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Difference between revisions of "Research Involving Human Subjects"
From Appalachian State University Policy Manual
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Policy 209 | Policy 209 | ||
== Introduction == | == Introduction == | ||
| + | === Institutional Review Board (IRB) Statement of Purpose === | ||
| + | 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. | ||
| + | |||
| + | 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 | ||
| + | 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. | ||
| + | |||
| + | 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 | ||
| + | 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 === | ||
| + | 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 === | ||
| + | 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. | ||
| + | |||
| + | On November 10, 2009, the IRB approved the following clarifications for the guidelines for Student Research and Faculty Responsibility: | ||
| + | #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 == | == Scope == | ||
Revision as of 17:17, 21 September 2011
Policy 209
Contents
1 Introduction
1.1 Institutional Review Board (IRB) Statement of Purpose
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.
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 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.
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 in the responsibility to establish and maintain an atmosphere where respect for the rights of individuals and compliance with applicable regulations is the standard.
1.2 Education in the Responsible Conduct of Research
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.
1.3 Student Research and Faculty Responsibility
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.
On November 10, 2009, the IRB approved the following clarifications for the guidelines for Student Research and Faculty Responsibility:
- 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.
2 Scope
3 Definitions
3.1 Definition phrase or word
- Definition summary
