IRB Committee Meeting Wednesday, September 15, 2010 Outside General Meetings Activity Update Approvals Study: Peer Mentor Home Health Aide Clinical Outcomes Protocol Reference #s: JHH Protocol #: W2010-02; Mt. Sinai GCO #: N/A PI: Antonette Mentor, L.C.S.W. Dear Ms. Mentor. Your project, Peer Mentor Home Health Aide Clinical Outcomes and request for a waiver (JHH Protocol #: W2010-02) has been approved by the JHH Institutional Review Board (FWA # 00005622) This project was reviewed via expedited review, with IRB requested changes approved on April 7, 2010. This approval is valid for the period 4/7/2010 4/6/2011. Study: Treating Subthreshold Depression in Nursing Home Residents with Serious Chronic Illness Protocol Reference #s: JHH Protocol #: 2010-01; Mt. Sinai GCO #: N/A PI: Amy Horowitz, DSW Dear Dr. Horowitz. The JHH Institutional Review Board (FWA # 00005622) has approved the project entitled, Treating Subthreshold Depression in Nursing Home Residents with Serious Chronic Illness (JHH Protocol #: 2010-01; Mt. Sinai GCO #: N/A). This project was reviewed at the April 7, 2010 meeting, with IRB requested changes approved on April 20, 2010. This approval is valid for the period 4/20/2010 4/19/2011. Study: Long-distance caregiving Unique challenges and implications of caregiving from afar Protocol Reference #s: JHH Protocol #: 2010-02; Mt. Sinai GCO #: N/A PI: Amy Horowitz, DSW Dear Dr. Horowitz. The JHH Institutional Review Board (FWA # 00005622) has approved the project entitled, Longdistance caregiving Unique challenges and implications of caregiving from afar (JHH Protocol #: 2010-02; Mt. Sinai GCO #: N/A). This project was reviewed at the April 7, 2010 meeting, with IRB requested changes approved on April 23, 2010. This approval is valid for the period 4/23/2010 4/22/2011. 1
Extensions Study: Continuity of Care for Pain, Depression, and Psychosis in Older Adults Protocol #s: JHH: 2006-08; Mt. Sinai GCO: N/A; Bronx VA: 2726-05-098 PI: Kenneth Boockvar, M.D., M.S. Dear Dr. Boockvar: The Jewish Home & Hospital Lifecare System Institutional Review Board (FWA #00005622) has approved the extension for the study project entitled: Continuity of Care for Pain, Depression, and Psychosis in Older Adults (JHH Protocol #: 2006-08; Mt. Sinai GCO #: N/A; Bronx VA Protocol #: 2726-05-098). This approval is valid for the period 4/5/2010-4/4/2011. Study: Clinical and Biologic Studies of Early Alzheimer s Disease Protocol #s: JHH: 1996-02, 2000-5, 2000-6; Mt. Sinai GCO: 79-141-0004/5; Bronx VA: N/A PI: Vahram Haroutunian, Ph.D. Dear Dr. Haroutunian: The Jewish Home & Hospital Lifecare System Institutional Review Board (FWA #00005622) has approved the extension for the study projects entitled: Project #5 Cardiovascular Risk Factors and Neuropsychological/Neurobiological Measures of Early Dementia (JHH IRB #2000-6, Mt. Sinai GCO #79-141 (0005) and Project Core B Clinical and Biologic Studies of Early Alzheimer s Disease (JHH IRB # s 1996-02 & 2000-5, Mt. Sinai GCO #79-141 (0004). This approval is valid for the period 06/9/2010-03/31/2011. Study: Enhancing Life for Residents with Dementia and their HCPs Protocol #s: JHH: 2008-05; Mt. Sinai GCO: N/A PI: Joann Reinhardt, PhD Dear Dr. Reinhardt: The Jewish Home & Hospital Lifecare System Institutional Review Board (FWA #00005622) has approved the extension for the study project entitled: Enhancing Life for Residents with Dementia and their HCPs (JHH Protocol #: 2008-05; Mt. Sinai GCO #: N/A). This approval is valid for the period 08/10/2010-08/9/2011. 2
Study: New Admissions Study Protocol #s: JHH: 2008-04; Mt. Sinai GCO: N/A PI: Amy Horowitz, DSW Dear Dr. Horowitz: The Jewish Home & Hospital Lifecare System Institutional Review Board (FWA #00005622) has approved the extension for the study project entitled: New Admissions Study (JHH Protocol # 2008-04; Mt. Sinai GCO #: N/A). This approval is valid for the period 8/11/2010-8/10/2011. Study: Evaluating DPOAEs and ALDs in Nursing Home Residents with Alzheimer s Disease Protocol #s: JHH: 2009-02; St. John s University: 0509-130 PI: Tina Jupiter, PhD Dear Dr. Jupiter; The JHH Institutional Review Board (FWA #00005622) has approved the extension of the project entitled, Evaluating DPOAEs and ALDs in Nursing Home Residents with Alzheimer s Disease (JHH Protocol #: 2009-02; St. John s U#: 0509-130). This extension is valid for the period 09/1/2010-10/8/2011. Please remember that we require submission of St. John s University approval documentation once it has been received in October 2010. 3
Modifications Study Protocols Study: Genetic Epidemiology of Alzheimer s Disease Among African Americans. Protocol Reference #s: JHH Protocol #: 2009-07; CPMC IRB #: 5534 PI: Jennifer Manly, PhD Dear Dr. Manly, The JHH Institutional Review Board (FWA #00005622) has approved the following modifications to the protocol summary for the project entitled, Genetic Epidemiology of Alzheimer s Disease Among African Americans (JHH Protocol #: 2009-07; CPMC IRB #: 5534). This project was reviewed at the December 2, 2009 meeting, with IRB requested changes approved on January 26, 2010. This approval is valid until 06/22/2010. Changed one of the sites at which procedures are being conducted: Item 1, Page 1, and Item 18, Page 12: One site at which procedures are being conducted is changed from Duke University to University of Miami. Expanded eligibility criteria for enrollment in the study: Item 5, Page 2: For inclusion criteria, native English-speakers, born in the United States, and identify 3 out of 4 of their grandparents as being US born and African American were removed. Item 6, Page 2: For exclusion criteria, Elders will be excluded from participation if they have history of clinical stroke, was removed. Removed one person from having access to information about the subjects that is identifiable: Item 13, Page 6: Research Assistant: Brianna Frazier was removed. Indicated second coordinator for the study: Item 21c, 21g, Page 14: Karmen Louie was added as a coordinator and her prior experience was briefly described. Study: Bereavement in Direct Care Workers Protocol Reference #s: JHH: 2009-06; GCO #: N/A PI: Kathrin Boerner, PhD Dear Dr. Boerner; The JHH Institutional Review Board (FWA #00005622) reviewed the following changes for the currently approved protocol entitled Bereavement in Direct Care Workers (JHH Protocol #: 2009-06; Mt. Sinai GCO #: N/A). This approval is valid for the period 5/27/10-12/22/2010. Protocol Title of the study changed from Bereavement in Certified Nursing Assistants to Bereavement in Direct Care Workers 4
Study procedures and interview are slightly different for HHAs to accommodate their situation Throughout: Language was changed from clients and residents to patients Questionnaire Additional questionnaire added: HHA version Consent/HIPAA forms Additional consent/hipaa added: HHA version Original consent/hipaa (now CNA version): Language was changed throughout from clients and residents to patients Waiver of Consent Section added to describe the research activity for which the waiver is requested for HHAs Language was changed throughout from clients and residents to patients Study: Treating Subthreshold Depression in Older Adults in Community-Based Rehab Protocol Reference #s: JHH Protocol #: 2008-01A; Mt. Sinai GCO #: N/A PI: Amy Horowitz, DSW Dear Dr. Horowitz: The Jewish Home & Hospital Lifecare System Institutional Review Board (FWA #00005622) has reviewed the following changes for the currently approved protocol entitled: Treating Subthreshold Depression in Older Adults in Community-Based Rehab (JHH Protocol #: 2008-01; Mt. Sinai GCO #: N/A). This approval is valid for the period 6/22/2010-1/18/2011. Protocol: 1. Page 2, Item 3: Entered a number of subjects that will be enrolled from Jewish Home. 2. Pg 4: Recruitment procedures changed from Study participants will be selected from male and female applicants for vision rehabilitation services to Lighthouse International or VISIONS, age 60 years and older to Study participants will be selected from male and female applicants for vision rehabilitation services to Lighthouse International, VISIONS, or Jewish Home Lifecare s Visually Impaired Program (VIP) age 60 years and older. 3. Pg. 4: The following recruitment procedures were added A research assistant at JHHLS will contact each applicant at JHHLS s VIP age 60 or older. The research assistant will approach the resident to describe the purpose of the study and determine their interest in participating. If interested, they will review the informed consent and HIPAA consent with the resident and ensure that the resident understands what the study involves. The interview will take place at that time if the resident is willing, or an appointment will be made to conduct the interview soon afterwards. 4. Page 4, Item 18(g): Provided an assessment of whether the research involves any physical, psychological, social and/or economic risk(s) and the magnitude of the risk(s) 5. Page 4, Item 18(h): Provided an assessment of the risk/benefit ratio of the research 5
6. Pg. 5: Recruitment procedures changed from If potential alcohol abuse is expected based on this score, the individual will be referred to a licensed master s level social worker (LMSW) at the Lighthouse or VISIONS to If potential alcohol abuse is expected based on this score, the individual will be referred to a licensed master s level social worker (LMSW) at the Lighthouse, VISIONS or Jewish Home Lifecare. 7. Pg. 5: Text changed from: Those with the latter three conditions will be referred to the LMSW at the Lighthouse or VISIONS to Those with the latter three conditions will be referred to the LMSW at the Lighthouse VISIONS, or Jewish Home Lifecare. 8. Page 5, Item 15: Detailed when/where/how consent will be obtained at Jewish Home. 9. Page 6, Item 17: Indicated if there will be a medical record review at the Jewish Home and list the names and departments of individuals with access. 10. Pg. 10: The data safety and monitoring plan changed from Based on these results, the Social Work Supervisor at Lighthouse International or VISIONS would be either be immediately contacted in order to further assess immediate suicidal risk or the interviewer would accompany the participant to the emergency room or call 911 to Based on these results, the Social Work Supervisor at Lighthouse International, VISIONS, or Jewish Home Lifecare would be either be immediately contacted in order to further assess immediate suicidal risk or the interviewer would accompany the participant to the emergency room or call 911. 11. Page 12, Item 21(b): Described the time allocation (in hours/week) of each coordinator. 12. Page 12, Item 21(e): Provided a number for the coordinator. Consent/HIPAA forms: 1. Two additional consent/hipaa added: In person screening (regular and large print) Research interview and intervention for those from Jewish Home Lifecare s VIP version (regular and large print) Study: Treating Subthreshold Depression in Older Adults in Community-Based Rehab Protocol Reference #s: JHH Protocol #: 2008-01A; Mt. Sinai GCO #: N/A PI: Amy Horowitz, DSW Dear Dr. Horowitz: The Jewish Home & Hospital Lifecare System Institutional Review Board (FWA #00005622) has reviewed the following changes for the currently approved protocol entitled: Treating Subthreshold Depression in Older Adults in Community-Based Rehab (JHH Protocol #: 2008-01; Mt. Sinai GCO #: N/A). This approval is valid for the period 8/16/2010-1/18/2011. Protocol: a. Pg 2: Indicate number of subjects to be enrolled at this site was changed from 15 To 20. b. Pg 4: Recruitment procedures changed from Study participants will be selected from male and female applicants for vision rehabilitation services to Lighthouse International, VISIONS, or Jewish Home Lifecare s Visually Impaired Program (VIP) age 60 years and older To Study participants will be selected from male and female applicants for vision 6
rehabilitation services to Lighthouse International, VISIONS, or Jewish Home Lifecare s Visually Impaired Program (VIP) age 60 years and older. Additionally, study participants will also be selected from JHL s Kittay House who are age 60 years and older. c. Pg. 5: Recruitment procedures changed from If potential alcohol abuse is expected based on this score, the individual will be referred to a licensed master s level social worker (LMSW) at the Lighthouse, VISIONS or Jewish Home Lifecare To If potential alcohol abuse is expected based on this score, the individual will be referred to a licensed master s level social worker (LMSW) at the Lighthouse, VISIONS, Kittay House or Jewish Home Lifecare. d. Pg. 5: The following recruitment procedures were added: Lighthouse International will do a presentation at Kittay House about age-related vision impairments in older adults. After the presentation, a research assistant from JHL will offer Kittay House tenants the opportunity to have a vision screening. If tenants are interested, the research assistant will administer a brief vision screening, which includes the Functional Vision Screening Questionnaire (FV). Tenants who score a 9 or greater on the FV, age 60 or older, regardless of having an eye disease and an eye exam in the past year will be approached about the study. Additionally, tenants that score a 7 or 8 on the FV, age 60 or older and have an eye disease, regardless of having an eye exam in the past year will also be approached about the study. The research assistant will approach the tenants to describe the purpose of the study and determine their interest in participating. If interested, they will review the informed consent and HIPPA consent with the resident and ensure that the resident understands what the study involves. The interview will take place at that time if the resident is willing, or an appointment will be made to conduct the interview soon afterwards. e. Pg. 5: Text changed from: Those with the latter three conditions will be referred to the LMSW at the Lighthouse VISIONS, or Jewish Home Lifecare To Those with the latter three conditions will be referred to the LMSW at the Lighthouse VISIONS, Kittay House or Jewish Home Lifecare. f. Pg. 6. The following consent procedures were added: For participants recruited through Kittay House, a JHL researcher will make in-person contact with the tenants, to determine the client s interest in participating in the study. Written consent will be obtained immediately before the interview. In order to ensure privacy and confidentiality, during the consent signing and research interview, a private and quiet setting will be offered to the participants. g. Pg. 7. Ami Tint, research assistant has been removed from the list of staff that will have access to medical record data. h. Pg. 7. In the section that describes what is being done for research purposes and what is being done as part of standard clinical care, the text changed from Both groups will receive Usual Care Vision Rehabilitation, which may include low vision clinical care, rehabilitation training in skills of daily living, orientation and mobility training, vocational training, computer training, and counseling. To Both groups affiliated with a vision rehabilitation agency will receive Usual Care Vision Rehabilitation, which may include low vision clinical care, rehabilitation training in skills of daily living, orientation and mobility training, vocational training, computer training, and counseling. i. Pg. 8. The text changed from Participants assigned to the comparison group will proceed in the rehabilitation program in the usual way. To Participants assigned to the 7
comparison group and who are affiliated with a vision rehabilitation agency will proceed in the rehabilitation program in the usual way. j. Pg. 10. The financial responsibility from the costs associated with participation in the study has changed from Participants will not be responsible for any costs associated with the study. This study is funded by the National Institute on Mental Health. Should participants seek services at Lighthouse International, VISIONS, or Jewish Home Lifecare, they would be responsible for all costs. To Participants will not be responsible for any costs associated with the study. This study is funded by the National Institute on Mental Health. Should participants seek services at Lighthouse International, VISIONS, Kittay House or Jewish Home Lifecare, they would be responsible for all costs. k. Pg. 10-11. The assessment and magnitude of risks changed from In the rare case that a participant shows serious distress, procedures are available at Lighthouse International, VISIONS, or Jewish Home Lifecare for counseling and referral by clinical social workers, and referrals to other community based mental health services will be available. To In the rare case that a participant shows serious distress, procedures are available at Lighthouse International, VISIONS, Kittay House or Jewish Home Lifecare for counseling and referral by clinical social workers, and referrals to other community based mental health services will be available. l. Pg. 12-13. The data safety and monitoring plan changed from Based on these results, the Social Work Supervisor at Lighthouse International, VISIONS, or Jewish Home Lifecare would be either be immediately contacted in order to further assess immediate suicidal risk or the interviewer would accompany the participant to the emergency room or call 911... Although participants in the treatment group will be asked not to receive other mental health counseling during the treatment period, if the clinical symptoms of participants in either arm of the clinical trial significantly worsen to meet criteria for a major depressive disorder, they will be referred immediately to the LMSW at the Lighthouse, VISIONS, or Jewish Home Lifecare for evaluation and alternate treatment (e.g., medication) if necessary In the rare case that a participant shows serious distress, procedures are available at Lighthouse International, VISIONS, or Jewish Home Lifecare for counseling and referral by clinical social workers, and referrals to other community based mental health services will be available. To Based on these results, the Social Work Supervisor at Lighthouse International, VISIONS, Kittay House or Jewish Home Lifecare would be either be immediately contacted in order to further assess immediate suicidal risk or the interviewer would accompany the participant to the emergency room or call 911... Although participants in the treatment group will be asked not to receive other mental health counseling during the treatment period, if the clinical symptoms of participants in either arm of the clinical trial significantly worsen to meet criteria for a major depressive disorder, they will be referred immediately to the LMSW at the Lighthouse, VISIONS, Kittay House or Jewish Home Lifecare for evaluation and alternate treatment (e.g., medication) if necessary In the rare case that a participant shows serious distress, procedures are available at Lighthouse International, VISIONS, Kittay House or Jewish Home Lifecare for counseling and referral by clinical social workers, and referrals to other community based mental health services will be available. Consent/HIPAA forms: 2. Two additional consent/hipaa added: 8
In person screening (regular and large print) Research interview and intervention for those from Jewish Home Lifecare s Kittay House version (regular and large print) 9
Terminations Study Protocols Study: Is There a Relationship Between the Solving of Jig-Saw Puzzles and the Cognition of Elderly Nursing Home Patients with Mild Cognitive Impairment? Protocol Reference #s: JHH Protocol #: 2009-01; Mt. Sinai GCO #: N/A PI: Gregory Poole-Dayan Dear Mr. Poole-Dayan: The Institutional Review Board (IRB) of Jewish Home and Hospital Lifecare System (JHL) has closed the following study as of April 20, 2010: Is There a Relationship Between the Solving of Jig-Saw Puzzles and the Cognition of Elderly Nursing Home Patients with Mild Cognitive Impairment? (JHH Protocol #: 2009-01; Mt. Sinai GCO #: N/A), with IRB approval no longer authorized beyond the stated date. We received your notice of termination on 4/19/10. Thank you for your cooperation and please contact us if you have any questions regarding this study. 10