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Assessing Risk in Human Research Protocols

While it is true that all researchers want their studies to be reviewed and approved quickly; it has to be borne in mind that risks in the study can slow the process. Evaluation of risks is a fundamental requirement as stated in DHHS and FDA regulations 45 CFR 46.111 and 21 CFR 56.111, which require clinical trials to satisfy these two important criteria before the research is granted IRB approval:

  • Minimizing the risk to subjects by the use of procedures that are in accordance with solid research design. This may require them to use procedures that are already being used on the subjects for diagnosing or treating
  • Weighing if the risks to subjects are judicious vis-à-vis the expected benefits

The level of risk assigned to a research protocol affects nearly all factors related to the research and determines these critical issues among others:

  • The mode of review
  • Whether or not additional approvals outside of the IRB are needed
  • If additional protections need to be put in place
  • Frequency of review
  • Consent requirements
  • Negotiation of indemnification language

So, clinical trials professionals doing human research protocols have to understand how risk levels are assigned and make preliminary determinations when designing the study, if they have to put in place protections that would reduce the level of risk. These protections provide greater flexibility in areas of their protocol, such as mode of review, consent, or data safety monitoring.

Thorough learning on risk in human research protocols

Sarah Fowler-Dixon, an Education Specialist and instructor with Washington University School of Medicine, who has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, and submission and reviewer forms often working with state and federal authorities; will shed light on all the important aspects of risk in human research protocols at a webinar that is being organized by MentorHealth, a leading provider of professional trainings for all the areas of healthcare.

Please register for this webinar and get a full understanding of the area of assessing risk in human research protocol.


Helping in decision-making

Sarah will offer insights into how to assess risk in human research protocols, which will help participants understand the criteria by which research studies are assigned a risk rating, what that risk rating means, and what they can do to minimize risks. She will help participants know how these decisions are made and what they can affect. This knowledge will be of high value and use when they are conducting risk assessments of their own.

She will cover the following areas at this webinar:

  • The importance of research risks defined in 21 CFR 50 and 45 CFR 46
  • Delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50
  • Review consent possibilities as allowed by the regulations
  • Discuss need for indemnification language in consent forms based on risk levels
  • Consider how risks can be minimized by using preliminary risk assessments.

This session will be highly useful to personnel involved in the areas concerning human research protocols, such as those in human subjects research, clinical research, coordinator positions, investigator positions, administration in charge of clinical research, regulatory compliance, and those involved in health plans and healthcare clearinghouses.

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