB, the IRB must find that the study is minimal risk, applicable laws are accounted for, and participants are appropriately treated throughout the research. When a “Limited Review” is required for an Exemption Determination, the IRB must find that the study has met the criteria for approval as defined in the federal regulation 45.CFR.46.111.a.8.  
: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 ===
5.3.3.2. Approved with Stipulations
:means Appalachian State University


=== Vulnerable Populations ===
If the study is approved with stipulations, the IRB staff will work with the PI to complete the necessary changes and finalize approval. Research procedures may not commence until final approval is granted.  
: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  ==
5.3.3.3. Deferred
=== Roles and Responsibilities ===
4.1.1 The protection of research subjects from unnecessary or unacceptable risk is a university-wide responsibility. The primary responsibility for the responsible conduct of research falls on the investigators (faculty, faculty associates, academic staff, graduate students, undergraduates, technicians, etc.) who are conducting the research. However, other persons not involved directly (faculty colleagues, department reviewers, department heads, deans, etc.) 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 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 The IRB shall report to the IO and consist of a minimum of five members, including:
#One member from a scientific area;
#One member from a nonscientific area;
#One member unaffiliated with the University;
#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.


4.1.4 The Chancellor shall appoint all members of the IRB for a term of one to three years and shall designate a Chair.  
If the convened IRB Full Board is unable to document that the criteria of approval detailed in 45 CFR 46.111 have been satisfied, then the IRB may defer the study. If the study is deferred, the IRB staff will work with the PI to prepare the study for review again.
4.1.5 The Office of Research Protections provides administrative support to the IRB, including but not limited to the following:
#Receipt and initial screening of requests for IRB review;
#Determining level of review in consultation with the IRB Chair when appropriate;
#Conducting primary reviews of exempt level studies;
#Conducting initial review of expedited studies;
#Preparing agenda, materials and recording minutes for all IRB meetings;
#Providing federal and state regulatory updates and guidance to the IRB;
#Developing required and appropriate Standard Operating Procedures for the protection of human subjects.


=== IRB Oversight ===
5.3.3.4. Not Approved


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.  
The study as submitted to the IRB for review, is not approvable and no research with human subjects may take place. This decision may only be made by a convened IRB Full Board with quorum. This decision may only be appealed/overturned by a convened IRB Full Board with quorum. Any appeal shall be in writing to the IRB Full Board and, upon request, the PI may present arguments and evidence to the IRB Full Board at a duly convened meeting of the IRB Full Board. While the PI may request notification of the appeal to the Provost or other academic administrator, the final decision of any appeal rests with the IRB Full Board and no further appeal shall be available to the PI.


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.  
5.3.3.5. Approval Period


=== Review Process ===
When an application is approved, the research approval period is issued. Any research done before or after this approval period is subject to an investigation of non-compliance. This includes recruitment of participants, consenting participants, collecting data from participants, implementing an intervention with participants, manipulating participants’ environment, and analyzing identifiable or re-identifiable private information. Under special circumstances, the IRB may require approval renewal for studies at increments shorter than one year. An approval period is applicable to all full board studies, and in some cases, studies receiving expedited approval or studies eligible for exemption.  
4.3.1 The IRB reviews protocols for research in accordance with federal regulations governing research with human subjects, state law, local requirements and University policy. 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 research proposals 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.
5.3.4 Ancillary Reviews


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.  
Research proposals approved by the IRB may be subject to ancillary reviews by University officials as appropriate.  


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.
'''5.4 Required Reporting Post-Approval Monitoring'''


=== Levels of Review ===
'''5.4.1. Required Reporting'''


4.4.1 Exempt Research and Limited Review.  
5.4.1.1. Non-compliance
#Certain categories of research protocols may be exempt from IRB review.  The IRB Administrator, in consultation with the IRB Chair, shall make a determination regarding exemption from review or limited review by the IRB. 
#The IRB shall not exempt research protocols from IRB review if they involve the following:
##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.


4.4.2 Expedited Review
University researchers conducting research with human subjects must comply with the provisions of the IRB-approved study as well as all related federal laws and regulations, university policies, and state and local laws. The failure (regardless of intention) to comply with any applicable federal laws and regulations, university policies, and state and local laws governing human research constitutes non-compliance. If a researcher becomes aware of any non-compliance, the researcher must report this to the IRB Office immediately. A non-compliance investigation will commence in accordance with the IRB unit standard for issues of non-compliance.  
#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 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 ===
5.4.1.2. Unanticipated Problems and Adverse Events


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.  
All Unanticipated Problems and Adverse Events must be reported by the researchers to the IRB office as soon as possible with all appropriate information for the IRB to make relevant determinations.


4.5.2 Members may participate and be counted toward quorum in meetings via teleconferencing technology. 
5.4.1.3. Participant Concerns and Complaints


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.
All participant complaints and concerns regarding the conduct of human subject research completed by University researchers should be brought to the attention of the IRB office. Complaints and concerns may be raised by past, present, and potential research participants, family members, designated spokespersons, or anyone else associated with the research project. Should a researcher receive a complaint or concern directly from a participant, the researcher must notify the IRB office of the issue as soon as possible. If the IRB office receives the complaint or concern, an IRB office representative will review the issue and take appropriate steps for resolution.  


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.  
'''5.4.2. Post-Approval Monitoring'''


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.
The IRB may conduct “for cause” and random audits of IRB approved research protocols in accordance with the IRB’s Standard for Post-Approval Monitoring.  


=== Informed Consent ===
'''5.5 Suspension or Termination of a Human Subjects’ Research Protocol'''


4.6.1 Informed Consent constitutes the very essence of protecting the rights of human subjects. 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.  
5.5.1. The IRB may suspend or terminate some or all research activities on a specific research protocol if events are identified that represent serious or continuing noncompliance or unanticipated problems involving additional or increased risk to subjects or others.  


4.6.2 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.
5.5.2. The IRB may suspend some or all of the research conducted by a principal investigator as a result of serious or continuing noncompliance or if there are unanticipated problems involving additional or increased risk to subjects or others.  
   
   
4.6.3 For research that is not exempt from IRB review, Informed Consent forms shall include at a minimum the following information:
5.5.3. Suspension or termination of a protocol or multiple protocols from one PI, is most often determined by the convened IRB Full Board with quorum. However, the IRB Chairperson in conjunction with the Director for Research Protections or Institutional Official has the authority to suspend some or all research activities if exceptional human subject safety issues are identified.
#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;
== 6. Cooperative Research ==
#A description of any benefits to the subject or to others that may reasonably be expected from the research;
 
#A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
Cooperative research projects are those projects that involve University and at least one other researcher not associated with University. When conducting cooperative research projects, each investigator is responsible for safeguarding the rights and welfare of human subjects, for complying with 45.CFR.46, and their affiliated IRB is responsible for oversight.
#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;
6.1. Any IRB that has a researcher engaged in a federally funded non-exempt cooperative research project, must rely upon the review and approval of a single IRB via a formal agreement.
#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
6.2. Any IRB that has a researcher engaged in an unfunded non-exempt cooperative research project, may rely upon the review and approval of a single IRB for research via a formal agreement. 
#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
6.3. Any IRB that has a researcher engaged in cooperative research eligible for an exemption determination, may rely upon the review and approval of a single IRB for research via a formal agreement.
##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.
 
6.4. Any investigator that is unaffiliated with an IRB, but engaging in cooperative human subjects research with a University researcher, must engage in a formal agreement with the IRB indicating that the unaffiliated investigator will abide by all University policies, standards, and requirements stated in the associated IRB approved protocol.


4.6.4 Informed Consents shall also confirm 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 his/her questions answered prior to, during and after participation in the research.
== 7. Data Management and Security ==


4.6.5 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:
Data must be managed as described in the approved IRB protocol and in accordance with all federal laws, state laws, local laws, and University data management standards.
#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.


4.6.6 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.  
== 8. IRB Office Standards ==


4.6.7 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:
All researchers conducting research with human subjects must adhere to all unit standards established by the IRB.
#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.


4.6.8 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.
== Additional Resources ==


=== Continuing Review & Post-Approval Monitoring ===
Forms


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.
Statutes


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.
[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]


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:
[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)]
#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.


=== Noncompliance and Reportable Event ===
[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]


4.8.1 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.
[https://www.ncleg.net/enactedlegislation/statutes/html/bychapter/chapter_90.html North Carolina Statute on Practice of Medicine]


4.8.2 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.
[https://researchprotections.appstate.edu/human-subjects Appalachian State University's Federal-wide Assurance]


4.8.3 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.
[https://researchprotections.appstate.edu/human-subjects-irb/irb-policies-and-guidelines Appalachian State University's Standard Operating Procedures for Human Subjects Research]


4.8.4 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.
Policies and Standards


4.8.5 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 his/her 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.
[https://policy.appstate.edu/Human_Subject_Research_Recruitment Appalachian State University’s Human Subject Research Recruitment Policy]


== Additional References ==
[https://security.appstate.edu/data-security Data Management Standard]
:[https://researchprotections.appstate.edu/human-subjects Appalachian State University’s Federal-wide Assurance]
:[https://researchprotections.appstate.edu/sites/researchprotections.appstate.edu/files/IRB%20SOP3%20Continuing%20Review%2011-12-2012.pdf Appalachian State University’s Standard Operating Procedures for Human Subjects Research]
:[https://policy.appstate.edu/Human_Subject_Research_Recruitment Appalachian State University’s Human Subject Research Recruitment Policy]
:[https://www.ncleg.net/enactedlegislation/statutes/html/bychapter/chapter_90.html North Carolina Statute on Practice of Medicine]


== Authority ==
[https://archives.ncdcr.gov/documents/universitygs2021pdf/open UNC System Office Records Retention and Disposition Schedule (2021)]
:[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.northcarolina.edu/apps/policy/index.php?pg=vs&id=s4428 The UNC Policy Manual 100.1, Section 502]


== Contact Information ==
== Administrative Unit Contact ==
:Office of Research Protections, (828) 262-7459 office, (828) 262-7459 fax, [email protected]
Director of Research Protections Division<br>
[https://research.appstate.edu/ Web Link]<br>
(828) 262-2901


== Original Effective Date ==
== History ==
:May 18, 2010


== Revision Dates ==
Issued: April 29, 2019
:April 29, 2019


[[Category:Contents]]
Revised:<br>
[[Category:Academic Affairs]]
December 1, 2021<br>
March 8, 2024<br>
January 27, 2025

Latest revision as of 15:27, 6 February 2025

University Policy 209

1. Purpose

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

2. Scope

All research involving human subjects that is conducted by University researchers – regardless of funding or funding source – must be reviewed and approved by IRB for the use of human subjects in research. This policy applies to all Appalachian faculty, staff, students and any other individual engaged in cooperative research with University that involves human subjects.

3. General Principles

All University researchers must adhere to ethical standards for the use of human subjects in their research. These principles and standards exist to protect the basic rights and welfare of humans participating in research. The Belmont Report establishes the principles of beneficence, justice, and respect for persons as core values in human subjects’ research. The ethical principles found in the Belmont Report are incorporated in 45.CFR.46.111 as criteria for IRB approval of research. Any research that departs from the spirit or practice of these principles and standards violates University policy and/or the federal regulation 45.CFR.46.

4. Definitions

4.1 Adverse Events

Means any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered “related” to the subject’s participation in the research. Adverse events encompass both physical and psychological harms.

4.2 Anonymity

Means that the identity of a subject cannot be matched to their responses, either directly through identifiers or by "linked" or "coded" responses.

4.3 Clinical Trial

Means a research study in which one or more human subjects is prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes.

4.4 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.

4.5 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.

4.6 De-Identified Data

De-identified data refers to the dataset that an investigator has created when they initially generated identifiable data and then removed all direct and indirect identifiers from the data set. The investigator at one time had access to identifiable/indirectly identifiable data, but they have removed the ID/code from the dataset or destroyed the linkage file and thus, the data can no longer be linked back to any individual subject in the study.

4.7 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.

4.8 Expedited Review

Means a review by the IRB Chair or designee of research proposals which involve minimal risk.

4.9 Full IRB Review

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

4.10 Human Subject

Means a living individual about whom a researcher 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.

4.11 Identifiable biospecimen

Means a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen (see 45 CFR 46 (e)(1)).

4.12 Identifiable private information

Means private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. This includes re-identification of the subject due to access, expertise, use of technology, and consideration of all data and information available.

4.13 Interactions

Means communication or interpersonal contact between the investigator and subject.

4.14 Intervention

Means both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

4.15 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.

4.16 IRB

Means the University’s institutional review board.

4.17 IRB Approval

Means the determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirements.

4.18 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.

4.19 Non-compliance

Failure of an investigator to follow the applicable laws, regulations, or institutional policies governing the protection of human subjects in research, or the requirements or determinations of the IRB, whether the failure is intentional or not.

4.20 Personally Identifiable Information (PII)

Means information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Whether certain information is considered PII requires a case-by-case assessment of the specific risk that an individual can be identified. In performing this assessment, researchers should recognize that non-PII can become PII whenever additional information is made publicly available — in any medium and from any source — that, when combined with other available information, could be used to identify an individual.

4.21 Private information

Means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Private information also means information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record, smartphone data, web browser history).

4.22 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.

4.23 Terms of Assurance

An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by the Secretary of Health and Human Services (HHS). Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human subjects at 45.CFR.46. The Federal wide Assurance (FWA) is the only type of assurance of compliance accepted and approved by the Office of Human Research Protections.

4.24 University

Means Appalachian State University.

4.25 Unanticipated problems:

Means any incident, experience, or outcome that meets all of the following criteria (as determined by the IRB):

4.25.1. The problem is unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied;
4.25.2. The problem is related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
4.25.3. The problem suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

4.26 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. Other examples of vulnerable populations include people who are situationally vulnerable due to their status such as employee, student, student-athlete, or people who are marginalized due to their individual identity or demographics.

5. Policy and Procedure Statements

5.1 Roles and Responsibilities

5.1.1 Research Investigators

The primary responsibility for the ethical and compliant conduct of research shall reside with the investigators who are conducting the research. This includes but is not limited to responsible and compliant research design, implementation, and the seeking of appropriate research protocol approvals. When student work is submitted to the IRB for review and approval, a University faculty member must serve as the primary investigator and as the student’s advisor, and must assume responsibility for the conduct of the student’s research under their direction.

5.1.2 Institutional Official

The Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the FWA. The IO is a Chancellor appointed individual of sufficient rank who has the authority to ensure that all obligations of the HRPP are carried out effectively and efficiently.

5.1.3 The IRB Chair

The IRB Chair promotes a culture consistent with the objectives of University’s HRPP, with special emphasis on the respect for and protection of individuals participating in research at the University. The IRB Chair presides over meetings of the fully convened IRB and ensures that the IRB carries out its duly authorized responsibilities as required by federal regulations, ethical principles, state laws, and University policy. The IRB Chair works closely with the IRB Office Staff and the IO to ensure that policies and procedures are current, research with human subjects, regardless of level of review, meet all necessary standards or criteria for approval.

5.1.4 The IRB Full Board

The IRB Full Board is made up of a diverse group of people proposed by the IRB Chair and the IO. The IRB Full Board must be composed of people who are scientists, non-scientists, unaffiliated with the University in any other way, and experts in research areas commonly employing human subjects at University, and those with expertise with unique or vulnerable populations. The IRB Full Board is responsible for reviewing and approving research with human subjects to ensure compliance and ethical treatment of participants. A convened IRB Full Board is the only authority that can “disapprove” a study.

5.1.5 Office of Research Protections

The Office of Research Protections provides administrative support and leadership to the IRB Office.

5.1.6 The IRB Office Staff

The IRB office is made up of administrative staff who are tasked with managing the daily operations for facilitating the review and approval for research with human subjects completed by Appalachian State University faculty, staff, and students. The IRB office, in conjunction with the IRB Full Board, is responsible for the interpretation and implementation of this Policy and all subsequent unit standards and operating procedures.

5.2 IRB Oversight

5.2.1 Any research involving human subjects, regardless of funding or funding source, where University faculty, staff or students are engaged in the project as research personnel, must be reviewed and approved by the IRB prior to implementation of any research procedures including recruitment and consent, implementation of intervention, interaction with participants, manipulation of participant’s environment, or access to private identifiable data.

5.3 Protocol Submission, Review, and Approval

5.3.1 Protocol Submission

5.3.1.1. University researchers are expected to complete thorough and internally consistent IRB applications adhering to all applicable laws, policies, regulations, and unit standards.

5.3.1.2. The IRB accepts IRB applications via an online electronic application system. This system allows researchers to submit an IRB application and related study materials to the IRB for review and approval. The online application system is accessible via University’s IRB Website.

5.3.1.3. A student may complete the IRB application and provide related materials. However the application itself must be formally submitted to the IRB by the student’s faculty advisor (FA), designated as the primary investigator (PI) in the application and all supporting documents. After ensuring all aspects of the application are complete, the FA may then certify the application and supporting documents for review by the IRB.

5.3.2 Protocol Review

Once the IRB application has been completed and all study materials have been uploaded into the electronic IRB application system, the IRB will review the application. There are four types of review for projects submitted to the IRB. Determination of the type of review will be made by the IRB office (in conjunction with the IRB Chair as appropriate) upon consideration of the submitted application and study materials.

5.3.2.1. Administrative review leading to an Exemption Determination

The federal regulations governing research with human subjects (45.CFR.46.104) detail categories of research involving human subjects that are deemed “exempt from the requirements of the regulation.” At University, the IRB office makes this determination, the researcher does not. This means that when a researcher submits an application to the IRB for review, that the IRB office will review the protocol and determine its eligibility for exemption. These studies are beholden to ethical standards and applicable federal, state, and local laws.

5.3.2.2. Limited review leading to an Exemption Determination

The federal regulations governing research with human subjects (45.CFR.46.104) detail categories of research involving human subjects that are deemed “exempt from the requirements of the regulation.” When a human subjects research protocol is minimal risk, fits into the regulatorily defined exemption categories, and the IRB completes a “Limited Review,” studies that may have required an Expedited review due to privacy and confidentiality concerns, may instead be eligible for exemption. A Limited review is completed by the IRB and ensures that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of their data.

5.3.2.3. Expedited Review

Expedited review consists of a review of a research protocol involving human subjects by the IRB chairperson or by an experienced reviewer designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. A study is eligible for Expedited review when the proposed research poses no more than minimal risk to participants and study procedures involve only one (or several) of the categories of research outlined by 45.CFR.46 and supplemental guidance. These categories will be maintained by HHS, updated as appropriate, and posted as a notice in the Federal Register. Studies undergoing Expedited review are subject to all aspects of 45.CFR.46.111.

5.3.2.4. Full Board Review

Studies requiring Full Board review and approval are studies that are considered “more than minimal risk,” testing a medical device for safety or efficacy, investigating a drug or biologic, or a study that is “minimal risk” but it does not fit into any eligible Expedited review categories. Studies requiring Full Board review are subject to all regulations set forth in 45.CFR.46 and the study may only be approved at a convened Full Board meeting with quorum.

5.3.2.5. Amendment Requests

Any changes to the research procedures or study documents in an IRB approved protocol - regardless of level or review - an Amendment Request must be submitted to the IRB office via the electronic IRB application system before any changes are implemented. No changes to the approved study protocol may be implemented until the Amendment Request is processed and approved by the IRB.

5.3.2.6. Annual Approval Renewal

All studies reviewed via the Full Board, some studies reviewed via Expedited procedures, or studies contractually obligated to do so, must undergo Annual Approval Review.

5.3.3 Protocol Approval

5.3.3.1. Approved

The study protocol was approved by the IRB, and research with human subjects as described in the approved protocol may commence.

5.3.3.1.a. For all non-exempt studies, in order for a study to be considered approved, the IRB must find that the study has met the criteria for approval as defined in the federal regulation 45.CFR.46.111.

5.3.3.1.b. For all studies resulting in an Exemption Determination from the IRB, the IRB must find that the study is minimal risk, applicable laws are accounted for, and participants are appropriately treated throughout the research. When a “Limited Review” is required for an Exemption Determination, the IRB must find that the study has met the criteria for approval as defined in the federal regulation 45.CFR.46.111.a.8.

5.3.3.2. Approved with Stipulations

If the study is approved with stipulations, the IRB staff will work with the PI to complete the necessary changes and finalize approval. Research procedures may not commence until final approval is granted.

5.3.3.3. Deferred

If the convened IRB Full Board is unable to document that the criteria of approval detailed in 45 CFR 46.111 have been satisfied, then the IRB may defer the study. If the study is deferred, the IRB staff will work with the PI to prepare the study for review again.

5.3.3.4. Not Approved

The study as submitted to the IRB for review, is not approvable and no research with human subjects may take place. This decision may only be made by a convened IRB Full Board with quorum. This decision may only be appealed/overturned by a convened IRB Full Board with quorum. Any appeal shall be in writing to the IRB Full Board and, upon request, the PI may present arguments and evidence to the IRB Full Board at a duly convened meeting of the IRB Full Board. While the PI may request notification of the appeal to the Provost or other academic administrator, the final decision of any appeal rests with the IRB Full Board and no further appeal shall be available to the PI.

5.3.3.5. Approval Period

When an application is approved, the research approval period is issued. Any research done before or after this approval period is subject to an investigation of non-compliance. This includes recruitment of participants, consenting participants, collecting data from participants, implementing an intervention with participants, manipulating participants’ environment, and analyzing identifiable or re-identifiable private information. Under special circumstances, the IRB may require approval renewal for studies at increments shorter than one year. An approval period is applicable to all full board studies, and in some cases, studies receiving expedited approval or studies eligible for exemption.

5.3.4 Ancillary Reviews

Research proposals approved by the IRB may be subject to ancillary reviews by University officials as appropriate.

5.4 Required Reporting Post-Approval Monitoring

5.4.1. Required Reporting

5.4.1.1. Non-compliance

University researchers conducting research with human subjects must comply with the provisions of the IRB-approved study as well as all related federal laws and regulations, university policies, and state and local laws. The failure (regardless of intention) to comply with any applicable federal laws and regulations, university policies, and state and local laws governing human research constitutes non-compliance. If a researcher becomes aware of any non-compliance, the researcher must report this to the IRB Office immediately. A non-compliance investigation will commence in accordance with the IRB unit standard for issues of non-compliance.

5.4.1.2. Unanticipated Problems and Adverse Events

All Unanticipated Problems and Adverse Events must be reported by the researchers to the IRB office as soon as possible with all appropriate information for the IRB to make relevant determinations.

5.4.1.3. Participant Concerns and Complaints

All participant complaints and concerns regarding the conduct of human subject research completed by University researchers should be brought to the attention of the IRB office. Complaints and concerns may be raised by past, present, and potential research participants, family members, designated spokespersons, or anyone else associated with the research project. Should a researcher receive a complaint or concern directly from a participant, the researcher must notify the IRB office of the issue as soon as possible. If the IRB office receives the complaint or concern, an IRB office representative will review the issue and take appropriate steps for resolution.

5.4.2. Post-Approval Monitoring

The IRB may conduct “for cause” and random audits of IRB approved research protocols in accordance with the IRB’s Standard for Post-Approval Monitoring.

5.5 Suspension or Termination of a Human Subjects’ Research Protocol

5.5.1. The IRB may suspend or terminate some or all research activities on a specific research protocol if events are identified that represent serious or continuing noncompliance or unanticipated problems involving additional or increased risk to subjects or others.

5.5.2. The IRB may suspend some or all of the research conducted by a principal investigator as a result of serious or continuing noncompliance or if there are unanticipated problems involving additional or increased risk to subjects or others.

5.5.3. Suspension or termination of a protocol or multiple protocols from one PI, is most often determined by the convened IRB Full Board with quorum. However, the IRB Chairperson in conjunction with the Director for Research Protections or Institutional Official has the authority to suspend some or all research activities if exceptional human subject safety issues are identified.

6. Cooperative Research

Cooperative research projects are those projects that involve University and at least one other researcher not associated with University. When conducting cooperative research projects, each investigator is responsible for safeguarding the rights and welfare of human subjects, for complying with 45.CFR.46, and their affiliated IRB is responsible for oversight.

6.1. Any IRB that has a researcher engaged in a federally funded non-exempt cooperative research project, must rely upon the review and approval of a single IRB via a formal agreement.

6.2. Any IRB that has a researcher engaged in an unfunded non-exempt cooperative research project, may rely upon the review and approval of a single IRB for research via a formal agreement.

6.3. Any IRB that has a researcher engaged in cooperative research eligible for an exemption determination, may rely upon the review and approval of a single IRB for research via a formal agreement.

6.4. Any investigator that is unaffiliated with an IRB, but engaging in cooperative human subjects research with a University researcher, must engage in a formal agreement with the IRB indicating that the unaffiliated investigator will abide by all University policies, standards, and requirements stated in the associated IRB approved protocol.

7. Data Management and Security

Data must be managed as described in the approved IRB protocol and in accordance with all federal laws, state laws, local laws, and University data management standards.

8. IRB Office Standards

All researchers conducting research with human subjects must adhere to all unit standards established by the IRB.

Additional Resources

Forms

Statutes

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

Policies and Standards

Appalachian State University’s Human Subject Research Recruitment Policy

Data Management Standard

UNC System Office Records Retention and Disposition Schedule (2021)

Administrative Unit Contact

Director of Research Protections Division
Web Link
(828) 262-2901

History

Issued: April 29, 2019

Revised:
December 1, 2021
March 8, 2024
January 27, 2025

Retrieved from "https://policy.appstate.edu/index.php?title=Research_Involving_Human_Subjects&oldid=26520"