Informed consent is a process. A written informed consent documents this process, but cannot serve as a substitute for it. No subject may be involved in research without the legally effective informed consent of the subject or the subject's legally authorized representative. This consent shall be sought under circumstances that provide sufficient opportunities for the subject to freely consider whether or not to participate. If the subject is a minor, written parental consent or legal guardian consent is required, and the investigator must obtain the assent of the child unless the child is incapable of giving assent.
The information given to the subject, or the subject's legally authorized representative, must be in simple, easily understood language. If the subject population is not English-speaking, the informed consent must be presented in whatever language is appropriate. If the person uses an alternative form of communication (e.g. Sign Language), the informed consent process must be designed to enable effective communication in the appropriate mode. (If a potential subject is illiterate, the investigator will be required to use a competent witness to verify voluntary informed consent.)
Written documentation of the consent process (e.g., a cover letter or cover sheet) is always required unless specifically waived by the IRB. The consent document should be signed by the subject or the subject's legally authorized representative unless this requirement is waived by the IRB.
In some types of projects, it may be important for information pertaining to consent to be provided verbally. In such an instance, a written summary (script) of what the potential subject will be told must be provided to the IRB for review and approval. Investigators should explain the rationale for not obtaining written informed consent in order that the IRB may approve such an exception.
No informed consent, whether oral or written, may waive or limit in appearance or in fact, the subject's legal rights, including any release of the institution or its agents from liability or negligence.
The following information must be a part of all written informed consent documents:
- A statement that the project is research and an explanation of the scope, aims and purposes of the research, and the experimental procedures to be followed, including the expected duration of the subject's participation. This statement should include a description of any anticipated benefits the subject or others might reasonably expect.
- Identification of the investigator, faculty sponsor (if relevant), as well as the name of any other sponsoring or funding source supporting the research. IUP should be identified as the responsible institution or as one of the responsible institutions.
- The following statement will be included in ALL written informed consents (including cover letters). It is suggested that this statement be inserted at the bottom margin of the form, letter or portion of the form that is to be retained by the subject.
THIS PROJECT HAS BEEN APPROVED BY THE INDIANA UNIVERSITY OF PENNSYLVANIA INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS (PHONE 724.357.7730). - A description of any reasonable foreseeable risks or discomforts to the subject (including likely results if an experimental treatment should prove ineffective). If the risk potential is currently unknown or unmeasurable, a statement to that effect will be required.
- A statement regarding the availability of compensation, medical treatment, or other services if injury occurs will be required for research which involves more than minimal risk. If compensation or medical treatment will be provided, information about how it may be obtained or where further information may be secured will be required.
- A statement of any new information developed during the course of the research which may relate to the subject's willingness to continued participation will be provided. Related to this, an offer to answer any questions the subject (or the subject's representative) might have regarding the subject's rights shall be included. This statement should include the name, address and/or telephone number of the principal investigator as the contact point if questions or problems should occur.
- A statement describing the method by which confidentiality of records identifying the subject will be maintained.
- A statement that participation is voluntary and that refusal to participate or a subsequent decision to discontinue participation will not result in penalty or loss of benefits to which the subject is otherwise entitled. This statement should include a description of the consequences, if any, that accompany such a decision to withdraw and should explicitly state methods of withdrawal.
- A copy of the informed consent shall be provided to the subject or the subject's legally authorized representative.
Federal law mandates that copies of all informed consents be retained for a minimum of three years after completion of the research. The principal investigator is responsible for the maintenance and retention of such records. If the principal investigator is a student, the faculty sponsor is responsible for the maintenance of these records. If the investigator leaves the institution within this three year period, all records must be forwarded to the Office of Assistant Dean for Research.
Examples of acceptable informed consent documents are included in the model protocols found on the Model Protocols and Consent Forms page. These are only to be used as examples or guides for the formulation of individual informed consents and not as standard forms. The specific form used for each project must be tailored to the subject characteristics, specifics of the project procedures, and nature of the potential risks to subjects.