Research Compliance

Case Human Research Protection Program

Community Outreach

Case Western Reserve University, The MetroHealth System, The University Hospitals of Cleveland, The Cleveland Clinic and the Louis Stokes Cleveland VA Medical Center are all member institiutions in the Case Human Research Protection Program.

This webpage was developed for potential participants or ("subjects") in research projects conducted by faculty, staff or students at our member institutions. It contains information about human-subjects research, links to useful sites, and contact information for concerns or suggestions for the improvement of the human research protection program.

			Questions on Human Subject Protection?
			•What is Human Subject Research? •What is an Institutional Review Board or IRB? •I was a subject in a research study at one of the institutions and now I have some questions about the research. Who should I contact? •Are there local educational opportunities that would help me learn more about human research protections? •Where can I learn more about human subject protection issues? •I have a suggestion for improving the human subjects protection program. Who should I contact?

What is Human Subject Research?
Investigators conduct research to add to our general knowledge about the world. When investigators involve humans as subjects in their research, then they must receive prior approval from an Institutional Review Board or "IRB". People often think of human subjects research as medical research, such as "clinical trials", but it also includes research in non-medical departments such as Psychology, Business, Anthropology and Sociology. It's important that potential subjects are fully informed about the research before they agree to participate (usually conveyed in the form of an informed consent document or similar information). Research subjects should know that participation is voluntary, and they may discontinue involvement at any time. Human Subjects Protection
What is an Institutional Review Board or IRB?
An "IRB" is a group of individuals that has the authority to approve all research activities at an institution. According to federal regulations (45 CFR 46), IRBs must have at least five members, with at least one member who is not affiliated with the institution (a "community member"), and the board should represent varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

I was a subject in a research study at one of the institutions and now I have some questions about the research. Who should I contact?
For questions about the research, we suggest that you contact the "Responsible" or "Principal Investigator", whose contact information is listed on the consent document that you should have received when you agreed to participate. If you do not have this information, please contact the IRB office at the institution where the research was done.

Are there local educational opportunities that would help me learn more about human research protections?
Yes - we invite you to attend our seminars on the protection of human subjects. While many of the offerings are designed for researchers, we think that potential subjects would also find them enlightening. See a listing of upcoming seminars.

Where can I learn more about human subject protection issues?
We welcome you to utilize the resources on our education page, which include online seminars and useful links. See education resources.

GetResearchSmart, an online resource that provides basic information to potential research subjects to assist them in making decisions about whether to participate in research studies is available at the following link: http://www.getresearchsmart.org/index.html.

Do you have a suggestion to improve the human subjects protection program?
If you have a suggestion to improve the human subjects protection program or community outreach programs, or if you would like to ask a question, please contact Christain LaMantia, Assistant Vice President for Research Compliance at Case Western Reserve University at (216) 368-4513 or clt@case.edu. We are continually updating our programs and would like to hear from you.