A central tenant of research ethics is informed consent. True informed consent puts most studies on very sound ethical footing. However, it is not always clear what constitutes informed consent. Further, in some specific cases, existing rules allow for research to proceed without informed consent. In this post, I’ll describe some of the principles from the Belmont Report that relate to informed consent. Then, I will show the specific parts of the Common Rule that relate to informed consent. Finally, I’ll summarize some commentary on the way the Common Rule handles informed consent.
The Belmont Report, which I described in an earlier post, argues that the requirement of informed consent comes from the principle of respect for persons. Further, the Belmont Report proposes three elements of informed consent: information, comprehension, and voluntariness. That is, participants should be presented information about the details of the study in a way that they can understand, and given that information, participants should be free to participate in the study or not.
However, the principle of respect for persons is just one of the three ethical principles in the Belmont Report. The other two are beneficence and justice. Since decisions about research ethics need to balance these three criteria, there may be cases where beneficence and justice will outweight respect for persons. In particular, the principle of beneficence, which calls for balancing the risks and benefits of research, could override the requirement for informed consent in some situations.
Detailed Requirements in Common Rule
The Common Rule, which operationalizes the principles of the Belmont Report, has eight standard elements for informed consent [§46.116(a)]:
(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;
(7) 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
(8) 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.
Further, the Common Rule has six optional elements for informed consent [§46.116(b)]:
(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.
However, IRBs can alter or waive the requirements for informed consent under two sets of conditions, which I will call a policy evaluation condition and a minimal risk condition.
The first way that IRBs can alter or waive the requirement for informed consent is for certainty types of program evaluation [§46.116(c)]:
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
(2) The research could not practicably be carried out without the waiver or alteration.
Second, an IRB can alter or waive the requirement for informed consent in certain minimal risk situations [§46.116(d)]
An IRB may approve a consent procedure which 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 IRB 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.
Commentary on Detailed Rules
A recent report by the National Research Council proposed a number of improvements to the informed consent procedures required by the Common Rule. A main goal of these proposals is to move from a process focused on checklists and documentation to a process focused on respecting participants. As an alternative to the current rules, the National Research Council highlights a goodness-of-fit framework where informed consent procedures are guided by:
1) the moral principles of respect, care, and justice
2) responsiveness to the abilities, values, and concerns of participants and their surrogates
3) awareness of the scientists’ own competencies and obligations
For more on possible improvements to the informed consent procedures, see Chapter 4 of the National Research Council report.