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Hepatitis C is a serious liver disease caused by the hepatitis C virus. A virus is a type of "germ" that is much smaller than a cell. Viruses copy themselves in cells, and this causes the disease.
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Virahep-C Supplementary Study Guidelines
I. General Considerations
Supplementary studies are studies that are not part of the Virahep-C core protocol, but that propose questions and test hypotheses that are relevant to, and congruent with, the goals and purposes of Virahep-C. Such studies require additional tests or data that are not routinely obtained in the main Virahep-C protocol. Supplementary studies may involve all Virahep-C participants and clinical sites, or subsets of either, depending on the eligibility criteria of the study, sample size needed, and interest of Virahep-C investigators in participating. Ideally, a supplementary study will require modest demands on the time and effort of participants, clinicians, and clinical center coordinators. These studies may include the use of stored specimen (serum and liver tissue) from Virahep-C participants.
Supplementary studies must be independently funded by the investigator or by resources obtained by the investigator.
Investigators not a part of Virahep-C must have at least one Virahep-C investigator as a sponsor and collaborator.
If Virahep-C data are to be used, data management must be performed by the Virahep-C Coordinating Center and the data from the supplementary study will become part of the Virahep-C archive. Raw and “processed” data will be archived. Any additional data or sample collection will become part of the Virahep-C study.
All analyses of data must be confirmed at the Virahep-C Coordinating Center and resources provided to the Coordinating Center for these efforts.
A short one-page initial proposal should be submitted for review by the Ancillary Subcommittee chair to determine the level of the study. The levels are defined as:
- primary – aims are part of the Virahep-C study protocol;
- related – not primary but using data collected for the main study;
- supplementary – aim is not within the study protocol and at least some of the data are not within the study protocol, but specimens collected for the study (e.g. blood samples, liver tissue) are utilized;
- outside – neither data nor specimens are part of the Virahep-C study.
The studies must first be approved by the Ancillary Studies Committee, followed by approval by the Virahep-C Steering Committee. Protocols should follow the general guidelines outlined below.
II. Format for Supplementary Study Protocols
Proposals should be easily read and understood by individuals who may not be experts in the scientific area of research, but who are sufficiently knowledgeable in scientific areas related to the research to be able to evaluate the proposal fairly. Proposals should be brief (fewer than 10 pages in length including appendices using Times New Roman Font 10), but contain sufficient detail to allow adequate scientific review and assessment of the relevance of the proposal to the Virahep-C study, as well as its impact on recruitment, follow-up and workload. Each proposal should include:
Criteria: Scientific
- list of current investigators (with principal investigator listed first). Curriculum Vitae of the principal investigator and biographical sketches for other investigators
- introduction and background with pertinent key references
- specific hypotheses and aims
- experimental design
- methods
- data analysis plan and sample size calculation
Criteria: Impact on Virahep-C
- list of sites that have expressed intent to participate
- resources required
- source of funding of project
- timeline
- relevance to Virahep-C hypothesis and interpretation of results
- impact on Virahep-C recruitment and conduct of study (details of the time and effort for subjects and work requirements for clinical center coordinators must be given)
- risks and safety concerns
- impact on Coordinating Center for data management and analysis
III. Approval Process
- Proposal should be sent to the Virahep-C Coordinating Center for initial review for completeness.
- The proposal will then be forwarded to the Ancillary Studies Committee chair, who will assign three reviewers who are not co-investigators on study proposal to determine the proposal’s scientific content and relevance to Virahep-C. The reviewers will be chosen from the Ancillary Studies Committee or from the Steering Committee, if necessary, in order to provide adequate expertise to review the study. A clinical center coordinator assigned by the Ancillary Studies Committee will review feasibility. The turnaround time for initial review is 1 month.
- If serious scientific, feasibility or safety concerns are raised by the reviewers, the reviews will be forwarded to the principal investigator for his/her consideration. This review is not meant to function as an internal review group or to provide extensive scientific feedback to applicants. The investigator has 2 weeks to respond to the initial reviewers and this response as well as the initial reviewers comments are provided to the Ancillary Study Committee members for final review and vote.
- The Ancillary Study Committee will hold a brief conference call to discuss the proposal, the reviews, and any subsequent response from the investigator. The Ancillary Study Committee will make a recommendation to the Steering Committee to Approve or Disapprove of the study and provide a summary statement based upon comments from the Ancillary Study Committee members. The focus of the comments will be based upon the study’s relevance to the Virahep-C hypothesis, scientific merit, and impact on Virahep-C. The impact of the study on recruitment, follow-up, and personnel time will have a major influence also. The minimum turnaround time for final review by the Ancillary Study Committee is 2 weeks, and maximum time is 4 weeks.
- Approval for a supplementary study to use Virahep-C stored specimen will be contingent upon the availability of the requested specimen. Additional considerations for such studies are the importance and uniqueness of the study should its approval and subsequent use of the specimen deplete the supply of stored specimen.
- The proposal itself and the summary statement from the Ancillary Study Committee with its recommendation regarding Approval/Disapproval will be forwarded to the Steering Committee for comment and formal vote to approve or not.
- A majority approval rating by the Steering Committee is required for a supplementary study to be accepted. The Steering Committee’s decision will be communicated to the principal investigator by the Steering Committee chairperson within 7-10 days.
- In the case that an investigator is unsuccessful at obtaining funding/resources to conduct a supplementary study that would deplete the Virahep-C blood or liver repository within 180 days of approval by the Steering Committee, the authorization to use the tissue will be withdrawn and the Steering Committee will consider other proposals to use the specimens. Within 5 working days of receiving a decision of the funding source, the investigator is required to inform the Coordinating Center of the decision; and if unsuccessful, whether a revised application is planned. A revised supplementary study proposal to use Virahep-C tissue must be submitted to the Steering Committee for reconsideration. Within 3 working days of being notified that the proposal was not successful in securing the funding/resources, the Coordinating Center will inform Steering Committee members of the availability of the stored specimen for other supplementary studies. All proposals (re-submission and new proposals) must be sent to the Coordinating Center for distribution to the Ancillary Committee for review.
- Individual sites wishing to join in a supplementary study may do so at any point during its submission, by notifying the Coordinating Center and the principal investigator of the supplementary study.
IV. Timing and Procedures for submission
A letter of intent sent to the project coordinator at the Coordinating Center is required at least two weeks before submitting the proposal. The letter of intent should include the title of the study, a brief abstract and the names of the investigators.
A proposal must be submitted no less than 3 months prior to a funding source submission date or starting date if funding is available. This allows 2 months for supplementary study review and 1 month for Steering Committee review of the revised proposal and mail ballot.
One copy of the letter of intent.
One paper copy plus an electronic copy on disk or via e-mail of the proposal should be sent to:
Laurie Koozer
Project Coordinator
University of Pittsburgh
Graduate School of Public Health
Phone: (412)624-9640
Fax: (412)383-5841
Email: koozerl@edc.pitt.edu
cc: belle@edc.pitt.edu
pr132q@nih.gov
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ACKNOWLEDGEMENT
In drafting these guidelines, we had the benefit of referring to guidelines from the following sources: the NIDDK and NHLBI-sponsored BARI 2D Trial and the NIMH-sponsored STAR*D.
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