Informed Consent Template- (at least) 12-point font
Delete all bolded instructions from actual consent
INFORMED CONSENT DOCUMENT
Providence College
Insert Title of Study
The document below is a model for an adult consent form. It is written at a 12th grade level and the
words would need to be altered for some potential participants. If you are intending to obtain assent
(required in addition to parental consent for youth aged 7 – 17) you can choose from among the
following alternatives:
a. Use this form, simplified enough that it can be used by both parents and children and
request both to sign.
b. Develop a separate written child assent form, allowing for child signatures, in addition to
obtaining parental permission (it may be preferable to allow the child an opportunity to
ask questions or decline participation without the parent/guardian present).
When drafting a written assent form, you should create a simplified version of the adult informed
consent document including all of the sections indicated here, and appropriate for the reading level
of the subjects. The IRB can provide a sample assent form upon request. For children under age 7,
describe the verbal assent procedure on page 3 of the Application.
You are being asked to participate in a research study about [insert general statement about study].
You were selected as a possible participant because [explain how subject was identified]. Please read
this form and ask any questions that you may have before agreeing to participate in the research.
Researchers from Providence College are conducting this study.
Background Information
The purpose of this research is [explain research question and purpose in lay language. The purpose
statement need not reveal the researcher’s hypothesis, and may be stated in general terms to avoid
demand characteristics. The purpose statement must not be false or misleading.]
If the investigators have a financial interest in the research or its outcomes, please add to this
section the following: Please note that the responsible investigator and/or other members of the research
team have a significant financial interest in [choose one: the sponsor of this research OR the
product/service being investigated in this study].
Procedures
If you agree to be a participant in this research, we would ask you to do the following things:
[describe the procedures to be followed (including audio/video taping); indicate expected frequency
and duration of the subject’s participation; identify any procedures that may cause distress or
discomfort]
Risks and Benefits to Being in the Study
This research has the following risks: First, [explain first risk, including the likelihood of the risk].
Second, [explain second risk, including the likelihood of the risk]. Third, …
If there are no foreseeable risks, state as such
If there are significant physical or psychological risks to participation, the participants should be
told the conditions that would warrant termination of the study. If there are potential emotional or
psychological risks, researchers should be prepared to offer a referral or a specific resource for
assistance to the participant.
The benefits of participation are [explain any direct benefits of participation that will be gained by the
participants. Benefits to others are important but are secondary to direct benefits. (Note: monetary
compensation is not considered a benefit.) If there are no benefits, state as such.]
Compensation
You will receive the following payment/reimbursement: [explain amount of payment or other
reimbursement information (e.g., class credits, tokens, etc.), as well as when payment and/or
reimbursement will occur. If there is no reimbursement, please delete this section.]
Costs
[Identify any monetary expenses that participants will incur as a result of participation in your
project. If there are no costs, please delete this section.]
Confidentiality
The records of this research will be kept private. In any sort of report we might publish, we will not
include any information that will make it possible to identify a participant. Research records will be kept
in a locked file, and access will be limited to the researchers, the college review board responsible for
protecting human participants, regulatory agencies, and [add only if applicable] sponsors and funding
agencies. The original data will be destroyed within [choose a time frame, usually within three to five
years after the study has been completed.]
[If tape or video recordings are made, explain who will have access to them, and when they will be
erased/destroyed.]
Voluntary Nature of the Study
Your participation is voluntary. If you choose not to participate, it will not affect your current or future
relations with the College [or with other cooperating institutions (insert names)]. There is no penalty
or loss of benefits for not participating or for discontinuing your participation.
[Explain any consequences (e.g., adjusted monetary benefits or loss of course credit) due to early
withdrawal. Explain how such withdrawal will be pro-rated (e.g., half of the money or extra credit
if discontinue participation half-way through).]
Contacts and Questions
The researchers conducting this study are [Responsible Investigator] and [Co-Investigator(s)]. You
may ask any questions you have now. If you have any questions later, you may contact them at [contact
information].
If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s)
about (1) concerns regarding this study, (2) research participant rights, (3) research-related injuries, or (4)
other human subjects issues, please contact the Chair of the Providence College Institutional Review
Board (IRB). Contact information for the IRB Chair can be obtained from the Office of Academic Affairs
(Provost), Harkins 208, (401) 865-2195 or irb@providence.edu.
You will be given a copy of this form for your records.
Statement of Consent
I have read the above information. I have received answers to the questions I have asked. I consent to
participate in this research. I am at least 18 years of age.
[Note to Researcher: If this form is used as a parental permission and assent form (usually
appropriate for teenage subjects), please omit “I am at least 18 years of age.”]
Print Name of Participant:
Signature of Participant:
Date:
Signature of Parent or Guardian:
[omit if not applicable]
Date:
Signature of Person Obtaining Consent:
Date:
[If you are audio or videotaping, please include a separate indication of permission for that. For
example:
Audio/Videotape Agreement
We are planning to audio/video-record you during this study. You have the right to refuse to be recorded.
If you do so, there is no penalty and you will still be able to participate.
_____ I give permission to be audio/videotaped (please answer next question).
_____ I do NOT give permission to be videotaped (skip to signature line).
If you gave permission to be audio/videotaped: Your audio/videotape will be erased at the completion of
this study unless you give permission below for it to be kept. If you give permission for your
audio/videotape to be kept, it may be played at professional meetings or for educational purposes. Your
name will never be used, and the audio/videotape will never be used in any other context.
_____ I give permission for my audio/videotape to be kept.
_____ I do NOT give permission for my audio/videotape to be kept.
Signature: _______________________________________Date: _______________ ]