Instructions for the Consent Document
Please read the following instructions before completing the consent template. Not following the instructions may delay the approval of your research proposal.
1)The consent must be written at the 5th grade reading level, should not contain any jargon or abbreviations, and should be checked for grammatical and spelling errors. (This document, for example, is written at the 12th grade level.)
2)The consent should not include any exculpatory language that waives or appears to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
3)Use the term consent document rather than consent form.
4)The title of the research should be the same as in the protocol.
5)In response to “Study Investigators” provide the names of all the study investigators, and indicate the name of the principal investigator. A student cannot serve as a principal investigator.
6)Avoid answering the questions in the first person. For example, in response to the question “What is the purpose of the study?” your answer should start as follows: “The purpose of the study is ------“, rather than “I understand the purpose of the study is ----“. In response to the question “What is my involvement for participating in this study?” your answer should start as follows: “You will be asked to complete a questionnaire on your health“, rather than “I understand that I will be asked to complete a questionnaire on my health“.
7)If your research has been funded, provide the name of the funding agency or sponsor. If not, just respond with “none”.
8)Your response to “How long am I expected to be in this study and how much of my time is required?” should be realistic so that the subject is fully aware of the time that it would take to undergo the procedures. Investigators tend to underestimate the time it would take to complete all the tests, questionnaires, etc. Also, indicate wherethe research will take place.
9)Your response to the question “What is my involvement for participating in this study” should describe all the tests, procedures, interventions, etc. that your subject will be asked to undergo and any questionnaires he or she will be asked to complete. This may be quite a lengthy section depending on the nature of your study.
10)Your response to the question “What are the risks of participating in this study?” should include physical, psychological, social, and/or privacy risks depending on the nature of your study. Even if the study is of minimal risk, a risk must be specified. Please do not submit a consent saying that there is no risk to the subject or that there is minimal risk without specifying the risk. For example, filling out questionnaires on the relationship with one’s children may remind the subject of some conflict in his or her relationship which may be upsetting. Also explain how you will minimize the risks that the subject might face and how you will deal with the risks if they occur during the study.
11)There may not be any benefits for the subject in participating in the study and if so this would need to be stated clearly. Please note that understanding the research process on the part of the subject in not a benefit.
12)The question on “What is an alternate procedure(s) that I can choose instead of participating in this study?” may not apply to all research studies.Usually for classroom studies, but may be applicable.Studies involving students should provide information on what alternative activity they could do in lieu of participation. A study that requires testing a novel therapy to improve a particular health aspect of the subject should provide information on an alternative therapy in case the person decides not to participate. The alternative therapy would be a standard therapy which would have to be specified as well as where the person can obtain the standard therapy.
13)The question on “How will my confidentiality be protected” should include information on what steps you will take to minimize breach of confidentiality during the data collection and intervention procedures, the procedures for de-identification, data use, storage, and the disposal of the primary data, etc.
14)In response to “Will I be given a copy of the consent to keep” the answer should be “yes” as required by the federal guidelines.
15)In response to the question “Who should I contact if I have questions regarding the study?” provide the names and telephone numbers (including area codes) of the investigators including the principal investigator.
16)Students who submit protocols and consents must have their advisors review and approve the documents before they are submitted to the IRB. Also required is an e-mail from the advisor that he or she has read the protocol and consent and the IRB guidelines have been followed.