Viterbo University Institutional Review Board ● 900 Viterbo Dr ● La Crosse, WI 54601 ● 608-796-3097
INFORMED CONSENT
Instructions: This template serves as a model to develop an informed consent form for research participants. The template is designed so that you can replace instructions (in blue) with information relevant to your study. Instruction boxes should be deleted before submitting your informed consent form to the IRB and research participants. This is a generic model; some studies may call for additional information not contained in this template. Additional samples of informed consent forms may be found on the IRB website.
TITLE OF PROJECT:
_______________________________________________________________________________________________
NAME OF
INVESTIGATOR(S):
_______________________________________________________________________________________________
PHONE and EMAIL OF PRIMARY INVESTIGATOR:
_______________________________________________________________________________________________
ADVISOR’S NAME for this
PROJECT:
_______________________________________________________________________________________________
ADVISOR’S
EMAIL:
_______________________________________________________________________________________________
Statement of Purpose
This section includes a statement that the study involves research, the research purpose, the expected duration of the subject's participation, a description of the procedures, and identification of any procedures which are experimental.
You are invited to participate in a research study being conducted by (names of investigators) at
Viterbo University. The purpose of this research is to (state the purpose) . We hope to learn (state what the study is designed to discover or establish) . You were selected as a possible participant in this study because (state why and how the participant was selected) .
If you decide to participate, you will be asked to (describe the procedures to be followed) . It may take approximately (amount of time) to participate.
Risks
Describe any foreseeable risks to the participant, such as physical injury, psychological stress, emotional discomfort, or disclosure of sensitive information. You should not state that there are no risks; all studies have risks, even if only time and inconvenience. If more than minimal
risk is present, state the precautions that will be taken to minimize the risk (e.g. a list of counseling services in the area).
Possible Examples:
There is a possibility that you may become uncomfortable answering the questions.
There is the possibility that you may have bruising after the blood draw.
Except for your time and inconvenience, there are no risks to you from participating in this study.
Benefits
Describe any benefits to the participant that may reasonably be expected from the research.
Do not promise benefits that are not yet known.
Possible Examples:
You may benefit by gaining experience and familiarity with the process of conducting research in psychology.
You will have a cholesterol screening at no charge.
While this study will have no direct benefit to you, this research will help us learn more about…
Alternative Procedures (If this section is not applicable then delete the entire section)
Describe any other treatments or procedures that might be available to the participant. If any standard treatments or procedures are being withheld due to participation in the study, they must be disclosed here. This section is not applicable for all studies.
(If applicable, describe other treatments that might be advantageous to the participant, including any standard treatments that are being withheld.)
Confidentiality
Describe the methods that will be used to protect the confidentiality of participants' information. You might explain how names will or will not be used, how data will be coded, and how data will be reported. Identify who will have access to the data. If information will be released to anyone other than the investigators (transcribers, translators, etc.), describe how confidentiality will be maintained. Describe how the data will be stored and ultimately destroyed. Be sure to include the specific location of the data storage. Indicate how long the data will be kept. Standard length of time to keep data is 3 years.
Any information obtained in connection with this study that can be identified with you will remain confidential and will be disclosed only with your permission. Information that carries personally identifying information will be kept in locked files. This consent form, with your signature, will be stored separately from the data collected so that your responses will not be identifiable. In any
written reports or publications, no one will be identified and only group data will be presented. All data will be destroyed after (amount of time: standard amount of time is 3 years) .
Limits of Privacy (This section can be deleted if your research topic is not asking anything that could raise these issues.)
Generally speaking, the researcher can assure you that she/he will keep everything you tell him/her or do for the study private. Yet there are times where the researcher cannot keep things private
(confidential). Faculty, students completing research under faculty mentors, and employees of
Viterbo University are considered mandated reporters and cannot keep certain kinds of information private (confidential) when:
The researcher finds out that a child or vulnerable adult has been abused.
The researcher finds out that that a person plans to hurt him or herself, such as commit suicide.
The researcher finds out that a person plans to hurt someone else.
There are laws that require many professionals to take action if they think a person might harm themselves or another, or if a child or adult is being abused. In addition, there are guidelines that researchers must follow to make sure all people are treated with respect and kept safe. In most states, there is a government agency that must be told if someone is being abused or plans to hurt themselves or another person. Please ask any questions you may have about this issue before agreeing to be in the study. It is important that you do not feel betrayed if it turns out that the researcher cannot keep some things private.
Compensation (Delete section if not applicable)
Describe any compensation being offered to research participants (such as money, course credits, etc.). If there is a possibility of a research-related injury, information as to the medical treatment and compensation available should be included. Indicate how compensation will be handled if the participant withdraws from the study.
(If applicable, describe any compensation being offered to research participants, including medical treatment available if injury occurs. Indicate how compensation will be handled if the participant withdraws from the study.)
Voluntary Participation
This section should include a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits.
Participation in this study is voluntary. Your decision whether or not to participate will not affect your future relations with Viterbo University in any way. If you decide to participate, you are free to stop at any time without penalty or loss of benefits to which you are otherwise entitled.
Whom to Contact for Answers to Questions
Explain whom to contact for answers to pertinent questions about the study and participants’ rights. Explain whom to contact in the event of a research-related injury. If a student is the principal investigator, include the name and contact information for the faculty advisor.
If you have any questions about this study, please contact us at (your contact information) . You may also contact Dr. David Bauer, Chair of Viterbo University’s Institutional Review Board, at djbauer@viterbo.edu
or 608-796-3712 with any concerns about this research.
Signature indicating Informed Consent
Your signature indicates that you are at least 18 years of age, have read and understand the information provided above, and have decided to participate in this study. You will be given a copy of this form to keep.
__________________________________
Signature of Participant
_________________________
Date
__________________________________
Signature of Investigator
_________________________
Date
Audio Video Consent Addendum to Informed Consent
If you plan to use audio or videotaping the following additional material and signature lines must be included on the Informed Consent. If you are not recording this entire section can be deleted.
You have already agreed to participate in a research study entitled: [Insert Study Title ] conducted by [ Insert Principal Investigator ] . We are asking for your permission to allow us to [include optional procedure such as audiotape (sound), videotape (picture), or both audio and videotape] as part of that research study. You do not have to agree to be recorded in order to participate in the main part of the study.
The recording(s) will be used for [include purpose of recording; e.g., sample language may include: analysis by the research team; possible use as a teaching tool to those who are not members of the research staff (i.e. for educational purposes); commercial purposes. If the tapes will be used for commercial purposes, the consent must specifically state whether or not the subject would be compensated for this use.]
The recording(s) will include [indicate whether the subjects name or any other identifier will be recorded. If videotaping will be utilized, indicate the extent to which subject’s identity would
be masked (e.g., Facial features partially blocked out; recording will not include facial pictures; recording will include full facial pictures.)]
The recording(s) will be stored [include measures taken to protect subjects privacy. For example: in a locked file cabinet with no link to subjects’ identity; in a locked file cabinet and linked with a code to subjects’ identity; in a locked file cabinet and labeled with subjects’ name or other identifiable information] and will be [indicate the length of time the recording(s) will be retained, e.g. destroyed upon completion of the study procedures; destroyed upon publication of study results; retained indefinitely.]
Your signature on this form grants the investigator named above permission to record you as described above during participation in the above-referenced study. The investigator will not use the recording(s) for any other reason than that/those stated in the consent form without your written permission.
__________________________________
Signature of Participant
__________________________________
Signature of Investigator
_________________________
Date
_________________________
Date