I. General Requirements.
No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear 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.
A. Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
1. A statement that the study involves research, an explanation of the purpose(s) of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that 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, if any, 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 is provided 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 subjects' rights, and whom to contact m 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 to receive for participation up to the point of their termination.
B. Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subjects' consent.
3. Any additional costs to the subject that may result from participation in the research.
4. The consequences of the subject's decision to withdraw from the research, and procedures for orderly termination of participation by the subject.
5. A statement that significant new findings developed during the course of the research which may relate to the subjects' willingness to continue participation will be provided to the subject.
6. The approximate number of subjects involved in the study.
C. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
1.The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the waiver or alteration;
3. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
D. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
1. The researcher demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
(i) programs under the Social Security Act, or other public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs; and
2. The research could not practicably be carried out without the waiver or alteration.
E. The informed consent requirements in these regulations are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
F. Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
II. Documentation of Informed Consent.
A. Except as provided in paragraph C of this section (below), informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
B. Except as provided in paragraph C of this section (below), the consent form may be either of the following:
1. A written consent document that embodies the elements of informed consent required by the Code of Federal Regulations. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
2. A “short form" written consent document stating that the elements of informed consent required by the Code of Federal Regulations have been presented orally to the subject or representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall signa copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the "short form."
C. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In documentation where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. Please see the following sample consent forms. Each contains the basic required elements for informed consent.
General Template for Informed Consent The template should be modified as needed to fit the specifics of the study.
Title of Study
You are invited to be in a research study on . . . You were selected as a possible participant because of . . . Please read this form and ask any questions you may have before agreeing to be in the study. Please understand that when researchers involve people in their research, we are required to tell you what your rights are as "a subject in a research study," as well as what will be done with the information collected and whether your name will appear anywhere, any potential risks involved from such participation, and who you can contact with your questions and any complaints. We must also document that we have provided you with this information before you decide whether or not you choose to participate.
This study is being conducted by Name, Affiliation as part of . . .
The purpose of this study is to . . .
If you agree to be in this study, I will ask you to do the following: . . . . Participation will take [indicate the amount of time, or range of times.]
Explanation of the method of insuring anonymity/confidentiality. Conditions under which identifiable data might be shared.
Describe the benefits to the participant and/or society to being in the study.
Describe the risks to the participant of being in the study. Indicate the methods for reducing those risks.
Indicate the participant's right to decline to be in the study, and the consequences of declining to participate. Indicate the participant's right to withdraw from the study after beginning it, and the consequences of withdrawing.
Provide contact information for questions and complaints. (Provide the name and contact information for the researcher, the advisor for student research, and the IRB Coordinator.
A copy of this form is provided for your use.
Statement of consent by the participant (see samples below) and possibly, signature.
This template is adapted from the University of Minnesota form.
Subject Consent Form Sample #1 for Participation of Human Subjects In Research
Project Title: Social Influence in Group Decisions
Researcher: Jane A. Doe, Dept. of Psychology, 1234 CSH, UW-SUPERIOR, (715) 394-xxxx
Description: The purpose of this experiment is to examine the social interaction patterns that develop within the small groups. If you volunteer for this research study, you will be asked to participate in a series of group discussions and decisions. Groups will vary from 3 to 9 persons and the topics discussed will relate to issues of common concern to young adults and college students. All other subjects in the study will be fellow students completing the research requirement for their psychology course. The topics are neither embarrassing nor intended to be upsetting. You will first be asked to complete a questionnaire and then will discuss one to six of the topics related to items on the questionnaire with other group members. You may be asked to attempt to reach total agreement among group members on the topics. A second response will then be requested to each question discussed. The total time for your participation will be one hour.
The results of each individual's participation will be strictly confidential. The results of your participation will be recorded by group only. No names or individual identifying information will be maintained. With the exception of the researchers involved in running this study, nobody will be allowed to see or discuss any of the individual responses. Your responses will be combined with many others and reported in group form in a professional journal article.
The risks to you are minimal though you may encounter other individuals attempting to change your mind on some issues during the group discussions. Though all subjects will be asked to keep their comments constructive, theresearchers are trained to step in to protect individuals from hostile or inappropriate comments made during discussions. The discussions will be discontinued if any of the group members cannot refrain from inappropriate remarks to others.
The overall nature of the study will be explained as soon as you have completed your session. A summary report and explanation of the results will be made available to you when the study is completed if you so request.
Authorization: I have read the above and understand the nature of this study and agree to participate. I understand that by agreeing to participate in this study I have not waived any legal or human rights. I also understand that I have the right to refuse to participate and that my right to withdraw from participation at any time during the study will be respected with no coercion or prejudice.
If you have any concerns about your treatment as a subject in this study, please call or write:
This research project has been approved by the UW-Superior Institutional Review Board for the Protection of Human Subjects, protocol #_______
Subject signature Date
*Subjects should be given a copy of this form for their records.
(Sample Informed Consent #2)*
The purpose of this experiment is to study how people remember lists of items. The results are intended to provide insights into memory processes.
You will be shown some lists of words one word at a time. After a given list has been presented, you will be asked to write down as many of those words as you can remember.
3. Time required:
Your participation will involve one session lasting approximately 45 minutes.
It is not anticipated that this study will present any risk to you other than the inconvenience of the time taken to participate.
5.Your rights as a subject:
(i) The information gathered will be recorded in anonymous form. Data or summarized results will not be released in any way that could identify you.
(ii)If you want to withdraw from the study at any time, you may do so without penalty. The information collected from you up to that point would be destroyed if you so desire.
(iii) At the end of the session, you have the right to a complete explanation ("debriefing') of what this experiment was all about. if you have questions afterward, please ask your experimenter or contact:
Dr. John Doe (or faculty sponsor's name, for students)
Dept of Psychology, UW-SUPERIOR, (715) 394- xxxx
Also, once the study is completed, you may request a summary of the results.
6. If you have any concerns about your treatment as a subject in this study, please call or write:
This research project has been approved by the UW-Superior Institutional Review Board for the Protection of Human Subjects, protocol # _______
I have read the above information and willingly consent to participate in this experiment.
Signed: ___________________ Date: ______________
*Subjects should be given a copy of this form for their records.
Subject Consent Form Sample #3 for Participation of Human Subjects in Research
PLEASE DO NOT PUT YOUR NAME ANYWHERE ON THIS SURVEY. There is no need to identify yourself.
You are being asked to complete this survey to help researchers better understand some of the behaviors and attitudes of college students in the Midwest. Many of the questions ask about your plans and activities with respect to career and family. Thus, for some respondents these may be current activities and for others they may require either a look into the past or into the future. Please be as honest with us as possible and answer all questions to the best of your knowledge. You should be able to complete the questionnaire in about 25 minutes.
Once the study is completed, a summary of the results will be made available through the Sociology Department office.
Your participation in this survey is entirely voluntary. By completing this survey you are giving your consent to be involved in the research. If at any point you decide that you do not want to complete the questionnaire, please return it and inform the administrator. Your course grades will not be affected if youdecide not to participate.
Please feel free to ask any questions you may have of the person who is giving you this survey, especially if there is a word or phrase you do not understand. Feel free to write in the margins if you feel you need room to express or explain an answer.
Thank you for your cooperation and the time that you have put into the project.
If you should have concerns about your treatment as a subject in this study, please call or write:
This research project has been approved by the UW-Superior Institutional Review Board for the Protection of Human Subjects, protocol #______
Again, please do not put your name anywhere on this survey.
Dr. Jane Doe, (715) 394-xxxx
*Appropriate for questionnaire/survey research, where data are recorded in an anonymous fashion, that does not address sensitive or illegal behaviors, and whose subjects are at least 18 years of age.
Subjects should be given this form for their records.