Research Involving Human Subjects: Difference between revisions

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Policy 209
University Policy 209
== Introduction ==
=== Institutional Review Board (IRB) Statement of Purpose ===
1.1.1 The IRB is responsible for protecting the rights and welfare of human subjects participating in research projects. The IRB acts according to policies set forth by the United States Department of Health and Human Services Public Health Service Act as amended (45 CFR 46). Compliance with these federal regulations not only safeguards human subjects and the institution sponsoring the research project, but also protects the researcher.


1.1.2 Any research that involves human subjects, whether funded internally or from extramural sources, or not funded, that is undertaken by an Appalachian State University faculty, academic staff or students, supported by or conducted at Appalachian State University, must be reviewed and approved by the IRB prior to soliciting subjects or collecting any data from any human subjects. The IRB defines research as a systematic investigation (i.e. having or involving a system, method or plan) conducted to develop or contribute to knowledge about the human experience. It is understood that such research may be disseminated by publication or in a public or professional forum. Based on the principle that the IRB
== 1. Purpose ==
exists to protect the rights and safety of individuals who participate as research subjects in projects administered by university faculty, staff and students, the IRB will review protocols for projects involving interviews recorded for research purposes.


1.1.3 While the IRB is empowered to review and approve (or disapprove) research involving human subjects, the protection of research subjects from unnecessary or unacceptable risks 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
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.
in the responsibility to establish and maintain an atmosphere where respect for the rights of individuals and compliance with applicable regulations is the standard.


=== Education in the Responsible Conduct of Research ===
== 2. Scope ==
1.2.1 It is the policy of Appalachian State University that all individuals engaged in research involving human participants must complete an educational program related to the responsible conduct of research prior to initiation of a research project. Effective July 1, 2008, the requirement can only be met by completing the CITI IRB training program.


=== Student Research and Faculty Responsibility ===
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.
1.3.1 Research conducted by students, such as thesis research and some class projects, requires the approval of the IRB prior to execution. It is the responsibility of faculty supervising research by students or staff to ensure that approval of the Board is obtained. Individual projects conducted primarily for instructional purposes within the context of a formal class, and not designed to contribute to generalizable
knowledge, do not meet the definition of “research” as defined in the federal guidelines. Thus, they do not require review by the Board, provided the instructor is prepared to accept professional and ethical responsibility for all research projects conducted in conjunction with the class. Under these conditions, no IRB application need be made but it is the instructor’s responsibility to monitor the ethical propriety of these projects, applying the criteria listed in this document.


1.3.2 On November 10, 2009, the IRB approved the following clarifications for the guidelines for Student Research and Faculty Responsibility:
== 3. General Principles ==
#Faculty members conducting class-based activities involving human subjects should request IRB review of the activities when there is a chance of public dissemination (i.e. presentation/publication outside of the classroom). In most cases, this can be accomplished by submitting a single request for IRB review of the class project.
#Students who are conducting human subject research that will likely be incorporated in a thesis project should submit a request for IRB review.
#In rare cases data collected in class-based projects that have not undergone prior IRB approval may be used for dissemination. Petition may be made to the IRB requesting such terms. In this case, a statement from the instructor of record must include the specific steps taken during data collection that ensured the ethical conduct of this research. Decisions on these requests will be made on a case-by-case basis.


== Scope ==
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.
2.1 This policy applies to all faculty, staff and students of Appalachian State University involved in research involving human subjects.


== Definitions ==
== 4. Definitions ==


=== Anonymity ===
'''4.1 Adverse Events'''
:means that the identity of a subject cannot be matched to his/her response.


=== Confidentiality ===
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.
:refers to the treatment of individual information gathered during the conduct of the research. An individual discloses information to the investigator with the expectation that the information will not be divulged to others in a manner inconsistent with the understanding of the original agreement.


=== Data Collection ===
'''4.2 Anonymity'''
:refers to any research procedure that is intended to elicit from or record the actions, reactions, attitudes, and/or behavioral manifestations of subjects participating in a research project.


=== Exempt Research ===
Means that the identity of a subject cannot be matched to their responses, either directly through identifiers or by "linked" or "coded" responses.
:refers to human subject research activities that fall into one or more of the federally defined exempt research categories. Exempt research does not mean the research protocols are exempt from IRB review, only that the research may not require a full IRB review, and may not be subject to other IRB requirements, such as annual reviews or informed consent. It is strongly suggested that informed consent be used whether required or not.


=== Expedited Review ===
'''4.3 Clinical Trial'''
:refers to the review by the IRB Chair or designate of research proposals which involve minimal risk or no-risk.


=== Full IRB Review ===
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.
:refers to the review of proposals conducted during an IRB meeting at which a quorum has been established.


=== Human Subject ===
'''4.4 Confidentiality'''
:refers to a living individual about whom a researcher obtains either identifiable private information, or data through intervention and/or interaction with the individual.


=== Informed Consent ===
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.
:refers to 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.


=== Minimal Risk ===
'''4.5 Data Collection'''
: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 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.
:refers to a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. In other words, the IRB defines research as a systematic investigation (i.e. having or involving a system, method or plan) conducted to develop or contribute to knowledge about the human experience. It is understood that such research may be disseminated by publication or in a public or professional forum. In addition, based on the principle that the Appalachian IRB exists to protect the rights and safety of individuals who participate as research subjects in projects administered by university faculty, staff and students, the IRB will review protocols for projects involving interviews recorded for research purposes.


=== Vulnerable Populations ===
'''4.6 De-Identified Data'''
:refers to subjects such as 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  ==
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.  
=== The Institutional Review Board (IRB) and Its Actions ===
4.1.1 In reviewing research proposals, the IRB has the authority to approve, require modifications in, defer, disapprove or terminate any research involving human subjects conducted under Appalachian State University’s auspices.


4.1.2 If at any time, the Board becomes aware of:
'''4.7 Exempt Research'''
#unanticipated problems involving risks to subjects, or
#other serious or continuing noncompliance with 45 CFR 46 or determinations of the Board, including ongoing human subject research which has not been reviewed by the Board,it may request a meeting with the PI and/or suspend the research until the problem can be further evaluated. Under these circumstances, the Authorized Institutional Official (the Dean of Graduate Studies and Research) must be made aware of the situation immediately, and he/she will be advised of any further sanctions subsequently recommended by the Board.


4.1.3 In these circumstances, the Board may impose sanctions on an individual by suspending the individual's right to conduct or supervise research involving human subjects, taking possession of the data collected by the non-compliant individual, withholding or revoking academic credit to a student researcher, and recommending discipline of a faculty member by the University. This list is provided by way of example only, and is not intended and should not be construed as exhaustive, in that individual situations may call for specific actions and remedies not identified herein.
Means human subject research activities which are minimal risk in nature and fall into one or more of the federally defined exempt research categories.


=== The Review Process ===
'''4.8 Expedited Review'''
4.2.1 The IRB reviews protocols for research in accordance with federal regulations governing research with human subjects. The Board may also apply such codes of professional ethics as it deems appropriate. These additional codes may or may not be addressed in federal documents. It is the policy of Appalachian State University that in order for any research protocol to be approved, the Board must determine that all of the following requirements are satisfied:
#Risks to subjects are minimized and are reasonable in relation to anticipated benefits of the research,
#Selection of subjects is equitable given the purposes and the setting of the research,
#Appropriate informed consent will be sought 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 insure 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.


4.2.2 The IRB may process a protocol in one of three ways:
Means a review by the IRB Chair or designee of research proposals which involve minimal risk.
#By exemption certification
#By expedited review
#By full review


4.2.3 Any research protocol which does not fall under the category definitions of exempted or expedited research as outlined below, or any protocol as specifically requested by the Board, shall undergo full review.
'''4.9 Full IRB Review'''


4.2.4 Upon review by the Board, the office of the IRB Administrator shall notify the PI by letter and/or email of the Board’s decisions, and conditions which must be met, if approval is to be awarded. Approval will not be granted until all specified conditions are met. The letter shall also
Means the review of proposals conducted during a convened IRB meeting at which a quorum has been established.
#Advise the PI to notify the IRB if there are any subsequent changes proposed in the research protocol. No changes may be initiated without IRB review and approval.
#Indicate the period for which approval is valid (1 year, in most cases).
#Require the PI to make an application for annual review should the study extend beyond the initial approval expiration date.
#Direct that during the course of the research, should an adverse event occur which threatens the health, safety or emotional well-being of a participant, or which increases the risks to subjects from that described in the approval documents for the project, the PI must suspend the research immediately and report the incident to the IRB Administrator. The IRB Administrator will investigate and determine the course of action to follow.


=== Categories of Review ===
'''4.10 Human Subject'''
==== Exempt Research ====
a. Certain categories of research protocols may be exempt from review. Only the IRB Administrator or IRB Associate Administrator is authorized to determine which protocols may be subject to limited review or may be exempt from review by the Board. Investigators who believe that their research meets the following criteria may request exempt status for their study when it is submitted to the Board, and list the justification. The IRB reserves the authority to require proposal modifications regarding human subject protection before approving the research as exempted from the requirements of the Common Rule.


b. Note that the exemption DOES NOT APPLY when the research activities include:
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.
#Prisoners, fetuses, pregnant women or human in-vitro fertilization.
#The review of medical records when the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects.
#Techniques which expose the subject to more than minimal risk.
#The deception of the subject.


c. The federal categories of research eligible for exemption certification are as follows:
'''4.11 Identifiable biospecimen'''
#Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
#Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews or observation of public behavior, unless: (i) information obtained is recorded in such a manner that participants can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of an individual’s response(s) outside of the research setting could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Surveys or interviews which include minors as subjects are not included in this exempt category.
#Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or observations of public behavior that are not exempt under (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personal identifiable information will be maintained throughout the research and thereafter.
#Research involving the collection or analysis of existing data, documents, records, pathological specimens, or diagnostic specimens, if such sources are a matter of public record or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
#Research and demonstration projects which are conducted by or subject to the approval of, department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under such programs; (iii) possible changes in or alternatives to such programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under such programs.
#Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U. S. Department of Agriculture.


==== Expedited Review ====
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)).
a. Federal regulations permit an expedited review procedure for 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 Board with the exception of disapproval. A research project may be disapproved only after full Board review as described in the next section. The Board shall be informed of all expedited reviews at its next full meeting.


b. Research activities that present no more than minimal risk (see glossary) to human subjects, and involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure. The activities detailed below should not be deemed to be of minimal risk simply because they are included on this list. Inclusion merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
'''4.12 Identifiable private information'''


c. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, or reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
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.


d. The expedited review procedure may not be used for classified research involving human subjects. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review used by the IRB — expedited or full. The categories in this list apply regardless of the age of subjects, except as noted. Categories one 1-7 pertain to both initial and continuing IRB review.
'''4.13 Interactions'''


=== Expedited Categories ===
Means communication or interpersonal contact between the investigator and subject.
==== ====
#Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
##Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
##Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
#Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
##From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
##From other adults and children, taking into consideration the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed 5 ml, or 3 ml per kg, whichever is less, in an 8-week period, and collection may not occur more frequently than 2 times per week.
#Collection of data through noninvasive procedures, i.e., not involving general anesthesia or sedation, routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, nor are studies of approved medical devices being considered for new indications.)
#Prospective collection of biological specimens for research purposes by noninvasive means.
#Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
#Collection of data from voice, video, digital, or image recordings made for research purposes.
#Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
#Continuing review of research previously approved by the full IRB as follows:
##When (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects.
##When no subjects have been enrolled and no additional risks have been identified.
##When the remaining research activities are limited to data analysis.
#Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.


==== Full Board Review ====
'''4.14 Intervention'''
Full board review must take place for all protocols that do not qualify as “exempt” or “expedited”, or as otherwise specified by the Board.


=== Procedures to Initiate Review ===
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.


4.5.1 Prior to the execution of any research involving human subjects, investigators shall have completed the mandated education described at the beginning of this document, and they shall have completed and submitted to the IRB Administrator copies of the protocol form along with copies of the proposed informed consent statement. The protocol form must provide the following information:
'''4.15 Informed Consent'''
#Name(s) and department(s) of investigator(s)
#Title of the study
#Signature of responsible faculty member
#Whether or not external funding is proposed
#Purpose of the study
#Description of subjects
#Description of methodology, including a copy of any instruments used
#Potential benefits and risks to the subject
#Anticipated beneficial knowledge resulting from the study
#Qualifications of investigator(s), e.g. a CV or experience in the specific research area
#Description of any deception
#Procedures for protecting the anonymity/confidentiality of subjects
#A copy of any recruiting materials or scripts.
#Method for insuring informed consent, including a copy of the proposed informed consent statement.


=== Informed Consent Guidelines ===
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.
4.6.1 Informed consent constitutes the very essence of protecting the rights of 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 individual subjects. The IRB will carefully review the proposed method for obtaining informed consent and the content of the document prepared for participants’ signatures. For research that is not exempt from IRB review, the informed consent form must include the following information:
#The title of the study, information on the purpose(s) of the research, a description of the method(s) and procedure(s) to be followed, including the intention to publish or disseminate the results of the study, and the amount of time the subject will spend in actual project participation.
#A description of any reasonably foreseeable risks or discomforts to the subject, including expected total time of participation. If disguised or deceptive procedures are to be used, a plan to debrief participants must be explained to the IRB.
#A description of any benefits to the subject or to others as a result of the information obtained from the research.
#A disclosure of appropriate alternative procedures that may be advantageous to the subject when making an informed decision whether or not to participate in the research (this pertains primarily to medical research and drug trials).
#A description of the measures to be taken to insure the confidentiality of data and the anonymity of individual subjects, if applicable, as well as any circumstances under which confidentiality CANNOT be guaranteed.
#The name and phone number of a contact person(s) who will be available to answer any questions the subject or his/her legally authorized representative may have regarding the research (student investigators must include the name, address, and phone number of his/her faculty supervisor), and "Questions regarding the protection of human subjects may be addressed to the IRB Administrator, Research and Sponsored Programs, Appalachian State University, Boone, NC 28608, (828) 262-2130, [email protected].”
#A clear explanation that participation is voluntary and that no penalty or loss of benefits to which the subject is otherwise entitled will occur should the subject either refuse to participate or decide to discontinue participation (at any time).
#Disclosure of costs to the subject, if any, because of his/her participation in the research; disclosure of compensation/reward to the subject, if any, for his/her participation in the research.
#For projects of more than minimal risk to subjects, a statement must be included that describes how the costs of medical care or other therapies required as a result of injury or mishap incurred while participating in the research will be handled. The Consent Form should also include information about the availability and extent of on-site medical treatment should an injury occur.
#The approval and expiration date for the consent form once approval of the project has been granted.
#The consent form must not include a statement releasing the investigator, sponsor, institution or its agents from liability or negligence.


4.6.2 These requirements are not intended to preempt applicable federal, state, or local laws which require additional 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.
'''4.16 IRB'''


4.6.3 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 provided that the IRB finds and documents:
Means the University’s institutional review board.
#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 subjects;
#The research could not practicably be carried out without the waiver or alteration; and
#Whenever appropriate, the subjects will be provided with additional pertinent information after participation.


4.6.4 When a consent form requires the signatures of research subjects and/or their parents or legal guardians, a copy of the signed form must be given to the subject/parent/guardian and a copy must be retained by the researcher for a minimum of three years after completion of the project. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects as described in 45 CFR Part 46.117.
'''4.17 IRB Approval'''


4.6.5 For exempt research, the researcher is expected to provide information to prospective subjects about the research. This information should include:
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.
#A statement of the purpose of the research
#An explanation of the procedures of the study
#Details of any foreseeable risks, benefits and compensation
#A clear explanation that participation is voluntary and that no penalty or loss of benefits to which the subject is otherwise entitled will occur should the subject either refuse to participate or decide to discontinue participation (at any time).
#Contact information for the investigator and faculty advisor if the investigator is a student.


4.6.6 In some cases, it may not be practical to provide this information to prospective subjects. In these cases of exempt research, investigators should provide an explanation of why it is impractical to provide this information to potential subjects to the IRB Administrators.
'''4.18 Minimal Risk'''


=== Investigator's Right of Appeal ===
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.


4.7.1 It is the policy of Appalachian State University that the final decision regarding approval or disapproval of all protocols rests with the IRB. In accordance with federal regulations, no research involving human subjects may be conducted under Appalachian State University's auspices without the prior and continuing approval of the Board. Any investigator who disagrees with a decision of the Board may request a hearing before the duly-convened IRB to appeal its decision. Relevant arguments and/or witnesses may be presented on behalf of the investigator. The investigator may also request that the Authorized Institutional Official be informed of the appeal. However, final decision rests with the Board.
'''4.19 Non-compliance'''


=== Continuing Review of Research ===
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.
==== After a research protocol has been reviewed by the IRB, it is the investigator's responsibility to report to the Board any proposed changes in the research as well as any unanticipated problems that arise involving risk to subjects. If deemed necessary, the IRB Administrator may determine that reconsideration of the protocol by the full Board is warranted. If such a determination is made, the procedures governing initial review of protocols will be utilized. ====


==== In addition, federal regulations require that the Board conduct continuing review of approved expedited and full Board approved proposals at least once per year. Exempted protocols require no continuing review. It is the principal investigator’s responsibility to initiate the request for continuation, which must include a summary of the protocol and a status report on the progress to date. In summary, the following must be submitted: ====
'''4.20 Personally Identifiable Information (PII)'''
#The number of subjects accrued.
#A summary of any adverse events or unanticipated problems involving risk to subjects, and of any withdrawal of subjects or complaints about the research since the last review.
#A summary of findings, and any amendments or modifications to the study.
#A copy of the current informed consent document


==== '''Failure by the investigator to initiate this annual review prior to the expiration date of the approval shall result in immediate termination of the research.''' ====
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.


==== Certain protocols may be reviewed more often than yearly, e.g.: ====
'''4.21 Private information'''
#Where protocols are considered to involve high risk, or have a high risk/benefit ratio.
#Where studies are complex involving unusual levels or types of the risks.
#For projects conducted by investigators who previously failed to comply with the requirements of the IRB.
#For projects where information has come to the attention of the IRB that protocol changes have been made without IRB approval.


=== IRB Membership ===
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).


==== The Board shall consist of a minimum of five members, including: ====
'''4.22 Research'''
#One member whose primary concern is in a scientific area
#One member whose primary concern is in a nonscientific are
#One member who has no affiliation with Appalachian State University
#Additional members to insure ethical treatment of subjects
#IRB Administrator, ex officio


==== The regular members will be appointed by the Chancellor of the University for a term of three years and the Board will report to the Authorized Institutional Official. The Chancellor of the University shall designate the Chair of the IRB. ====
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.


=== IRB Meetings and Deadlines ===
'''4.23 Terms of Assurance'''
==== Initial and continuing reviews of research will be conducted at meetings of the IRB convened monthly. 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. Expedited reviews can be performed as described above in the absence of an IRB meeting. Teleconferencing may be used for any members to participate in the meeting, and they shall be counted toward the quorum. Approval of research is by 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 has been restored. ====


==== Review of proposed protocol changes will be conducted at IRB meetings with a quorum present, except where expedited review is appropriate. Minor changes in previously approved research can be approved under an expedited review procedure as above. Any revisions to a protocol should be incorporated into the written protocol with the revision dates noted on the protocol itself. ====
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.


==== All necessary review materials must be submitted to the office of the IRB Administrator at least two weeks before the meeting at which they will be considered. Complete copies of all materials to be reviewed will be distributed to the full Board at least one week in advance of the meeting at which they will be considered. ====
'''4.24 University'''


==== Minutes of each IRB meeting shall document the deliberations, actions, and votes for each protocol whether undergoing initial or continuing review. Votes shall be recorded as the number “For”, “Opposed”, and/or “Abstaining”. Any unusual degree of risk or an approval period less than one year shall be documented explicitly in the minutes. ====
Means Appalachian State University.


==== There shall be a monthly summary of Board actions forwarded to the Dean of Graduate Studies. IRB records will be retained for at least three years, and records relating to research that is conducted will be retained for at least three years after completion of the research. ====
'''4.25 Unanticipated problems:'''


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


== Authority ==
: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'''


== Contact Information ==
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 ==


== Effective Date ==
'''5.1 Roles and Responsibilities'''


== Revision Dates ==
'''5.1.1 Research Investigators'''
Approved 5/18/2010
 
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.
 
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
 
[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]
 
Policies and Standards
 
[https://policy.appstate.edu/Human_Subject_Research_Recruitment Appalachian State University’s Human Subject Research Recruitment Policy]
 
[https://security.appstate.edu/data-security Data Management Standard]
 
[https://archives.ncdcr.gov/documents/universitygs2021pdf/open UNC System Office Records Retention and Disposition Schedule (2021)]
 
== Administrative Unit Contact ==
Director of Research Protections Division<br>
[https://research.appstate.edu/ Web Link]<br>
(828) 262-2901
 
== History ==
 
Issued: April 29, 2019
 
Revised:<br>
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

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