Investigator Guidelines
IRB
With the launch of the MWCCS Combined Cohort Study, a single Institutional Review Board (sIRB) has been mandated by NIH with Johns Hopkins University (JHU) serving as the sIRB on record. Initiating a new project or adapting significant changes in the MWCCS study wide protocol will require the sIRB approval of JHU. For initial research studies involving a few MWCCS clinical research sites, one must obtain its own Institution’s IRB approval or IRB approval through JHU. When obtaining IRB approval, one must assess any cost associated with the submission. All staff that will be involved will require appropriate orientation and/or training to carry out new protocols.
Given the size of the MWCCS structure and the volume of research being conducted, all investigators who are bringing new projects to the MWCCS will need to consider three elements: time, communication, and teamwork.
TIME
No one sub-study can take precedence. To get application paperwork from the consortium, or to organize a newly approved project, you will cue up behind others already in process – so start early. Notify Project Directors (PDs) well in advance of any due dates and be specific regarding your needs and time-table. Negotiation of the budget must be completed with each site before grant submission, and as soon as funding is approved or cuts are required, you need to contact sites. You should start by contacting the Project Director at your local site.
COMMUNICATION
Organize your information into a comprehensive request. For example, if you are applying for a new grant, you may need the following: investigator biographies, other support information, certification of human subjects protection training, investigators’ disclosure of financial interest, institutional agreement to participate, budgets, etc… A flurry of individual requests causes confusion and items are likely to be overlooked. Send requests to the PDs via electronic mail. Direct your data requests to the PD at the MWCCS Data Analysis and Coordinating Center (DACC) or your local PD.
TEAMWORK
The MWCCS consortium has unique aspects to its organization and the requirements for carrying out additional projects may vary. The PD is intimately aware of the resources, organization, and limitations of their specific MWCCS site. PDs are also experienced in organizing and coordinating multi-center studies. However, you must keep in mind that the MWCCS consortia have limited administrative staff and while they can provide you with the information you request – you may have to be responsible for formatting some items to meet your needs. Once funded, you will be responsible for the bulk of the work required in organizing the protocol and developing data forms and consent templates. These should be reviewed by your local PD prior to submission to the DACC. These forms are needed for IRB submission so they must be distributed at least two months before you anticipate starting enrollment. As with the core study and all sub-studies of the MWCCS, the PDs are happy to work with the investigator in a team effort to make your research a success and hope you will draw on their resources early in the process.
