SCHOOL OF MEDICINE

Department of Medicine

Indiana Alcohol Research Center

Legal Issues in Research

Researchers seeking to administer alcohol in their studies have to take into account a complicated balancing of the medical science, the legal requirements and the cultural context that may make turn research that is legal into unethical research. The debate about at what age drinkers can be included in a study is clouded when it comes to the administration of alcohol by the researcher. It is not easy being an alcohol researcher. It is not easy being on the Institutional Review Board for Human studies either. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) asked its Advisory Council to create the Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation (revised May 2005). Sean O'Connor and Linda L. Chezem from the Indiana Alcohol Research Center participated in the 2005 work of updating and revising the original guidelines.

Animal Use in Research
The use of animals in research is predicated upon many practical considerations. The cost of research using human subjects is much greater than that of using animal models. But the economic aspect is not the best reason for the use of animals; rather, the ethical requirements from the Nuremberg Code forward have guided the research use of animals before testing upon humans. Two excellent web resources for considering the ethical use of animals in research are listed below:

Foundation for Biomedical Research
National Association for Biomedical Research (NABR)

Protecting the Study Patients' Sensitive Information
The protection of the study patient's sensitive information is an ethical responsibility that is as important as assuring the patient safety in other aspects. People may be greatly harmed and may even harm themselves or others when their sensitive information is disclosed. The history of patient protection is a short one in the United States and we now have several mechanisms aimed at protecting the patients.

The preservation of trust in the researchers and the research enterprise is essential to the continuation of research. The use of information gathering technology and electronic communications pose unrecognized danger to research participation. If the study patients fear or experience the disclosure of their sensitive information, recruitment of participants and participation in studies will be greatly hampered.

The sending of email that contains a patient's name and connects it to a study may be an unwarranted risk of exposure if that email is to or from an entity (university, government agency, etc.) that is covered by freedom of information statutes, state or federal. While this section will focus on the federal statutes and regulations, the state statutes should not be ignored.

Certificate of Confidentiality
The most complete protection to the privacy of a study subject is provided by a certificate of confidentiality. But the researchers should be cautioned that the protection from the certificate is dependent upon the researcher and staff maintaining the security of the names and information in an absolute fashion. Such protection of the subjects identity is fragile and easily misunderstood.

Legal and Ethical Protections for Study Patients/Subjects  (PowerPoint)

Statutes and Regulations
Federal Statute Creating for the Certificate of Confidentiality (current language):

42 U.S.C. §241(D):
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals. (As amended from the original Act.)

A fascinating account of how the first published case involving the certificate of confidentially was brought to court may be read in Confidentiality - The Case of People vs. Newman (Chapter 6, Methadone Treatment in Narcotic Addiction: Program Management, Findings, and Prospects for the Future. New York: Academic Press; 1977).

An excerpt is posted at http://www.drugpolicy.org/library/methadonep6_library.cfm.

Federal and State Cases
Application of the statute creating the certificate of confidentiality is found in People v. Newman, 32 N.Y.2d 379 at 384 (1973), cert. den. 414 U.S. 1163 (1974).

Underage Drinking
This is a source of great debate in the United States and worldwide. At what age should alcohol use be permitted? For the most recent in science, see a videotaped presentation on Adolescent Development and Alcohol Use.