Subject #:______
Date:______
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
TITLE OF STUDY: The effects of long-term meditation training on pre and postmortem biological processes.
INTRODUCTION AND PURPOSE
You are invited to participate in a research study that seeks to understand the effects of long-term meditation training on biological processes during the death process. Your participation is entirely voluntary. Participation in this study will involve observation and recording of your biological processes as you pass away. There are no major risks to participation. The information from these methods will add to our understanding of the biophysiological correlates of the death process.
WHAT ARE THE PROCEDURES FOR THIS STUDY?
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As part of this study, we will be measuring your “brain waves”, also called EEG, for the duration of our observation. What will place four sensors, called ‘EEG electrodes’, on your head. A special kind of paste which conducts small brain signals from your scalp to the electrode inside the sensor will also hold the sensor in place. The sensors will allow us to record your brain activity as long as they are hooked up.
Illustration 1: Head Electrodes
We will also measure your respiratory activity by placing a flexible belt around your chest to record the rise and fall of your chest as you breathe in and out.
Illustration 2: Respirator Belt
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We will measure your cardiovascular activity, called EKG, with three flat sensors that will be attached to your torso and foot, like stickers. These sensors will be used to record the naturally-occurring electrical activity that is generated by your heartbeat.
Illustration 3: EKG
Lastly, we will apply two small sensors to the tips of your fingers that measure perspiration and blood oxygenation.
None of the sensors that we place on your body are invasive in any way. They will simply be placed against the surface of your skin, and held in place with a small piece of tape, or with a special adhesive paste. None of the sensors send any electrical or any other type of energy to your body, but simply listen to and record signals produced by the natural biological processes of your body.
Throughout the duration of your participation we will also record changes in your body temperature with a special camera that can see and record temperatures.
It will take about 20-30 minutes to place all of the sensors prior to recording.
WHAT ARE THE COSTS TO ME FOR MY PARTICIPATION? WILL I BE PAID FOR PARTICIPATING?
There will be no cost associated with any part of this study. You will be paid $25 if you choose to participate.
WHAT ARE THE POTENTIAL BENEFITS TO ME FOR MY PARTICIPATION?
No direct benefit to you is expected from participating in this study. However, your participation in this research may benefit other people in the future by helping us learn more about the connections between long-term meditation training and brain and body processes at the time of death.
WHAT ARE THE POTENTIAL RISKS, DISCOMFORTS, AND INCONVENIENCES TO ME?
We foresee few risks from the above procedures. There is occasionally mild discomfort during the application of the EEG or other electrodes associated with having them stuck to one’s skin. On rare occasions, individuals with very sensitive skin or skin allergies may experience a slight irritation at the site of sensor application.
The skin will not be broken or pierced in any way by the sensors used in this study. We use strictly non-invasive procedures to collect measurements.
There may be some discomfort associated with having researchers present as one passes away. To mitigate this risk Key Personnel conducting data collection will be doctors from the local Tibetan Medical Institute and Delek Hospital. The doctors will be (1) familiar to you and your family, (2) will be from the same cultural background, and (3) would likely be present even in the absence of research. Furthermore, you have the option of using only the EKG, respiration belt and cameras, to minimize the amount of touching of the body, especially the head, at the time of death.
WHO SHOULD NOT PARTICIPATE IN THIS STUDY?
You must be free of neurological problems to participate in this study. Neurological problems include seizure disorders (such as epilepsy), Parkinson’s disease, tremors, multiple sclerosis, Alzheimer’s disease, and a history of stroke or head injury. If you believe you have a neurological disorder or if you have any questions about this section, please ask the experimenter before you sign this consent form.
WHO WILL SEE THE RESULTS OF THIS RESEARCH?
Your participation in this study is confidential, which means that only authorized study personnel will have access to the information you give us. Authorized study personnel will include select personnel in the Laboratory for Affective Neuroscience (under the direction of Richard J. Davidson, Ph.D.). All data will be stripped of personal information and identified by an identification number only. The results of this study may be published or presented at professional conferences, but you will not be identified by name.
WHO WILL PARTICIPATE IN THIS STUDY?
This study will enroll long-term meditation practitioners, and similarly aged people who are not trained in meditation from the South Asian Tibetan community, who are nearing the end of their lives.
IS MY PARTICIPATION VOLUNTARY?
Yes, your participation in this study is entirely voluntary. You may withdraw from this study at any time. Your decision not to participate or to withdraw will not affect any benefits to which you are entitled.
Before you sign this form, please ask questions on any aspects of this study that are unclear to you. You may take as much time as necessary to think this over. You are free to withdraw from this study at any time. For information on the rights of research subjects, or to address any questions or concerns you may have, you may contact :
Dr. Dawa, director of the Tibetan Medical & Astro. Institute
1892-222618
or you may contact :
Dr. Tsetan, Chief Medical Officer of the Tibetan Delek Hospital
1892-22053
.
Authorization: I, ______, have read the above and decided to participate in the
(Printed name of subject)
research project described there.
______
Signature of Subject Date
______
Signature of Person Obtaining Consent Telephone
Comprehension Questionnaire
1.) What is the purpose of this study?
2.) What will be measured in this study?
- Brian waves
- Respiration
- Heartbeat
- Perspiration/blood oxygenation
- Body temperature
3.) Will we be cutting or piercing your skin in any way?
4.) Does it cost anything to participate?
5.) What are the risks of participating?
6.) What are the benefits of participating?
7.) Will your name be used?
8.) Will you be paid for participating?
9.) Who will participate in this study?
10.) Can you choose not to participate?
11.) Who will see the results of the study?
12.) Who should not participate in the study?
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Version 5, 8/4/2005 5 ALL