UMASS BOSTON INSTITUTIONAL REVIEW BOARD
GENERIC CONSENT FORM
Please Note: There are many different ways to construct a consent document.
Investigators are encouraged to create a form that best fits the context, population, and
other parameters of the proposed study. Investigators should construct forms that
participants can easily understand in terms of language, tone, grammar and content.
With the exception of the certification at the end of the form, consent forms should be
written in second person (If you agree to participate in the study, this is what you are
asked to do:). It is necessary to include each of the required elements of informed
consent, they are identified in bold face in each section of this form.
In the case of participants who are minors or are otherwise incapable of giving
informed consent (e.g., severe cognitive disability) the consent process should be
conducted with a parent, guardian, or legal representative. Additionally, the researcher
will need to gain assent from the study participants.
University of Massachusetts Boston
Department of _______________
100 Morrissey Boulevard
Boston, MA. 02125-3393
Consent Form For [Title of Research Project]
Principal Investgator:
Introduction and Contact Information
You are asked to take part in a research project that______ (briefly state what is being
studied). The researcher is _______(name, title, dept.). Please read this form and feel
free to ask questions. If you have further questions later,_______(name), will discuss
them with you. His/her telephone number is ______.
Required Element:
A statement that the study involves research.
This section should provide a general statement about the research and a brief
introduction to the investigators (name, title, dept. Students must include the name and
phone number of the academic advisor)
Description of the Project:
This study_________ (state the purpose of the research). Participation in this study will
take ______(state the duration of participation). If you decide to participant in this
study, you will be asked to ______(state or list specific study procedures.)
Required Elements:
An explanation of the purpose of the research, duration of participant participation and
the procedures to be followed.
Please note, any incentives (financial or others) offered to participants should be included
in the discussion of the research procedures.
Risks or Discomforts:
The primary risk associated with this study is the emergence of negative or distressful
feelings in completing the research materials. You may speak with______ (name of the
researcher, if applicable) to discuss any distress or other issues related to study
participation. If you wish to discuss concerns with ___________(other resources such as
counselor), you are encouraged to contact _________(provide phone number, address,
etc.)
Required Element:
An explanation of any risks or discomforts that might reasonably be expected to occur.
Risks or discomforts may be physical, psychological, and/or social, etc. Please note,
because all research involves some element of risk, it is not acceptable to state that
research has no risk. If you believe that the research risk is no greater than the risk
ordinarily encountered in daily life or in the performance or routine examinations or
activities, then it is appropriate to state that the research is of “minimal risk”(see 45 CFR
46.102(i)).
If you anticipate that participants may experience discomfort or distress that is greater
than minimal risk, they should be informed of this possibility. Participants should also be
informed of resources that are available to assist them.
Confidentiality and Anonymity:
Your part in this research is confidential. That is, the information gathered for this
project will not be published or presented in a way that would allow anyone to identify
you. Information gathered for this project will be stored in a locked file cabinet and only
the research team will have access to the data.
This study is designed to be anonymous. That is, the information collected will not
include information that specifically identifies you such as your name or telephone
number. After you return the research materials, there will be no way of linking your
identity to the data collected.
Required Element:
A statement should be included describing the extent to which confidentiality (i.e., the
procedures used to not disclose identifying information and to protect the identity of
participants in non-anonymous studies) of data will be maintained. If personal
identifying information will be destroyed during the course of the research or at its
conclusion, state when the link between identifying information and participant data will
be destroyed.
When appropriate, data collection should be anonymous (no attempt is made to link
identifying information such as names, addresses, social security number to the study
data). Studies cannot be both anonymous and confidential. Please make sure that you
use the correct term to describe your study (see the following examples).
Voluntary Participation:
The decision whether or not to take part in this research study is voluntary. If you do
decide to take part in this study, you may terminate participation at any time without
consequence. If you wish to terminate participation, you should ______ (state the
procedure for terminating participation such as directly telling or phoning the
investigator). Whatever you decide will in no way______ (penalize you, affect your
grade, status as a student/resident/patient, etc.)
Required Elements:
A statement that participation in the research is voluntary and that refusal to participate
or withdrawing from participation will involve no penalty or loss of benefits to which
the participant is otherwise entitled.
Rights:
Required Elements:
An explanation of whom to contact for answers pertinent to questions about the research
and research participants’ rights, and who to contact in the event of a research related
injury to the subject
You have the right to ask questions about this research before you sign this form and at
any time during the study. You can reach ________ (name of the investigator and contact
information and for students the name and contact information for the research advisor).
If you have any questions or concerns about your rights as a research participant, please
contact a representative of the Institutional Review Board (IRB), at the University of
Massachusetts, Boston, which oversees research involving human participants. The
Institutional Review Board may be reached at the following address: IRB,, Quinn
Administration Building-2-080, University of Massachusetts Boston, 100 Morrissey
Boulevard, Boston, MA 02125-3393. You can also contact the Board by telephone or e-
mail at (617) 287-5370 or at human.subjects@umb.edu.
Signatures
Required Element:
Space for signature and date of participant or participant's legally authorized
representative.
I HAVE READ THE CONSENT FORM. MY QUESTIONS HAVE BEEN ANSWERED.
MY SIGNATURE ON THIS FORM INDICATES THAT I CONSENT TO PARTICIPATE
IN THIS STUDY. (add when appropriate and necessary: I ALSO CERTIFY THAT I AM
18 YEARS OF AGE OR OLDER.)
_________________________________ ___________
Signature of Participant Date
Signature of Researcher Date
__________________________________
Typed/Printed Name of Participant
_________________________________
Typed/Printed Name of Researcher
Note, when applicable, the consent form should also include the following required
elements of informed consent:
In studies involving greater than minimal risk to participants, a statement regarding
whether compensation or medical treatments are available if research related injury
occurs and how to obtain relevant information.
When applicable, participants should be informed of any direct benefits that will result
from study participation.
Please note that payment or receipt of any type of token or incentive is not a benefit of
study participation. Incentives for research participant should be included in discussion
of the research procedures. Benefits include anticipated positive outcomes associated
with the research (e.g., receipt of a particular service such as psychotherapy or a medical
examination at no cost, etc.) If there are no direct benefits to participants, you may omit
this section in the consent form.
UMASS BOSTON INSTITUTIONAL REVIEW BOARD
GENERIC TAPE CONSENT FORM
Instructions: You should modify this form to fit the parameters of your study. Keep in
mind that participants must give permission for each type of usage. In addition,
participants must be given the option of erasing the tape upon conclusion of the
interview, task, etc. Permission should also be time-bound and specify an expiration date
whereby the tape will be destroyed. You may combine consent for taping with the study
consent form, however, it must be clear that participants are consenting to 1) the research
and 2) taping procedures.
CONSENT TO AUDIO- OR VIDEOTAPING & TRANSCRIPTION
STUDY NAME
RESEARCHER’S NAME & AFFILIATION
This study involves the audio taping (videotaping) of your interview with the researcher.
Neither your name nor any other identifying information will be associated with the
audiotape (videotape) or the transcript. Only the researcher team will be able to listen
(view) to the tapes.
The tapes will be transcribed by the researcher and erased once the transcriptions are
checked for accuracy. Transcripts of your interview may be reproduced in whole or in
part for use in presentations or written products that result from this study. Neither your
name nor any other identifying information (such as your voice or picture) will be used in
presentations or in written products resulting from the study.
Immediately following the interview, you will be given the opportunity to have the tape
erased if you wish to withdraw your consent to taping or participation in this study.
By signing this form you are consenting to (INCLUDE ONLY THOSE OPTIONS THAT
ARE BEING USED):
having your interview taped;
to having the tape transcribed;
use of the written transcript in presentations and written products.
By checking the box in front of each item, you are consenting to participate in that procedure.
This consent for taping is effective until the following date: _________________. On or
before that date, the tapes will be destroyed.
Participant's Signature ___________________________________________
Date___________
Updated 11/26/2007