Human Subjects Protection

Responsible Conduct of Research and Human Subjects Protection Training

Human subjects protection training is required for all key study personnel working on the research study, including those who are obtaining consent. UConn Health accepts training from the Collaborative Institutional Training Initiative (CITI) and the NIH, with a refresher every three years.  Some institutions vary in the frequency of this training requirement.  See the corresponding links below for more information.  Additional information may be found at NIH: Training for CICATS investigators and NIH: Protection of human research participants.

The following are defined by the NIH Responsible Conduct of Research requirements:

Definition of Responsible Conduct of Research

For the purpose of this Notice: responsible conduct of research is defined as the practice of scientific investigation with integrity.  It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.   See this link for more NIH definitions.

Basic Principles

The following principles are based on several key concepts about responsible conduct of research and best practices that have evolved over the past two decades’ experiences:

  1. Responsible conduct of research is an essential component of research training.  Therefore, instruction in responsible conduct of research is an integral part of all research training programs, and its evaluation will impact funding decisions.
  2. Active involvement in the issues of responsible conduct of research should occur throughout a scientist’s career.  Instruction in responsible conduct of research should therefore be appropriate to the career stage of the individuals receiving training.
  3. Individuals supported by individual funding opportunities such as fellowships and career development awards are encouraged to assume individual and personal responsibility for their instruction in responsible conduct of research.
  4. Research faculty of the institution should participate in instruction in responsible conduct of research in ways that allow them to serve as effective role models for their trainees, fellows, and scholars.
  5. Instruction should include face-to-face discussions by course participants and faculty; i.e., online instruction may be a component of instruction in responsible conduct of research but is not sufficient to meet the NIH requirement for such instruction, except in special or unusual circumstances.
  6. Instruction in responsible conduct of research must be carefully evaluated in all NIH grant applications for which it is a required component.

Policy

NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.  This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011.  This Notice applies to the following programs:  D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R.   This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

 

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