How to Apply for Biospecimens

When you are ready to initiate a request for the PATH Study biospecimens, begin by submitting a concept statement.

1. Download and complete the PATH Study Concept Statement template. You will be asked to provide:
   • Your affiliation and contact information;
   • A short description of your proposed study – background and hypothesis, specific aims, approach (study design, comparison groups, and biospecimen analyses), and consistency with PATH Study objectives and/or research priorities for tobacco regulatory science; and,
   • Using the BAP indicator variables in the Master Linkage Files (MLF) that are available as RUF or PUF, and any relevant questionnaire or biomarker data to define your subgroups of interest, create a cross tab to show BAP specimen availability based on your inclusion criteria. These variables will be used to generate your official Biospecimen Availability Report.
2. Submit your concept statement to the PATH Study team at PATHStudyBiospecimens@westat.com. The window for the first submission of concept statements is one month.

The PATH Study team will complete a review of your concept statement.

1. Upon receipt of your concept statement, the PATH Study team will determine whether your requested biospecimens are available and work with you to update your concept statement as needed. The window for checking biospecimen availability and submitting revised concept statements is one month.
2. The PATH Study Biospecimen Access Committee (BAC) will review your concept statement and evaluate your proposed study for feasibility, scope, and consistency with PATH Study objectives, and/or research priorities for tobacco regulatory science. The BAC is composed of scientists from within the PATH Study Biospecimen Access Program and the research community. They make recommendations to PATH Study management who in turn, makes the final decisions. This review period is two months.
3. At the end of the review period, the PATH Study team will e-mail a notification of the final decision to you. If your concept statement is approved, the notification e-mail will include a letter which indicates that your requested biospecimens are available. You must include this letter with your application submission.

If your concept statement is approved, you may submit an application electronically through the NIH X01 grant submission process. The application submission window is eight weeks. Review the submission schedule for more information.

Applications must be prepared using the SF424 Research and Related (R&R) forms, the SF424 (R&R) Application Guide and the PATH Study specific instructions published in the Resource Access Award announcement, PATH Study Biospecimen Access X01 Award Notice. This announcement also provides the electronic link to access and submit the application forms.

When you are ready to submit an application, go to the link in the PATH Study Biospecimen Access X01 Award Notice to complete the SF424 R&R forms and submit them through Grants.gov. You must also include with youments that your requested biospecimens are available. You must also include with your application submission, the letter from the PATH Study team, which documents that your requested biospecimens are available. The application will not be accepted without this letter.

The NIH and the PATH Study team will complete an administrative and scientific review of your application.

1. Upon receipt of your application in Grants.gov, the Center for Scientific Review, NIH will evaluate it for completeness and compliance with application instructions. When the administrative review is complete, NIH will forward your application to the PATH Study team.
2. The PATH Study BAC will review your application for scientific and technical merit. The review criteria are listed in the PATH Study Biospecimen Access X01 award notice. The BAC will make recommendations and then submit your application to PATH Study management, who will make the final decisions. The review period is four months.
3. At the end of the review period, the PATH Study team will e-mail a notification of the final decision to you.

Although you do not need Institutional Review Board (IRB) approval to apply for biospecimens, you will be required to submit proof of IRB approval for your proposed use of biospecimens before they will be released to you. In addition, if you are interested in using the data in the biomarker RUF to prepare your concept statement and/or full application for PATH Study biospecimens, you are required to apply for access to the biomarker data and to submit proof of IRB approval for your use of the biomarker data in a separate process, which is available through PATH Study Biomarker RUF page. Please allow additional lead-time to gain access to RUF data before you begin the process to obtain access to PATH Study biospecimens.