Obtaining Consent/Assent

The methods used to obtain consent may vary. They should be designed to fit the nature of the research, the nature and magnitude of the risks involved, the research setting, the nature of the subjects who will participate, and the requirements of applicable policies, laws, and regulations. If appropriate justification is given, an oral or passive consent process may be approved by the HSRB.

In order to obtain informed consent, Federal regulations require that certain information must be provided to each subject:

  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; A description of any reasonably foreseeable risks or discomforts to the subject; A description of any benefits to the subject or to others which may reasonably be expected from the research;

  2. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

  3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

  4. 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;

  5. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

  6. 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.

When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. The approximate number of subjects involved in the study.

The HSRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the HSRB finds and documents that:

  1. The research involves no more than minimal risk to the subjects;

  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

  3. The research could not practicably be carried out without the waiver or alteration;and

  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.