Request for Information and Comments on Fostering Research Integrity and the Responsible Conduct of Research, 66341-66342 [2020-22992]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices
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
Office of the Assistant
Secretary for Health, HHS.
ACTION: Request for information (RFI).
AGENCY:
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.
SUMMARY:
Interested parties are to
submit comments electronically to
OASH-ORI-Public-Comments@hhs.gov.
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 § 93.300(c), an institution
must:
jbell on DSKJLSW7X2PROD with NOTICES
ADDRESSES:
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
VerDate Sep<11>2014
18:05 Oct 16, 2020
Jkt 253001
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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
66341
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?
E:\FR\FM\19OCN1.SGM
19OCN1
66342
Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
18:05 Oct 16, 2020
Jkt 253001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Respiratory Sciences.
Date: November 9–10, 2020.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Xiang-Ning Li, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5112,
MSC 7854, Bethesda, MD 20892, 301–435–
1744, lixiang@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Shared
Instrumentation: Genomics Studies.
Date: November 9, 2020.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Contact Person: Elena Smirnova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187,
MSC 7840, Bethesda, MD 20892, 301–357–
9112, smirnove@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group; HIV
Coinfections and HIV Associated Cancers
Study Section.
Date: November 12, 2020.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jingsheng Tuo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3196,
Bethesda, MD 20892, 301–451–5953, tuoj@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Radiation Therapy and Biology
SBIR/STTR.
Date: November 13, 2020.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bo Hong, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6194, MSC 7804, Bethesda, MD
20892, 301–996–6208, hongb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Shared Instrumentation: Bioengineering
Sciences and Technologies (S10).
Date: November 13, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: James J. Li, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5148,
MSC 7849, Bethesda, MD 20892, 301–806–
8065, lijames@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–19–
367: Maximizing Investigators’ Research
Award (R35—Clinical Trial Optional).
Date: November 13, 2020.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Elena Smirnova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187,
MSC 7840, Bethesda, MD 20892, 301–357–
9112, smirnove@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Myalgic
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[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]
[[Page 66341]]
-----------------------------------------------------------------------
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).
-----------------------------------------------------------------------
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?
[[Page 66342]]
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
