All participants in this study will be emailed a consent form that you can sign online. That form explains more about the study so you can make an educated decision about whether or not to have an interview. Here is the study information contained on that form:
What are some of the important aspects of this research study that I should be aware of?
- You are being invited to take part in a research study that uses interviews to understand more about how people who are pregnant or lactating (breastfeeding) make decisions about whether or not to use cannabis (marijuana).
- The following pages explain this study so that you can decide if you want to take part. It is up to you whether you would like to do an interview. Feel free to ask us questions if anything below is not clear.
- This study uses 1-hour telephone interviews with people who are now, or were recently, pregnant or breastfeeding to understand how they made decisions about cannabis use. There is no commitment beyond the one interview.
- The only risks we know of to participating in this study are risk of feeling upset about the conversation or risk of privacy breach.
- If you participate in this study you may help us understand how to communicate about risks and benefits of cannabis use in pregnancy and lactation, and what are the best ways to investigate this in a bigger study in the future.
Why are we doing this research study?
This project is a small first study of how pregnant and lactating (breastfeeding/chestfeeding) people in Massachusetts make decisions about whether and when to use cannabis (marijuana/”pot”). The purpose of this research study is to:
- Gain a better understanding of what information people do and don’t use to make cannabis use decisions in pregnancy or lactation, and
- Learn what would be the best ways to investigate this further in a future, larger study.
Who can participate in this research study?
You may be eligible to take part in this study if you:
- Are 21 years old or older
- Are currently pregnant or have been pregnant in the past year,
- Are currently considering, or have in the past year considered, whether to start, continue, or stop using cannabis while you were pregnant or lactating,
- Are able to speak, read, and understand spoken English, and
- Are able to spend 60 minutes on the telephone with a researcher for an interview.
Where will this research study take place and how many people will participate?
A researcher will call you for a private telephone interview at a time convenient to you. We plan to conduct interviews with 25-30 people in this study.
What will I be asked to do and how much time will it take?
If you decide to take part in this study, here is what will happen:
- A researcher will contact you to arrange a good time and place to conduct a private telephone interview with you.
- We will e-mail you this consent form to complete. If you have any questions about the consent form you can ask us before or during your interview.
- The total time this interview will take is approximately 60 minutes. After your interview we will not contact you again.
- The interview will ask you about your experiences with your pregnancy, breastfeeding (if applicable), and cannabis, including how you decided whether or not to use while pregnant or lactating. You may skip any questions you feel uncomfortable answering.
- If you give permission, this interview will be audio recorded by the researcher. If you would prefer not to be recorded, the researcher will take detailed notes of the conversation.
- We will type up the words from the audio recording and keep that version (a transcript) for use in the study. Any identifying information such as names, dates, or places will be removed from the transcript to protect your privacy.
This is a research study that involves questions related to sensitive topics that may cause distress. As researchers, we do not provide mental health services and we will not be following up with you after this study. However, we want to provide every participant in this study with contact information for available clinical resources, should you decide you need assistance at any time. We have a handout of counseling resources available to participants at interviews.
Will being in this research study help me in any way?
You may not benefit directly from participating in this study. However, taking part in this study may help us better understand how to communicate about risks and benefits of cannabis use in pregnancy and lactation. Your feedback in this study will also help us learn how best to study this topic in a larger study in the future.
What are the risks of being in this research study?
We do not expect this study to expose you to any risks. However, it is possible that our conversation could bring up topics that may be upsetting or bring up negative feelings. You can refuse to answer any question you do not wish to answer and you can stop the interview at any time. A handout with local mental health support services, including crisis hotlines, is available from the researcher. The risk of breach of confidentiality always exists. If there were to be a privacy breach your personal information could be discovered, which could potentially expose participants to social, economic, or physical risks. Although the State of Massachusetts has legalized cannabis use for adults, use continues to be stigmatized in some communities, and known use could result in loss of employment, child custody challenges, or intimate partner violence. To minimize this risk we will collect as little personal information as possible, de-identify our research data as soon as possible, and delete it as soon as we no longer need it.
How will my personal information be protected?
Your privacy and confidentiality is important to us. The following procedures will be used to protect the confidentiality of your study records:
- The researchers will keep all study records, including any codes to your data, in a secure location. Paper files will be kept in a locked file cabinet in a locked office at the University of Massachusetts Amherst, and digital files will be kept in secure online storage of the University of Massachusetts Amherst.
- Research records will be labeled with a code. A master key that links names and codes will be maintained in a separate and secure location. The master key and audio recordings will be destroyed 3 years after the close of the study.
- Only the researchers working on this study will have access to your address or contact information, and only for the purpose of arranging your interview. After your interview any such information will be destroyed.
- Audio recordings will be transcribed only by a transcription service with secure procedures and a nondisclosure agreement. This transcript will leave out names, places, dates, or other privacy-sensitive information. Original audio recordings will be destroyed once the transcription process is complete.
- All electronic files containing identifiable information (such as the audio recording of your interview) will be password protected. Any computer hosting such files will also have password protection to prevent access by unauthorized users. Only the members of the research staff will have access to the passwords.
- At the end of this study, the researchers may publish their findings. Information will be presented in summary format and you will not be identified in any publications or presentations. Your name and personal information will not be used in any reports that result from this study. You will only be referred to with a number or pseudonym (made up name).
Will my information be used for research in the future?
Identifiers will be removed and the de-identified data (transcripts with no names or identifying information left in) may be used for future research without additional informed consent from you.
Will I be given any money or other compensation for being in this research study?
To thank you for participating in an interview we will offer you a $25 Amazon.com gift card.
Who can I talk to if I have questions?
Take as long as you like before you make a decision. We will be happy to answer any question you have about this study. If you have further questions about this project or if you have a research-related problem, you may contact the researcher, Devon Greyson (413-545-6322; firstname.lastname@example.org). If you have any questions concerning your rights as a research subject, you may contact the University of Massachusetts Amherst Human Research Protection Office (HRPO) at (413) 545-3428 or email@example.com.
What happens if I say yes, but I change my mind later?
You do not have to be in this study if you do not want to. If you agree to be in the study, but later change your mind, you may drop out at any time. There are no penalties or consequences of any kind if you decide that you do not want to participate. Information about you collected before you quit may still be used in a study report if you withdraw after the report has been written. If you withdraw we will remove your information from future reports wherever possible.
What if I am injured?
The University of Massachusetts does not have a program for compensating subjects for injury or complications related to human subjects research, but the study personnel will assist you in getting treatment.
Subject statement of voluntary consent (to be completed at an interview):
- When signing this form I am agreeing to voluntarily enter this study.
- I have had a chance to read this consent form, and it was explained to me in a language which I use.
- I have had the opportunity to ask questions and have received satisfactory answers.
- I have been informed that I can withdraw at any time.
- A copy of this Informed Consent Form has been given to me.
Please respond to each of the following:
1. Do you agree to voluntarily have an interview with this study?
2. Do you give permission for us to audio record your interview?
3. If you would like to receive an Amazon.com gift card as a thank-you for your interview, please provide the email address to which this should be sent:
Signature: Name: Date: