Proposals submissions are processed by the Protocol Screen Committee (PSC). They should be submitted to:
George Sopko, M.D., MPH, Project Officer
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute, NIH
6701 Rockledge Drive, Room 9176
Bethesda, Maryland 20892-7940
Email: sopkog at nhlbi.nih.gov
Susanne May, PhD
ROC Clinical Trial Center
1107 NE 45th St., Suite 505
Seattle, WA 98105-4689
Email: sjmay at u.washington.edu
Protocol Screening Committee
Review new research ideas and proposals from external investigators, industry, or other agencies. The PSC is comprised of six senior members from the Research Outcomes Consortium (ROC) and will screen new proposals for potential suitability as trials to be conducted by ROC. Note that internal applications from ROC members should be directed to the specific protocol committee or to the Steering Committee.
The review process is as follows:
- External investigators will submit their proposal (see below) to NHLBI or to ROC.
- The PSC will meet quarterly by conference call and will review the protocol with regards to potential suitability as a trial to be conducted by ROC.
- The PSC will advise the external investigator that their protocol:
- is of interest and will be forwarded to the ROC steering Committee for further review,
- is not of interest to ROC (these protocols will be briefly presented to the Steering Committee), or
- requires revision or clarification.
- The full Steering Committee will further review the recommended proposals on a quarterly basis and will recommend further development or not.
- For those proposals deemed acceptable, an ad hoc committee of investigators will be struck and this Protocol Development Committee will work with the external investigator to fully develop a research protocol.
- Any proposals ultimately chosen for actual study by ROC will be subject to the ROC Industry Relationships Policies and the Authorship Policies.
The guidelines for external proposals are as follows:
External applicants will submit a 5-page proposal (bibliography on additional pages). The proposal should contain the following elements:
- Introduction with Hypothesis and Research Question.
- Background and Significance.
- Summary of Methods:
- Study design,
- Study population,
- Outcome measures,
- Intervention, and
- Sample size.
- Feasibility Issues:
- Logistical implementation issues,
- Regulatory issues regarding new devices.
- Estimated overall budget,
- Proposed support by the external agency (direct funding, equipment).