[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Pages 44028-44030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Opportunity To Co-Sponsor Office for Human Research Protections 
Research Community Forums

AGENCY: Office for Human Research Protections, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: The Office for Human Research Protections (OHRP) announces the 
opportunity for non-federal public

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and private sector entities to co-sponsor OHRP Research Community 
Forums (RCFs). Potential co-sponsors must have an approved Federal-wide 
Assurance with OHRP, be recipients of HHS grants for human subject 
research, and have a demonstrated interest and experience in the 
protection of human subjects in research. Potential co-sponsors must 
also be capable of sponsoring and managing various discrete sessions or 
events associated with the RCF and be willing to participate 
substantively in the co-sponsored activity.

DATES: Requests for co-sponsorships of RCFs are received throughout the 
year at the address below. OHRP expects to co-sponsor up to four RCFs 
each year. Requests are being received for RCFs that will take place in 
2018 or beyond.

ADDRESSES: Requests for co-sponsorships should be sent to [email protected] with ``Co-sponsorship for OHRP RCFs'' in the subject field 
or by mail to OHRP at 1101 Wootton Parkway, Suite 200, Rockville MD 
20852.

SUPPLEMENTARY INFORMATION: 

Description

    The Office for Human Research Protections (OHRP) provides 
leadership in the protection of the rights, welfare, and well-being of 
subjects involved in research conducted or supported by the U.S. 
Department of Health and Human Services (HHS). The OHRP is a program 
office within the Office of the Assistant Secretary for Health, Office 
of the Secretary, HHS.
    OHRP provides clarification and guidance, develops educational 
programs and materials, maintains regulatory oversight, and provides 
advice on ethical and regulatory issues in biomedical and behavioral 
research. OHRP also supports the Secretary's Advisory Committee on 
Human Research Protections (SACHRP), which advises the Secretary of 
Health and Human Services on issues of human subject protections.
    Consistent with OHRP's mission and the applicable statutory 
authority, 42 U.S.C. 289, the Research Community Forum (RCF) provides 
an educational opportunity to discuss with the public and to provide 
clarification and guidance regarding contemporary ethical issues in the 
protection of human research participants. The Research Community Forum 
(RCF) consists of two educational activities: A 1-day conference (RCF-
C) focused on ethical concerns and regulatory issues pertaining to 
contemporary issues in human research protections, and a 1-day 
interactive workshop (RCF-W) focused on the interpretation and 
application of HHS regulations and policies. OHRP will provide a small 
co-sponsoring financial contribution to support the RCF.
    Co-sponsors will assist with conference and agenda development, 
coordination, financial management, and meeting logistics in 
conjunction with OHRP staff.
    Co-sponsors can charge registration fees to recover costs 
associated with the events; however, co-sponsors may not set 
registration fees at an amount higher than necessary to recover related 
conference expenses. Further, we expect co-sponsors to be solely 
responsible for collecting and handling any registration fees 
collected.
    Eligibility for Co-Sponsorship: The co-sponsoring institution must 
have an approved Federal-wide Assurance with OHRP and be a recipient of 
HHS grants for human subject research. The selected co-sponsoring 
organization(s) shall furnish the necessary personnel, materials, 
services, and facilities to administer its responsibility for the 
conference. These duties will be outlined in a co-sponsorship agreement 
with OHRP that will set forth the details of the co-sponsored activity, 
including the requirements that any fees collected by the co-sponsor 
shall be limited to the amount necessary to cover the co-sponsor's 
related conference expenses.
    Co-sponsoring institutions will be asked to sign a Co-Sponsorship 
Agreement with HHS. This Co-Sponsorship Agreement does not represent an 
endorsement by OHRP of the co-sponsors' policies, positions, or 
activities. Additionally, this Agreement will not affect any 
determination concerning activities by the co-sponsors that are 
regulated by OHRP.
    The following Model Co-Sponsorship Agreement is presented only as 
an example. The assignment of duty and responsibilities in the 
Agreement will be discussed and agreed upon with each o-sponsor on a 
case by case basis and as applicable.

Model Co-Sponsorship Agreement

    The Office for Human Research Protections (OHRP) and [co-sponsor] 
(if more than one co-sponsor, include all names followed by ``jointly 
referred to as co-sponsoring institutions'') agree to co-sponsor a 
Research Community Forum according to the understanding expressed 
below:

1. Background

    The event is an OHRP Research Community Forum (RCF) tentatively 
titled, [Title].
    The forum will be held on [Date] at [Location].
    The Forum is a 2-day educational outreach initiative that provides 
a 1-day conference focusing on ethical and regulatory issues pertaining 
to hot-button or topical matter in human research protections, and a 1-
day interactive workshop focusing on the HHS regulations and policies 
on human research protections and their applicability. The Forum 
features distinguished faculty members from academia and the Federal 
Government. It is designed for professionals engaged in or who have 
interest in the protection of human subjects in research. These may 
include bioethicists, academics, institutional review board (IRB) 
chairs, members and staff, investigators and research staff, and 
institutional officials.
    The co-sponsoring institution for this educational event, [co-
sponsor], has an approved Federal-wide Assurance with OHRP and is a 
recipient of HHS grants for human subject research. OHRP has 
collaborated with [co-sponsor] (if more than one co-sponsor, include: 
``, [co-sponsor], and others.'') to develop a comprehensive agenda that 
addresses the provisions of the HHS Protection of Human Subjects 
Regulations, 45 CFR part 46, and the ethical principles of The Belmont 
Report.
    OHRP fulfills its mission, pursuant to 42 U.S.C. 289, by providing 
an education program where clarification and guidance with respect to 
ethical issues raised in connection with biomedical or behavioral 
research involving human subjects can be addressed. This forum co-
sponsored with [co-sponsor] is an important component of the OHRP 
educational program for fiscal year [year].

2. Responsibilities for Developing the Event

    OHRP and [Co-sponsor] have collaborated, and will continue to 
collaborate, on all phases of event planning, including:
     Establishing a planning committee;
     Identifying program objectives;
     Developing, reviewing and approving the final agenda; and
     Preparing web-based advertising.
    [Co-sponsor] has or will:
     Create an event Web site;
     Secure a facility for the Forum (conference and workshop);
     Provide audio-visual equipment;
     Arrange for professional video-recording of 
presentation(s) by speaker(s) [XXX] at OHRP's request;
     Handle or support the collection of registration fees;
     Provide administrative staff to develop the program, 
conduct

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registration, obtain accreditations for continuing education units as 
appropriate and handle all logistical support leading up to and at the 
forum;
     Provide travel expenses for additional academic faculty;
     Duplicate all forum materials and prepare participant 
notebook as appropriate;
     Distribute and collect from speakers signed authorization 
forms (wording and format provided by OHRP) that permit OHRP to retain 
and re-use speakers' presentations as well as any video recordings of 
the presentations obtained in the course of the Forum for educational 
purposes;
     Provide OHRP with copies of the speakers' slide 
presentations (slides and any associated video recordings), as well as 
any video-recordings of conference presentations obtained in the course 
of the Forum, no later than 4 months after the RCF;
     Produce and share with OHRP a summary and evaluation 
report as well as the list of participants with their email 
information.

3. Registration Fees and Other Charges

    [Co-sponsor] has established a tentative registration fee schedule, 
$[Amount] for the 1-day conference; $[Amount] for the 1-day workshop; 
and $[Amount] when registering for both conference and workshop. These 
registration fees are no higher than necessary for [co-sponsor] to 
recover its share of the costs for co-sponsoring this event and may be 
lowered, as the arrangements for the forum event are made and expenses 
are incurred.
    HHS staff will be serving as faculty members and resource people. 
There is no attendance fee for HHS staff.
    [Co-sponsor] does not intend to sell educational materials 
pertaining to this event.

4. Independently Sponsored Portions of Event

    [Co-sponsor] may decide to independently provide food for lunch 
and/or at breaks for the Workshop/Event attendees as a discrete portion 
of the event. The workshop/event agenda will indicate that this portion 
of the event is independently sponsored by [co-sponsor]. OHRP staff and 
resources will not be used to develop, promote, or otherwise support 
this portion of the event.

5. Fund Raising

    [Co-sponsor] will make clear in any solicitation for funds to cover 
its share of the event costs that it, not OHRP, is asking for the 
funds. [Co-sponsor] will not imply that OHRP endorses any fund raising 
activities in connection with the Forum. [Co-sponsor] will make clear 
to donors that any gift will go solely toward defraying the sponsorship 
expenses of the event, not to OHRP.

6. Promotional Activity

    [Co-sponsor] will not use the event primarily as a vehicle to sell 
or promote products or services. [Co-sponsor] will ensure that any 
incidental promotional activity does not imply that OHRP endorses any 
of its products or services. [Co-sponsor] will make reasonable efforts, 
subject to OHRP review, to segregate any incidental promotional 
activity from the main activities of the event.

7. Event Publicity and Endorsements

    [Co-sponsor] will not use the name of OHRP or any of its 
components, except in factual publicity for the specific event. Factual 
publicity includes dates, times, locations, purposes, agendas, fees, 
and speakers involved with the event. Such factual publicity shall not 
imply that the involvement of OHRP in the event serves as an 
endorsement of the general policies, activities, or products of [co-
sponsor]; where confusion could result, publicity should be accompanied 
by a disclaimer to the effect that no endorsement by OHRP is intended. 
[Co-sponsor] will clearly state on the agenda that OHRP did not provide 
funding for the breaks and lunch at the forum. [Co-sponsor] will state 
on the agenda which organization provided the funding for the breaks 
and lunch at the forum. [Co-sponsor] will clear all publicity materials 
for the event with OHRP to ensure compliance with this paragraph.

8. Records

    Records concerning the event shall account fully and accurately for 
the financial commitments and expenditures of OHRP and [co-sponsor]. 
Such records shall reflect, at a minimum, the amounts, sources, and 
uses of all funds.

9. Public Availability

    This co-sponsorship agreement, as well as the financial records 
described in paragraph 8, shall be publicly available upon request.

10. Co-sponsorship Guidance

    OHRP and [co-sponsor] will abide by the legal memorandum of August 
8, 2002, ``Co-Sponsorship Guidance,'' issued by the HHS Designated 
Agency Ethics Official.
    Evaluation Criteria: After engaging in exploratory discussions with 
potential co-sponsors, OHRP will select the co-sponsor or co-sponsors 
that would best fulfill OHRP's mission. Evaluation may include the 
following criteria:
     Qualifications and capability to fulfill co-sponsorship 
responsibilities;
     Suitability of the location of the proposed event in terms 
of the overall geographical distribution of OHRP-RCFs;
     Interests in human research protections that complement 
and promote OHRP's interests and agenda;
     Creativity and innovations related to the human research 
protections topics proposed to cover;
     Creativity in enhancing the conference, including ideas 
for improving the event based on prior RCFs;
     Potential for reaching, generating, and engaging attendees 
from diverse key stakeholders;
     Availability and description of facilities needed to 
support the RCF;
     Availability of administrative expertise, experience, and 
support (including accounting and event management) for the logistics 
of hosting events of a similar scale.

FOR FURTHER INFORMATION CONTACT:  [email protected] or call OHRP's 
Division of Education and Development (DED) at 240-453-6900.

    Dated: June 29, 2016.
Karen DeSalvo,
Acting Assistant Secretary for Health.
[FR Doc. 2016-16004 Filed 7-5-16; 8:45 am]
 BILLING CODE 4150-36-P