How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial

Why Should You Attend:

The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research and to maximize the safety of subjects once they are enrolled in the project.

Submitting an IRB application right the first time requires a lot of attention to detail. Once a successful application is approved, it is important to keep up with the continuing requirements/submissions/changes etc. Attend this webinar to learn what the IRB is looking for and how to expose and fix problem before they threaten you trial and learn about the role and responsibilities of an efficient well rounded CRC.

Areas Covered in the Webinar:

• IRB- Purpose, Use, Responsibilities.
• IRB Application Process.
• Single center trial vs. Multiple center trial.
• Privately vs. Government sponsored trials.
• Research Team and IRB.
• IRB Document management.
• How to prevent problems.
• What to do prior to submitting application to the IRB, when the trial is on going and after the trial is complete.
• Continuing review, Annual Review.

Who Will Benefit:

This webinar will provide valuable assistance to all involved in conducting clinical trials at a research site:

• Research Managers
• Clinical Research Coordinators
• Principal Investigators, Co-investigators, Student Investigators
• Administrative managers in charge of Clinical Research
• Regulatory, Compliance Associates and Managers
• Personnel applying to IRBs for a single/multiple center trial
• Researchers working on a protocol

Instructor Profile:

Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has worked in the healthcare industry in various roles for the past 20 years. She has worked in healthcare research with a primary focus on cardiology for 7 years. She has experience with conducting clinical trials, investigator initiated trials, starting a research program in a hospital, health services research, grant submission, business development and fundraising. She served on a study coordinator advisory committee of a global CHF/hyponatremia clinical trial.

Topic background:

An institutional review board ( IRB ), also known as an independent ethics committee ( IEC ) or ethical review board ( ERB ), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects . In the United States , the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections ) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific , ethical , and regulatory.

IRBs are most commonly used for studies in the fields of health and the social sciences, including anthropology , sociology , and psychology . Such studies may be clinical trials of new drugs or devices, they may be studies of personal or social behavior, opinions or attitudes, or they may be studies of how health care is delivered and might be improved.

The purpose of an IRB review is to assure Appropriate steps followed to protect the rights and welfare of humans participating as subjects in a research study. It also assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.

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