A Guide to Medaille College s Institutional Review Board (IRB)

Transcription

1 A Guide to Medaille College s Institutional Review Board (IRB) Updated October 3, 2016

2 What is the Medaille College IRB? IRB = Institutional Review Board Purpose to ensure, both in advance and through periodic review, that all necessary steps are taken to protect the rights and welfare of humans who participate in research conducted at the College or by members of it. Operates in accordance with FDA regulations regarding research with human participants

3 Why does the IRB evaluate research? To ensure that: potential risks to human participants are identified and measures to minimize such risks are incorporated whenever possible. benefits of proposed research outweigh potential risks to participants. the safety of all human participants is maintained throughout data collection. selection of human participants is fair and free from bias or prejudice. all research participants provide informed consent and that such consent is appropriately documented. appropriate precautions are followed to maintain the privacy of individual participants and the confidentiality of all data collected. additional precautions are incorporated for the protection of vulnerable individuals (e.g., children, those with cognitive impairments, etc).

4 What does the IRB have authority to do? After reviewing a research proposal, the IRB may: Approve Request more information Require modifications Defer action Reject After reviewing ongoing research, the IRB may: Suspend or terminate if research is not conducted in accordance with IRB requirements or is causing unexpected harm to human participants

5 Who Needs IRB Approval? Anyone conducting research with human participants requires IRB approval Research: a systematic investigation designed to develop knowledge that can be generalized Human participant (or subject): a living individual about whom an investigator (professional or student) conducting research obtains data through intervention or interaction with the individual, or through identifiable private information If you plan to present, publish, or otherwise share results of a research study involving human participants, you will need IRB approval.

6 Examples of Research Administering surveys or questionnaires Conducting interviews or focus groups Reviewing and analyzing existing data Testing new educational materials Observing behavior

7 How to get IRB Approval To apply for research approval, please visit Medaille College s new online IRB application system:

8 Tips for Writing an IRB Application IRB members come from a variety of disciplines. To ensure that they understand your research purpose, procedures, benefits and risks, etc., be sure to: Use everyday language Limit discipline-specific jargon and acronyms If you must use them, please define them clearly. Address all required parts of the application

9 Ethics Certificates Required for every researcher listed on application Can be obtained through passing the online course at: Certificates must be uploaded with application

10 IRB Submission Deadlines Medaille s IRB meets to review research applications on the third Thursday of every month. Research applications must be submitted at least two weeks prior to be reviewed. If submitted later than that, application will be reviewed at the following month s IRB meeting.

11 Medaille College s IRB Members Patrick McDonald, IRB Administrator Kelly Ahuna, PhD IRB Co-Chair Lesley Capuana, PhD IRB Co-Chair Kathleen Shanahan, PhD IRB Member Keith Klosterman, PhD IRB Member Bernadette Clabeaux, PhD IRB Member Nicole Fox, PhD External IRB Member

12 Questions? For additional information about the IRB, please contact Patrick McDonald, IRB Administrator, at or (716)