Office of Research Protections
About
Our mission is to forge a partnership with the Main Line Health research community to conduct safe and ethical research. We are committed to guiding researchers in maintaining the highest standards of regulatory compliance with local, state and federal requirements. The ORP views research integrity as an integral measure of our success and looks to develop educational opportunities that continue and expand ethical research endeavors.
We are always looking to improve upon our processes and to that end we encourage you to visit our What's New section for the most recent updates to our policies and procedures for the IRB, IACUC and safety. Please feel free to contact our staff with any questions or concerns.
Main Line Health, Inc. is committed to safeguarding the rights and welfare of persons participating in research conducted under its jurisdiction. To that end it is cognizant of the Declaration of Helsinki—a code of ethics for clinical research—which had been approved by the World Medical Association initially in 1964. Additionally, Main Line Health, Inc. subscribes to and abides by the Belmont Report which contains a statement of basic ethical principles governing research involving human subjects which was issued by the National Commission for the Protection of Human Subjects in 1978. Aware of its role in perpetuating ethical standards in the application of sound medical research, Main Line Hospitals maintains the above referenced documents on-site as a written embodiment of the ethical foundation for all research conducted on Main Line Health campuses.
Contact us
The Office of Research Protections
Lankenau Institute for Medical Research
100 East Lancaster Avenue
Wynnewood, PA 19096
mlh_irb@mlhs.org
| Jack Medendorp, MS, BSN, RN, CIP Director, Office of Research Protections MedendorpJ@mlhs.org 484.476.2692 |
Sandy Alyanakian IRB Specialist, Office of Research Protection AlyanakianS@mlhs.org 610.225.6222 |
Considering participation in a research study?
Before joining a research study, we encourage you to learn more about your rights as a research volunteer and the risks and benefits of being in research. The information here may help you make the right decision.
- Becoming a Research Volunteer – US Office of Human Research Protection - OHRP English (PDF) or OHRP Spanish (PDF)
- National Institutes of Health (NIH) – Clinical Research Trials and You
- The Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process.
If you would like more information about participating in research, or if you would like to discuss concerns, problems or provide input, please contact the Main Line Health Institutional Review Board at 484.476.2692 or 610.225.6221, or by email at mlh_irb@mlhs.org.
Reporting concerns, problems or questions
Research participants are encouraged to express any concerns, problems or questions regarding their involvement in a research study.
- You may speak directly to the investigator or members of the study staff.
- If you would like to speak to someone who is not affiliated with a specific research study to obtain more information about your rights as a research subject, you may contact:
- Albert A, Keshgegian, MD, PhD, Chairman, Main Line Health Institutional Review Board – 484.476.3552
- Jack Medendorp, Director, Office of Research Protections – 484.476.2692
- If you would like to discuss concerns or provide input, please contact the Main Line Health Institutional Review Board at 484.476.2692 or 484.476.3552, or by email at mlh_irb@mlhs.org.
What is an Institutional Review Board?
The IRB is federally mandated group of individuals which reviews all research studies to ensure they are ethical and safe and meet federal requirements. Only research studies that meet these requirements obtain approval from the IRB. Once approved, the IRB continues to monitor the progress and safety of all research studies. IRBs members have diverse backgrounds and include scientists, non-scientists and community members. The Main Line Health IRB includes representatives of the Main Line community.
In the United States the Food and Drug Administration (FDA) and the Department of Health and Human Services (specifically Office for Human Research Protections, or OHRP) issued federal regulations for IRBs to accomplish the goal of protecting the rights and welfare of human subjects participating in research.
Community outreach
Main Line Health clinical research staff attends community events to educate our community and raise awareness and understanding of the research programs we offer. Main Line Health also sponsors community health activities which may include discussions on the research programs we offer.
For more about specific research studies conducted at Main Line Health, please contact:
- Center for Clinical Cardiology – Ann Marie Chikowski, RN, BSN, CCRC
- Center for Clinical Cancer Research – cancertrials@mlhs.org
- Clinical Research Center, LIMR, Other Clinical Areas – Sarah Windawi, MPH
Safety
At LIMR, safety is a priority in all aspects of our research. There are four committees within LIMR that oversee laboratory safety: the Institutional Biosafety Committee (IBC), Institutional Chemical Safety Committee (ICC), Institutional Radioactive Safety Committee (IRC) and the LIMR General Safety Committee. These groups develop, implement, and coordinate the laboratory, biological, chemical and radiation safety programs for all of LIMR's research laboratories. In addition, the LIMR General Safety Committee assists Principal Investigators in providing training on general laboratory safety and overseeing the proper use and disposal of hazardous materials.
The LIMR IBC oversees research involving recombinant DNA, pathogenic organisms, and/or human or non-human primate derived materials (e.g., cell lines, tissues, fluid). Additionally, the Committee oversees all projects involving infectious agents (RG-2 and RG-3) and certain toxins, which are on the CDC Select agents list.
It is the responsibility of the Principal Investigator to submit the proposed research to the LIMR IBC, ICC, and/or IRC for approval before the research has begun. Research may not begin until the study protocol has been reviewed and approved by the respective safety committees.