Institutional Review Board, Hospital for Special Surgery
July 26, 2012
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Sandra Goldsmith, MA MS RD
Dana Friedman, MPH
Robyn Wiesel, CHES
Linda Roberts, LCSW
Huijuan Huang, MPA
Karla Felix, MA MPhil
The goal of this study is to assess the interests and needs of the public and patient community served by HSS in a series of focus group discussions to be conducted in the summer of 2012. Written observations and transcribed audio-recordings will be collected and analyzed to assess community needs. Ten to twelve people will participate in each of 9 focus group sessions (4 with existing participants and 5 with prospectives), for a target enrollment of 90-108 participants in this study.
Recruitment efforts will be focused on two main groups of participants – existing and prospective PPED participants – who will meet the following inclusion criteria:
• Existing participants refer to individuals who have attended PPED programs in the past. Rookies are those who have been participants for less than one year, and veterans have attended programs for over a year. Two sessions will be conducted with rookies and 2 with veterans.
• Prospective participants have never attended PPED programs. This study will recruit members of 2 senior centers (1 with primarily English-speaking attendees and the other serving English and Spanish-speaking members) and 1 faith-based organization (serving English and Spanish-speaking members).
Participants must be either English- or Spanish-speaking in order to participate in the study, since focus group materials will only be prepared in these languages and have not been translated into any other language.
Due to the nature of the study, individuals with cognitive impairments will be excluded from the study. A brief six-item screener derived from the Mini-Mental State Examination (MMSE) will be administered by program staff during recruitment to determine whether potential participants possess the cognitive ability (through three-item recall and three-item temporal orientation) to participate in the study. The screener is a reliable instrument for identifying subjects with cognitive impairment, is comparable to the full MMSE, and can be administered by telephone or
Dana Friedman, MPH