You are not required to have funding for your study before you apply for the PATH Study biospecimens. However, you are required to submit proof of funding within 12 months after receiving notice that your application is approved.

Anyone from the general scientific community including academic institutions, and industry and biotech companies can apply for the PATH Study biospecimens. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives and/or research priorities for tobacco regulatory science will be given highest priority for access to these biospecimens. Studies that address other objectives that advance the knowledge of tobacco use and/or tobacco-related health outcomes will also be considered.

The PATH Study biospecimens are only available to U.S.-based investigators.

You may submit more than one application at a time as long as the study hypotheses and aims are different.

If your application is not approved, you should contact the PATH Study team at PATHStudyBiospecimens@westat.com to discuss your options for re-submission. You may be asked to revise and resubmit both the concept statement and application or to only revise and resubmit the application. Alternatively, you may choose to appeal the rejection by submitting a formal letter to the PATH Study team at PATHStudyBiospecimens@westat.com within 30 days of the date on the decision letter. The letter must address specific issues raised within the review and provide a clear rationale for the appeal. The PATH Study management will review your letter and make a final decision within 30 days of receiving your appeal. The outcome of the appeal is final.

Your concept statement and application will be reviewed by the PATH Study Biospecimen Access Committee (BAC) and the PATH Study management (Program Officials with the Center for Tobacco Products, U.S. Food and Drug Administration and the National Institute of Drug Abuse, National Institutes of Health). The BAC members consist of individuals who are internal and external to the PATH Study team. The BAC members have expertise in biospecimen and laboratory science, tobacco research, and tobacco policy and regulation, and may call upon experts in other research areas to help them with specific reviews.

Concept statement submission and review takes three months. You must submit your concept statement during the first of these three months - the submission deadline is on the last day of this month. The next two months are for the concept statement review, including checking for availability of requested biospecimens. Notification of the decision will be e-mailed to you at the end of these two months. For more information, see the Application Submission Schedule.

Application submission and review takes five months. The submission deadline is on the last day of the second month. The next three months are used for application review. Notification of the decision will be e-mailed to you at the end of these three months. For more information, see the Application Submission Schedule.

After your application is approved, you must submit additional documents before we ship your biospecimens. These include proof of funding for laboratory analyses; letters of commitment from other investigators who are providing biospecimens to your project (if applicable); and proof of IRB (Institutional Review Board) approval or exemption. You will also be required to sign a PATH Study Material Transfer Agreement. You have up to one year after the date on your approval notification to obtain and send these documents to us. After we receive them, we will ship your biospecimens.

If your application is approved, there will be no costs to you for retrieving the PATH Study biospecimens from long-term storage or packaging and shipping them to your laboratory.

After you receive the PATH Study biospecimens, you have up to two years to analyze them.

You are required to destroy any residual PATH Study biospecimens after your laboratory analyses are complete and provide signed documentation that these materials have been destroyed. Alternatively, you may request to use residual biospecimens for follow-up studies by submitting an addendum to your original application. Additional work cannot begin until you obtain approval from the PATH Study.

You are not required to submit the results of your laboratory analysis of the PATH Study biospecimens to the PATH Study. However, you are required to share the data to the greatest extent possible and consistent with the NIH Data Sharing Policy and the policies set forth by the project funding agency(ies).

You are free to publish and present the results derived from analyzing PATH Study biospecimens. However, you must adhere to NIH Public Access Policy (2008) which requires you to submit or have submitted for you, all manuscripts accepted for publication, on the National Library of Medicine's PubMed Central. You must also adhere to any policies set forth by the project funding agency(ies). In addition, we recommend that you send the final manuscript citation to NAHDAP for inclusion in the PATH Study bibliography.

When you publish the results of your PATH Study biospecimen research, you should acknowledge the PATH Study by using the following language: These analyses were conducted using materials whose collection was funded by the United States Department of Health and Human Services. National Institutes of Health. National Institute on Drug Abuse, and United States Department of Health and Human Services. Food and Drug Administration. Center for Tobacco Products. Population Assessment of Tobacco and Health (PATH) Study [United States]. This manuscript does not necessarily reflect the opinions or views of the NIH or the FDA.

You can find detailed information in the PATH Study Biospecimen Access — Policies and Procedures for Investigators. This document describes specific policies and procedures you must follow when applying for PATH Study biospecimens. We highly recommend that you review this manual prior to preparing a concept statement and application. You may also contact the PATH Study team directly at PATHStudyBiospecimens@westat.com.

Biomarker data is not available for all participants. Serum and urine biospecimens from subsamples of the PATH Study participants (n≈7,000 for serum; n≈11,500 for urine) were analyzed for biomarkers of potential harm and tobacco exposure. Each participant subsample includes tobacco nonusers as well as a diverse mix of tobacco product users. Tobacco product users were defined based on questionnaire data (available in the PATH Study public-use files and includes exclusive current cigarette users, current users of other tobacco products, experimental only users of any tobacco product, and former users of tobacco products. You may complete an online application process to obtain access to the biomarker data. Go to the PATH Study restricted-use files (RUF) page of the NAHDAP website for more information on how to apply for access to biomarker data.

You do not need IRB approval prior to submitting a concept statement or an application to apply for access to PATH Study biospecimens. You will be required to submit proof of IRB approval or exemption for your proposed use of biospecimens after your application is approved and before your samples will be shipped. However, if you are interested in using the biomarker data or questionnaire data available in the PATH Study restricted-use files (RUF), and think this data will help you develop your concept statement or application, you will have to complete a separate process to apply for RUF data. This process requires submitting an application to NAHDAP and showing IRB approval for your proposed use of data.

The PATH Study asks a variety of different questions that can be used to define tobacco user groups across the 10 products about which the adult respondents were asked. Some of the variables included in the adult questionnaire (restricted or public) data sets include current established use, current experimental use, and past 30-day use. These are defined below, but we acknowledge that these are not the only definitions in which researchers may be interested.

Current Established Use: Current established use is defined as using a tobacco product "every day" or "some days" as well as meeting a threshold for lifetime use. For cigarette smokers, this threshold is smoking at least 100 cigarettes in their lifetime. For all other tobacco products, it is defined as using the product "fairly regularly".

Current Experimental Use: Current experimental use is defined as using a tobacco product "every day" or "some days" but has NOT met the threshold for lifetime use.

Past 30-Day Use: Past 30-day use is defined as using a tobacco product at least 1 day in the past 30 days.

The Biospecimen Access Program (BAP) has extracted genomic DNA (gDNA) from selected study participant samples. The BAP is presently accepting Concept Statements requesting extracted gDNA samples (see the How to Apply page on the BAP website). Only samples from study participants who provided informed consent for genetic testing (~6,600) can be released to researchers.

Currently, the PATH Study has no plans to perform genetic or epigenetics testing (e.g., genotyping or microarrays) on PATH Study biospecimens. The PATH Study is accepting Concept Statements from researchers interested in performing these analyses.

Based on language in the PATH Study consent form, researchers cannot test PATH Study biospecimens for biomarkers of drug use, including marijuana. Although use of marijuana is legal in some states, it is still Schedule 1 and illegal under federal law (as defined in Section 812 of the Controlled Substances Act 21 U.S.C. ยง801 et seq., CSA). Thus, the PATH Study is not permitted to release biospecimens for the analysis of marijuana metabolites.

Contact Us

For inquiries regarding the PATH Study biospecimen resource and procedures for access, contact the PATH Study team at PATHStudyBiospecimens@westat.com.

To link directly to the PATH Study Biospecimen Access Program page via shortened URL, use http://bit.ly/2wBFOtc