Institutional Review Board (IRB)
Article I, Purpose
The purpose of the IRB is to ensure that any research involving human subjects that is conducted by the administrators, faculty, staff, or students conforms to the College’s Mission, Professional Codes of Conduct, and Federal Guidelines of the Department of Health and Human Services. Research is defined as any systematic, empirical investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. All proposed research is reviewed by the IRB to ensure that risks to human subjects are minimal and that human subjects are treated in a manner that conforms to the ethical guidelines of the Department of Health and Human Services and the ethics codes of professional organizations.
Where research involves the collection of medical information, proposals are reviewed to ensure that the handling of such information conforms to the Health Insurance Portability and Accountability Act (HIPAA) “Privacy Rule,” a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that protects certain health information.
The IRB includes research conducted by outside investigators in which students of the College are used as participants. All research involving human subjects conducted at the College of Mount Saint Vincent must be approved by the Institutional Review Board prior to the initiation of the research project. Conducting human subjects’ research without IRB approval constitutes scientific misconduct and is grounds for disciplinary action under the College of Mount Saint Vincent Scientific Misconduct Policy.
Faculty who require students to conduct projects within the confines of a course will be required to undergo training, preferably an online course such as the CITI or NIH Office of Extramural Research, so that faculty are aware of the rules and regulation involved in protecting individuals. Subsequently, it is at the discretion of the faculty member to review each student’s project and to determine whether IRB approval should be obtained.
All researchers will be required to undergo training, preferably an online course such as the CITI or NIH Office of Extramural Research, so that researchers are aware of the rules and regulations involved in protecting individuals. The certificate of completion from the CITI or NIH Office of Extramural Research is expected to be submitted along with the researcher’s IRB application. IRB members will not participate as subjects in IRB protocols.
Article II, Duties
- The committee meets monthly per academic term. At the end of the academic semester, the IRB shall announce the days and dates of the upcoming meetings to the College community via email. The meeting days and dates will also be posted on the CMSV IRB webpage. IRB forms for research proposals will be provided on the CMSV webpage.
- Research proposals must be received two weeks prior to the respective meeting date.
- If research proposals are not approved, they are returned to the submitting researchers with detailed guidelines for revision. The revised proposal is then resubmitted to the Committee Chair who is authorized by the entire committee to approve the revised research proposal if all of the required revisions are effectively made.
- Upon approval, the principal investigator will receive official notification that the research proposal was approved and is valid for one (1) year from the date approved. If the research is to continue after the one year expiration, the principal investigator is required to complete a research continuation form, which is available on the CMSV IRB webpage.
- If the researcher’s protocol needs to be altered after the original application is approved, the researcher will need to complete an IRB amendment form and send it to the IRB for approval.
- Upon completion of the research, the principal investigator is required to complete a research closure form along with the results of the research to the college IRB.
Article III, Membership
- Membership includes one faculty each from the departments of natural science, nursing, social science, as well as one at large member. Membership will be determined from the College of Mount Saint Vincent’s annual general election.
- If members from the respective departments/disciplines do not self-nominate, the IRB chair will contact the department Chairs in order to identify individuals to serve on the IRB committee.
- An external reviewer will be appointed by consensus agreement within the IRB to serve as a volunteer.
- All members on the IRB committee will be required to undergo training, preferably an online course such as the CITI or NIH Office of Extramural Research, so that members are aware of the rules and regulations involved in protecting individuals.
- Membership is for a two year period and reappointment for a second two year period is permitted.
- In the case of a member who cannot complete his/her term, a replacement will be appointed by the department.
Article IV, Officers
- At the end of the academic year, the Committee shall elect a Chairperson and Secretary.
- In the event that the officer cannot complete his/her term, a replacement will be elected by the committee.
Article V, Duties of Officers
- Chairperson. The Chairperson of the IRB shall preside over all meetings and organize the agenda. The Chairperson shall also communicate with researchers about their proposals and send them to the committee members in a timely fashion.
- Secretary. The Secretary shall record the minutes of each meeting and circulate them to the committee members in a timely manner. At the subsequent committee meeting, the IRB members shall vote to approve the minutes. Once approved, the Secretary shall upload the meeting minutes via the College of Mount Saint Vincent’s shared Google drive. The Secretary shall also keep records of the minutes on file as well as assign protocol numbers to each IRB application.
Article VI, Meetings
- Generally, the committee shall convene regularly on a monthly basis during the academic semester of the Fall and Spring.
- If there are no proposals to discuss or further business to discuss, the chairperson of the committee can cancel the meeting.
- The chairperson can also schedule additional meetings as needed.
Article VI, Minutes
Upon approval, minutes shall be uploaded via the College of Mount Saint Vincent’s shared Google drive.
Article VIII, Amendments
All amendments will be in accordance with the By-Laws of the College Governance System: General Information