The following consent forms were approved by the U. C. Berkeley Committee for Protection of Human Subjects (project number 94-8-86) and the U.C. San Francisco Committee on Human Research (approval number H7063-08927-04). Note that the formatting is different from the forms actually given subjects.
University of California, San Francisco, Department of Radiology
and
University of California, Berkeley, Departments of Anthropology and Linguistics
MRI Normal Subject Consent Form
INTRODUCTION/PURPOSE
A joint study is being carried out by investigators from the Department of Radiology at the University of California, San Francisco (Sarah Nelson, PhD) and the Departments of Anthropology (Vincent Sarich, PhD and Tom Schoenemann, graduate student) and Linguistics (William S.-Y. Wang, PhD) at the University of California, Berkeley to determine whether normal differences in various dimensions of brain anatomy relate to normal differences in cognitive behavior. For this portion of the study, the investigators wish to obtain information from magnetic resonance imaging (MRI) on variation in brain anatomy, and that is why I have been asked to volunteer.
PROCEDURES
If I agree to participate in this portion of the study, an MRI exam will be performed. I will first be asked a number of questions concerning my health, lack of metal implants and absence of claustrophobia. I will be weighed, have my sitting height and standing height measured, and have skinfold thicknesses taken on one of my arms. I will lie down on a narrow bed which will then be moved into a tunnel that is 6 feet by 2.5 feet. I will lie there quietly for about a half hour during which time I will hear machine-like banging noises. Ear plugs will be provided to reduce the sound level. Communication with the doctors and technologists outside will be possible at all times by a microphone and loudspeaker. If I wish to be removed from the magnet, this will be done immediately. I may be asked to volunteer for a second exam in order to test the reproducibility of this MRI data.
RISKS AND DISCOMFORTS
There could be some risks or discomforts from participating in this portion of the study including the following:
1. Because the MRI machine attracts certain metals, it could move metallic objects within the MRI room during my examination, which could in the process possibly harm me. Precautions have been made to prevent such an occurrence.
2. While there are no significant risks from MRI as it is to be performed, my participation may mean some added discomfort for me. I may be bothered by the loud noise and feelings of claustrophobia during the study. I will be allowed to have a family member or friend accompany me into the MRI room.
3. Because the measurement of skinfold thicknesses involves the pinching of a fold of skin from my arm under a standard pressure, I may experience some discomfort. While there are no significant risks from this procedure, it may cause a slight amount of pain.
4. Confidentiality: My records will be kept as confidential as is possible under law. No individual identities will be used in any reports or publications resulting from this study.
If I am injured as a result of participating in these procedures, treatment will be available. The costs of such treatment may be covered by the University of California, San Francisco, depending on a number of factors. The University does not normally provide any form of compensation for injury. For further information about this matter, I may call the office of the Committee on Human Research at (415) 476-1814.
BENEFITS
This study may provide no direct benefit to me, but the investigators may learn more about the relationship between normal variation in anatomy of the brain and normal variation in behavioral ability as a result of my participation, which in turn may help them understand the evolution of the human brain and its relationship to behavior.
QUESTIONS
I have talked with one of the following investigators: Dr. Nelson, Dr. Sarich, or Mr. Schoenemann, about this study and have had my questions answered satisfactorily. If I have any questions, I may call Dr. Nelson at (415) 476-8855, Dr. Sarich at (510) 527-2460, or Mr. Schoenemann at (510) 649-7631.
PAYMENT
I will be reimbursed in cash for my participation at a rate of $10 per hour and I will be paid immediately following my MRI exam. I will be paid for the time I spend participating (with fractions of an hour prorated at the hourly rate), even if I choose to discontinue participation in the middle of the MRI exam. If I complete the MRI and cognitive testing examinations I will receive a bonus of $15 giving an expected total payment of $45.
RIGHTS
My participation in research is voluntary. I have the right to decline to participate or to withdraw at any time. I have been given a copy of this consent form and the Experimental Subjects' Bill of Rishts. If I am associated with the University of California, or any other university, my status with that institution will not be affected in any way if I decline to participate or withdraw at any time.
University of California, Berkeley, Departments of Anthropology and Linguistics
and
University of California, San Francisco, Department of Radiology
Cognitive Testing Normal Subject Consent Form
INTRODUCTION/PURPOSE
A joint study is being carried out by investigators from the Department of Radiology at the University of California, San Francisco (Sarah Nelson, PhD) and the Departments of Anthropology (Vincent Sarich, PhD and Tom Schoenemann, graduate student) and Linguistics (William S.-Y. Wang, PhD) at the University of California, Berkeley to determine whether normal differences in various dimensions of brain anatomy relate to normal differences in cognitive behavior. In the first portion of the study, the investigators wish to obtain information from a variety of cognitive tests on normal variation in cognitive ability, and that is why I have been asked to volunteer. I may be asked to participate in the second portion of the study in which a magnetic resonance imaging (MRI) scan will be performed.
PROCEDURES
If I agree to participate in this portion of the study, a diverse set of cognitive tests will be performed. I will be asked a number of questions regarding my educational background and income and that of my parent's, my participation in physical activity (such as sports, etc.), my preference of hand use and that of members of my family, my degree of social involvement, my mental and medical health history, my age, and the number of siblings I have. For most of the time I will sit at a desk. Some of the tasks will involve writing answers on a form that I will be given, some will involve pressing certain keys on a computer keyboard in response to various kinds of information presented on the computer screen, and some will involve simply speaking answers out-loud into a tape-recorder. I will also be asked to throw darts at a board located in the same building. Most of the tasks are very short, and none take longer than 20 minutes to complete. The total testing time will be about 2 hours. I will be given periodic breaks between sets of tasks. The testing will take place at Professor William Wang's laboratory, the Project on Linguistic Analysis (POLA) located at 2222 Piedmont Avenue, U.C. Berkeley.
RISKS AND DISCOMFORTS
1. With the exception of the dart throwing task, I will be exposed to no physical risks or discomfort. All the procedures are quite benign, requiring no more concentration than taking a test or writing a paper. However, during the dart throwing task, it is possible that I may accidentally stick myself, or drop a dart on some part of my body. Precautions have been made to lessen the chance of such an occurrence.
2. Confidentiality: Records will be kept as confidential as is possible under law. No individual identities will be used in any reports or publications resulting from this study. After the tape recordings are transcibed they will be erased. Until they are transcribed, the tapes will be kept in a locked cabinet in Professor Vincent Sarich's office.
BENEFITS
This study may provide no direct benefit to me, but the investigators may learn more about the relationship between normal variation in behavioral ability as a result of my participation, which in turn may help them understand the evolution of behavior and its relationship to the human brain.
QUESTIONS
I have talked with one of the following investigators: Professor Nelson, Professor Sarich, or Mr. Schoenemann, about this study and have had my questions answered satisfactorily. If I have any questions, I may call Dr. Nelson at (415) 476-8855, Dr. Sarich at (510) 527-2460, or Mr. Schoenemann at (510) 649-7631.
PAYMENT
I will be reimbursed in cash for my participation at a rate of $10 per hour and that I will be paid immediately following the cognitive testing portion of this study. I will be paid for the time I spend participating (with fractions of an hour prorated at the hourly rate), even if I choose to discontinue participation at any time in the middle of the cognitive testing portion of the study. If I complete both the MRI and cognitive testing examinations I will receive a $15 bonus giving an expected total payment of $45.
RIGHTS
My participation in research is voluntary. I have the right to decline to participate or to withdraw at any time. I have been given a copy of this consent form. If I am associated with the University of California, or any other university, my status with that institution will not be affected in any way if I decline to participate or withdraw at any time.
Copyright 1997 by Paul Thomas Schoenemann