Responsible Conduct of Research (RCR)

1.4 Responsible Conduct of Research (RCR)

In response to a perceived need by federal and private granting agencies and associations, the University has published its Plan for Training in the Responsible Conduct of Research and Mentoring of Graduate Students and Post-Doctoral Researchers, outlining the responsibilities of faculty and University officials to provide training to students and postdoctoral fellows in the responsible conduct of research. Variations in the National Science Foundation (NSF) and National Institutes of Health (NIH) requirements are described below.

NSF expects institutions to be able to verify that those students (undergraduates and graduates) and postdoctoral researchers who receive NSF funds (support from salary and/or stipends on NSF grants) will obtain RCR training. The RCR training requirement applies to all proposals submitted or due on or after January 4, 2010 to conduct research and excludes, for example, conference, symposium, workshop, or travel proposals. BU certifies in each relevant NSF proposal that it has a plan to ensure compliance with these requirements. The plan, cited above, requires the lead researcher—referred to as the Principal Investigator (PI) or Program/Project Director (PD)—to ensure that their covered trainees complete the training.

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 receive instruction in the responsible conduct of research. This applies to 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. These NIH grant applications must describe the RCR instructional program to be provided, and OSP will provide the PI/PD with a template for the RCR Training Plan. Training plans must be reviewed and approved by OSP.

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1.4.1 Authorship

Investigators should understand and properly fulfill their responsibilities with respect to authorship consistent with the uniform requirements for manuscripts submitted to journals, many of which have established standards.

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1.4.2 Mentorship/Supervision of Trainees

Trainees, both predoctoral and postdoctoral, have the right and the responsibility to ensure that they are adequately supervised during their research training and that the research itself is performed in a manner which reflects high standards for the responsible conduct of science.

In addition, NSF has issued revised guidelines to implement the mentoring provisions of the America COMPETES Act (ACA) (Pub. L. No. 110-69, Aug. 9, 2007). As specified in the ACA, each proposal that requests funding to support postdoctoral researchers must include a description of the mentoring activities that will be provided. Proposals that do not comply with this requirement will be returned without review (see NSF’s Grant Proposal Guide, Chapter II for further information about the implementation of this new requirement).

The Plan for Training in the Responsible Conduct of Research and Mentoring of Graduate Students and Post-doctoral Researchers spells out generic responsibilities for mentoring and as the plan is implemented, additional resources will be made available.

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1.4.3 Management of Data

There are numerous ethical issues associated with the collection of research data. Among the key ethical issues that should be identified and discussed before research proceeds are what methods should be used to obtain data, which parties are rightfully entitled to ownership of data, and the proper means of disclosing data.

The procedures used for collecting data can vary greatly depending on the type of research being conducted. However, a vital component of any data collection is good record keeping. Responsible research practice typically requires that notebooks are maintained in a precise and detailed manner. Without complete documentation of how research data were obtained it can be difficult for the researcher to defend a patent application, or for others to replicate an experiment.

Data ownership is another important issue pertaining to research, due in part to the future research opportunities and/or possible commercial applications that the data may present. When an agreement is established among researchers, institutions, and funding sources, the issue of data ownership should be directly addressed.

Data disclosure and data sharing also raise a host of ethical issues. For example, if a researcher has access to proprietary information, the researcher might have a duty not to reveal that information to other individuals unless they are entitled to it. Additional privacy and confidentiality concerns can emerge if data from research with human subjects is shared without consulting relevant ethical and legal guidelines.

The University requires that all documents related to federally sponsored projects, including primary research data, be available to federal auditors for the period specified by federal regulation—in most cases, three years from the filing of the final required financial report. Non-federal sponsors typically require that records of a project be retained for a period of three to seven years. This requirement applies to original data as well as financial records relating to a project, and includes records in all formats, including paper and electronic files.

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