General Requirements of Informed Consent

No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.  An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.  The information given to the subject or the representative shall be in language understandable to the subject or the representative.  No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. 

Basic elements of informed consent shall include the following: 

  • 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 which are experimental;
  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • Description of any benefits to the subjects or to others which may reasonably be expected from the research;
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might advantageous to the subject
  • Statement describing the extent, if any to which confidentiality of records identifying the subject will be maintained;
  • 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 for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of research-related injury to the subject
  • 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.

Where appropriate, the following elements of informed consent must also be included:

  • A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable;
  • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  • Any additional costs to the subject that may result from participation in the research;
  • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that significant new findings developed during the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  • The approximate number of subjects involved in the study.

CUHSR has the authority to approve a consent procedure which does not include or which alters some or all of the previously mentioned elements of informed consent or waive the requirements for informed consent if, either:

  • The research involves no more than minimal risk;
  • The waiver or alteration does not adversely affect the rights and welfare of the subjects;
  • The research could not practically be carried out without waiver or alteration; and
  • Wherever appropriate, the subjects will be provided with additional pertinent information.

OR

  • The research is to be conducted for the purpose of demonstrating or evaluating:
    1. federal, state, or local benefit or service programs which are not themselves research programs;
    2. procedures for obtaining benefits or services under these programs; or
    3. possible changes in or alternatives to these programs or procedures; and
  • The research could not practicably be carried out without the waiver or alteration.