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.

 

Multi-Site considerations

Consent forms (CFs) need to contain NYSPI-IRB required language in certain sections (see subheading Template Language), and need to conform to the NYSPI-IRB format.  However, beyond that, the CFs provided by the sponsor of a multi-site trial sometimes contain elements that the NYSPI-IRB does not usually favor.  For example, CFs sometimes contain lists of all the procedures carried out for each study visit, going on for many pages.  The NYSPI-IRB typically favors shorter consent forms.  The NYSPI-IRB’s main concern is that overlong CFs interfere with the informed consent process, by providing a document where the important issues of risk and alternatives and so forth can get lost in all the details. However, the NYSPI-IRB will consider accepting such elements (such as long lists of procedures) if it is justified and offset by other features.  For example, a clearly worded Cover Summary Sheet helps to provide potential participants an overview before launching into the details of the main consent.   Also helpful are explicit details in the PSF about the consent process and how sufficient time will be allotted for review and discussion of the CF.