Frequently Asked Questions

Biomarker data is not available for all participants. Serum, plasma, and urine specimens from subsamples of the PATH Study participants were analyzed for biomarkers of tobacco exposure and potential harm. Each participant subsample includes people who do not use tobacco as well as people who use a diverse mix of tobacco products. People who use tobacco were defined based on questionnaire data (available in the PATH Study public-use files) and includes people who are current exclusive cigarette users, people who currently use other tobacco products, people who are experimental only users of any tobacco product, and people who used tobacco products previously. The Biospecimen Access Program Introduction” page under “Biomarker data” provides tables that indicate what analytes are analyzed at each wave, as well as when initial biomarker restricted-use files (BRUF) data are expected to be released. You may apply online to access the biomarker data. Go to the PATH Study BRUF page of the NAHDAP website for more information on accessing biomarker data.

Biospecimen Access Program indicator variables for Wave 1 through Wave 5 are available in the Restricted-Use Files (RUF) or Public-Use Files (PUF) version of the Master Linkage File (MLF). To access these files, click on the “Population Assessment of Tobacco and Health (PATH) Study [United States] Master Linkage Files (ICPSR 38008)” from the PATH Study Series page.

To access the RUF, follow the application instructions to submit at NAHDAP. Once you have access to the RUF, you can get more information on merging the Master Linkage File with the questionnaire data in Chapter 7 of the RUF User Guide. Information on linking files is also available in Chapter 7 of the PUF User Guide. Once merged with the questionnaire data, you can identify tobacco use (or other) variables of interest and generate cross tabs with the Biospecimen Access Program (BAP) indicator variables. This will approximate the number of participants with at least one aliquot available. These variables are updated once a year. Please submit a concept statement so an official Biospecimen Availability Report can be generated and variable availability can be determined.

• Objective 1: Identify and explain between-person differences and within-person changes in tobacco-use patterns, including the rate and length of use by specific product type and brand, product/brand switching over time, uptake of new products, and dual- and poly-use of tobacco products (i.e., use of multiple products within the same time period and switching between multiple products).
• Objective 2: Identify between-person differences and within-person changes in risk perceptions regarding harmful and potentially harmful constituents, new and emerging tobacco products, filters and other design features of tobacco products, packaging, and labeling; and identify other factors that may affect use, such as social influences and individual preferences.
• Objective 3: Characterize the natural history of tobacco dependence, cessation, and relapse, including readiness and self-efficacy to quit, motivations for quitting, the number and length of quit attempts, and the length of abstinence related to various tobacco products.
• Objective 4: Update the comprehensive baseline and subsequent waves of data on tobacco-use behaviors and related health conditions, including markers of exposure and tobacco-related disease processes identified from the collection and analysis of biospecimens, to assess between-person differences and within-person changes over time in health conditions potentially related to tobacco use, particularly with use of new and different tobacco products, including modified-risk tobacco products.
• Objective 5: Assess associations between TCA-specific actions and tobacco-product use, risk perceptions and attitudes, use patterns, cessation outcomes, and tobacco-related intermediate endpoints (e.g., biomarkers of exposure and biomarkers related to disease). Analysis will attempt to account for other potential factors, such as demographics, local tobacco-control policies, and social, familial, and economic factors, that may influence the observed patterns.
• Objective 6: Assess between-person differences and within-person changes over time in attitudes, behaviors, exposure to tobacco products, and related biomarkers among and within population sub-groups identified by such characteristics as race-ethnicity, gender, and/or age, or by risk factors, such as pregnancy or co-occurring substance use or mental health disorders.
• Objective 7: To the extent to which sample sizes are sufficient, assess and compare samples of people who used tobacco products previously and people who never used tobacco products for between-person differences and within-person changes in relapse and uptake, risk perceptions, and indicators of tobacco exposure and disease processes.
• Objective 8: Use data from the PATH Study’s baseline and follow-up waves on tobacco-use behaviors, attitudes, and related health conditions, including potential markers of exposure and related disease processes identified from the analysis of biospecimens, to screen and subsample respondents for participation in formative and/or nested studies conducted during and after the PATH Study’s waves of data and biospecimen collection.

The Biospecimen Access Program (BAP) has extracted genomic DNA (gDNA) from selected Wave 1 study participant blood 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 can be released to researchers. Buffy coat and buccal cells from these participants are also available to researchers.

Currently, biomarker data from only urine, serum, and plasma are available; no genetic data has been analyzed as part of the PATH Study. Researchers interested in gDNA data must apply to the Biospecimen Access Program and request gDNA aliquots from Wave 1 to conduct their own analyses.

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 illegal drug use, including cannabis. Although medical and/or adult use of cannabis is legal in many states, it is still classified as a Schedule 1 substance and illegal under federal law (as defined in Section 812 of the Controlled Substances Act 21 U.S.C. §801 et seq., CSA).

Thus, the PATH Study is not permitted to release biospecimens for the analysis of cannabis metabolites.

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

The PATH Study asks a variety of different questions that can be used to define groups of people who use the ten tobacco 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 people who smoke cigarettes, 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 Master Linkage File (available within the restricted-use files or public-use files) contains indicator variables for participants who have at least one available aliquot for the Biospecimen Access Program. These variables, when linked with the questionnaire and/or biomarker data, allow investigators to explore specimen availability for their subgroups of interest while completing their concept statement. These variables are available for Wave 1 through Wave 5 for each specimen type available at that wave (e.g., Wave1_BAP_Urine; Wave1_BAP_Plasma; etc.).

Anyone from the general scientific community can apply for the PATH Study biospecimens. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives (detailed in the “What are the PATH Study objectives?” above) 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 investigators located in the U.S.

You are not required to have funding for your study before you apply for access to the PATH Study biospecimens. However, you are required to submit proof of funding within 12 months after receiving notice that your biospecimen access application is approved. The PATH Study does not provide funding for Biospecimen Access Program studies.

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 any samples can 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 the analyses of these data will help you develop your concept statement or application, you need to complete a separate process to apply for the use of the RUFs. This process requires applying to NAHDAP for access to these data and showing IRB approval for your proposed use of data.

Concept statement submission and review takes four (4) months. You must submit your concept statement during the first of these four months – the submission deadline is on the last day of this month. The next three (3) 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 this 3-month review period. For more information, see the Application Submission Schedule.

Application submission and review takes six (6) months. The submission deadline is on the last day of the second month. The next four (4) months are used for application review. Notification of the decision will be e-mailed to you at the end of this 4-month review period. For more information, see the Application Submission Schedule.

If your application is approved, you must submit additional documents before we can ship your biospecimens to you. These include proof of funding for laboratory analyses and proof of IRB approval or exemption. If applicable, you must submit letters of commitment from other investigators who are providing additional biospecimens to your project. You will also be required to sign a PATH Study Material Transfer Agreement. You have 12 months from the date on your approval letter to obtain and send these documents to us. After we receive them, we will ship your biospecimens to you.

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

If your concept statement or 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 of your application 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. 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 PATH Study management (Program Officials within the Center for Tobacco Products, U.S. Food and Drug Administration and the National Institute on 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. Other experts may be invited to review for specific topics and research areas as needed.

If your application is approved, there will be no costs to you for retrieving the PATH Study biospecimens from the biorepository 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 on these biospecimens cannot begin until you obtain approval from the PATH Study.

You are not required to submit the results of your laboratory analyses 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 request 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:
This manuscript is supported with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, and the Center for Tobacco Products, Food and Drug Administration (FDA), Department of Health and Human Services, under contract to Westat and through an interagency agreement between the FDA Center for Tobacco Products and the Centers for Disease Control and Prevention. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Department of Health and Human Services or any of its affiliated institutions or agencies.