Clinical trials study management

Data Safety & Monitoring

Researchers must create a plan for monitoring data for safety when studies with human subjects meet the threshold of greater than minimal risk.

Consent Process Development

Obtaining the informed consent from research participants is a basic ethical tenet of scientific research in humans. Researchers conducting nonexempt human participant research must first obtain approval for the research from an Institutional Review Board (IRB) and then obtain the informed consent of each participant, unless the requirement for obtaining informed consent has been waived appropriately by the IRB.

The purpose of informed consent is to ensure that research subjects fully understand the nature of their proposed participation in research and consent willingly to take part. Informed consent addresses the "respect for persons" principle of the Belmont Report. As stated in the Belmont Report "Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness." View the full Belmont Report through the U.S. Department of Health & Human Services.

It should always be remembered that informed consent is an ongoing process, not a single event, designed to provide potential research subjects with all of the relevant information they need to make a fully informed, autonomous decision as to whether they wish to participate in a research study. The elements of informed consent are usually described as:

  • disclosure
  • understanding
  • decision-making capacity
  • voluntariness

Development of the informed consent process should consider:

  • local culture
  • conditions of local health services
  • languages
  • social norms
  • conditions special to the type of participants

Please review the sections of the University’s Human Research Protection Policy Manual pertaining to informed consent:

Additional resources and consent forms: