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Informed Consent Guidelines

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 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 minor.

Illiterate or Mentally Impaired Participants

These are 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

The (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. You may use this  to get started.

1. 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.
2. State whether data will be collected from the participants anonymously and whether those data will be held in confidence.
3. 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.
4. 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 entitled benefits.
5. Describe any reasonably foreseeable risks or discomforts the participant may experience.
6. 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.
7. Describe any benefits to the participant or to others which may be reasonably expected from the research.
8. 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.
9. Include the principle investigator's contact information.
10. Indicate that participants will receive a copy of the consent form.
11. State that the study has been "approved by the ÐÜèÔÚÏßÊÓƵ Human Subjects Review Board" and that the participants may contact the HSRB chair if necessary and provide contact information.
12. Include a signature line for the research participant, legal guardian and/or witness.