Opportunity To Co-Sponsor Office for Human Research Protections Educational Workshops, 44027-44028 [2016-16007]
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Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices
Dr.
Eileen Storey, NIOSH, Respiratory
Health Division, Surveillance Branch,
1095 Willowdale Road, Morgantown,
WV 26505. Telephone (304) 285–5754
(this is not a toll-free number).
FOR FURTHER INFORMATION CONTACT:
Dated: June 30, 2016.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
[FR Doc. 2016–15978 Filed 7–5–16; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Opportunity To Co-Sponsor Office for
Human Research Protections
Educational Workshops
Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
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 cosponsorships should be sent to OHRPEDU@HHS.GOV 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:
OHRP-EDU@HHS.GOV or call OHRP’s
Division of Education and Development
(DED) at 240–453–6900.
SUPPLEMENTARY INFORMATION:
ehiers on DSK5VPTVN1PROD with NOTICES
SUMMARY:
Description
The Office for Human Research
Protections (OHRP) provides leadership
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15:04 Jul 05, 2016
Jkt 238001
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 cosponsor’s related conference expenses.
Co-sponsoring institutions will be
asked to sign a Co-Sponsorship
Agreement with HHS. This CoSponsorship Agreement does not
represent an endorsement by OHRP of
the co-sponsors’ policies, positions, or
activities. Additionally, this agreement
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
44027
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 [cosponsor] (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 [cosponsor] 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
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06JYN1
44028
Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices
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.
ehiers on DSK5VPTVN1PROD with NOTICES
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 [cosponsor] 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.
VerDate Sep<11>2014
15:04 Jul 05, 2016
Jkt 238001
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 [cosponsor]. 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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 cosponsor 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Opportunity To Co-Sponsor Office for
Human Research Protections
Research Community Forums
Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Office for Human
Research Protections (OHRP) announces
the opportunity for non-federal public
SUMMARY:
E:\FR\FM\06JYN1.SGM
06JYN1
Agencies
[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Pages 44027-44028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16007]
-----------------------------------------------------------------------
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 OHRP-EDU@HHS.GOV 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: OHRP-EDU@HHS.GOV 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