What a consent form should contain?
This set of questions is designed to help you prepare a cover letter (1-15) or a consent form (1-17) for a project with human research participants
1. Is the title of the study at the top of the consent form? Will prospective participants understand that title? The title on the consent form need not be the project title or the title of a dissertation or article.
2. Does the consent form state the general purpose of the study (what the researcher expects to learn)?
3. Does the consent form state how the study relates to the program of work of student investigators (class project, honors thesis, dissertation, etc.)?
4. Does the consent form tell the subject why and how he or she was selected as a possible participant? Is the number of potential subjects indicated?
5. Does the consent form explain the procedure of the study (time, frequency, nature of information, questions asked, observations made, etc.)?
6. Does the consent form describe any potential risks that are involved in the project and the procedures adopted to minimize or reduce the possibility of risk?
7. Does the consent form state that the participants do not have to answer every question?
8. If there are benefits to the participants, are they identified in the consent form? If there are no benefits to the participants are they told this? Are claims of benefits to "society" realistic? If the subjects are compensated, is the payment schedule specified and fair?
9. If the project requires that a standard treatment be withheld, is this clearly stated in the consent form? If alternative treatments are available, are they described?
10. Does the consent form address the privacy of the participant`s responses? If responses are to be aggregated, report this. If the subject cannot be linked to his or her responses by anyone, the responses are anonymous. If you or your research associates can determine who gave which responses, but will prevent others from linking names and responses, the responses are confidential.
11. If the participants are videotaped or audiotaped, the participant must be told how the tapes will be stored and used and the final disposition of the tapes (e.g., erased after transcription or coding, stored for possible future analysis in a file cabinet in the investigators locked office, etc.).
12. Does the consent form indicate that the subject has a right to choose to participate in the study and that the subject`s decision will not affect his or her relationship with the institution conducting study or other agencies associated with the study? (Specify these.)
13. Does the consent form indicate that the subject may withdraw from the study at any time? Are situations where the subject`s participation can be terminated described?
14. Does the consent form indicate where the subject can contact the investigator to have questions answered? If the principal investigator is a student, is the supervising professor identified and his or her phone number given? Are non-medical faculty given the title of Professor or Ph.D., and not Dr. (which may imply medical supervision).
15. Is the participant told that he or she may keep the cover letter or a copy of the consent form?
16. If the study imposes more than minimal risks or is likely to create concern on the part of the participants, is the name and phone number of the chair of the Institutional Review Board (IRB) given?
17. Is there a provision for parental consent for a child\\\'s participation and child assent (if the child is between 7 and 17)?
This is a standard checklist this and similar are used through out the world for biomedical research. When you are preparing consent form it can help in keeping track.
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