[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66341-66342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22992]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Request for Information and Comments on Fostering Research 
Integrity and the Responsible Conduct of Research

AGENCY: Office of the Assistant Secretary for Health, HHS.

ACTION: Request for information (RFI).

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SUMMARY: The Department of Health and Human Services (HHS), Office of 
Research Integrity (ORI) seeks information and comments from entities 
and individuals regarding activities that foster research integrity and 
promote the responsible conduct of research under 42 CFR part 93. In 
particular, ORI is interested in learning about best practices, 
challenges, and needs related to teaching the responsible conduct of 
research, promoting research integrity, and preventing research 
misconduct. ORI will use this information to support the goal of 
conducting outreach and developing educational resources that best 
support the Public Health Service (PHS) funded research community.

DATES: Responses to the RFI must be received electronically at the 
email address provided below no later than 5:00 p.m. ET on the 60th day 
following the date of publication in the Federal Register.

ADDRESSES: Interested parties are to submit comments electronically to 
[email protected]. Include ``RCR RFI'' in the subject 
line of the email. Mailed paper submissions and electronic submissions 
received after the deadline will not be reviewed.

FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, Director, Office 
of Research Integrity, 1101 Wootton Parkway, Suite 240, Rockville, MD 
20852, (240) 453-8200.

SUPPLEMENTARY INFORMATION: The Public Health Service Policies on 
Research Misconduct, 42 CFR parts 50 and 93, establish several 
requirements regarding the fostering of an environment that promotes 
research integrity and discourages research misconduct. Institutions 
must adhere to these requirements to receive PHS funding. Per Sec.  
93.300(c), an institution must:

Foster a research environment that promotes the responsible conduct 
of research, research training, and activities related to that 
research or research training, discourages research misconduct . . .

    ORI conducts outreach and develops educational resources that aid 
institutional efforts ``to teach the responsible conduct of research, 
promote research integrity, prevent research misconduct, and . . . 
respond effectively to allegations of research misconduct. . . .'' 65 
FR 30600, 30601 (May 12, 2000). ORI has created materials and offered 
workshops and other events to assist research institutions in meeting 
their requirements. ORI is interested in hearing from the biomedical 
research community on ways that ORI can improve upon its efforts to 
support institutions in this endeavor. To this end, ORI seeks 
information and comment from biomedical research institutions about 
best practices, challenges, and needs related to teaching the 
responsible conduct of research (RCR), promoting research integrity 
(RI), and preventing research misconduct.
    This RFI focuses on establishing a greater understanding of the 
needs, best practices, and challenges related to three categories:
    (a) Using Training and Education To Foster Research Integrity;
    (b) RI/RCR Program Administration and Facilitation of Training; and
    (c) RI/RCR Training Sessions.
    Information collected in response to this request will be used to 
inform the development of future educational resources and outreach 
activities.

Using Training and Education To Foster Research Integrity

    ORI seeks to understand the key challenges to using training and 
educational efforts to foster a climate that encourages research 
integrity and the responsible conduct of research.
    1. What challenges have been encountered?
    2. Where those challenges may have been overcome, what has made the 
difference?
    3. Where those challenges have not been overcome, what would make a 
difference?

RI/RCR Program Administration and Facilitation of Training

    ORI recognizes that the approach to and implementation of research 
integrity/responsible conduct of research (RI/RCR) training programs 
varies within the biomedical research community. To better understand 
the nature of these programs as well as best practices, challenges, and 
needs related to program administration and the facilitation of 
training, ORI asks the following:
    1. How are institutions' RI/RCR programs structured, with respect 
to courses, format, frequency, scope, and content? What about this 
structure may be of interest or benefit to others administering RI/RCR 
programs?
    2. How are institutions' programs administered? Who or what group 
is responsible for: Instruction, programming, administration, 
oversight, and financial support? Do institutions' research integrity 
officers (RIO) play a role in the program? Do research mentors play an 
active role in the program? What additional resources are needed from 
the administrative perspective?
    3. Which members of institutions' research communities participate, 
as learners, in the RI/RCR training program? What benefits or drawbacks 
pertain to this composition of program participants?
    4. Does current institutional policy mandate participation in the 
RI/RCR training program? If so, for which members of the research 
community? If mandated participation requirements extend beyond funding 
agency requirements, please share the rationale for requiring this 
participation.
    5. What fields of research are represented by the participants in 
the RI/RCR training program?
    6. What topics, related to the research environment, research 
integrity, and/or the responsible conduct of research, does the program 
cover?
    7. Are any topics covered due to a locally perceived or expressed 
need? Please explain.
    8. Which topics are most popular with participants?
    9. Which topics are the most difficult to cover and why? What 
resources would make inclusion and discussion of these topics easier 
and/or more effective?
    10. Do resource constraints (e.g., materials for instruction, 
training for instructors, staffing, financial) limit presentation of 
certain topics? Which topics, and why? What resources would be most 
useful in addressing this?

RI/RCR Training Sessions

    To inform the development of educational and training resources 
that support the needs of the biomedical research community, ORI seeks 
information on institutional experiences, practices, and needs related 
to RI/RCR training sessions.
    1. How long, on average, does it take to prepare a new course or 
training session?
    2. How frequently is the material in a training session or course 
revised? How often are new training sessions or courses developed? How 
often are old training sessions or courses discontinued?

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    3. Do training materials and resources used in the course or 
training session(s) come from outside the institution? If so, where? If 
the program or instructor creates custom materials and resources for 
use in the course or training session, please describe any related 
benefits or drawbacks.
    4. What approaches engage learners and create an interactive 
session (e.g., lectures, seminars, small group discussions, audience 
polling, problem solving, role play)? Are different approaches used 
when training faculty, staff, students, or postdoctoral researchers?
    5. What types of resources seem most effective or engaging (e.g., 
videos, infographics, scenarios, case studies, slide decks); how is 
this assessed? Does this vary depending on the group of learners (i.e., 
faculty, staff, students, or postdoctoral researchers)?
    6. Is the impact of a training session assessed? If so, how, and 
what metrics gauge success?
    7. What do learners ask for, instructionally or programmatically, 
that can or cannot be addressed?
    8. What resources are needed to more fully engage learners and/or 
address their training related requests?

Collection of Information Requirements

    Please note: This RFI is issued solely for information and planning 
purposes; it does not constitute a solicitation for: Request for 
Proposals (RFPs), applications, proposal abstracts, or quotations. This 
RFI does not commit the U.S. Government to contract for any supplies or 
services or to make a grant award. Further, ORI is not seeking 
proposals through this RFI and will not accept unsolicited proposals. 
Responders are advised that the U.S. Government will not pay for any 
information or administrative costs incurred in responding to this RFI; 
all costs associated with responding to this RFI will be solely at the 
expense of the interested parties. ORI notes that not responding to 
this RFI does not preclude participation in any future procurement, if 
conducted. It is the responsibility of the potential responders to 
monitor this RFI announcement for additional information pertaining to 
this request.
    ORI will actively consider all input as our office plans education 
and outreach activities. ORI may or may not choose to contact 
individual responders. Such communications would be for the sole 
purpose of clarifying statements in the responders' written responses. 
Responses to this notice are not offers and cannot be accepted by the 
U.S. Government to form a binding contract or to issue a grant. 
Information obtained as a result of this RFI may be used by the U.S. 
Government for program planning on a non-attribution basis. Respondents 
should not include any information that might be considered proprietary 
or confidential. This RFI should not be construed as a commitment or 
authorization to incur cost for which reimbursement would be required 
or sought. All submissions become U.S. Government property and will not 
be returned.

Elisabeth A. Handley,
Director, Office of Research Integrity.
[FR Doc. 2020-22992 Filed 10-16-20; 8:45 am]
BILLING CODE 4150-31-P