Informed Consent

Appendix C. Trainee/Scholar Consent Form

Form Approved

OMB No. 0910-NEW

Exp. Date XX/XX/20XX

Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey

Consent Form

You are invited to participate in an online survey about your experiences and thoughts around your current or previous participation in a training program or training activities funded through the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). RTI International, a non-profit research institute in North Carolina, is conducting this research. It is part of a project supported by FDA CTP.

Your participation in this research study is voluntary. You may choose not to participate. There are no right or wrong answers. You may skip any questions you do not want to answer, and you may stop at any time. There will be no negative consequences if you choose to stop or if you choose not to participate at all.

Up to 350 individuals are being asked to participate in this research.

What is the purpose of this research?

The purpose of this study is to collect information on tobacco regulatory science training programs and activities and capture trainee experiences. Your participation will help the FDA by providing valuable information that will help improve future trainee programs.

What procedures are involved?

This online survey will take about 10 minutes.

What are the potential risks and discomforts?

To the best of our knowledge, the questions you will be answering have no more risk of harm than you would experience in everyday life. Questions of a highly personal nature will not be asked.

Are there benefits to taking part in the research?

Taking part in this research study may not benefit you personally, but we may learn new things that will help others in CTP-funded training programs.

What other options are there?

You have the option to not participate in this study.

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 2 minutes per response (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

What about privacy and confidentiality?

Your responses will be kept private to fullest extent allowable by law. We will not share your answers with anyone outside the research team. All data will be stored securely. Each participant’s data will be assigned a unique study identification number that corresponds with information they provide. No personally identifiable information will be stored with the data collected; only the study identification number will be stored with the data. Only research staff will have a crosswalk that links study IDs to participant names. No study participant names or other identifying information will be included in any reports or data sets.

We will use the information from these surveys, along with other data we collect, to produce a report for the FDA. Although your answers will inform that report, we will not use your name in the report or attribute any specific information to you or to other participants.

What are the costs for participating in this research?

There are no costs to you for participating in this research.

Will I be reimbursed for any expenses or paid for participation in this research?

You will not receive any financial compensation for participation.

Can I withdraw or be removed from the study?

You are free to discontinue participation at any time. You may stop the survey at any time without penalty.

Who should I contact if I have questions?

You may ask questions or express concerns about this consent form, the study, or your rights as a research participant, or report problems at any time before, during, or after the study. You may contact the research team through the Project Director of the study (Karen Crotty, 919-541-6536, kcrotty@rti.org).

Do you agree to participate in the survey?

Yes No