Consent

Investigators are responsible to discuss the research with subjects, and to document the subjects' consent to participate. The consent process must be adapted to the decision-making needs of the subject.  Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.

• Federal regulations describe the required elements of consent.

  1. A statement that the study involves research, an explanation of the purposes and the expected duration of the subject's participation, and a description of the  procedures, noting any procedures which are experimental;
  2. A description of reasonably foreseeable risks or discomforts;
  3. A description of benefits to the subject or others that may reasonably be expected;
  4. Disclosure of appropriate alternative procedures or courses of treatment;
  5. A statement of the degree to which confidentiality of records identifying the subject will be maintained;
  6. For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
  7. Who to contact for answers to questions about the research, about research subjects' rights, and about research-related injury;
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled

• There are additional elements that must be included if appropriate.

  1. A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
  2. Anticipated circumstances under which the subject's participation may be terminated without the subject's consent;
  3. Additional costs that may accrue to the subject as a result of participation;
  4. Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
  5. A statement that any significant new findings that may relate to the subject's willingness to continue will be provided;
  6. The approximate number of subjects involved in the study.

• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:

  1. The research involves no more than minimal risk to subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. When appropriate, subjects will be provided with additional pertinent information after participation.