Policies & Process
Proposals for collaborative investigations are welcome. All projects using the Agricultural Health Study are done in collaboration with AHS investigators. AHS Policy 2-4 - Guidelines for Collaboration (PDF, 82 KB) was established by the AHS Executive Committee to ensure that collaborations are conducted in accordance with applicable NIH requirements for data sharing and the protection of the privacy and confidentiality of human subjects. The policy for establishing collaboration is summarized as follows.
- Contact Executive Committee member
- Register on AHS STaRS
- Submit Proposal/Data Request
- Notification of review result
- Annual Progress Reports
- Publication Guidelines
- Contact Executive Committee member.
A researcher interested in conducting a collaborative investigation within the Agricultural Health Study (AHS) should first contact a member of the AHS Executive Committee (EC) and provide a brief description of the proposed project. The AHS EC member will forward this summary to other AHS EC Members to assess whether there are already approved studies in the area and to determine the appropriate AHS investigator involvement. All collaborative efforts must include at least one AHS researcher as a co-investigator or facilitator who will help the investigator by providing necessary information about the cohort.
- Register on AHS STaRS.
The next step for establishing collaboration is the preparation of a formal AHS Data Request using the application form available on the AHS Study Tracking and Review System (STaRS). A researcher will first be required to register on STaRS. Once registration is approved, a researcher will have access to the information for collaborators maintained on the AHS StaRS website.
- Submit Proposal/Data Request.
The proposal/data request should include a concise summary of the research hypothesis and the proposed study design. The proposal must identify the institution and/or affiliation of the researcher and all potential collaborators. Requests submitted by the first Monday of the month will be reviewed that month, whereas proposals received after the first Monday of the month will be reviewed the following month.
- The AHS Executive Committee will evaluate requests for data, use of biological samples, and/or add-on studies. Proposed research will be evaluated based on potential overlap with other ongoing studies, methodological soundness, scientific validity and importance, investigator's access to funding necessary to conduct the work, and relevance to our agricultural cohort.
- Existing data:
When submitting a data request to utilize existing data, investigators should submit a completed variable checklist. The variables requested from each questionnaire type and the years for which the data are needed should be indicated on the request form. Investigators can find the questionnaires on STaRS or the questionnaires page. Investigators should make requests for only those variables that are pertinent to the research question posed. No identifying information on individual participants will be provided.
- Existing specimens:
Studies that involve the use of biological specimens currently stored in repositories (e.g., buccal cells) will require additional justification and review due to the limited supply of biological materials available. Information on sample volume requirements, validation of proposed assays, and statistical power estimates are required.
- New Data Collection:
Studies that involve new data collection that involves contact with the AHS cohort must be coordinated with other efforts to minimize the burden on study participants. The AHS co-investigator will be responsible for coordinating the efforts with other field efforts.
- IRB and Scientific Peer Review:
For studies using existing specimens or collecting new data, final approval is contingent upon scientific review and human subjects approval. For intramural scientists this may be the review process within their agency. For extramural scientists, the review process may be that by the granting agency. In all cases, documentation of the review process is required and a written record of the review must be provided to the Executive Committee. The AHS EC reserves the right to require additional review as deemed necessary. Other restrictions may apply in order to protect the privacy and other rights of study participants.
- Notification of review result.
The investigator will receive notification from the AHS STaRS system about the outcome of the review by the AHS Executive Committee.
When the Data Request is approved by the AHS EC, the researcher must complete and sign a Confidentiality Agreement (PDF, 21KB) before the data can be released. The Confidentiality Agreement/No Publication Agreement prohibiting the use of the AHS data for other than the pre-specified uses outlined, must be signed by the extramural lead investigators and should be returned to the AHS per the form instructions, in conjunction with submission of the AHS STaRS application form.
With all AHS research, the rights and privacy of cohort members must always be respected as outlined in the AHS study protocol. Initial contact with the cohort member, must be cleared through the EC. Informed consent agreements and privacy and human subject research policies dictate that personal identifiers of study participants can only be made available to government scientists and their collaborators.
- Annual Progress Reports.
The researcher must provide annual updates on the status of research project on the AHS STaRS. The update should include any abstracts submitted for presentation and any manuscripts submitted for publication.
- Publication Guidelines.
A copy of all manuscripts developed using data from the Agricultural Health Study must be submitted to AHS STaRS for approval by the Executive Committee prior to submission for publication. The review will be completed within 30 days of submission. It is the responsibility of the senior AHS investigator who serves as coauthor to assist the lead author in meeting AHS requirements in conducting studies and publishing results using AHS data.
If you are interested in working with AHS data, the first step is to contact the appropriate investigator for the appropriate area of research.