Requesting Permission to Recruit at Oak Hammock: Policies and Forms

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

1. 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.
2. All projects will be advertised, for a one-month period, on Channel 71 (the in-house text information channel)
3. 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.