81_FR_44156 81 FR 44027 - Opportunity To Co-Sponsor Office for Human Research Protections Educational Workshops

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)

Page Range44027-44028
FR Document2016-16007

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 Issue 129 (Wednesday, July 6, 2016)
[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.

-----------------------------------------------------------------------

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



                                                                           Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices                                              44027

                                             FOR FURTHER INFORMATION CONTACT:   Dr.                   in the protection of the rights, welfare,             will not affect any determination
                                             Eileen Storey, NIOSH, Respiratory                        and well-being of subjects involved in                concerning activities by the co-sponsors
                                             Health Division, Surveillance Branch,                    research conducted or supported by the                that are regulated by OHRP.
                                             1095 Willowdale Road, Morgantown,                        U.S. Department of Health and Human                     The following Model Co-Sponsorship
                                             WV 26505. Telephone (304) 285–5754                       Services (HHS). The OHRP is a program                 Agreement is presented only as an
                                             (this is not a toll-free number).                        office within the Office of the Assistant             example. The assignment of duty and
                                               Dated: June 30, 2016.                                  Secretary for Health, Office of the                   responsibilities in the Agreement will
                                                                                                      Secretary, HHS.                                       be discussed and agreed upon with each
                                             Frank Hearl,
                                                                                                        OHRP provides clarification and                     co-sponsor on a case by case basis and
                                             Chief of Staff, National Institute for                   guidance, develops educational                        as applicable.
                                             Occupational Safety and Health, Centers for
                                                                                                      programs and materials, maintains
                                             Disease Control and Prevention.                                                                                Model Co-Sponsorship Agreement
                                                                                                      regulatory oversight, and provides
                                             [FR Doc. 2016–15978 Filed 7–5–16; 8:45 am]
                                                                                                      advice on ethical and regulatory issues                 The Office for Human Research
                                             BILLING CODE 4163–19–P                                   in biomedical and behavioral research.                Protections (OHRP) and [co-sponsor] (if
                                                                                                      OHRP also supports the Secretary’s                    more than one co-sponsor, include all
                                                                                                      Advisory Committee on Human                           names followed by ‘‘jointly referred to
                                             DEPARTMENT OF HEALTH AND                                 Research Protections (SACHRP), which                  as co-sponsoring institutions’’) agree to
                                             HUMAN SERVICES                                           advises the Secretary of Health and                   co-sponsor an Educational Workshop
                                             Opportunity To Co-Sponsor Office for                     Human Services on issues of human                     according to the understanding
                                             Human Research Protections                               subject protections.                                  expressed below:
                                                                                                        Consistent with OHRP’s mission and
                                             Educational Workshops                                                                                          1. Background
                                                                                                      the applicable statutory authority, 42
                                             AGENCY:  Office for Human Research                       U.S.C. 289, OHRP Educational                             The event is an OHRP Educational
                                             Protections, Office of the Assistant                     Workshops aim to provide clarification                Workshop/Event tentatively titled,
                                             Secretary for Health, Office of the                      and guidance to the public on how to                  [title].
                                             Secretary, Department of Health and                      interpret, implement, and comply with                    The Workshop/Event will be held on
                                             Human Services.                                          the HHS-regulations on the protection of              [Date] at [Location].
                                             ACTION: Notice.                                          human subjects in research. Workshops                    The Workshop/Event is a [half/1-day]
                                                                                                      are moderate size half-day or one-day                 educational outreach initiative that
                                             SUMMARY:   The Office for Human                          events that typically accept between 120              provides education and training
                                             Research Protections (OHRP) announces                    and 140 attendees.                                    focusing on the HHS policies and
                                             the opportunity for non-federal public                     Co-sponsors will assist with                        regulations on human research
                                             and private sector entities to co-sponsor                workshop and agenda development,                      protections and their applicability. The
                                             OHRP Educational Workshops.                              coordination, financial management,                   Workshop/Event is designed for
                                             Potential co-sponsors must have an                       and meeting logistics in conjunction                  professionals engaged in human subject
                                             approved Federal-wide Assurance with                     with OHRP staff.                                      research, including, but not limited to,
                                             OHRP, be recipients of HHS grants for                      Co-sponsors can charge registration                 institutional review board (IRB) chairs,
                                             human subject research, and have a                       fees to recover costs associated with the             members and staff, investigators and
                                             demonstrated interest and experience in                  events; however, co-sponsors may not                  research staff, and institutional officials.
                                             the protection of human subjects in                      set registration fees at an amount higher                The co-sponsoring institution for this
                                             research. Potential co-sponsors must be                  than necessary to recover related                     educational activity, [co-sponsor], has
                                             willing to participate substantively in                  conference expenses. Further, we expect               an approved Federal-wide Assurance
                                             the co-sponsored activity.                               co-sponsors to be solely responsible for              with OHRP and is a recipient of HHS
                                             DATES: Requests for co-sponsorships of
                                                                                                      collecting and handling any registration              grants for human subject research.
                                             OHRP Educational Workshops are                           fees collected.                                       OHRP has collaborated with [co-
                                                                                                        Eligibility for Co-Sponsorship: The                 sponsor] (if more than one co-sponsor,
                                             received throughout the year at the
                                                                                                      co-sponsoring institution must have an                include, [co-sponsor], and others) to
                                             email address below. OHRP co-sponsors
                                                                                                      approved Federal-wide Assurance with                  develop a comprehensive agenda that
                                             a limited number of Educational
                                                                                                      OHRP and be a recipient of HHS grants                 addresses the provisions of the HHS
                                             Workshops with institutions each year.
                                                                                                      for human subject research. The                       Protection of Human Subjects
                                             Requests are being received for
                                                                                                      selected co-sponsoring organization(s)                Regulations, 45 CFR part 46, and the
                                             Educational Workshops that will take
                                                                                                      shall furnish the necessary personnel,                ethical principles of The Belmont
                                             place in the fall of 2016 or beyond.
                                                                                                      materials, services, and facilities to                Report.
                                             ADDRESSES: Requests for co-                              administer its responsibility for the                    OHRP fulfills its mission pursuant to
                                             sponsorships should be sent to OHRP-                     workshop. These duties will be outlined               42 U.S.C. 289 by providing an education
                                             EDU@HHS.GOV with ‘‘Co-sponsorship                        in a co-sponsorship agreement with                    program where clarification and
                                             for OHRP Educational Workshops’’ in                      OHRP that will set forth the details of               guidance with respect to ethical issues
                                             the subject field or by mail to OHRP at                  the co-sponsored activity, including the              raised in connection with biomedical or
                                             1101 Wootton Parkway, Suite 200,                         requirements that any fees collected by               behavioral research involving human
                                             Rockville MD 20852.                                      the co-sponsor shall be limited to the                subjects can be addressed. This
                                             FOR FURTHER INFORMATION CONTACT:                         amount necessary to cover the co-                     workshop/event co-sponsored with [co-
                                             OHRP-EDU@HHS.GOV or call OHRP’s                          sponsor’s related conference expenses.                sponsor] is an important component of
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                                             Division of Education and Development                      Co-sponsoring institutions will be                  the OHRP educational program for fiscal
                                             (DED) at 240–453–6900.                                   asked to sign a Co-Sponsorship                        year [year].
                                             SUPPLEMENTARY INFORMATION:                               Agreement with HHS. This Co-
                                                                                                      Sponsorship Agreement does not                        2. Responsibilities for Developing the
                                             Description                                              represent an endorsement by OHRP of                   Event
                                               The Office for Human Research                          the co-sponsors’ policies, positions, or                 OHRP and [co-sponsor] have
                                             Protections (OHRP) provides leadership                   activities. Additionally, this agreement              collaborated, and will continue to


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                                             44028                         Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices

                                             collaborate, on all phases of the                          HHS staff will be serving as faculty                with OHRP to ensure compliance with
                                             development of the workshop/event,                       members and resource people. There is                 this paragraph.
                                             including:                                               no attendance fee for HHS staff.
                                                                                                                                                            8. Records
                                                • Establishing a planning committee;                    [Co-sponsor] does not intend to sell
                                                • Identifying program objectives;                     educational materials pertaining to this                 Records concerning the event shall
                                                • Developing, reviewing and                           event.                                                account fully and accurately for the
                                             approving the final agenda;                                                                                    financial commitments and
                                                                                                      4. Independently Sponsored Portions of
                                                • Preparing web-based advertising;                    Event
                                                                                                                                                            expenditures of OHRP and [co-sponsor].
                                             and                                                                                                            Such records shall reflect, at a
                                                • Conducting the workshop/event.                         [Co-sponsor] may decide to                         minimum, the amounts, sources, and
                                                [Co-sponsor] has or will:                             independently provide food for lunch                  uses of all funds.
                                                • Advertise and promote the                           and/or at breaks for the workshop/event
                                                                                                      attendees as a discrete portion of the                9. Public Availability
                                             workshop/event to achieve an
                                             attendance of around 120 or more                         event. The Workshop/Event agenda will                   This co-sponsorship agreement, as
                                             individual attendants;                                   indicate that this portion of the event is            well as the financial records described
                                                • Secure an appropriate facility for                  independently sponsored by [co-                       in paragraph 8, shall be publicly
                                             the Workshop/Event;                                      sponsor]. OHRP staff and resources will               available upon request.
                                                • Provide audio-visual equipment;                     not be used to develop, promote, or
                                                                                                                                                            10. Co-Sponsorship Guidance
                                                                                                      otherwise support this portion of the
                                                • Handle or support the collection of                                                                          OHRP and [co-sponsor] will abide by
                                                                                                      event.
                                             registration fees, if any;                                                                                     the legal memorandum of August 8,
                                                • Provide administrative staff to                     5. Fund Raising                                       2002, ‘‘Co-Sponsorship Guidance,’’
                                             conduct registration, obtain                                [Co-sponsor] will make clear in any                issued by the HHS Designated Agency
                                             accreditations for continuing education                  solicitation for funds to cover its share             Ethics Official.
                                             units as appropriate, and handle all                     of the event costs that it, not OHRP, is                 Evaluation Criteria: After engaging in
                                             logistical support leading up to and at                  asking for the funds. [Co-sponsor] will               exploratory discussions with potential
                                             the Workshop/Event;                                      not imply that OHRP endorses any fund                 co-sponsors, OHRP will select the co-
                                                • Provide travel expenses for                         raising activities in connection with the             sponsor or co-sponsors that would best
                                             additional academic faculty where                        workshop/event. [Co-sponsor] will make                fulfill OHRP’s mission. Evaluation may
                                             applicable;                                              clear to donors that any gift will go                 include the following criteria:
                                                • Prepare Workshop/Event materials                    solely toward defraying the sponsorship                  • Qualifications and capability to
                                             for participants as appropriate;                         expenses of the event, not to OHRP.                   fulfill co-sponsorship responsibilities;
                                                • Distribute and collect from guest                                                                            • Suitability of the location of the
                                             speakers signed authorization forms                      6. Promotional Activity
                                                                                                                                                            proposed event in terms of the overall
                                             (wording and format provided by                             [Co-sponsor] will not use the event                geographical distribution of OHRP
                                             OHRP) that permit OHRP to retain and                     primarily as a vehicle to sell or promote             workshops;
                                             re-use speakers’ presentations as well as                products or services. [Co-sponsor] will                  • Potential for reaching, generating,
                                             any video-recordings of the                              ensure that any incidental promotional                and engaging adequate number of
                                             presentations obtained in the course of                  activity does not imply that OHRP                     attendees from local stakeholders;
                                             the Workshop/Event for educational                       endorses any of its products or services.                • Availability and description of
                                             purposes;                                                [Co-sponsor] will make reasonable                     facilities needed to support the
                                                • Provide OHRP with copies of guest                   efforts, subject to OHRP review, to                   workshop;
                                             speakers’ slide presentations (slides and                segregate any incidental promotional                     • Availability of administrative
                                             any associated video-recordings) as well                 activity from the main activities of the              support for the logistics of hosting such
                                             as video-recordings of the workshop/                     event.                                                workshops.
                                             event sessions, if any, no later than 4
                                                                                                      7. Event Publicity and Endorsements                     Dated: June 29, 2016.
                                             months after the workshop/event;
                                                                                                                                                            Karen B. DeSalvo,
                                                • Produce and share with OHRP a                          [Co-sponsor] will not use the name of
                                             summary and evaluation report as well                    OHRP or any of its components, except                 Acting Assistant Secretary for Health.
                                             as the list of participants with their                   in factual publicity for the specific                 [FR Doc. 2016–16007 Filed 7–5–16; 8:45 am]
                                             email information.                                       event. Factual publicity includes dates,              BILLING CODE 4150–36–P
                                                OHRP will provide program support                     times, locations, purposes, agendas,
                                             to [co-sponsor], provide advertising, and                fees, and speakers involved with the
                                             fund the travel of HHS staff to serve as                 event. Such factual publicity shall not               DEPARTMENT OF HEALTH AND
                                             faculty. [Co-sponsor] will be responsible                imply that the involvement of OHRP in                 HUMAN SERVICES
                                             for all other costs of the workshop/                     the event serves as an endorsement of
                                                                                                      the general policies, activities, or                  Opportunity To Co-Sponsor Office for
                                             event.
                                                                                                      products of [co-sponsor] where                        Human Research Protections
                                             3. Registration Fees and Other Charges                   confusion could result, publicity should              Research Community Forums
                                               [Co-sponsor] has established a                         be accompanied by a disclaimer to the                 AGENCY:  Office for Human Research
                                             tentative registration fee schedule, i.e.,               effect that no endorsement by OHRP is                 Protections, Office of the Assistant
                                             $[XXX] for general attendees [$XXX] for                  intended. [Co-sponsor] will clearly state             Secretary for Health, Office of the
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                                             early registration. These registration fees              on the agenda that OHRP did not                       Secretary, Department of Health and
                                             are no higher than necessary for [co-                    provide funding for the breaks and                    Human Services.
                                             sponsor] to recover its share of the costs               lunch at the forum. [Co-sponsor] will                 ACTION: Notice.
                                             for co-sponsoring this event and may be                  state on the agenda which organization
                                             lowered, as the arrangements for the                     provided the funding for the breaks and               SUMMARY:  The Office for Human
                                             workshop/event are made and expenses                     lunch at the forum. [Co-sponsor] will                 Research Protections (OHRP) announces
                                             are incurred.                                            clear all publicity materials for the event           the opportunity for non-federal public


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Document Created: 2016-07-06 07:56:04
Document Modified: 2016-07-06 07:56:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesRequests for co-sponsorships of OHRP Educational Workshops are
Contact[email protected] or call OHRP's Division of Education and Development (DED) at 240-453-6900.
FR Citation81 FR 44027 

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