The regular conduct of research at Oak
Hammock is consistent with the
community's principles, and it is consistent with the Oak Hammock/UF
partnership. At the same time, the research committee feels strongly
that research must be done using a "community partnership model". That
implies that there must be support, agreement, active participation,
criticism, feedback and response to research requests and feedback from
the community.
A chief function of the Research Advisory Committee is gatekeeping. It
is important that only a limited number of protocols might be approved
simultaneously. Too many projects at one time might dilute the ability
for any single study to successfully recruit. Second, a steady
"onslaught" of studies is likely to create the impression of Oak
Hammock
(in members' eyes) as a laboratory or source of "guinea pigs", which
would diminish member enthusiasm for research over time. It is
important that we avoid the objectification of members as "subjects"
and nothing more. Active participation by Oak Hammock members in
research screening is an important safeguard to ensure community
involvement.
Application
procedure
Researchers must ELECTRONICALLY submit a package of materials to the
Research Advisory Committee Chair, Michael Marsiske, mmarsisk@phhp.ufl.edu.
These materials will be reviewed by the
committee. The materials to be sent, without exception, include
- UF IRB protocol, as approved by the IRB
- Consent form, stamped by the UF IRB (thus, scanned copies must be submitted
electronically)
- Advertisement/flyer, stamped by the UF IRB (thus, scanned copies must be submitted
electronically)
- Letter of approval from the UF IRB
- Cover sheet (available here)
- "Layperson's description". A sample is here. You can also see the descriptions of approved protocols in our project list.
The Layperson's description is a 250 to 500 word document, written in
lay
"newspaper" style, which includes the following elements: An
investigator photograph, a one-paragraph biography of the principal
investigator, particularly describing why the research is interesting
and important, and a one-paragraph summary of known findings in the
field and what unique questions the study will answer. If the study is
approved, this will be posted on the Oak Hammock website. (After the
research is completed, an additional paragraph describing study
findings, in similar lay terms, will also be required. The cover letter
also requires a commitment to this.) For a sample layperson's
description,
click here.
Deadlines
and review
Applications to mmarsisk@phhp.ufl.edu
are due by close-of-business on
the 15th of each month, and must be submitted electronically as
Microsoft Word or pdf documents. Scans of the stamped IRB approval
materials are required.
Applications will be reviewed within 7 days of receipt, unless further
information is needed. If the committee requires further information, a
face-to-face meeting may be requested. Committee members will convey
their up-or-down decisions, with feedback to the committee chair, who
will compile them and disseminate back to the applicant and to the Oak
Hammock staff.
Quorum
A vote by the majority of the committee shall constitute quorum. The
current committee numbers 5 members; thus 3 members is quorum. When the
6th member is appointed, 4 members shall constitute quorum
Anticipated
approvals
Thus, the Research Advisory Committee will typically approve a study to
recruit for a one-month
period.
At
present, no more than one study may recruit at Oak Hammock at any time.
If the
community continues to find research participation to be interesting
and worthwhile, the number of
concurrent studies allowed to recruit may be increased. It is
anticipated that, at the maximum, up to two concurrent protocols in any
one month period, with up to two new protocols every month. The exact
number and spacing of protocols will be adjusted by the committee based
on early experiences and ongoing feedback.
The committee cannot control the length of exposure of any one study at
Oak Hammock. However, in the prioritization of protocols,
preference
will be given to studies which minimize participant contact hours and
which minimize the duration of follow-ups. This serves as a
"resource
conservation" strategy, to reduce the amount of time that Oak Hammock
members are "consumed" by a single project.
Recruitment
methods
There are three modalities for recruitment by approved studies, agreed
upon by the Dean of Residents at Oak Hammock
- Approved protocols
must provide, to Oak Hammock, within 7 days of approval, copies of
their
IRB-approved recruitment flyer. Investigators must deliver one flyer
for each residence at Oak Hammock. These will be distributed, free of
charge, in member mailboxes.
- All projects will be advertised, for a one-month
period, on Channel 71 (the in-house text information channel)
- Researchers must schedule, ideally within 7 to 14
days of
approval, but no more than 30 days after approval, a "Research Town
Hall" with the Dean of Residents, in which they can introduce their
study, take questions and do on-site recruitment. If more than one
project is approved in a given 30-day period, both studies should
attempt to be represented at the same Town Hall.
Monthly
"Research Town Halls"
For consistency — under the assumption that eventually one to two
protocols will
be approved for recruiting in a given month — it is recommended that
the
Dean of Residents schedule a regular, monthly Research Town Hall. These
would be loosely structured open forums, in which investigators
introduce their study, take questions and do on-site recruitment. A
regular day and time would probably facilitate participation of
members.
Research
involving Assisted Living and Nursing Home
The committee will receive applications intended to recruit
participants
from the Assisted Living and Nursing Home facility. Research involving
members of these facilities is more difficult, because of the issues
of vulnerable populations, perceived freedom of choice and competency
to consent. The committee felt, however, that the potential benefits of
research in these facilities could still outweigh the risks. To ensure
that the rights of members of these facilities are maximally protected,
additional procedures are in place for recruitment requests
at these facilities.
- The COO and other designated health care personnel
(particularly
including the Director of Nursing or other relevant administrative
staff, as identified by the COO) will be asked to participate in the
approval process for such projects.
- Investigators must present additional HIPAA-related
approvals from UF, even if they do not wish to
access protected health information.
- All petitioners for AL and NH studies MUST schedule a
face-to-face meeting with the committee. No
decisions will be made without a face-to-face meeting, which gives the
committee the right to address questions and concerns.
- Prior to the onset of data collection, approved
investigators must have a Federal
Wide Assurance in place at Oak Hammock. Investigators are responsible
for preparing all paperwork and documentation related to this process.
- Investigators must work closely with Oak Hammock
staff to arrange
any family contacts and other special information needed to facilitate
contact with vulnerable populations.
- Investigators, as part of their IRB approvals, must
document a specific set of procedures with
regard to proxy consent, in the event that requested participants are
determined to be ineligible to consent on their own.
Special
face-to-face meetings
Mandatory face-to-face meetings between the research committee and
investigators must occur for research involving the Assisted Living and
Nursing Home units. Such meetings may also be requested, at the
discretion of the committee, for situations where the committee or
particular members require further information. Such meetings must
include health administrators responsible for those facilities, such as
the COO and the DON.
