NIH Requirements for Training in Responsible Conduct of

NIH Requirements for Training in Responsible Conduct of Research Jun Panee, Ph. D September 10, 2018 OLA HAWAII Mentoring Bootcamp

What is “Research”? • Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. - Dept. of Health and Human Services, 1992, p. 45 CFR 46. 102(d)

What is “Systematic Investigation” To be considered a “systematic investigation”, the concept of a research project must meet all of the following: • Attempt to answer research questions (in some research, this would be a hypothesis). • Is methodologically driven, that is, it collects data or information in an organized and consistent way. • The data or information is analyzed in some way, be it quantitative or qualitative data. • Conclusions are drawn from the results. http: //www. csusm. edu/gsr/irb/policy_guidelines/definition. html

What is “Generalizable Knowledge” would include one or more of the following features: • The information contributes to a theoretical framework or an established body of knowledge; • The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study; • Publication, presentation or other distribution of the results is intended to inform the field of study; • The results are intended to be replicated in other settings http: //www. csusm. edu/gsr/irb/policy_guidelines/definition. html

NIH “RCR” definition • Responsible Conduct of Research (RCR) 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. *Integrity: the quality of being honest and having strong moral principles; moral uprightness. grants. nih. gov/grants/guide/notice-files/NOT-OD-10 -019. html

Basic Principles of NIH RCR • Responsible conduct of research is an essential component of research training. – Instruction in RCR is evaluated in all NIH grant applications for which it is a required component. – Training occur throughout a scientist’s career. – Instruction should include face-to-face discussions by course participants and faculty. – Research faculty serve as role models for their trainees, fellows, and scholars.

RCR in NIH Grants • RCR instruction is required for awardees of NIH training, career development award (individual or institutional), research education grant, and dissertation research grant. • Applies to : D 43, D 71, F 05, F 30, F 31, F 32, F 33, F 34, F 37, F 38, K 01, K 02, K 05, K 07, K 08, K 12, K 18, K 22, K 23, K 24, K 25, K 26, K 30, K 99/R 00, KL 1, KL 2, R 25, R 36, T 15, T 32, T 34, T 35, T 36, T 37, T 90/R 90, TL 1, TU 2, and U 2 R. • Also applies to any other NIH-funded programs that require instruction in RCR. grants. nih. gov/grants/guide/notice-files/NOT-OD-10 -019. html

RCR Training frequency • Instruction in RCR must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. • It is highly encouraged that initial instruction during predoctoral training occurs as early as possible in graduate school. • Individuals at the early career investigator level (including mentored K awardees and K 12 scholars) must receive instruction in RCR at least once during this career stage. • Senior fellows and career award recipients (including F 33, K 02, K 05, and K 24 awardees) may fulfill the requirement for instruction in RCR by participating as lecturers and discussion leaders. grants. nih. gov/grants/guide/notice-files/NOT-OD-10 -019. html

RCR Training format • A combination of didactic and small-group discussions (e. g. case studies). • Substantial face-to-face discussions by course participants and faculty. • on-line training alone is not sufficient to meet the NIH requirement except in special or unusual circumstances. grants. nih. gov/grants/guide/notice-files/NOT-OD-10 -019. html

Faculty Participation in RCR • Training faculty and sponsors/mentors are highly encouraged to contribute to formal instruction • As discussion leaders, speakers, lecturers, and/or course directors. • Rotation of training faculty may be a useful way to achieve the ideal of full faculty participation • Informal instruction: • laboratory interactions

Duration of RCR Instruction • Substantive contact hours between the trainees and the faculty – at least eight contact hours • A semester-long series of seminars/programs may be more effective than a single seminar or one-day workshop – topics developed in sufficient depth – learning better consolidated – subject matter synthesized in a broader conceptual framework

RCR Subject Matter The following topics have been incorporated into most acceptable plans for such instruction: • conflict of interest – personal, professional, and financial • policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices • mentor/mentee responsibilities and relationships • collaborative research including collaborations with industry • peer review • data acquisition and laboratory tools; management, sharing and ownership • research misconduct and policies for handling misconduct • responsible authorship and publication • the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research grants. nih. gov/grants/guide/notice-files/NOT-OD-10 -019. html

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