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Name: Responsible Conduct in Research Policy - Interim
Responsible Office: Research

Applies to: (examples; Faculty,Staff, Students, etc)

Faculty , Staff , Students , Contractors_Vendors

Policy Overview:

Issued: 05-01-2017
Next Review Date: 05-01-2018
Frequency of Reviews: Annually

St. Louis College of Pharmacy is committed to ensuring that all persons conducting research for which it is responsible will maintain the appropriate ethical standards to ensure scientific integrity and meet the expectations of program sponsors and the general public.

This policy outlines the responsible conduct in research training requirements applicable to covered persons working on grants or awards sponsored by the NSF, NIFA, and NIH.

This policy applies to all individuals conducting research at or in their capacity as employees or students at St. Louis College of Pharmacy.


Details:

Responsible Conduct of Research Training - NSF, NIFA and NIH

The National Science Foundation (NSF) requires responsible conduct of research (RCR) training for all undergraduates, graduates, and post-doctoral fellows who conduct research supported by NSF funds. All institutions submitting applications must certify at the time of application submission that plans are in place to provide appropriate training and oversight of the RCR training. Certification of compliance with the requirements is given by the chief research administrator designated by the President.

Similarly, the National Institutes of Health (NIH) requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, or dissertation research grant must receive RCR training. This requirement also applies to all faculty, including new faculty, mid-career faculty and senior faculty, and professional and scientific employees receiving funding from these sources. Plans to meet the RCR requirements must be specified in the principal investigator's proposal application.

The National Institute of Food and Agriculture (NIFA) also considers education in RCR as essential in the preparation of future scientists. By accepting a NIFA award, the grantee assures that program directors, faculty, undergraduate students, graduate students, postdoctoral researchers, and any staff participating in the research project receive appropriate training and oversight in the responsible and ethical conduct of research and that documentation of such training will be maintained. Grantees are advised that the documentation of the training is subject to NIFA review upon request.

NSF Training Requirements

NSF expects institutions to be able to verify that students receiving NSF funds, either in salary support or stipends to conduct research, receive RCR training. Unlike NIH, NSF has not specified the content for training and expects each institution to determine curriculum, taking into consideration the types of research conducted at the institution and the needs of the students who intend to pursue basic or applied research careers.

The RCR training requirement applies to new proposals to conduct research, excluding, for example, conference, symposium, workshop, or travel proposals.

The College’s Chief Research Administrator and the Research Integrity and Safety Committee (RISC) will coordinate educational training to meet the National Science Foundation (NSF) responsible conduct of research (RCR) training requirements. These options may include successful completion of the core modules of the online RCR Basic Course hosted by the Collaborative Institutional Training Initiative (CITI) or an academic course(s) or educational program(s) in RCR approved by the CRA and RISC.

Option 1: Online RCR Training

Individuals selecting the web-based program to meet RCR requirements must complete and pass the tests covering the following RCR core areas:

  • Authorship
  • Collaborative Research
  • Conflicts of Interest
  • Data Management
  • Mentoring
  • Peer Review
  • Plagiarism
  • Research Involving Human Subjects
  • Research Misconduct
  • Using Animal Subjects in Research

Optional modules offered in the CITI online RCR program include:

  • Environmental and Social Dimensions of Engineering Research 
  • Export Controls and National Security
  • Research, Ethics, and Society

Estimated time to complete the required modules is 1½ to 3 hours.  

Accessing the Training

You will need to create an account in the CITI program before you can access the training. Once you've created your account, you can take the course and exam listed in the "My Courses" section under the St. Louis College of Pharmacy heading.

Results

Your score must be 80% or greater to receive certification of training. If your score is less than 80%, you will be allowed to retake the quiz. Your results will automatically be forwarded to the chief research administrator. Please be sure to print a copy of certification for your files.

Questions

If you have any questions or need help with accessing the training, please contact Karen Siebert, chief research administrator, Karen.Seibert@stlcop.edu, 446-8422.

Training for Research Involving Humans, Animals, and Biohazards 

Individuals conducting research involving humans, animals, and biohazards will also be required to take the training components required by the Institutional Review Board (IRB), the designated Institutional Animal Care and Use Committee (IACUC) or Institutional Biosafety Committee (IBC), and the RISC.

NIFA Training Requirements

The NIFA training requirements can be met by following the same training guidelines as for NSF, which are noted above.

NIH Training Requirements

NIH requires the submission of an instructional plan addressing the responsible conduct of research. The November 24, 2009, notice NOT-OD-10-019 established a new expectation for the format of the training, subject matter, faculty participation, duration and frequency of instruction. The 2009 update specifies that online courses can be a valuable supplement but they are not considered adequate to address the RCR requirements except in special instances of short-term training programs or unusual and well-justified circumstances. Acceptable training plans generally include a minimum of eight substantive hours of face-to-face instruction over the following subject matter:

  • 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.

Training may be given as a semester-long series or a single one-day workshop. Investigators may develop their own training format. The CRA and RISC will maintain a list of courses that meet the NIH requirements.

Requirements for successful completion of the course will be outlined in each course syllabus. In general, students must attend at least 80% of the class sessions and earn at least 80% of the points on homework assignments to receive certification that NIH, NSF, or USDA NIFA training requirements have been met. Students who do not meet these requirements must re-take the course to receive certification.

NIH guidance documents also indicate that “Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.”

Frequency: Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years.

Applicability: This requirement 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.

Credit:  The College may allow persons who have completed qualified training for another employer or organization to provide proof of such training to satisfy this policy.

Responsibilities:

Position/Office/Department

Responsibility

Chief Research Administrator

Coordinating and monitoring compliance

 

 

 

 

 

 

Supplemental Information:

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