Appendix H. 2021 TRS Trainee Survey_Clean_0887

Form Approved

OMB No. 0910-0887

Exp. Date 05/31/2023

Center for Tobacco Products,

Food and Drug Administration

Funded Trainee/Scholar Survey

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 10 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.

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

Please read the following definitions of key terms found throughout the survey. This information is very important to make sure that your responses are correct.

What is tobacco regulatory science (TRS)?

Regulatory science is a scientific discipline that ensures that scientifically valid techniques, tools, and models are available to evaluate products and informs regulatory actions that promote optimal public health outcomes. Tobacco regulatory science is a type of regulatory science focused specifically on tobacco that seeks to inform FDA’s regulatory authority. Tobacco regulatory science enables FDA to assess the “net” impact of tobacco products on population-level health.

What is TCORS?

Tobacco Centers of Regulatory Science (TCORS) grants are designated funding through the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) to support research to inform the regulation of tobacco products.

What is a K Award?

A K award is a research career development award to provide individual and institutional research training opportunities (including international) to trainees at the undergraduate, graduate, and postdoctoral levels. K awards include K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K43, K76, and K99/R00 awards.

What is CTP-funded?

Both TCORS and other National Institutes of Science (NIH) grants and projects (including K awards) funded by the FDA CTP are considered CTP-funded awards.

What qualifies as tobacco regulatory science (TRS) training?

Any tobacco regulatory science (TRS) training activity, program, or experience that has been supported by either a TCORS training grant (e.g., a formal or informal TCORS training program) or other TRS-related training supported through an individual K award. Examples include TRS-related seminars, webinars, conferences, and mentor programs.

What is considered a formal TRS training program?

This term refers to a TRS training resulting program funded by a TCORS grant or other TRS training program (not under TCORS). TCORS grants fund TRS training and career enhancement activities designed to create future generations of tobacco regulatory science researchers. Other TRS training programs may offer similar TRS training and career enhancement activities but, instead of being funded by a TCORS grant, are funded by other CTP-funded NIH grants.

Am I a CTP-funded trainee/scholar?

For the purpose of this survey, a trainee/scholar is an individual who is currently funded (in part or wholly) through a TCORS project or CTP-funded K award.

Welcome to the CTP FDA Funded Trainee/Scholar Survey. Please answer the following questions.

1. Please check the box that best describes your current position [Single select].

Graduate student

Post-doctoral Fellow

Faculty

Public sector researcher/analyst/advocate

Private sector researcher/analyst/advocate

Other: (please specify) ____________

2. What is your current funding status? Select all that apply. [Multi-select]

Fully funded on one or more TCORS grants

Partially funded on one or more TCORS grants

Not funded on a TCORS grant, but work with a TCORS research team, on a TCORS research project, or use TCORS data, etc.

Fully funded on one or more CTP-funded K awards

Partially funded on one or more CTP-funded K awards

Not funded on a CTP-funded K award, but work with a CTP-funded research team, on a CTP-funded research project, or use CTP data, etc.

Other (please specify): ______________

Don’t know

3. How long [FILL for current trainees: have you received] [FILL for former trainees: did you receive] CTP funding? [single select]

Less than 1 year

1 to 2 years

More than 2, but less than 5 years

More than 5 years

I don’t know

4. A trainee/scholar is an individual who is funded (in part or wholly) through a TCORS project or CTP-funded K award. Please check the box that best describes your tobacco regulatory science (TRS) training status. [single select]

I am a current trainee participating in a formal TCORS training program

I am a current trainee participating in a formal TRS training program (not under TCORS)

I am a former trainee who participated in a formal TCORS training program

I am a former trainee who participated in a formal TRS training program (not under TCORS)

I have never participated in a formal TCORS or TRS training program

I don’t know

5. Over the past year, which of the following TRS trainings did you attend? Select all that apply. [Multi-select except “I have not attended TRS training activities”; current trainees ONLY]

TRS training activities at my institution

TRS training activities at another institution (not my primary institution)

NIH Tobacco Regulatory Science Program (TRSP) meeting

Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) webinar/events

TCORS meeting

I have not attended TRS training activities in the past year

Other, please specify­­­­­­­­­­­­­­­­­________________

6. Have you participated in any of the following activities during your TRS training? For those activities that you participated in, please rate their usefulness for your professional development and career. [single select for each row; current trainees ONLY]

	Did not you participate	Not useful	Somewhat useful		Very useful
Formal coursework	0	1		2		3
Online classes, short courses, webinars, and other training opportunities	0	1		2		3
Research projects	0	1		2		3
Internships	0	1		2		3
Work with mentors	0	1		2		3
TRS-related conferences and workshops organized by NIH/FDA	0	1		2		3
TRS-related conferences and workshops NOT organized by NIH/FDA	0	1		2		3
TCORS working groups	0	1		2		3
Journal clubs	0	1		2		3
Mentored grant writing	0	1		2		3
Presentations	0	1		2		3
Scientific writing (e.g. writing journal articles, abstracts, dissertations)	0	1		2		3
Other, specify: __________	0	1		2		3

7. Have you participated in any of the following Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) - supported activities or resources during your TRS training? For those activities that you participated in, please rate their usefulness for your professional development and career. [single select per row; current trainees ONLY]

	Did not participate?	Not useful		Somewhat useful		Very useful
CASEL webinars	0		1		2		3
TRS Knowledge Center	0		1		2		3
CASEL trainee events	0		1		2		3
Other, specify: __________	0		1		2		3

8. Have you learned about any of the following topics during your TRS training? For each topic you learned about, please indicate how much your knowledge increased about the topic during your TRS training. [single select per row; current trainees ONLY]

	Did not learn about topic		Knowledge did not increase		Knowledge increased somewhat	Knowledge increased greatly
Health consequences of tobacco use and population health impact	0	1		2			3
Tobacco Control Act/FDA regulatory framework	0	1		2			3
Tobacco control policies and programs	0	1		2			3
Tobacco and nicotine product diversity	0	1		2			3
Vulnerable populations	0	1		2			3
Skills: research, dissemination, testimony	0	1		2			3
Addiction	0	1		2			3
Litigation and disclosure (legal review and challenges to FDA regulation and tobacco-related litigation)	0	1		2			3
Marketing/Communication	0	1		2			3
Toxicology	0	1		2			3
Economics: Cost/Benefits (theory, cost of tobacco use, cost-effectiveness analyses)	0	1		2			3

9. Using a scale of 1 (Not at all), to 3 (Very well), please indicate how well your TRS training has prepared you to… [single select per row; current trainees ONLY]

	Not at all	Somewhat	Very well
Identify research gaps, formulating research questions, and analyzing evidence relevant to tobacco regulation	1	2	3
Identify and understand CTP authority and FDA policy priorities	1	2	3
Use FDA priorities and proposed regulatory policies to inform and develop innovative research questions	1	2	3
Design and conduct research studies to inform policy and population level health	1	2	3
Understand and participate in the process of submitting FDA docket comments	1	2	3
Participate in FDA public workshops	1	2	3

10. Using a scale of 1 (Not at all) to 3 (Very well), please indicate how well your TRS training has prepared you to…: [single select per row; current trainees ONLY]

	Not at all	Somewhat	Very well
Communicate TRS findings to the scientific community (e.g., publishing in peer review journals, presenting at scientific meetings/conferences)	1	2	3
Communicate TRS findings to policymakers and regulatory staff (e.g., submitting to FDA docket, presenting at FDA public workshops)	1	2	3
Communicate TRS findings to the general public (e.g., communication with the press or through social media platforms)	1	2	3
Engage in career planning	1	2	3
Participate in leadership activities	1	2	3
Identify funding sources and apply for research funding/grants	1	2	3
Develop an active professional network	1	2	3

11. How likely is it that you will pursue a career related to TRS? [single select; current trainees ONLY]

Not at all likely

A little likely

Somewhat likely

Very likely

Extremely likely

12. On a scale of 1 (Not at all knowledgeable) to 5 (Extremely knowledgeable), how knowledgeable were you about TRS before you started your training? [single select; restrict to current and former trainees]

[programming instruction: program response options as horizontal scale]

Not at all knowledgeable (1)

2

3

4

Extremely knowledgeable (5)

13. On a scale of 1 (Not at all knowledgeable) to 5 (Extremely knowledgeable), how knowledgeable are you about TRS now? [single select; restrict to current and former trainees]

[programming instruction: program response options as horizontal scale]

Not at all knowledgeable (1)

2

3

4

Extremely knowledgeable (5)

14. During the past year, how many times have you engaged in the following? If you did not engage in an activity in the past year, please enter “0.” [single select per row; current trainees ONLY]

Activity	Number of times
a. Submitted TRS-related journal articles for publication in a peer-reviewed journal
b. Published TRS-related journal articles in a peer-reviewed journal
c. Contributed to comments for FDA/CTP tobacco regulatory science dockets
d. Presented work at TRS-related conferences or TRS-related meetings
e. Other (specify):

15. How many mentors do you have in your TRS training program? Please enter “0” if you do not have a mentor. [single select; current trainees ONLY]

______ Number [If zero, skip to Q17 “Have you submitted any funding applications…”]

16. During your TRS training, how effective has your primary mentor been in … [single select; current trainees ONLY]

	Not at all effective	Slightly effective	Moderately effective	Very effective	Extremely effective
a. Supporting your professional growth	1	2	3	4	5
b. Helping you connect with scientists in the tobacco regulatory science field.	1	2	3	4	5
c. Helping you connect with scientists outside of the tobacco regulatory science field	1	2	3	4	5
d. Helping you develop research projects	1	2	3	4	5
e. Helping you apply for research funding/submit grants	1	2	3	4	5
f. Helping you manage research projects	1	2	3	4	5
g. Helping you develop conference presentations	1	2	3	4	5
h. Helping you develop publications (e.g., shares authorship on papers, suggests journals)	1	2	3	4	5

17. During your TRS training, have you contributed (as principal investigator, co-principal investigator, or co-investigator) to any competitive or non-competitive funding applications? Select all that apply. [multi-select; current trainees ONLY]

Yes, I have contributed to competitive funding application(s)

Yes, I have contributed to non-competitive funding application(s)

No, I have not contributed to any funding applications ---GO TO QUESTION 20

18. Please provide information for the grant application(s)/funding award(s) referenced in Question 17. For each grant/award, use the drop-down menus to respond to each item. [programming instruction: create dropdowns; single select; current trainees ONLY]

	Role (PI, co-PI, co-I)	Funding agency (gov’t, industry, etc.)	Status (funded, not funded, pending)	TRS related
				Yes	No
Grant/ Award 1				1	2
Grant/ Award 2				1	2
Grant/ Award 3				1	2

18. Before you started your TRS training, what was the highest degree you held? Please indicate the year you received the degree. [single select; current and former trainees]

Degree	Expected Year (yyyy)
High school
Bachelor’s
Master’s
Professional Doctorate (i.e. MD, JD)
Research Doctorate (i.e. PhD, ScD)
Other (specify):

20. Which of the following describes the focus of the degree you selected in Question 20? Select all that apply. [multi-select; current and former trainees]

Biochemistry

Bioengineering

Biophysics

Biotechnology

Cell & Developmental Biology

Chemistry

Environmental Sciences

Genetics

Immunology

Microbiology and Infectious Disease

Molecular Biology

Neuroscience

Public Health

Nutritional Sciences

Pharmacology/Toxicology

Physiology

Plant Biology

Psychology

Physics

Social Sciences

Statistics and/or Research Methods and/or Informatics

Other (please specify) ____________________________

21. Before you became involved in TRS work, was your research focused on tobacco regulatory science? [single select; current and former trainees]

Yes

No

22.Is your current research focused on tobacco regulatory science? [single select]

Yes

No

23. Please indicate the degree you are currently seeking and what year you anticipate graduating, if known. If you are not currently seeking a degree, please select “I am not currently seeking a degree.” [programming instruction: allow just one checked box; current trainees ONLY]

Degree	Expected Year (yyyy)
I am not currently seeking a degree (e.g., postdocs)---GO TO QUESTION 25
Bachelor’s
Master’s
Professional Doctorate (i.e. MD, JD)
Research Doctorate (i.e. PhD, ScD)
Other (specify):

24. Which of the following describes the focus of the degree you are currently seeking? Select all that apply. [multi-select; current trainees reporting currently seeking a degree ONLY]

Biochemistry

Bioengineering

Biophysics

Biotechnology

Cell & Developmental Biology

Chemistry

Environmental Sciences

Genetics

Immunology

Microbiology and Infectious Disease

Molecular Biology

Neuroscience

Public Health

Nutritional Sciences

Pharmacology/Toxicology

Physiology

Plant Biology

Psychology

Physics

Social Sciences

Statistics and/or Research Methods and/or Informatics

Other (please specify) ____________________________

25. How do you describe yourself? [single select]

Male

Female

Other, please specify_______________

26. Are you of Hispanic or Latino origin? [single select]

Yes

No

27. What is your race? Select one or more. [multi-select]

American Indian or Alaska Native

Asian

Black / African American

Native Hawaiian or Other Pacific Islander

White / Caucasian

Thank you very much for your participation.