CONSENT TO PARTICIPATE

Purpose

You are being invited to participate in a research study. The purpose of this study is to describe practices and attitudes of critical care clinicians on free valproate (VPA) therapeutic drug monitoring (TDM). The results of this survey will inform future research on free VPA TDM and provide insight into TDM practice pattern variation.

Who may Participate and Study Procedures

Participants will be identified via email/listserv posts to professional societies and social media. In order to participate in this research, you must be a physician, advanced practice provider (APP), pharmacist, or other critical care clinician who participates in the ordering and interpretation of VPA concentrations. This survey asks you to read and respond to questions regarding VPA TDM. You will also answer question on basic demographics and facts about your institution and how you would respond to theoretical clinical situations. We expect 100-200 particpants to complete the survey.

Participation is Voluntary

You do not need to participate in this research. There is no penalty for not participating. This survey will take approximately 6-12 minutes.

Risks and Benefits 

This research is not designed to provide benefit directly to those who participate. You will not be compensated for your participation. The primary benefit of this study will be the opportunity to contribute to knowledge about free VPA TDM. The only known risk of participating is a small chance that someone would be able to see the data you provide or will know that you were the one who provided it. We will take reasonable precautions to avoid this. Collected information will not be directly used in clinical care. We do not plan on collecting any sensitive information. Institution-specific information (i.e. valproic acid concentration reference ranges at a specific institution) may be externally collected or verified from publically available sources but no attempt to identify individual participants will be made. Participation is voluntary and you can stop at any time. Deciding not to participate won't affect medical care you receive at Mass General Brigham now or in the future, or any benefits you receive now or have a right to receive. 

Confidentiality 

This survey is anonymous. All information will be kept confidential. Data will be stored in a password-protected desktop that is secured from public access. Your de-identified information will not be used or shared with other researchers.

Funding

This study has received no internal or external funding.

Contact 

If you have questions about this research, please contact the principal investigator:

Andrew J. Webb, PharmD, BCCCP
Clinical Pharmacist, Neurocritical Care
Department of Pharmacy, Division of Clinical Pharmacy
Massachusetts General Hospital
Boston, MA
ajwebb@mgh.harvard.edu

If you'd like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Mass General Brigham IRB at (857) 282-1900.

PARTICIPATING EXPRESSES YOUR CONSENT 

If you do not want to participate, you may stop now. You may return a blank or spoiled survey.

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