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The Common Rule for Protection of Human Subjects

The Common Rule for the Protection of Human Subjects is part of the U.S. Code of Federal Regulations. It controls the use of human subjects in experimental testing. Along with protecting the physical safety and well being of subjects, the Rule also protects the privacy of individuals and their personal information.

Who Must Comply With the Rule?

  • Any research conducted or supported by a Federal department or agency
  • Any research not conducted or supported by the government is still subject to the institutional review board and documentation of informed consent requirements of the policy
  • Any research that department or agency heads may require to comply with the policy

The following include all research activities that are exempt from the policy:

  • Any research taking place in commonly accepted educational settings (ie: research on educational strategies, instructional techniques, curriculum)
  • Any research that uses educational tests, surveys, interviews, or observation of public behavior unless personally identifiable information is obtained and may be linked with the test subject in the records or disclosure of the subject’s responses could be publicly damaging.
  • Any research that uses educational tests, surveys, interviews or observations of public behavior where the human subject is an elected official or candidate for office or where federal regulations require confidentiality to be maintained.
  • Any research that involves collecting existing data, documents, or specimen if the source is publicly available or the subjects cannot be identified through the information
  • Any projects that are conducted to study, evaluate or examine: public benefit or service programs; the procedures for obtaining such benefits; possible changes to the benefits or service available
  • Any research that involves testing the taste of quality of food as long as: the food is wholesome and without additives; the food contains ingredients considered safe by the Food and Drug Administration or Environmental Protection Agency

Institutional Review Boards

Before any research may be conducted, an institution that must comply with the policy must file written assurance with the Office for Protection from Research Risks, Health & Human Services. For an assurance approval, an institution must provide proof that an institutional review board (or several)  has approved the research to be conducted and that the research will be continually reviewed by the committee.

It is the duty of Institutional Review Board (IRB) to approve, monitor and review all research involving human research subjects. All IRBs are composed of at least five members, experience and diverse enough to make sound decisions regarding the project being conducted. In addition, each IRB must contain a “Community Member” that is not a scientist or affiliated with the agency.

Informed Consent

Before a subject may participate in a research project the investigator must obtain legally effective informed consent. As one of the Fair Information Practice Principles, consent is vital to protecting an individual’s privacy and well being.

A subject should receive adequate time to consider their participation. The information they receive must be written in clear and understandable language. Further more, no consent may include exculpatory language, which completely frees the researchers from responsibility towards protecting the subject and their privacy.

In order to make informed consent, prospective subjects must receive the following information:

  • Any reasonable benefits and complications they may experience
  • A list of alternative treatment options
  • A statement regarding how the confidentiality of documents containing identifiable information will be maintained
  • Explanations of compensation or further medical treatment, should an injury occur
  • Contact information should the subject have further questions regarding their rights, or should an injury occur
  • A statement reminding the subject that their participation is voluntary and that they will receive no penalty for refusing to participate

The rule also prohibits the use of undue influence or coercion to obtain consent. Undue influence may include providing subjects with large sums of money or other benefits which may cloud the decision-making process. For research being conducted in schools where credit may be used as an incentive to participate, a non-research based alternative to receive the same credit must also be made available to the students.

Summary:

The Common Rule for Protection of Human Subjects is an important policy dealing with the physical safety of research subjects and the handling of their personal information. Continuous research is required to advance science, develop new technologies and determine whether products are safe for human consumption. Regardless of their status, compensation or reasons for entering a study, test subjects are guaranteed protection under this policy.

CIPP/G Candidate Preparation

In preparation for the Certified Information Privacy Professional Government exam, a privacy professional should be comfortable with topics related to this post including:

•   Common Rule for Protection of Human Subjects (II.B.b.iv.)

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