Consent Form Guidelines

Your application to the Institutional Review Board requires a copy of your consent statement or form. The informed consent must be on S.U. letterhead unless exempted by the IRB. Even if you are asking to use oral consent, you still must attach a copy of your oral consent script (what you will read to the subjects.) Both oral and written informed consent must include the following information:

1. The consent form must be on S.U. letterhead unless exempted by the IRB.
2. The consent form needs to include the project title at the top.
3. You must state clearly the purpose of the study in lay language avoiding the use of technical terms and using language appropriate to the targeted subject group.
4. You must state clearly the procedure to be used. Do not assume that the general public is familiar with any specialized procedures. Instead, explain what is involved.
5. It must be clear that confidentiality is protected or if data collection does not allow responses to be connected with a particular participant that anonymity is ensured. However, the consent form for focus groups should explain that confidentiality cannot be guaranteed in group situations.
6. It must be clear that participation is voluntary.
7. You must state that subjects "may refuse to take part in the research or withdraw at any time without penalty."
8. State the benefits to the subject which might reasonably be expected from participating in the research.
9. State the risks to the subject in participating in the research.
10. You must state who will be receiving the information obtained from the study.
11. For adult subjects, a statement that the subject is 18 years or older and date of birth must appear as part of the consent document.
12. If you wish to tape subjects, include a request to tape explaining the type (e.g. videotaping in the classroom, audio taping single or group interviews, etc.) and the disposition of the tape(s) when the study is complete. If the tapes will be used for any other purpose, clearly state the reason and circumstances; if there is no other use of the tape, simply stating that it will be erased when the study is complete is sufficient.
13. Researchers who plan to ask subjects about their or others' illegal activities (underage drinking, drug use, etc.) must clarify this on the consent and include the following sentences: "The researcher is not immune to legal subpoena about illegal activities. Although it is very unlikely, if law enforcement officials asked to see my data, I would have to give it to them."
14. When appropriate, provide participants with referrals for counseling services on campus to address any concerns they have about their behavior and/or psychological state.
15. When applicable include the following sentence in the consent form: "We have not set aside money to pay for related injuries. Signing this form does not waive any legal rights."
16. The consent form should list the name, with contact information, of the faculty member and research staff (if applicable), if people have questions, concerns, or complaints about the research, (only when appropriate add: or if there are research related injuries).
17. The consent form should list the name, with contact information, of the Syracuse University Institutional Review Board in case the participant has any questions about his or her rights as a research participant, the participant has questions, concerns, or complaints that they wish to address to someone other than the investigator, or if the participant cannot reach the investigator, (only when appropriate add: or if there are research related injuries).
18. A space for the printed name and a space for the signature of the participant should be included at the bottom of the consent form.
19. A space for the printed name and a space for the signature of the investigator should be included at the bottom of the consent form.
20. The consent form must be 12pt font or larger.
21. If consent form consists of more than a single page, the pages must be numbered.
22. You must state that the study involves research.
23. You must explain the expected duration of the participant’s participation.
24. You must differentiate procedures that are part of the research and those that are being done for other purposes.
25. Indicate that you will give a copy of the consent form to each participant.
26. Disclose any appropriate alternative procedures, if any that might be advantageous to the participant. For example, in the case of students from a subject pool, any alternative methods by which course credit can be obtained.
27. If the research involves more than minimal risk, contact the IRB office for additional information that should be included.
28. When appropriate, the informed consent form should include the IRB approved language regarding Certificates of Confidentiality. Please make the following addition to your informed consent regarding Certificates of Confidentiality: “There have been very few reported court cases on the legality of Certificates of Confidentiality. The certificate’s authority has been upheld by one New York Court of Appeals’ decision.”

The mandate of the Institutional Review Board is to assure that all rights and privileges of human subjects are protected. Careful attention to your consent form will facilitate the processing of your application.

Example: Generic Model Informed Consent

Your Consent form must be on your SU departmental letterhead with address and telephone number.

MODEL INFORMED CONSENT

(This form is to be used as a guideline for question No. 8 of the Institutional Review Board's Protocol Application. Written consent should always be on SU letterhead unless exempted by the IRB. Be sure to include information pertinent to the protocol you will be submitting. The bold, italicized parts in parentheses are to be filled in by you.)

Project Title

My name is (name of person doing project), and I am a (under grad/grad student, professor, etc.) at (name of institution/facility, etc.) I am inviting you to participate in a research study. Involvement in the study is voluntary, so you may choose to participate or not. This sheet will explain the study to you and please feel free to ask questions about the research if you have any. I will be happy to explain anything in greater detail if you wish.

I am interested in learning more about (what the research is about.) You will be asked to (state what the subject will be asked to do.) If there are procedures that will be done anyway, differentiate them from those that are part of the research. This will take approximately ___ min/hrs of your time. All information will be kept ____ *(either (a) anonymous, in the case where data collection does not allow responses to be connected with a particular subject or (b) confidential, in the case where subjects' identities need to be retained or can be associated with their responses); (If anonymous: this means that your name will not appear anywhere and no one will know about your specific answers except (myself, faculty advisor and/or research team, as appropriate)). (If confidential: I will assign a number to your responses, and only (I, my faculty advisor and/or research team, as appropriate) will have the key to indicate which number belongs to which participant. OR In any articles I write or any presentations that I make, I will use a made-up name for you, and I will not reveal details or I will change details) about (where you work, where you live, the specific nature and degree of your disability.) For focus groups add:

Confidentiality cannot be guaranteed in group situations. Other participants in your group will know how you answer questions. While we will discourage anyone from sharing this information outside of the group, we cannot guarantee confidentiality by other group members. We will do our best to keep all of your personal information private and confidential but absolute confidentiality cannot be guaranteed.

Only when appropriate include the following: If you wish to tape subjects, include a request to tape explaining the type (e.g. videotaping in the classroom, audio taping single or group interviews, etc.) and the disposition of the tape(s) when the study is complete. If the tapes will be used for any other purpose, clearly state the reason and circumstances; if there is no other use of the tape, simply stating that it will be erased when the study is complete is sufficient.

The benefit of this research is that you will be helping us to understand (topic of research.) This information should help us to (benefit of the research, better understanding, etc.) If there are no benefits to the participant state: There are no benefits to you by taking part. Otherwise state: By taking part in the research you may experience the following benefits (list reasonably expected benefits. The risks to you of participating in this study are (state the risks to subjects.) These risks will be minimized by (state the procedures you will use to minimize the risks.) If you do not want to take part, you have the right to refuse to take part, without penalty. If you decide to take part and later no longer wish to continue, you have the right to withdraw from the study at any time, without penalty. If you have any questions, concerns, complaints about the research, (only when appropriate add: or suffer a research related injury) contact the (list faculty member and research staff) at (list contact information for faculty member and research staff). If you have any questions about your rights as a research participant, you have questions, concerns, or complaints that you wish to address to someone other than the investigator, if you cannot reach the investigator, or (only when appropriate add: you have been injured by the research), contact the Syracuse University Institutional Review Board at 315-443-3013.

All of my questions have been answered, I am over the age of 18 and I wish to participate in this research study. I have received a copy of this consent form.

Only when appropriate include the following:

___ I agree to be (video/audio taped).

___ I do not agree to be (video/audio taped).

_________________________________________    _________________________
Signature of participant                                                                          Date

_________________________________________    _________________________
Print name of participant                                                                       Date of Birth

_________________________________________    _________________________
Signature of investigator (or witness)                                               Date

_________________________________________   
Print name of investigator (or witness)                                          

 

SAMPLES FOR COMPLETING INFORMED CONSENT

*Anonymous and Confidential Data Collection
Indicate whether data collection will be (a) anonymous or (b) confidential.

The term "anonymous" is used when the investigator collects no identifying information about subjects, and thus, an individual data sheet cannot be connected with a specific subject (by the investigator or anyone else) once the data is collected. Video/Tape-recording, by its very nature, cannot be considered anonymous

The term “confidential” is used in the case where subjects' identities need to be retained or can be associated with their responses.

Abuse
If a researcher is asking about care taking practices or observing in the child's home, the researcher would need to indicate what their reporting responsibility is in the event of suspected child abuse or neglect. Another example might be if the researcher determined that subjects were at risk for harming themselves or others. If the researcher felt bound to notify someone about that risk, subjects should be notified of that obligation when asking for participation.