Propuestas de mejora para la disminución de las brechas identificadas

University of North Carolina at Chapel Hill Information about a Research Study IRB Study # 14-2989

Title of Study: Coping with Attention Deficit Hyperactivity Disorder During Pregnancy

Principal Investigator: Jessica Sparrow

Principal Investigator Department: School of Nursing Principal Investigator Phone number: xxx-xxx-xxxx

Principal Investigator Email Address:[email protected] What are some general things you should know about research studies? You are being asked to take part in a research study. To join the study is voluntary.

You may refuse to join, or you may withdraw your consent to be in the study, for any reason, without penalty.

Research studies are designed to obtain new knowledge. This new information may help people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies. Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. You will be given a copy of this consent form. You should ask the

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researchers named above, or staff members who may assist them, any questions you have about this study at any time.

What is the purpose of this study?

There is limited literature to describe how ADHD manifests during pregnancy, nor are there standard guidelines to address management of ADHD when a woman becomes pregnant. Pregnant women are often faced with choices for how to manage their ADHD symptoms if they stop medication during pregnancy. There exists little in the literature describing a woman's coping process during this time. These interviews are intended to provide preliminary

information that will assist with the development of a pilot study to gain more information about the management of ADHD symptoms during pregnancy.

The purpose of this research study is to obtain information about how women cope with their ADHD symptoms during their pregnancy.

You are being asked to be in the study because you are a woman diagnosed with ADHD, between the ages of 18-40 and delivered a baby less than 5 years ago.

Are there any reasons you should not be in this study?

You should not be in this study if talking about your coping experience with ADHD during your pregnancy would make you feel uncomfortable or distressed.

How many people will take part in this study?

There will be up to three women who will participant in this study. How long will your part in this study last?

Participation in this study will include one interview, which will last approximately 60-90 minutes with the option of a follow up interview within 14 days, if you choose.

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You will be called by Carolina Outreach to schedule an interview

During the interview with Ms. Sparrow you will be assigned a pseudonym. You will be asked a series of questions about your ADHD experience and decision-making during your pregnancy. Though your participation is required for you to be involved in this research study, it is not required for you to answer each question; you may skip a question, or stop the interview at any time with no repercussions. At the end of the research study you will be given the opportunity to schedule a follow up interview within 14 days from the date of the interview.

What are the possible benefits from being in this study?

You will not benefit personally from being in this study. The information gained from the study will be used to assist with the development of a pilot study in which more women will be interviewed to share their experiences.

What are the possible risks or discomforts involved from being in this study?

There are no known risks to this study. However, it is possible you may experience emotional discomfort as you describe your experiences of coping with your ADHD symptoms during pregnancy, if those experiences were negative. If this were to happen you should report this to Ms. Sparrow.

What if we learn about new findings or information during the study?

You will be given any new information gained during the course of the study that might affect your willingness to continue your participation.

How will your privacy be protected?

The following are confidentiality practices that will be implemented to increase the level of confidentiality and maintained throughout this study: The principal investigator (Jessica

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Sparrow) is the only person who will be knowledgeable of your identifiable information No other person related to this study will see any identifying information and it will never be

transcribed or recorded. You will be assigned an alias and your real name will never be disclosed Data collection instruments will not contain any identifying information

You will not be identified in any report or publication about this study and no voluntary

disclosures will be made. A digital voice recorder will be used to record the interview, and after the interview, your audio recording will be moved to password-protected computer and saved in a unique password-protected file. The information will be digitally transcribed by Ms. Sparrow and also saved to a password-protected computer in a password- protected file. Ms. Sparrow will be the only person to have access to these transcribed documents. During transcriptions, all identifying names, titles, and characteristics will be omitted or substituted for fictitious ones. The recordings will be deleted after the transcription process is complete, no later than three days after the interview. References or quotations from the transcripts may be used as content in the final paper for this project, but these, too, will contain no identifying information. Participants will not be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if

disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety.

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You can withdraw from this study at any time, without penalty. Ms. Sparrow also has the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped.

Will you receive anything for being in this study?

You will be receiving a $40.00 Target gift card for taking part in this study. Will it cost you anything to be in this study?

If you enroll in this study, you might have costs, which include:

Travel expenses and childcare that incur because of your participation in this study. What if you have questions about this study?

You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study (including payments), complaints, concerns, or if a research- related injury occurs, you should contact Ms. Sparrow, listed on the first page of this form. What if you have questions about your rights as a research participant?

A committee that works to protect your rights and welfare reviews all research on human volunteers. If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113.

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