Policies & Procedures
Policies & Procedures
POLICY OF BOARD OF TRUSTEES PEARL RIVER COMMUNITY COLLEGE
Use of Human Subjects in Research Projects
Adopted January 13, 2009
Policy: It is the policy of Pearl River Community College to comply with all applicable Federal Regulations regarding the use of human subjects in research projects; respect the rights, wellbeing and personal privacy of individuals; assure a favorable climate for the conduct of academic-oriented inquiry; and protect the interests of Pearl River Community College.
Procedure: This policy regarding the use of human subjects in grant-funded research activities recognizes the institution's responsibility to comply with applicable Federal Regulations; protect the rights, well-being and personal privacy of individuals; assure a favorable climate for the conduct of academic-oriented inquiry; and, protect the interests of Pearl River Community College. 1. Any principal investigator related to Pearl River Community College (as defined below) who engages in scholarly research involving human subjects, either on- or off-campus, must apply to the Institutional Review Board (IRB) for approval of the research. Such approval must be obtained before undertaking the research. Individuals who meet the definition of a "principal investigator" must apply for approval from Pearl River Community College's Institutional Review Board even if their research has been approved by another institution's or organization's Institutional Review Board. Under this policy, the following individuals are considered to be principal investigators: • Pearl River Community College faculty and staff, • Pearl River Community College faculty who are on leave, and who are conducting grantfunded research involving human subjects either at Pearl River Community College, with grant funds administered by Pearl River Community College, or with Pearl River Community College students. • Researchers not affiliated with Pearl River Community College who are conducting primary research with human subjects on campus. These unaffiliated researchers include visitors to the campus and off-campus scholars engaged in human subjects research on campus. While at Pearl River Community College, these individuals may, through the courtesy of an on-campus liaison, conduct Board-approved research on human subjects. The liaison should provide the visitor with appropriate institutional forms, including this Policy, and assure that the forms are sent to the Board before the research is undertaken. 2. No grant-funded research activity involving human subjects shall be undertaken unless the Institutional Review Board has reviewed and approved such activity. This review shall determine whether the activity/research design will adequately protect the rights and welfare of such subjects. 3. Renewal petitions Projects eligible for continued funding beyond the duration of the initial project award are subject to renewal application review. Projects for which scope of work or activities that involve human subjects change substantially during the project are also subject to renewal application review. 4. Minimum Risk Proposals - Expedited Review Research activities which involve no more than minimal risk and which only involve human subjects as outlined below may be reviewed and approved by the Institutional Review Board through its expedited review procedure. Under this procedure, the Institutional Review Board review may be carried out by the Chair of the Board, or, in the Chair's absence, by a member of the Board designated by the Chair. In reviewing research under this procedure, the reviewer may not disapprove the research. A research activity can only be disapproved after review by the full Board. The following activities shall be eligible for expedited review: a. Minor changes in previously authorized research during the period for which approval is authorized. b. Research involving survey or interview procedures where all of the following conditions occur: • Responses are recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects. • The subject's responses, if they become known outside of the research, would not place the subject at risk of civil or criminal liability or be damaging to the subject's financial standing or employability. • The research does not deal with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, and is not likely to cause the subject undue stress, fatigue, or any other psychological reactions. • The research proposal makes adequate provision for obtaining the informed and voluntary participation of subjects. If, in the reviewer's judgment, the proposal goes beyond the criteria for expedited review, it shall be subject to full Board review and approval. The Chair shall provide to the Institutional Review Board summaries of research proposals certified through expedited review procedures and copies of review disposition letters to investigators. All other cases require a full board review. 5. Institutional Review Board a. The purpose of the Institutional Review Board is to conduct initial and continuing reviews of projects that involve the use of human subjects in accordance with the policy. b. The Institutional Review Board will be composed of the following six members: the Chief Planning Officer (Chair), Institutional Research Specialist, Director of Development Foundation, and Alumni Association, Director of Workforce Education, Community Representative, and Grants Accountant and others appointed by the President as needed. c. In the event that a conflict of interest arises with a member of the Institutional Review Board related to a project under review, the member will not participate in the review process for that project. d. The Institutional Review Board will be guided by and operate in compliance with applicable sections of Title 45, CFR, Part 46, Protection of Human Subjects, June 23, 2005. e. The Institutional Review Board will accept petitions for review from principal investigators at any time and will return decisions within twenty (20) working days. Decisions will be in writing. To be eligible for review, Petitions for Review will contain the following information: • Name of Principal Investigator with e-mail address and telephone number with signature and date. • Name of Co-Principal Investigators with e-mail addresses and telephone numbers. • Administering division or department of project. • Project duration. • Project title. • Funding Agency and Proposal ID number (if applicable). • Statement addressing real or potential conflict of interest. • Indication of whether or not the project may be exempt from full Board review. • Brief statement of how human subjects are to be involved in the project. • Project summary. • Copy of the grant proposal. The following types of projects are exempt from Institutional Review Board review: data gathered for the purposes of fundraising; market research for the purposes of admissions recruiting; recruiting efforts for faculty or staff; and statistical data collected for the management of institutional affairs, including surveys of students, prospective students, and alumni. Please note that a project that does not clearly fall into one of these categories should be brought to the IRB Chair for a determination of whether it is exempt. The determination as to whether a project is exempt from Board review cannot be made by the principal investigator(s) themselves. PEARL RIVER COMMUNITY COLLEGE Petition to Institutional Review Board New Application __________ Renewal Application __________ Name of Principal Investigator: ______________________________________________ Telephone Number: _________________ Email address:________________________ Name of Co-Investigator:___________________________________________________ Telephone Number: _________________ Email address:________________________ Name of Co-Investigator:___________________________________________________ Telephone Number: _________________ Email address:________________________ Administering Division/Department of Project: ____________________________________ Project Duration: _________________________ Project Title: _______________________________________________________________ Funding Agency and Proposal ID Number (if any): __________________________________ Conflict of Interest: Investigators __ do or __ do not have a real or potential conflict of interest. Does this project meet condition (a) or (b) outlined below that will make it exempt from full Board review? ____Yes ____ No a. Minor changes in previously authorized research during the period for which approval is authorized. b. Research involving survey or interview procedures where all of the following conditions (Common Rule Section 101 subsection b) occur: • Responses are recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects. • The subject's responses, if they become known outside of the research, would not place the subject at risk of civil or criminal liability or be damaging to the subject's financial standing or employability. • The research does not deal with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, and is not likely to cause the subject undue stress, fatigue, or any other psychological reactions. • The research proposal makes adequate provision for obtaining the informed and voluntary participation of subjects. Include a brief statement of how human subjects are involved in the project: ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ Project Summary attached? ____ Yes ____ No Project Proposal attached? ____ Yes ____ No Principal Investigator Signature: _____________________________________ Date:_________________ Print Name: ________________________________________