About the Research Advisory Committee
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- Ashlynn Ellis
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1 About the Research Advisory Committee The Board of Directors at Oak Hammock has formed a research advisory committee. The committee has two major functions. First, the committee provides a single point of information, so that members can find out about the latest research studies and offerings in one convenient location. Second, the committee screens and approves all studies seeking to recruit participants at Oak Hammock. In addition to protecting the safety and comfort of members, the committee also strives to maintain an orderly flow of research projects, so that members have a reasonable number of opportunities to select from at any time. Current members of the committee are listed below and may be contacted via e mail at any time. Please direct programmatic or organizational questions to the Chair, who will make sure your questions are answered as soon as possible. Oak Hammock Member Representatives Member E mail Website Carol Reed Ash, EdD, RN, FAAN carolash@gator.net Reed Ash Website Rufus Broadaway, M.D. broadruf@gator.net Broadaway website University of Florida Representatives Member Website Michael Marsiske*, Ph.D., College of Public Health & Health Professions mmarsisk@phhp.ufl.edu Marsiske website Robin L. West, Ph.D., College of Liberal Arts & Sciences rwest@geron.ufl.edu Donna Neff, RN, Ph.D., College of Nursing dneff@nursing.ufl.edu 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)
2 "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, which 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 IRBapproved recruitment flyer. Investigators must deliver one flyer for each residence at Oak Hammock. These will be distributed, free of charge, in member mailboxes.
3 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. Approved Research at Oak Hammock The lists that follow are projects that have been approved for recruitment at Oak Hammock. Each project is carefully reviewed and discussed by the review committee, which is made up of UF scientists and residents of Oak Hammock.
4 Often, the committee will contact investigators for clarification and further details. Once a study is approved, investigators are generally given one month to distribute flyers, schedule a "Research Town Hall", and to contact interested participants to enroll them in the study. To find out more about a study, click on either the "flyer" or "layperson's description" links below. These will summarize, in general terms, what each study is about. To ask more questions, or to get in touch with study staff, click on the investigator name(s). These will open up e mail windows for you to contact each team. If a study is interesting to you, feel free to contact the investigator, even if the official recruitment window has closed. Often studies are able to accommodate interested participants for longer periods of time. Projects that are currently recruiting Investigator Project Title Approved Flyer Layperson's Description Beverly Roberts, RN Ph.D. "Effects of Tai Chi on physical performance, functional limitation and disability" (July 15 August 15, 2006) here here W. Keith Berg, Ph.D "Age differences in planning abilities: Younger and older adults" (July 15 August 15, 2006) here Peter A. Giacobbi, Jr., Ph.D and Michael Marsiske, Ph.D. "Beliefs and attitudes held by adults about initiating and maintaining an exercise program" (June 15 July 15, 2006) here Research is another great way that Oak Hammock integrates with its academic partner, and offers opportunities to members that might not generally be available. It is also a great way for Oak Hammock members to make even more contributions to the health and well being of fellow mature adults now and in the future. For Members About the Research Advisory Committee. List of current and past approved projects at Oak Hammock, with links to IRB approved flyers, "layperson's descriptions" of projects, and investigator contacts. For Investigators Requesting permission to recruit at Oak Hammock: Policies and Forms. Example of "Layperson's Description". You can also see the descriptions of approved protocols in our project list. List of current and past approved projects at Oak Hammock, with links to IRB approved flyers, "layperson's descriptions" of projects, and investigator contacts. A Unique Relationship with Shands Hospital Oak Hammock is especially proud of our special relationship with Shands Hospital, the teaching hospital associated with the University of Florida. As part of our affiliation agreements, this nationally recognized hospital has created the Shands Oak Hammock Advantage Program, which offers prompt physician referral services to the best experts in all medical fields. Shands goal is to roll out the red carpet for Oak Hammock members when it comes to accessing hospital services.
5 Shands Hospital: Excellence in Medical Care One of the many reasons members move to Oak Hammock from all over the country is the knowledge that they will receive excellent medical care should they need it. Shands Healthcare, affiliated with the University of Florida, is one of the Southeast s premier health systems including eight hospitals, two academic medical centers, four community hospitals and two specialty hospitals. Within the Shands Healthcare system, medical teams work together to utilize the latest diagnostic and therapeutic innovations to optimize treatment outcomes. Through their multi disciplinary approach to treatment plans, they have achieved both a regional and national reputation of being one of the leading hospitals in the nation. With multi specialty group practices based in Gainesville and Jacksonville, approximately 1,000 University of Florida faculty physicians provide care in Shands facilities and more than 80 outpatient practices throughout the region. A few of Shands centers of excellence include: Orthopedics Neurological Services Heart Care Cancer Transplants.
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