Sample Informed Consent Form printable pdf download

Consent Form

Thiel College Institutional Review Board

Any researcher who intends to work with human subjects should seek legally effective "informed consent

from each prospective subject or the subject's legally authorized representative." Under federal

regulations, this is mandatory rather than an optional matter because informed consent is "one of the

primary ethical requirements underpinning research with human subjects," reflecting the principle of

respect for persons.

It is our experience that 90% of delays in the processing of IRB applications result from inadequate or

missing Consent Forms. We urge all applicants to submit a consent form.

Below you will find details on how to prepare an informed consent form. Once you have completed it, you

will submit it along with your application and any other required documents via our online application.

Preparing an Informed Consent Document

In reviewing your application, the IRB reader will look for an informed consent document and will check to

make sure that it contains all of the following information:

1. The document describes, briefly and simply, what the research is about.

2. It tells the subjects what they will be asked to do and for how long.

3. It explains any risks and benefits. If there is no direct benefit to the subject, the document

should explain what the study hopes to discover and why.

4. If you promise to protect your subjects' identity, you must describe how you will do this. If it is

impossible for you or anyone else to link the data you collect to a specific person, then you may

promise to guarantee your subjects' anonymity. However, in most cases it will be possible to use

your records to identify a subject. In that case, the most you can promise is to keep the subjects'

personal information private to the extent allowed by law.

5. The document describes any compensation the subject will receive and conditions under which

no payment or partial payment will be made.

6. The document makes it clear that participation is voluntary.

7. It tells subjects that they may skip questions or withdraw from the study at any point without

penalty.

8. It gives the subjects the names, addresses, and telephone numbers or e-mail addresses of

persons to contact if they have questions or concerns about the study. The IRB asks that name,

address, and telephone number or e-mail address be included for the investigator and his or her

faculty advisor (if the investigator is a student).

9. It tells subjects that if they have questions or concerns, they may also contact the IRB chair, c/o

the Office of the Associate Dean of the college (see examples below).

10. It does not contain "exculpatory language." Subjects must not be asked to waive (or appear to

waive) any of their legal rights, nor may they be asked to release the investigator, any funding

organization, or Carleton College from liability for negligence. By signing the consent document,

Sample Informed Consent Form