INFORMED CONSENT
In general, a consent form should contain a) a brief description of the research (without identifying any hypotheses) b)a description of participants’ rights and c) a clear indication of the level of confidentiality of the data/records.
More specifically, the consent form should include the following:
1.
a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a basic description of the procedures to be followed (not including manipulations or deception), and identification of any procedures which are experimental;
2.
a description of any reasonably foreseeable risks or discomforts to the subject;
3.
a description of any benefits to the subject or to others which may reasonably be expected from the research;
4.
a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5.
a statement describing the extent to which confidentiality of records identifying the subject will be maintained;
6.
for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7.
an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury to the subject; and
8.
a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled ( 45 CFR 46.116a
).
For more details about consent form guidelines, please refer to the IRB policy document.
Included below is a sample consent form for a student research project, as well, that provides an illustration of how prospective research participants can be informed of the nature of the study and their participation, the risks and benefits of participation, and of how to contact the researcher, her advisor, and the IRB in the event that the participant has questions or concerns.
Waiver of Documentation of Consent
It is important to note that in many cases – particularly with student research – the IRB recommends that researchers consider applying for a waiver of documentation of consent – in which research participants consent to participate, but do not actually sign a consent form for the researcher to keep on file. Waivers of documentation of consent are typically granted for research involving minimal risk using mailed or internet surveys or telephone interviews. Less

common, but still eligible for a waiver of documentation of consent is research for which sensitive or potentially incriminating information in collected and thus the usual requirement of storing consent documents could itself potentially pose a risk of identification for participants.
A researcher who is granted a waiver of documentation of consent would still provide her research participants with a statement of consent like the sample below, but that statement would not include a signature line since no documentation of consent is required. In this case, the sample consent form below would be appropriate with the portion below the line removed.

Sample Consent Form – Student Project
This is a research project conducted by ( student name ) member’s name
) faculty member in the Department of
and is under the direction of (
( department name ) at faculty
Bridgewater
College. You are being asked to participate in a study concerned with puzzle solving and pop culture. In this study, you will have 15 minutes to work on a crossword puzzle. After the 15 minutes, you will be asked to fill out questionnaires concerning the experience.
The risks in this experiment are minor, such as potential feelings of embarrassment or awkwardness depending on how well you do on the puzzle. However, because the researchers will be the only ones to record your performance, any feelings of embarrassment should be momentary . To reduce further risk, your responses will remain confidential and will only be identified in the data as a research number. The data from the research study may be published at a later date but the information will not contain any type of identifying material.
Other than learning about research methodology there are no immediate benefits to participants in this project.
However, the data produced by participants will benefit the field of psychology as a whole in its endeavor to understand cognitive puzzle solving processes and memory for certain cultural events.
This research study is completely voluntary. You may choose to stop your participation at any time prior to the completion of the study without penalty. Your participation is appreciated.
If you have any questions please contact ( student name ) at (phone and email) or if you prefer, you may contact ( faculty member’s name
) at (phone and email) . The Bridgewater College Institutional
Review Board (IRB) has approved this project. If you have questions related to human participants, feel free to contact Dr. Jill Lassiter, the IRB Chairperson at jlassite@bridgewater.edu
or (540) 828-5739.
I understand that my participation in this research project involves [ the description of what the participant will do in during the course of the study ] . I understand that my participation is voluntary, and that I may leave the study at any time without penalty. I know that all of my responses will be stored confidentially. I understand that the researcher ( student name ) will answer any questions about this research at the conclusion of the experiment and that I may also contact the faculty sponsor, ( faculty member’s name
) , at (phone and email) with questions about the research or my rights as a research participant.
I attest that I am at least 18 years of age. I have read the above and give my full consent to participate in this study.
Name (Please Print): ___________________________________ Date: __________
Signature: ____________________________________________

Sample Statement to Include for Physical- or Athletic Activity-Based Research
I understand the nature and scope of the activity listed above. I understand that there are risks associated with the activity but that they are minimal in nature. I further understand that Bridgewater College, its trustees, employees, students, agents or instructors (“indemnified parties”) do not guarantee the safety of the participants with respect to this activity. I fully assume the risks of all dangers associated with this activity and understand that I am responsible to exercise due care in the performance of this activity for my own safety.
In consideration of being permitted to enroll and participate in this activity, I hereby release, indemnify, hold harmless, and forever discharge the indemnified parties from any and all claims, demands, costs, charges, causes of action, expenses for harm, injury, damage or any loss of any kind which I may sustain as a result of, or relating to, participating in this activity. I agree that this release shall be legally binding on me, my heirs, estate, assigns, legal guardians, and personal representatives. This liability release in not intended to immunize the indemnified parties from acts of gross negligence or willful and wanton misconduct.