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The Informed Consent Process

Informed consent is central to the ethical conduct of research with human subjects. Researchers must obtain fully informed consent in all non-exempt research with human subjects. The informed consent document must be signed by the subject before any research is initiated. This principle precludes the use of incomplete disclosure of the nature of the research, deception, and so-called "passive consent."

When subjects are children (under 18) or not competent to consent the parent or legal guardian must sign the consent form. Investigators should be guided by the elements of informed consent, as outlined by the Federal government:

 
Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
 
Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.
 
 
  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental
  2. A description of any reasonably foreseeable risks or discomforts to the subject
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; An explanation of whom to contact, together with phone numbers, for answers to pertinent questions about the research and research subjects' rights, and whom to contain in the event of a research-related injury to the subject. (The investigator should be the contact for questions about the research and the University Director of Research should be the contact for questions about the rights of subjects)
  7. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The following conditions should govern the consent process:

  • Prospective subjects should be free to consider whether to participate (i.e., they should not be rushed, excessive payments should not be offered, nor should other undue influence or coercion be exerted).
  • The informed consent document should be written in language understandable to the subjects. If the subjects are non-English-speaking, the document should be translated.· Where the potential need to report illegal activity to the authorities exists (e.g., child abuse, drug and alcohol abuse by minors), the subjects should be so informed before agreeing to participate
  • Where there is reason for special concern (e.g., regarding pressure on potential subjects), the IRB may require monitoring (such as a third party observer).
  • Subjects should be given a copy of the consent form as a reminder of the information conveyed.
  • Consent forms must be retained for at least three years following the conclusion of a research project. The IRB may sometimes approve the use of a "short form" consent document, which means that the information is presented without benefit of a written version of the consent document. However, the IRB must first review and approve a written summary of what will be presented. Each oral presentation must be witnessed by a third person, who must sign both the consent form and a copy of the written summary of the presentation. A copy of the summary must be presented to those who sign the consent form for future reference.
  • If vulnerable populations are involved, additional safeguards are generally required. In the case of children, in addition to the required parental/guardian consent, an "assent" document should be prepared, written in language the child will understand.
  • When the Informed Consent document has IRB approval, the Office of Research will stamp the form approved and insert the approval and expiration dates. This stamped document is the official one that should be given to subjects, signed, and returned to the investigator for safekeeping. The investigator must retain signed consent forms for at least three years past completion of the research activity and should inform the Office of Research in writing of where the forms are kept. IRB approval of the research together with the informed consent document expires one year from the date of initial approval. It is the responsibility of the researcher to insure timely application for continuing IRB Review and approval as necessary. The IRB has the authority to observe or have a third party observe the consent process.

Guidance on Alteration or Waiver of Consent

Please contact the Chairperson of the IRB or the Director of Research if you have any questions regarding informed consent.