UNIVERSITY OF PENNSYLVANIA  OFFICE OF REGULATORY AFFAIRS
3624 Market Street, Suite 301 S, Philadelphia, PA 19104-6006
Protocol #:
INFORMED CONSENT WORKSHEET
Is Element Addressed?
No
Waived
Yes
Provide Provide
comme comme
nt
nt
Elements
Comments
Required Elements
Study design. Statement that the study involves research,
an explanation of the purpose of the research, expected
duration of the subject's participation, a description of the
procedures followed, and identification of any procedure that
is experimental, information about prior, similar, or related
studies.
Risks. Description of reasonably foreseeable risks and
discomforts.
Benefits. Description of benefits to the subject or others.
Alternatives. Disclosure of appropriate alternative
procedures or courses of treatment, if any, which may be
advantageous to the subject.
Confidentiality. A statement describing the extent to which
confidentiality of records identifying the subject will be
maintained. For investigational drug or device studies, a
statement that FDA may review the records.
Compensation. For research involving more than minimal
risk, a statement that compensation will be provided for
injury proximate to enrollment in the study.
NOTE:
• Include an explanation as to whether or not compensation
was available if injury occurred.
• If compensation is available when injury occurred, an
explanation as to what it consisted of or where further
information might be obtained.
Contact. Whom to contact with questions about the
research, and subjects’ rights and whom to contact in the
event of a research-related injury including name or office
and telephone numbers.
Voluntary. A statement that participation is voluntary,
refusal to participate will involve no penalty or loss of
benefits, the subject may withdraw at any time without
penalty or loss of benefits.
Additional Elements
YES
NO
Waived Comment
N/A If Waived, NO or N/A
Unforeseeable risks. A statement that the treatment or
procedure may cause risks to the subject (or embryo or
fetus) which are currently unforeseeable.
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Informed Consent Checklist
Version: 8 May 2008
UNIVERSITY OF PENNSYLVANIA  OFFICE OF REGULATORY AFFAIRS
3624 Market Street, Suite 301 S, Philadelphia, PA 19104-6006
NOTE: Include this statement if the research involves
investigational drugs or devices or the risk profile is not well
known. Include if the research involves women and the risk
profile is not well known.
Termination. Anticipated circumstances under which the
subject's participation may be terminated by the investigator.
NOTE: Include if the investigator may terminate the subject’s
participation without regard for the subject’s consent. Include
the circumstances under which termination could occur.
Additional costs. Additional costs to the subject that may
result from participation in the research.
NOTE: Include if the subject may incur any additional costs.
Disclose the additional costs to the subject.
Voluntary withdrawal. The consequences of a subject's
decision to withdraw and procedures for orderly end of
subject's participation.
NOTE: Include if there are any potential adverse
consequences of withdrawal (physical, social, economic,
legal, or psychological). Disclose the potential
consequences. Include any procedures the subject should
follow to prevent harm.
New findings. A statement that significant new findings
developed during the course of research which may relate to
the subject’s willingness to continue participation will be
provided.
NOTE: Include if the research will take place over a span of
time in which significant new findings could occur that could
alter a subject’s willingness to continue in the study.
Number of subjects. The approximate number of subjects
involved in the study.
NOTE: Include if the number of subjects participating locally
or on total might be important in the prospective subjects’
decision making processes. For example, clinical trials
where there is little or no experience in humans or the
numbers are very large and the safety profile may be better
understood.
Documentation of Informed Consent
Informed consent must be documented in writing and signed
and dated by the subject unless waived under HHS 45 CFR
46.117. Documentation may not be waived for FDA
regulated research except under 21 CFR 50.23
Exculpatory Language
No informed consent, written or oral, may include
exculpatory language through which the subject or
representative waives or appears to waive any legal rights,
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Informed Consent Checklist
Version: 8 May 2008
UNIVERSITY OF PENNSYLVANIA  OFFICE OF REGULATORY AFFAIRS
3624 Market Street, Suite 301 S, Philadelphia, PA 19104-6006
or releases or appears to release the investigator, sponsor,
institution, or its agents from liability for negligence.
Conflicts of Interest Disclosure
Include a disclosure of conflicts of interest involving
Investigator and others engaged in research, if any.
Payment for Participation
Describe payment for participation and disbursement
schedule. Where there is none, so state.
Reporting Requirements
Include statements regarding reporting requirements in
accordance with PA law, for example, child abuse,
communicable diseases. See Guidance on PA Law.
HIPAA Authorization, if required, either within the
informed consent document on in a stand alone
Authorization For.
List of PHI collected as part of the study
Who may use disclose the information
Who may receive the information
Duration of authorization or no expiration
Right to revoke authorization
Reference to Notice of Privacy Practices
Information disclosed outside covered entity
may not be protected
Page 3 of 3
Informed Consent Checklist
Version: 8 May 2008