Plan for Sharing Research Data

Per one of the latest NIH regulations, specific clause has to be added to any grant/contract application addressing a method of Data Distribution. Please click here to access Summary of NIH "Implementation of Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research".

Sample insert (to be customized by the PI):

All the participating researchers have made a commitment to publish, in a timely manner, all the relevant scientific information that they will derive during this project. Unpublished information could be made available to interested parties via a request to the Principal Investigator, in writing, to the address below, or by email.

PI's mailing address
phone number
fax number
email

The sharing of unpublished information may be subject to confidentiality issues relating to our collaborations with other scientists in academic or corporate laboratories, and will need to be discussed with the appropriate institutions before any request is granted, wholly or in part.

Plan for Sharing of Model Organisms (Research Resources)

The NIH Policy On Sharing Of Model Organisms For Biomedical Research was published in the NIH Guide on May 7, 2004. This is an extension of NIH policy on sharing research resources, and reaffirms NIH support for the concept of sharing. The new policy became effective with the October 1, 2004 receipt date for applications or proposals to NIH. If development of model organism is anticipated, the grant application must include a plan for data sharing as part "I", Resource Sharing. Please refer to the links below for more information and for NIH acceptable samples of part "I" inserts. In those cases when development of model organism is not anticipated, omit part "I" completely.

The investigator must include information in his/her Progress Reports concerning requests they receive for the model organism and their fulfillment of those requests. The Grants and Contracts office recommends that investigators whose research will result in the development of model organism set up a spreadsheet and record incoming requests at the time they receive them (mane, institution, and date) and fulfill them (date). If a good process is established at the beginning of the project, it will be painless to include this information in the Progress Report. Otherwise, investigators will have to resort to retroactively generating this information.

For new grant applications, investigators should have their distribution plans reviewed simultaneously by the Grants & Contracts office and by the Office of Technology Development (212/746-6186). Please make proper arrangements before submitting your application for institutional signature.

Examples of Plans for Sharing of Model Organisms and Related Resources (09/08/2004) - The precise content and level of detail to be included in a sharing plan depends on several factors, such as the status of the development of a model organism, the method of sharing and the potential impact of intellectual property rights on the available of the animal model. Three sample plans have been developed to assist the applicant community in responding to this policy:

• A simple plan that may be appropriate for a project, which has the goal of producing a model organism but has not produced one (Organism Sharing Simple).
• A plan for sharing mice (Organism Sharing Mouse)
• An example of a complex plan for sharing mice with IP held by various parties (Organism Sharing Complex).

Instruction in the Responsible Conduct of Research

The NIH has updated its policy on the Instruction in the Responsible Conduct of Research for trainees, fellows, participants and scholars receiving support through any NIH training, career development award, research education grant and dissertation research grant. NOT-OD-10-019 goes into effect for all new/renewal applications submitted on or after January 25, 2010; and for non-competing continuations on January 1, 2011. The responsible conduct of research component must contain the following five topics:

• Format
• Subject Matter
• Faculty Participation
• Duration of Instruction
• Frequency of instruction

The responsible conduct of research component will now be evaluated and be part of the peer review process. After the application has been reviewed and an impact/priority score assigned, the plan will be rated as ACCEPTABLE or UNACCEPTABLE. The results of the review of the plan for instruction in responsible conduct of research will not be a factor in the determination of the impact/priority score. However, regardless of the impact/priority score, applications with unacceptable plans will not be funded until the applicant provides an acceptable revised plan.

RCR NIH Template

For more information, please contact:

Mary Simmerling, Ph.D.
Director, Responsible Conduct of Research
212-746-4809
mcs2006@med.cornell.edu