Clinical Research Support Office/CRSO
B. Human Research Participant Advocacy
The role of the Research Subject Advocate/Clinical Research Officer is to champion the mission of the safe and ethical conduct of research through all the activities of the Hospital. Dr. Rhonda Kost has held this role since its inception at Rockefeller University in 2001. Dr. Kost brought to this position extensive experience as a clinical investigator, in the herpesviruses, and in HIV. She has made profoundly important contributions to the program at Rockefeller University and has also taken a leadership role nationally as President of the GCRC Society of Research Subjects Advocates. The second Clinical Research Support Office goal, Human Research Participant Advocacy, is intimately tied to, and partially fulfilled by, many of the regulatory support activities identified above. Human research subject advocacy begins with a strong infrastructure to support clinical research, including DSMP assistance and implementation; Human Subjects Protection and Clinical Research Ethics Education; and Monitoring, and Informed Consent authoring assistance, since these all impact the safe and ethical environment of human research conduct. Policies that support the conduct and enforcement of all these essential practices are also crucial components of human research subject advocacy. The CTSA support will allow expansion of the Research Subject Advocacy roles served by the Clinical Research Officer to engage the Clinical Research Support Office (CRSO).
In addition to ensuring safe, ethical and compliant research, Research Subject Advocacy initiatives available to research participants include:
- On-line access to information for Volunteers/participants at Rockefeller, and through national resources
- The Clinical Research Office sponsors the Patient Recruitment and Outreach Program (PROP), hosting the 1-800RUCARES volunteer information and referral line; please see individual protocol listings for more details
- The Patient Information Brochure, a multidisciplinary effort of the Hospital departments, is available in-house to inpatient and outpatient research participants.
- Clinical Research for Adults
- Pediatric Clinical Research
- Interpreter Services - -Interpreter services are available 24 hours a day/7 days a week in many languages;
- FAQ About Informed Consent
- The Clinical Research Support Office staff are available to counsel and educate research participants and staff to assure that Human Subject Protections that are in place during the conduct of clinical research. The Clinical Research Support Office staff are available to assist in the investigation, communication and resolution of any issues that arise pertaining to the conduct of human subjects research.
Specific additional initiatives to be developed in the Clinical Research Support Office to expand Research Subject Advocacy in the Center for Clinical and Translational Research include:
- Expanded Participant Recruitment & Outreach Activities, including outreach to minorities,
- An Informed Consent Enhancement Project, including a multi-disciplinary program of Plain Language Writing Training, Hands-on Informed Consent Training, Informed Consent observations, "Teach Back" Evaluation of Comprehension, and refinement of outcome measures.
- Research Health Literacy project, including the development of tools for assessments and intervention.
- Enhancement of Interpretation Services for Non-English Speaking Volunteers; recently services were expanded at the Rockefeller University Hospital to provide telephone interpreter services in over 20 languages, and a webpage for research staff with detailed information on the correct use of translations and interpreters.
- Quality assurance of the use of interpreters through assessment and education of research staff as appropriate.
- Facilitated Translation Services for Investigators and Volunteers;
- Research Subject Engagement Programs - Pilot IRB Membership to include former or current Research Participants, Informed Consent and Recruitment Review Focus Groups; and a Research Participant Advocacy Board
- The Picker Perception of Care Survey - NIH/RUH Clinical Research Version - to identify best practices and performance improvement goals locally and for national benchmarking purposes;
- Development of Outcomes Measures in Advocacy and Human Subjects Protection Training.
All of the staff of the CRSO contribute to the enhancement of Research Subject Advocacy through support of the mission of the CRSO. Each staff member will participate in the development and implementation of one or more of the new advocacy initiatives listed above.
Participant Recruitment and Outreach activities encompass the Participant Recruitment and Outreach Program, PROP, and other aspects of advocacy and support that will be enhanced in the CTSA. Specifically, the external Rockefeller Hospital website, www.rucares.org , has expanded capability under development to provide an interactive patient recruitment database to which potential volunteers can register in order to receive protocol or disease-specific recruitment information. This will supplement the existing capability to view protocols and eligibility criteria, and to locate contact information online.
Cross cultural sensitivity to improve minority recruitment and engagement will be emphasized through s and on-line educational modules hosted at www.citiprogram.org, including: Culturally Competent Informed Consent; Group Harms: Research on Culturally or Medically Vulnerable groups (hosted on www.citiprogram.org, projects to further engage the community and integrate feedback include development of Research Participant IRB membership, a Research Participant Advisory Panel, as well as Focus Groups for the development of advertisements and Informed Consent Forms for complex or difficult-to-recruit protocols.
Innovative Assessment Tools
The fulfillment of the Research Subject Advocacy functions will be assessed in part using the Picker Clinical Research Participant Perception of Care Survey, an outcomes assessment instrument under development.