Informed Consent to Participate in Study of Psychodrama Effects
INTRODUCTION You are invited to join a research study to look at the effectiveness of psychodrama. Please take whatever time you need to discuss the study with your family and friends, or anyone else you wish to. The decision to join, or not to join, is up to you. In this research study, we are investigating/testing/comparing/evaluating the results of psychodrama therapy.
WHAT IS INVOLVED IN THE STUDY? If you decide to participate you will be asked to fill out 4 scales, one demographic questionnaire, and a checklist before and after a session of psychodrama. We think this will take you 5-10minutes at the start of the session and less than that at the conclusion. The investigators may stop the study or take you out of the study at any time they judge it is in your best interest. They may also remove you from the study for various other reasons. They can do this without your consent. You can stop participating at any time. If you stop you will not lose any benefits.
RISKS This study involves no known risks. There may be risks that we cannot predict.
BENEFITS TO TAKING PART IN THE STUDY It is reasonable to expect the following benefits from this research: that your answers will help us understand what results come from psychodrama. However, we can’t guarantee that you will personally experience benefits from participating in this study. Others may benefit in the future from the information we find in this study.
CONFIDENTIALITY We will take the following steps to keep information about you confidential, and to protect it from unauthorized disclosure, tampering, or damage: ___________ Data will be coded and kept in confidential files so that your answers will not be traceable to you. Numeric data will be aggregated and analyzed at a central location from a number of different locations, but identifiers will have been removed before that occurs. The study is concerned with how psychodrama is or is not effective and is not directed at any particular individual’s reactions to it. Every effort will be made to keep your identity confidential. The only place where a file will exist that contains your name in this study will be in the office where you sign up to participate.
INCENTIVES none
YOUR RIGHTS AS A RESEARCH PARTICIPANT Participation in this study is voluntary. You have the right not to participate at all or to leave the study at any time. Deciding not to participate or choosing to leave the study will not result in any penalty or loss of benefits to which you are entitled, and it will not harm your relationship with your provider.
CONTACTS FOR QUESTIONS OR PROBLEMS Call ____________________ at ___________________ or email___________ at ___________if you have questions about the study, any problems, unexpected physical or psychological discomforts, any injuries, or think that something unusual or unexpected is happening.
Contact _____________________________if you have any questions or concerns about your rights as a research participant. Consent of Subject (or Legally Authorized Representative) Signature of Subject or Representative
Date _________________________________________________ [The template for this consent form was taken from the Office for Protection of Research Subjects website of the Department of Health and Human Services in October 2014. You should check your local institution and jurisdiction for other requirements.
