Informed Consent Under Scrutiny Suggestions for Improvement

Abstract

At the end of this centennial, as the 50th anniversary of the Nuremberg Code is commemorated, the consensus on individual autonomy and insistence on informed consent to research, that for the past 50 years has characterized bioethical thinking in human experimentation, is being scrutinized. Ethical difficulties with the informed consent principle include: 1. philosophically, a person's free “will” is a rather primitive and, essentially, negative human driving force; 2. neither on the part of the physicians nor on the part of die patients does informed consent respectively mean loss of responsibility or taking full responsibility; 3. informed consent is frequently less important to patients with chronic diseases and the elderly, because such groups have different priorities; 4. when it is realistic to believe that certain new treatments will lead to important progress, commitment to individual free “will” may be outweighed by the interest of the community. Ethical difficulties with the informed consent process include: 1. informed consent does not cover all of the major ethical questions involved in clinical research; 2. informed consent may be an obstacle to research when it causes enrollment difficulties; 3. informed consent may be inadequate sometimes and give rise to misleading promises; 4. the execution of the consent process may sometimes be too time- and cost-consuming an activity.

Consent information forms tend to create a positive attitude on the part of the participants, and do so by giving information of borderline adequacy. Suggestions for improvement of the consent information form would have to include: 1. Adequate information on both benefits and risks; 2. emphasis on the testsubjects' responsibilities; 3. a rationale for randomization; 4. a note about the premise of the physician-patient relationship; 5. an educational note about the negative properties of free “will”; 6. information about the hypotheses being tested; 7. information about ethical issues that are addressed through different routes; 8. disclosure about possible conflicts of interests.

We recommend that while there are additional ways to ensure the patients' best protection, the informed consent must stay, and should serve to inform patients and motivate them to participate in a trial on proper grounds.