Informed consent is an agreement between the investigators and the research
participants. A signed informed consent form notifies potential research
participants of their obligations and rights, and lets them know in advance
what they are agreeing to do as a participant in a particular research
study. Informed consent ensures that participants know that their participation
is voluntary and notifies participants that they may withdraw from the
study at any time. Participants also have a right to know how their personal
information will be protected, secured and destroyed. Take the CITI
ethics tutorial titled "Informed Consent" for more information
on informed consent procedures.
All participants in a study should sign a copy of the Informed Consent
Form (IFC). The investigator should retain all signed copies of the IFC,
as well as provide a copy for each participant to keep. Study participants
are given a copy of the consent to be used as a reference document to reinforce
their understanding of the study and to provide contact information should
any questions or concerns about the study arise in the future.
Special Considerations for Vulnerable Populations
- Minor Participants: The use of minors as participants
requires consent by a parent or legal guardian as well as assent by the
- Illiterate or Mentally Impaired Participants: Human
participants considered mentally incapable of consenting or incapable
of reading an informed consent form
- Participation of persons considered mentally incapable of consenting
on their own require consent by a court-appointed guardian.
- Illiterate persons may have the consent form read to them and "make
their mark." There are regulations that require a signature of a
witness to the consent process and signature of the person conducting
the consent interview.
- Investigators should not enroll participants who may not truly
understand what they have agreed to do.
Language Interpretation Issues
- The Informed Consent Form should be in the primary language of the
research participant, or at least in a language in which the participant
is considered fluent.
- The investigator should submit a translated consent form for HSRB review
along with a certification from the translator that the English and non-English
versions are the same.
- While a translator may be used to facilitate conversation with the
participant, routine ad hoc translation of the consent document may not
be substituted for a written translation.
Checklist for Informed Consent Forms
Code (46.116) specifies the requirements for IFC. We have
provided a brief checklist that is sufficient for some projects. Please
check the Federal code if your project involves risk, vulnerable populations,
or complex interventions.
- Specify the purpose of the study and the duration of the subject's
participation, describe the activities in which the participant will
be engaged, and identify any procedures that are experimental.
- State whether data will be collected from the participants anonymously
and whether those data will be held in confidence.
- Explain how or when participants will be photographed or videotaped.
A separate consent signature should be obtained for this. In addition,
participants have the right to know how this data will be handled so
as to protect their confidentiality and anonymity.
- Advise participants that they are free to refuse to participate and
free to withdraw from the study at any time without penalty or loss of
- Describe any reasonably forseeable risks or discomforts the participant
- For studies that involve greater than minimal risk, explain whether
any medical treatments are available if injury occurs and if so, what
they consist of, or where further information may be obtained. Explain
whether any compensation or incentives are provided for research participation.
- Describe any benefits to the participant or to others which may be
reasonably expected from the research.
- Tell participants who to contact for answers to questions about the
research, about their rights as participants, and about any research-related
stress or injuries.
- Include the principle investigator's contact information.
- Indicate that participants will receive a copy of the consent form.
- State that the study has been "approved by the Hope College Human Subjects
Review Board" and that the participants may contact the HSRB chair if
necessary and provide contact information.
- Include a signature line for the research participant, legal guardian,