Yale University
Adult Consent/Adolescent Assentfor Participation in a Research Project
200 FR 2 (2017-1)
Study Title:
Investigator:
Funding Source:[if applicable]
HSC #:
PLEASE NOTE THAT ALL ITALICIZED FONT SHOULD BE REVISED TO FIT THE STUDY AND ALL ‘IF APPLICABLE’ ITEMS SHOULD EITHER BE FILLED IN OR DELETED AS NECESSARY
Purpose:
You are invited to participate in a research study designed to examine describe the purpose and goals of the study.You have been asked to take part because [explain briefly why the prospective subject is eligible to participate]. [If appropriate, state the approximate number of subjects and/or research sites involved in the study.]
Procedures:
If you agree to take part, your participation in this study will involve description of tasks (completing a survey asking about x, interview, etc.) We anticipate that your involvement will require x minutes/hours. You will receive x dollars for participating (as applicable).(If enrolling prisoners and paying them: Explain that they are not allowed to have money put into their account while in prison. The payment can either be held until they get out if that date is close or they can name someone else (not in prison) to receive the money for them).
If this protocolprospectively assigns research subjects to one or more interventions and has a health related biomedical or behavioral outcome the following language is required. A description of this research study will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Risks and Benefits:
You may experience description of risks (distress over the nature of the questions, etc. List these in hierarchical order). (If there are no physical risks, include the following):There are no known or anticipatedrisks associated with this study.(If anonymous do not include the following 2 sentences) However,[if applicable, some questions may make you uncomfortable and] there is the possible risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.
Although this study will not benefit you personally, we hope that our results will add to the knowledge about describe public good. Alternatively, if there is a benefit to participants, so state.
For studies which involve more than minimal risk of harm to subjects include: If you are hurt or injured as a result of your participation in this study, [indicate whether treatment will be made available, and who will be responsible for its cost.]
Confidentiality:
All of your responses will be held in confidence / anonymous—choose only one. Only the researchers involved in this study and those responsible for research oversight(such as representatives of the Yale University Human Research Protection Program, and the Yale University Human Subjects Committee, offices responsible for fiscal monitoring, if applicable) will have access to any information that could identify you/that you provide (if anonymous). [Describe the methods used to safeguard the confidentiality of subjects’ data (e.g., coding data or samples with numbers, storing research materials in locked cabinets, password-protecting data stored on a computer, etc.]
(If you are conducting a study on Amazon’s MTurk you must use the following)“The researcher will not know your name, and no identifying information will be connected to your survey answers in any way. The survey is therefore anonymous. However, your account is associated with an mTurk number that the researcher has to be able to see in order to pay you, and in some cases these numbers are associated with public profiles which could, in theory, be searched. For this reason, though the researcher will not be looking at anyone’s public profiles, the fact of your participation in the research (as opposed to your actual survey responses) is technically considered “confidential” rather than truly anonymous.”
(If you are conducting a focus group use the following)Please remember that while we (the researchers) will keep your information confidential and will remind all participants that what is said in the group should not be repeated outside of the group, we have no control over what happens outside of the group.You are reminded to not share anything you wouldn't want repeated outside of this group.
For HIPAA covered studies involving PHI include: Except as permitted by law, your health information will not be released in an identifiable form outside of the Yale University research team, collaborating researchers’ institution and (describe any other groups who would have accessif applicable). Examples of information that we are legally required to disclose include abuse of a child or elderly person, or certain reportable diseases. Note, however, that your records may be reviewed by those responsible for the proper conduct of research such as the Yale University Human Research Protection Program,Yale University Human Subjects Committee or representatives of the U.S. Department of Health and Human Services or the name of research sponsor (if applicable).The information about your health that will be collected in this study includes: (Specify as appropriate)
Information may be re-disclosed if the recipients are not required by law to protect the privacy of the information. At the conclusions of this study, any identifying information related to your research participation will be destroyed, rendering the data anonymous [OR will be retained indefinitely].
By signing this form, you authorize the use and/or disclosure of the information described above for this research study. The purpose for the uses and disclosures you are authorizing is to ensure that the information relating to this research is available to all parties who may need it for research purposes.
This authorization to use and disclose your health informationcollected during your participation in this studywill never expire.
Voluntary Participation:
Your participation in this study is voluntary. You are free to decline to participate, to end your participation at any time for any reason, or to refuse to answer any individual question without penalty.Your decision whether to participate or not will have noeffect your relationship with (NGO, university, community leaders, hospital, etc., if applicable).
For studies involving HIPAA include:You may withdraw or take away your permission to use and disclose your health information at any time. You may withdraw your permission by telling the study staff. If you withdraw your permission, you will not be able to stay in this study. When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others until the end of the research study, as necessary to insure the integrity of the study and/or study oversight.
For studies involving the psychology subject pool include: Your participation in this study is extremely valuable for our research, and we hope that participating will prove to be an educational experience for you. In addition, however, please remember that this is only one of the ways in which you can fulfill your “experimental participation” credits for Introduction to Psychology. Other ways, as detailed in the form handed out to you in class, include serving as an observer of 5 experiments, or arranging for other options of equivalent educational value (e.g., writing essays) through your instructor.
For studies that involve prisoners include:
Being in this research project will have no effect on your sentence, the length of sentence, or parole.
You will not receive better living conditions, medical care, and quality of food, amenities, or opportunities for earnings than what is normally provided in the prison environment.
Questions:
If you have any questions about this study, you may contact the principal investigator, investigator name and contact information. Include appropriate local contact name and telephone number if conducted in collaboration with a non-Yale researcher.
If the study falls under HIPAA requirements, add: If, after you have signed this form you have any questionsabout your privacy rights, please contact the Yale Privacy Officer at 203-432-5919[Add country code, if applicable].
If the study involves the psychology subject pool include: If you have questions about the Psychology Subject Pool, you may contact the coordinator at 432-4518, or
If you would like to talk with someone other than the researchers to discuss problems or concerns, to discuss situations in the event that a member of the research team is not available, or to discuss your rights as a research participant, you may contact the Yale University Human Subjects Committee, 203-785-4688, [Add country code if applicable] . Additional information is available at
Agreement to Participate:
I have read the above information, have had the opportunity to have any questions about this study answered and agree to participate in this study.
(printed name)(date)
(signature)
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Signature of Person Obtaining ConsentDate
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