IRB Informed Consent Form
01.18.2019
Page 1 of 4
INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES
Whom to Contact about this study:
Principal Investigator:
Department:
Contact Information:
Invitation to be part of a research project:
Background Information:
Important Information:
Title of Project
Principal Investigator's Name
Department
Telephone number and/or email address
You are invited to participate in a research study investigating (state what is being studied). This study is being
conducted by (xxxxxx, a/an (graduate/undergraduate) student(s) at South Piedmont Community College under
the supervision of xxxxxxx, a faculty member in the Department of xxxxxx). You were selected as a possible
participant in this research because (state how and why the subject was selected). Please read this form and ask
questions before you agree to be in the study.
The purpose of this study is to (provide a general statement about what the study is designed to discover or
establish). Approximately (xx) people are expected to participate in this research.
*The purpose of this study is to [provide more information about study purposes]. If you choose to participate,
you will be asked to [do what, when, where, and how]. This will take approximately [period of time/number of
visits].
*Risks or discomforts from this study include [briefly describe].
*Benefits of this study include [briefly describe].
*There are alternative procedures or courses of treatment including [describe or remove if not applicable].
*Taking part in this research project is voluntary. You do not have to participate and you can stop at any time.
IRB Informed Consent Form
01.18.2019
Page 2 of 4
Procedures:
Risks and Benefits of being in the study:
The study has several (or use the word minimal, if that is the case for your study) risks. First, ____________
second, _____________ (Risks must be explained, including the likelihood of the risk. Describe discomforts
and inconveniences the subjects may reasonably expect. If the subjects will be told of significant physical or
psychological risks to participation, they also must be told under what conditions the researcher will terminate
the study.)
The benefits to participation are (State benefits. If there are no direct benefits to the subjects, state "There are
no direct benefits to you for participating in this research."). (If applicable, describe appropriate alternative
procedures that might be to the subject's advantage, if any. Any standard treatment that is being withheld must
be disclosed.)
Compensation:
If you participate, you will receive (Include payment or reimbursement information here. Explain when
disbursement will occur and conditions of payment. Delete this section if it is not applicable).
Additional Information:
Biospecimens may be used for commercial profit and individuals participating in this research project [will/will
not] share in this commercial profit.
Clinically-relevant results, including individual research results, [will/will not] be shared with individuals
participating in this research project [describe how].
IRB Informed Consent Form
01.18.2019
Page 3 of 4
Confidentiality:
Voluntary nature of the study:
Any information obtained in connection with this research study that can identify you will be disclosed only
with your permission; your results will be kept confidential. In any written reports or publications, no one will
be identified or identifiable and only group data will be presented. (If it applies to your study, include ways in
which you will maintain confidentiality, e.g “No one in the daycare center will know your child’s results.” If
you release information to anyone for any reason, you must state the persons or agencies to whom the
information will be furnished, the nature of the information to be furnished, and the purpose of the disclosure.)
Research results will be secured and only the research team will have access to this data during the project.
Data analysis will be completed by (specify the ending date of your research). All original reports and
identifying information that can be linked back to you will be destroyed at the conclusion of this research
project and will not be used for any subsequent research studies. (If tape or video recordings are made, explain
who will have access to them, if they will be presented to others for educational purposes, and when they will
be erased or destroyed.)
Participation in this research study is voluntary. Your decision whether or not to participate will not affect your
current or future relations with (the name of any other cooperating institution or) SPCC in any way. If you
decide to participate, you are free to stop at any time without affecting these relationships. (Explain here if
monetary benefits will be adjusted if the subject withdraws early).
New Information:
If during the course of this research study the researcher(s) learns about new findings that might influence your
willingness to continue participating in the study, the researcher(s) will inform you of these findings. (This
section is optional. Consult your advisor to decide if it applies to your study).
IRB Informed Consent Form
01.18.2019
Page 4 of 4
Contacts and questions:
You may keep a copy of this form for your records.
Statement of Consent:
You are making a decision whether or not to participate. Your signature indicates that you have read this
information and your questions have been answered. Even after signing this form, please know that you may
withdraw from the study at any time.
_______________________________________________________________________________________
Par
ticipant Name
_______________________________________________________________________________________
Signature of Participant (Must be 18 years old to sign) Date
_______________________________________________________________________________________
Sig
nature of Researcher Date
If you have any questions, please feel free to contact me, xxxxx, (or one of the researcher’s xxxxx xxxxx at
xxx-xxx-xxxx or xxxxx xxxxx) at xxx-xxx-xxxx. You may ask questions now, or if you have any additional
questions later, we will be happy to answer them. If you have other questions or concerns regarding the study
and would like to talk to someone other than the researcher(s), you may also contact the SPCC Institutional
Review Board at IRB@spcc.edu.
I consent to participate in the study. (If you are video- or audio-taping your subjects, include a statement such
as "and I agree to be videotaped.")