Responsible Conduct of Research

Policy 6.7
Approved by:	President
Responsible Officer:	Vice President of research and economic development
Responsible Office:	research and economic development (red)
Originally Issued:	09/07/2010
Last Revision:	01/29/2024
Category:	research, sponsored programs, and intellectual properties
Related Policy
SDBOR Policy 4:42 Academic Misconduct

I. REASON FOR THIS POLICY

Every institution that conducts research must maintain a responsible conduct of research policy. Dakota State University (DSU) is committed to ethical and responsible conduct of research first and foremost because that commitment is a cornerstone of good science. Effective January 4, 2011, the America COMPETES (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Act was signed into law. This Act updated earlier legislation (Stevenson-Wylder 1980), re-delegated regulatory authority in the Federal Register (78 FR 4766) and cross-referenced definitions of research misconduct (42 CFR 93). The National Science Foundation (NSF), the National Institutes of Health (NIH) and other federal funding agencies updated their policies to align with America COMPETES during the same year the law passed. For institutions receiving federal funding, this guidance requires the Authorized Organizational Representative(s) to certify that the institution provides appropriate training and oversight in the responsible and ethical conduct of research.

II. DEFINITIONS

1. Authorized Organizational Representative (AOR). Designated representative of the University to funding agencies in matters related to proposal submission and award administration of grants, cooperative agreements, and contracts, including sub-awards. DSU’s AORs include the Chief Research Officer (CRO) and one primary designee for routine operations, usually a staff member in Research & Economic Development.
2. Chief Research Officer (CRO). Individual who provides operational and regulatory oversight for all research at an institution.
3. Co-Principal Investigator (Co-PI). Individual who assists a Principal Investigator (PI) as a member of a research team’s “senior personnel” (NSF, NSA) or “key personnel” (NIH and some other agencies). PIs often delegate specific project duties to Co-PIs, even if the PI retains primary responsibility for the related outcomes. See also PI.
4. Institutional Official (IO). Individual responsible for research compliance oversight, including responsible conduct of research (RCR), research with human subjects, and research-related export controls.
5. Investigator. May be used interchangeably with Researcher to refer to anyone engaged in a research investigation, usually to produce generalizable knowledge, regardless of the funding status of the specific research project.
6. Other Personnel. Includes any personnel on a project, regardless of funding status, who are not PI or Co-PIs, and who may or may not be investigators/researchers, including but not limited to postdoctoral scholars, other professionals, graduate students, undergraduate students, administrative or clerical staff, or others whose work does not align with one of these categories. See also PI, Co-PI, and Senior Personnel.
7. Principal Investigator (PI). Individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project. PIs must meet certain eligibility requirements as outlined in federal, state, and university rules and restrictions as noted in solicitations for said grants, agreements, contracts, and projects. Most agencies use the PI on a very short list of project contacts. For purposes of this policy, PI refers to any individual submitting or any faculty member sponsoring student research application to DSU’s IRB and who must comply with human subjects federal regulations and institutional procedures. See also Co-PI.
8. Research. A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR Protection of Human Subjects §46.102(l)
9. Researcher. May be used interchangeably with Investigator to refer to anyone engaged in a research investigation, usually to produce generalizable knowledge, regardless of the funding status of the specific research project.
10. Senior Personnel. Includes the PI and all co-PIs on a given project, regardless of funding status.
11. Supervising Faculty. Includes any faculty member(s) engaged in the supervision of student research, regardless of funding status. This is the primary party responsible for ensuring that student researchers complete all appropriate/applicable RCR training. Supervising faculty are often PIs, but some PIs will delegate these supervisory duties to a co-PI.

III. STATEMENT OF POLICY

1. Federal Requirements. Dakota State University will demonstrate its commitment to Responsible Conduct of Research by meeting or exceeding all applicable federal and other agency requirements.
2. Training. Training in the Responsible Conduct of Research (RCR) is required for all DSU researchers, whether they are students, faculty, or staff. This policy applies regardless of the funding status of the research. At minimum, DSU researchers must:
   
   1. Take RCR training through the Collaborative Institutional Training Initiative (CITI) appropriate to the type of research they do (two options: Research With Human Subjects OR Research Without Human Subjects).
   2. Attend in hybrid synchronous format and via asynchronous recording a series of research training seminars that address a variety of compliance matters, including research ethics and other topics within Responsible Conduct of Research.
3. Policy Enforcement.
   1. This policy will be available to every DSU researcher via RED-organized trainings, and it will be furnished again as a reminder to researchers submitting proposals for internal or external funding.
   2. Projects may be randomly selected for audit to ensure compliance with this policy and the related regulatory requirements that inform it.
       

Exclusions
None

Exceptions
None

IV. PROCEDURES (MAJOR)

1. Research and Economic Development (RED) Staff will notify all faculty conducting research of the RCR training requirements, work with the University Research Committee to plan and conduct the RCR seminars and ensure compliance with federal and state agencies’ regulatory guidance as required. In addition, RED staff will ensure that the RCR seminars are recorded and uploaded for asynchronous use. Records of RCR training and related documentation, including recordings of in-person and hybrid seminars, will be maintained by RED staff to demonstrate institutional regulatory compliance.
2. RCR Module Pass Rate. Each person engaged in research (paid or unpaid) is required to have a foundation of documented training in RCR. This requirement can be met by having the student take and pass (minimum 80% passing score) the applicable RCR module(s) provided in the Collaborative Institutional Training Institute (CITI): https://www.citiprogram.org/default.asp?language=english.
   
   
3. RCR Seminars. Each investigator who conducts research, regardless of funding status, will be required to participate in at least some synchronous (face-to-face) training to ensure compliance with federal guidance. Demonstrating this participation will depend primarily on the researcher’s depth of involvement with research projects so content can be tailored for high relevance to researcher interests. Adherence/commitment to synchronous training participation and/or leadership will be assessed within normal faculty and staff annual review procedures and through random compliance audits.
   
4. Communication. 
   1. Research and Economic Development (RED) staff will announce synchronous sessions via campus email and calendar systems.
   2. Research and Economic Development (RED) staff will provide information on the RCR policy and procedures to new faculty at New Faculty Orientation, during onboarding processes, at College meetings, at trainings both synchronous and asynchronous, and elsewhere as requested.
5. Records. A record of the CITI Responsible Research module progress and completion is provided electronically by CITI to no fewer than two Research (RED) staff. CITI completion and attendance at synchronous hybrid seminars will be forwarded to the offices of College Deans and the Provost/Senior VP for Academic and Student Affairs.

V. RELATED DOCUMENTS, FORMS AND TOOLS

Collaborative Institutional Training Initiative (CITI)

NSF Responsible and Ethical Conduct of Research

NIH Responsible Conduct of Research

NIH RCR Training Page

VI. POLICY HISTORY

ADOPTED: 09/07/2010
REVISED: 01/29/2024