Informed Consent Agreement for Participation in a Research Study
Investigator:
Contact Information:
Title of Research Study:
Sponsor:
Introduction (recommended)
You are being asked to participate in a research study. Before you agree, however, you
must be fully informed about the purpose of the study, the procedures to be followed, and
any benefits, risks or discomfort that you may experience as a result of your participation.
This form presents information about the study so that you may make a fully informed
decision regarding your participation.
Purpose of the study: (In a few sentences, describe the overall purpose of the study. For
this section, and all sections of the consent form, use simple, plain English. This section
is required.)
Procedures to be followed: (Here describe the research procedures to be followed,
including duration of the subject’s participation. Experimental procedures must be
identified. This section is required.)
Risks to study participants: (Describe any reasonably foreseeable risks or discomfort to
the subject. This section is required.)
Benefits to research participants and others: (Here describe benefits, if any, to the
subject or to others which may reasonably be expected from the research. Do not list
compensation, if any, as a benefit. If there are no benefits to the subject, indicate that
there are none. This section is required.)
Alternative procedures or treatments available to potential research participants:
(Here list any appropriate alternative procedures or courses of treatment that might be
advantageous to the subject. If none are known, omit this section.)
Record keeping and confidentiality: (Describe record keeping procedures, including
who will have access to records, whether and how confidentiality will be maintained, and
what information is expected to be reported. Include the following statement, “Records
of your participation in this study will be held confidential so far as permitted by law.
However, the study investigators, the sponsor or it’s designee and, under certain
circumstances, the Worcester Polytechnic Institute Institutional Review Board (WPI IRB)
will be able to inspect and have access to confidential data that identify you by name.
Any publication or presentation of the data will not identify you.” This section is
required.)