Preparing Pharmacists for Public Health Services (PrePPS) Phase I

Informed Consent

Jenny Newlon, PharmD, PhD, Multi-Principal Investigator
Sally Rafie, PharmD, Multi-Principal Investigator
EmpoweRx, Inc

Key Information
The following is a concise and focused presentation of key information to assist you in understanding why you might or might not want to participate in this research.

• You are being asked to be in a research study because you are either a community pharmacist or a pharmacy faculty member in the United States.
• Your participation is voluntary. You may refuse to participate or withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. Refusal to participate or withdrawal from participation will not affect your employment status.
• Your alternative is to not take part in this study.
• The purpose of this study is to better understand what pharmacists and pharmacy faculty need to better develop clinical decision-making skills.
• Your participation in this study is expected to last no more than 1 hour.
• The main study procedures include an individual interview, conducted online.
• The risks of this study include All research carries the risk of breach of confidentiality which means that someone outside of our study could figure out that you were in the study or information was yours.
• There is no direct benefit to you from taking part in this study. However, information we learn from this study may help people in the future. Having more information from the answers in this research study might help us or other researchers understand more about how to best prepare the current and future pharmacy workforce for providing public health services, such as contraceptive, PEP/PrEP, or tobacco cessation prescribing services.

This overview does not include all the information you need to know before deciding whether to take part in this study. Additional detail is given in the rest of this consent form found on the pages that follow. Be sure to review the rest of this consent form before deciding to participate.

Who Is the Study Team and How Is This Study Funded?
This research study is being conducted by Jenny Newlon and Sally Rafie at EmpoweRx, Inc. The NIH has provided funding for this study.

How Many People Will Take Part in This Study?
About 5 pharmacists and 5 pharmacy faculty are expected to participate in this study.

What Is Involved in This Research Study
All participants will be asked to participate in a virtual interview about goals, needs, barriers, and motivations when it comes to learning or teaching skills in preparation for providing pharmacist-provided public health services. Your participation will last no more than 1 hour. The interviews audio and video will be recorded. You may keep your camera off if you wish.

Will Participating in This Study Benefit Me?
Participating in this study may not benefit you directly, but it will help us learn more about how to best prepare the current and future pharmacy workforce for providing public health services, such as contraceptive, PEP/PrEP, or tobacco cessation prescribing services.

What Are the Risks Associated With This Research?
You may find answering some of the questions upsetting, but we expect that this would not be different from the kinds of things you discuss with family or friends. You may skip any questions you don’t want to answer, and you may end the interview at any time. Your participation in this study is completely voluntary, and your alternative is to not take part in this study.

What Are the Costs of Taking Part in This Study?
There are no costs to you for taking part in this study. All the study costs, including any study tests, supplies, and procedures related directly to this study, will be paid for by the study.

Will There Be Compensation for Participating?
If you participate in this study, you will be compensated $50 for your time within 2 weeks of completing your interview. The $50 will be provided via e-gift card or visa card at the email address you provide. If you have any questions related to compensation, please contact Jenny Newlon at 858-412-0984 or jenny@birthcontrolpharmacist.com.

What About Confidentiality?
To the extent allowed by law, every effort will be made to keep your personal information confidential. However, information from this study may be looked at by the research team, the institution EmpoweRx, Inc, the sponsor/funding agency supporting this study, the National Institutes of Health (NIH), and those responsible for overseeing the conduct of research. This may include representatives from the federal Office for Human Research Protections (OHRP) or other regulatory agencies, the Institutional Review Board (IRB), and the Biomedical Research Alliance of New York. While these parties are aware of the need to keep your information confidential, total confidentiality cannot be guaranteed. The results of this study may be presented at meetings or in publications; however, you will not be identified in these presentations and/or publications.

If you take part in this study, you will be assigned a unique subject code to help protect your privacy. Your study records and study samples will be labeled with this code that does not directly identify you. The study site staff will securely store the linking code between your name and study information.

Your information will be assigned a code number that is unique to this study. The list connecting your email address to this number will be kept in a password protected file and only the Principal Investigator and other researchers will be able to see the survey you participated. No one at the NIH will be able to see your survey or even know whether you participated in this study. When this study is completed and the data have been analyzed, the list linking participant’s email addresses to study numbers will be destroyed. Study findings will be presented only in summary form and your email address will not be used in any report. While the investigator(s) will keep your information confidential, there are some risks of data breaches when sending information over the internet that are beyond the control of the investigator(s).

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. Researchers with this Certificate will not disclose or use information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, even if there is a court subpoena.

Exceptions include:
A federal, state, or local law that requires disclosure
Your explicit approval for the researchers to release your name and/or personally identifiable information.
What About Identifiable Private Information?

Identifiers might be removed from your identifiable private information. After such removal, the information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent.

Whom Do You Call if You Have Questions or Problems?
If you have any questions about this study, please contact Jenny Newlon at 858-412-0984 or jenny@birthcontrolpharmacist.com.

If you have any questions or complaints, you may contact a person not on the research team at the Biomedical Research Alliance of New York Institutional Review Board at (516) 318-6877 or at www.branyirb.com/concerns-about-research.

By completing this form, you are consenting to participate in this study.
*Please print or save a copy of this form for your records.*