Instructions for INFORMED CONSENTFORM
A completed protocol must include a copy of the Informed Consent Form or a statement as why individual
consent forms will not be used.
- All research protocols submitted to the IRB shall include a proposed participant consent form with the heading “Informed Consent to Participate in Human Subject Research.” The form shall, at a minimum, include the following requirements:
1.A fair explanation of the procedures to be followed and their purposes, including Identification of any procedures that are experimental, the expected duration of the subject’s participation, and the identity of those persons primarily responsible for conducting the research and analysis of the data gathered;
- A description of any reasonably foreseeable discomforts and risks to the subjects as well as any safeguards or treatment available to the subject should distress or injury occur;
- A description of any benefits to the subject or to others in general which may reasonably be expected from the research;
- A disclosure, if appropriate, that other alternative procedures or courses of treatment exist in addition to those employed in the research that might be advantageous to the subject;
- A statement explaining to the subject efforts to be employed by the researchers to maintain the confidentiality of records produced during the research identifying the subject;
- An offer to answer any inquiries concerning the procedures with specific information about who to contact with pertinent information (address, phone number, e-mail address);
- An instruction that participation is voluntary, that the subject may discontinue participation or may refuse continuing participation without penalty or loss of benefits to which the subject is otherwise entitled, and that all data collected up to that point will be destroyed;
- For full board protocols, the following are usually required: a signature and date line for the subject, or the subject’s legally authorized representative, documenting that the subject has read and understands the consent given, that participation is voluntary and that no promises or threats have been made to or against the subject to obtain the subject’s consent to participate.
B.The agreement, written or oral, entered into by the subject should include no exculpatory language through which the subject is made to waive or to appear to waive any of his or her legal rights, or to release the institution or its agents from liability for negligence.
C.Informed consent is typically documented. For most Full Board protocols, a copy of the signed informed consent form must be obtained from each subject for the PrimaryInvestigator's files and a copy should be given to each subject (or legal Representative). The subject's copy must include the name, address, and telephone number of the person to whom complaints or reports of injury may be addressed:
Dr. Debbie Palmer, Chair
Institutional Review Board for the Protection of Human Subjects
Department of Psychology
Science Building, D240
University of Wisconsin-Stevens Point
Stevens Point, WI 54481
(715) 346-3953
(INFORMED CONSENT FORMS LACKING THIS REFERENCE WILL NOT BE APPROVED)
D.If translators are used for subjects who do not speak English, the translator should also sign the
consent form indicating that they have accurately translated the Informed Consent Form and the
research procedures and that the translator believes that the subject understands these procedures.
- For Exempt and Expedited protocols, informed consent may often be obtained by including an explanation of all the elements at the beginning with a statement that completion of the procedure (such as the questionnaire) constitutes informed consent. If you follow this procedure, you must still provide the subject with access to the form offering to answer inquiries and informing the subject of complaint procedures. Please see the sample consent form for the proper format for this.
Please note: Three examples of Informed Consent Forms follow. These are provided for illustrative purposes only. With the exception of the section regarding complaint procedures, there is no set wording that is required.
Forms revised February 28, 2017
SAMPLE A – CONSENT FORM
(This is an example of a consent form used when researchers will interact with subjects in some direct fashion)
Informed Consent to Participate in Human Subject Research
Dr. Jane Doe, Professor of Communicative Sciences and Disorders at the University of Wisconsin-Stevens Point is conducting a study to determine which hearing tests produce the most accurate information for diagnosing hearing loss. You are being asked to participate in this study.
As part of the study, your hearing will be tested using three different methods. Two of these tests are standard tests that are used currently for diagnosing hearing problems. One of the tests that you will experience is a new test that is currently being evaluated to determine if it is as good as or better than those that are now being used. Because you will be tested three times, it will take longer than a typical hearing test and it is anticipated that all testing will take approximately two hours of your time.
It is helpful to be able to compare the results from each test on the same individuals. You can choose, however, to have only one test to evaluate your hearing and this would not mean that the diagnosis and treatment recommendations that you receive would be less accurate in any way.
Participating in this study should pose no medical risk to you. However, because the results of your hearing tests will not be available to you until all three tests have been administered, you may feel some anxiety about the status of your hearing and whether or not you have any hearing loss.
As a result of your participation in this study, you will have more information about your hearing than you would typically receive from a single test. In addition, this study will assist audiologists in determining which if any of these tests provide the best diagnosis of hearing loss.
For the purpose of the study, your test results will be coded so that your name will not appear on any of the forms used for data analysis. No information about you will be released to anyone other than yourself and publication or presentation of the study data would in no way identify you as a participant. Only Dr. Jones will have access to the names associated with the codes and this information will be kept in a locked file cabinet in her office and destroyed following three years past the end of the study.
If you want to withdraw from the study, at any time, you may do so without penalty. Any information collected on you up to that point would be destroyed.
Once the study is completed, you may receive the results of the study. If you would like these results, or if you have any questions in the meantime, please contact:
Dr. Jane Doe
Communicative Disorders
College of Professional Studies
University of Wisconsin – Stevens Point
Stevens Point, WI 54481
(715) 346-xxxx
If you have any complaints about your treatment as a participant in this study or believe that you have been harmed in some way by your participation, please call or write:
Dr. Debbie Palmer, Chair
Institutional Review Board for the Protection of Human Subjects
Department of Psychology
Science Building, D240
University of Wisconsin-Stevens Point
Stevens Point, WI 54481
(715) 346-3953
Although Dr.Palmer will ask your name, all complaints are kept in confidence.
I have received a complete explanation of the study and I agree to participate.
Name______Date______
(Signature of subject)
Print Name ______
This research project has been approved by the UWSP Institutional Review Board for the Protection of Human Subjects.
SAMPLE B – CONSENT FORM
(This is an example of a consent form that, while essentially utilizing a survey, will also include observation. A signed consent would also be recommended if there was a risk of distress even if only completing a questionnaire.)
Informed Consent to Participate in Human Subject Research
Dr. John Doe, Professor of Sociology at the University of Wisconsin-Stevens Point, and his student, William Jones, are conducting a study on how medical professionals relate to patients. We would appreciate your participation in this study, as it will assist us in making recommendations for improving the teaching of health professionals and the way they treat you.
As part of this study, we would like to observe your visits during the next month with your doctor, nurse, and health technicians. To do this, a trained health researcher will be present in the room to take notes. We will only observe your office visit with your doctor and the office staff. We will not observe your treatment in the examining room. We would also like to ask you questions on a questionnaire after each visit. At no time will our study interfere with your treatment.
Although we could study this question by just interviewing your doctor and the office staff, we feel that speaking with patients is the best way to find out if they are receiving good medical treatment.
We do not anticipate the study will present any medical or social risk to you other than the inconvenience of the extra time required for you to answer the questionnaire.
While there may be no immediate benefit to you, we anticipate that the results of this study will help health professionals improve communication with patients.
The information we gather through observation or that you give us in the questionnaire will be recorded in anonymous form. We will not release information on you to your doctor or to anyone else in a way that could identify you.
If you want to withdraw from the study at any time, you may do so without penalty. The information collected on you up to that point would be destroyed.
Once the study is completed, we would be glad to give you the results. In the meantime, if you have any questions, please ask us or contact:
Dr. John Doe
Department of Sociology
University of Wisconsin-Stevens Point
Stevens Point, WI 54481 (715) 346-xxxx
If you have any complaints about your treatment as participant in this study, please call or write:
Dr. Debbie Palmer, Chair
Institutional Review Board for the Protection of Human Subjects
Department of Psychology
Science Building, D240
University of Wisconsin-Stevens Point
Stevens Point, WI 54481
(715) 346-3953
Although Dr. Palmer will ask your name, all complaints are kept in confidence.
I have received a complete explanation of the study and agree to participate.
Name______Date ______
(Signature of subject)
Print Name ______
This research project has been approved by the UWSP Institutional Review Board for the Protection of Human Subjects.
SAMPLE C – CONSENT FORM
(This is an example of a consent form used when data will be collected in an anonymous survey and no signed form is necessary)
Informed Consent to Participate in Human Subject Research
Dr. Jane Doe and Dr. John Doe, both professors of Education at the University of Wisconsin-Stevens Point would appreciate your participation in a research study designed to determine what kinds of communication is used between students and teachers. You are being asked to complete an anonymous survey that should take up no more than 15 minutes of your time.
While this information could be obtained by interviewing you, we feel that the survey is the quickest and easiest method for obtaining this information.
We anticipate no risk to you as a result of your participation in this study other than the inconvenience of the time to complete the survey. You could, however, experience some discomfort if you have had an uncomfortable interaction with a teacher and your completing the survey causes you to remember this.
While there may be no immediate benefit to you as a result of your participation in this study, it is hoped that we may gain valuable information about interpersonal communication when relationships end that will be of future value to society.
The information that you give us on the questionnaire will be recorded in anonymous form. We will not release information that could identify you. All completed surveys will be kept in a locked file cabinet in the office of Dr. Jane Doe and will not be available to anyone not directly involved in this study.
If you want to withdraw from the study at any time, you may do so without penalty. The information collected on you up to that point would be destroyed.
Once the study is completed, we would be glad to give you the results. In the meantime, if you have any questions, please ask us or contact:
Dr. Jane Doe or Dr. John Doe
School of Education
University of Wisconsin-Stevens Point
Stevens Point, WI 54481 (715) 346-xxxx
If you have any complaints about your treatment as participant in this study, please call or write:
Dr. Debbie Palmer, Chair
Institutional Review Board for the Protection of Human Subjects
Department of Psychology
Science Building, D240
University of Wisconsin-Stevens Point
Stevens Point, WI 54481
(715) 346-3953
Although Dr. Palmer will ask your name, all complaints are kept in confidence.
Your completion and submission of the survey to the researchers represents your consent to serve as a subject in this research.
This research project has been approved by the UWSP Institutional Review Board for the Protection of Human Subjects.