Research Involving Human Subjects - Excelsior College
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Research Involving Human Subjects
The purpose of this Policy and Procedure is to assist investigators planning to conduct research involving human subjects in designing their research and submitting it for approval.
Human subjects research must be reviewed if conducted by any faculty, staff, students, or any other person under the auspices of the College.
Statement of Policy
- In accordance with state and federal regulations and professional standards of ethical conduct, it is the responsibility of the College to reasonably ensure that, in research conducted under its auspices, the rights and welfare of human subjects are adequately protected. The primary responsibility for protecting human subjects, however, rests with each individual who initiates, directs, or engages in research.
- In order for the College to fulfill its responsibility, the College has established an Institutional Review Board (IRB). The IRB is authorized to review and approve all research involving human subjects conducted under the auspices of the College, regardless of the source of funding.
a. "Human Subjects Research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge, which involves the collection of data from or about living human beings. It does not include research using published or publicly available documents or research on elected or appointed public officials or candidates for public office.
b. The members of the IRB are appointed to a three-year term by the provost and chief academic officer. In addition to other requirements of state and federal regulations, the membership of the IRB shall be composed of individuals of varying backgrounds who are qualified through maturity, experience, expertise, and the diversity of the members' racial and cultural backgrounds to assure complete and adequate review of activities commonly conducted under the College's auspices, and to ensure respect for its advice and counsel for safeguarding the rights and welfare of human subjects. The IRB shall possess the professional competence necessary to ascertain the acceptability of proposals in terms of institutional commitment and regulations, applicable law, standards of professional conduct and practice, and community attitudes.
c. The determination regarding whether a given activity should be considered human subjects research will be made by the IRB or its designee.
d. Certain categories of research involving little or no risk to subjects need not be reviewed and approved by the full IRB, but are eligible for less intensive review procedures.
e. The IRB shall develop and promulgate appropriate categories of research and determine the review procedures for each category.
f. The IRB shall apply additional criteria (PDF) during the review of research involving Excelsior College prospective and enrolled students, faculty, staff, or alumni.
Planning a Research Project
When an investigator plans to conduct research involving human subjects, he/she is advised to contact the chair of the IRB (or a designee) who also functions as the human subjects research officer (HSRO) as early as possible. Email them at IRB@excelsior.edu Aspects of a project which may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way which will facilitate approval.
The Principal Investigator (PI) must participate in a Protecting Human Research Participants training session that is conducted or approved by the Health and Human Services/NIH. The PI must submit a certificate of completion that is not over 3 years old.
Determining Human Subjects Involvement
The initial determination as to whether a research project should be considered human subjects research should be made by the investigator. He/she should consult the HSRO (or designee) for advice on this question. Final authority for making this determination rests with the IRB or its designee.
In general, research that involves data gathered solely for internal use (e.g., program evaluation or institutional research) would not need to be reviewed. If, however, the results of this research will be disseminated to audiences external to the College, then the research must receive prior approval. If no dissemination is planned at the time the data are gathered, but the possibility of future dissemination exists, the project director would be advised to submit the project for approval prior to initiating the research.
Once it has been determined that an activity is to be considered human subjects research, it will be reviewed under one of three categories: Category I is eligible for "exempt from review," Category II requires "expedited review," Category III is "full review." The review procedures for each of these are described below. Each researcher should make the initial determination regarding the appropriate category of review, although the IRB or its designee may require review under another category. All proposals must be sent to the IRB for a final determination of the level of review required for that project. The researcher can always request a higher level than that required.
Below are listed the project categories, along with examples of the types of projects included in each category:
Project Category I (Exempt from Review)
- Research can be approved as "exempt" if it is no more than "minimal risk" and fits one of the 6 federally designated exempt review categories. Studies that may qualify for "Exempt" must still be submitted to the IRB for review. (OPRS, U.S. Gov. http://oprs.usc.edu/review/typesofirb/
- Research that examine de-identified data previously collected by the college such as course and graduate survey responses
- Research that involves no participation by students, staff, or faculty
- Research the utilizes aggregate unpaired data that is analyzed using simple statistics for re