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, and has made profoundly important contributions to the program at Rockefeller University. She took a leadership role nationally as President of the GCRC Society of Research Subjects to lead the development of the RSA Best Practice Functions and led a taskforce study of the implementation of research participant advocacy at other institutions. Human research subject/participant advocacy begins with a strong infrastructure to support clinical research, including DSMP assistance and implementation; Human Subjects Protection and Clinical Research Ethics Education; and study conduct oversight, 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 of these essential practices are also crucial components of human research subject advocacy.
In addition to ensuring safe, ethical and compliant research, Research Subject Advocacy initiatives available to research participants include:
- On-line access to study information for Volunteers/participants at Rockefeller, and through clinical trial registration.
- The Clinical Research Office sponsors the Clinical Research Recruitment Outreach and Support Service (CRROSS) hosting the 1-800-RUCARES volunteer information and referral line for one-on-one pre-screening and referral to research studies. Every caller is also offered entry into the Research Volunteer Repository (RVR).
- The Research Volunteer Repository is an IRB-approved registry that volunteers may enroll in in order to be contacted about future research opportunities. The Repository helps to afford fair access to all volunteers interested in research participation.
- The Outpatient Unit Information Handbook is available in-house to research volunteers on their first visit to the outpatient unit.
- Clinical Research Brochure for adults
- Pediatric Clinical Research Brochure
- Genetic Clinical Research Brochure
- Interpreter Services - -Interpreter services are available 24 hours a day/7 days a week in many languages.
- 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.
- Recruitment staff collaborate with Community Engagement staff to enhance outreach to under represented communities, and to conduct engagement activities with the public. One such activity, a Community engagement studio, brings the lay public and the researcher together to refine a study idea to better reflect the priorities and preferences of the patient/community.
- All participants in research studies at Rockefeller are offered the Research Participant Perception Survey to provide anonymous feedback on their participation experience. This validated tool affords 1) actionable feedback on the research experience, 2) quality measures for recruitment, consent, study conduct, and operational aspects of clinical study management, 3) the ability to benchmark intra-institutionally, and 4) the vision of benchmarking nationally. More details about the instrument itself are provided. The survey is administered confidentially by a third party on Rockefeller's behalf to preserve anonymity.
All of the staff of the CRSO, and other CCTS and Hospital departments contribute to the enhancement of Research Subject Advocacy through support of the mission of the CRSO.
Cross-cultural sensitivity to improve minority recruitment and engagement is emphasized through an on-line educational modules hosted at www.citiprogram.org, including modules addressing groups requiring additional considerations such as children, culturally vulnerable groups, and others.
Innovative Assessment Tools
The fulfillment of the Research Subject Advocacy functions will be assessed in part using the Research Participant Perception Survey, a validated research participation outcomes assessment instrument.