81 FR 44027 - Opportunity To Co-Sponsor Office for Human Research Protections Educational Workshops

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 129 (July 6, 2016)

The Office for Human Research Protections (OHRP) announces the opportunity for non-federal public and private sector entities to co- sponsor OHRP Educational Workshops. 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 be willing to participate substantively in the co- sponsored activity.

[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Pages 44027-44028]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Opportunity To Co-Sponsor Office for Human Research Protections 
Educational Workshops

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 and private sector entities to co-
sponsor OHRP Educational Workshops. 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 be willing to participate substantively in the co-
sponsored activity.

DATES:  Requests for co-sponsorships of OHRP Educational Workshops are 
received throughout the year at the email address below. OHRP co-
sponsors a limited number of Educational Workshops with institutions 
each year. Requests are being received for Educational Workshops that 
will take place in the fall of 2016 or beyond.

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

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

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, OHRP Educational Workshops aim to provide 
clarification and guidance to the public on how to interpret, 
implement, and comply with the HHS-regulations on the protection of 
human subjects in research. Workshops are moderate size half-day or 
one-day events that typically accept between 120 and 140 attendees.
    Co-sponsors will assist with workshop 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 
workshop. 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 co-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 an 
Educational Workshop according to the understanding expressed below:

1. Background

    The event is an OHRP Educational Workshop/Event tentatively titled, 
[title].
    The Workshop/Event will be held on [Date] at [Location].
    The Workshop/Event is a [half/1-day] educational outreach 
initiative that provides education and training focusing on the HHS 
policies and regulations on human research protections and their 
applicability. The Workshop/Event is designed for professionals engaged 
in human subject research, including, but not limited to, institutional 
review board (IRB) chairs, members and staff, investigators and 
research staff, and institutional officials.
    The co-sponsoring institution for this educational activity, [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 workshop/event 
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

[[Page 44028]]

collaborate, on all phases of the development of the workshop/event, 
including:
     Establishing a planning committee;
     Identifying program objectives;
     Developing, reviewing and approving the final agenda;
     Preparing web-based advertising; and
     Conducting the workshop/event.
    [Co-sponsor] has or will:
     Advertise and promote the workshop/event to achieve an 
attendance of around 120 or more individual attendants;
     Secure an appropriate facility for the Workshop/Event;
     Provide audio-visual equipment;
     Handle or support the collection of registration fees, if 
any;
     Provide administrative staff to conduct registration, 
obtain accreditations for continuing education units as appropriate, 
and handle all logistical support leading up to and at the Workshop/
Event;
     Provide travel expenses for additional academic faculty 
where applicable;
     Prepare Workshop/Event materials for participants as 
appropriate;
     Distribute and collect from guest 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 Workshop/
Event for educational purposes;
     Provide OHRP with copies of guest speakers' slide 
presentations (slides and any associated video-recordings) as well as 
video-recordings of the workshop/event sessions, if any, no later than 
4 months after the workshop/event;
     Produce and share with OHRP a summary and evaluation 
report as well as the list of participants with their email 
information.
    OHRP will provide program support to [co-sponsor], provide 
advertising, and fund the travel of HHS staff to serve as faculty. [Co-
sponsor] will be responsible for all other costs of the workshop/event.

3. Registration Fees and Other Charges

    [Co-sponsor] has established a tentative registration fee schedule, 
i.e., $[XXX] for general attendees [$XXX] for early registration. 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 workshop/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 workshop/event. [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 workshops;
     Potential for reaching, generating, and engaging adequate 
number of attendees from local stakeholders;
     Availability and description of facilities needed to 
support the workshop;
     Availability of administrative support for the logistics 
of hosting such workshops.

    Dated: June 29, 2016.
Karen B. DeSalvo,
Acting Assistant Secretary for Health.
[FR Doc. 2016-16007 Filed 7-5-16; 8:45 am]
 BILLING CODE 4150-36-P