Question

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HUMAN PARTICIPANTS AND ANIMAL SUBJECTS IN RESEARCH

Any scientist who conducts research with human participants needs to protect the interest of research subjects by complying with federal, state, and local regulations and with relevant codes established by professional groups. These provisions are designed to ensure that risks to human participants are minimized; that risks are reasonable given the expected benefits; that the participants or their authorized representatives provide informed consent; that the investigator has informed participants of key elements of the study protocol; and that the privacy of participants and the confidentiality of data are maintained.

U.S. federal regulations known as the Common Rule lay out requirements for research involving human participants. The Common Rule specifies which types of research fall under its jurisdiction, the provisions for obtaining informed consent, the procedures needed to gain approval of a project, and the training that researchers must undergo to use human participants in research. Federally funded research involving human participants also must be reviewed and approved by independent committees known as Institutional Review Boards (IRBs).² IRBs must approve all research covered by the Common Rule, must conduct regular reviews of such research, and must review and approve proposed changes in ongoing research. IRBs also have the authority to monitor informed consent procedures, gather information on adverse events, and examine conflicts of interest. These policies generally are observed for non-federally funded research as well and are followed in an increasing number of countries around the world.

The involvement of human participants in research can raise difficult questions. Should people be asked to participate in studies that involve some risk to themselves with no prospect of benefits? How should consent provisions be modified for children, prisoners, the mentally ill, the undereducated, or other vulnerable populations? Should the same provisions apply to all research conducted everywhere in the world, or should standards be modified to reflect local conditions? Formal training in bioethics is sometimes needed to analyze the complex moral issues raised by human participation in research, and various bodies, such as the President’s Council on Bioethics in the United States, are continuing to study these issues. At a minimum, anyone who engages in research that involves humans must be aware of all relevant regulations and have appropriate training.               The use of animals in research and research training is     also subject to regulations and professional codes. The federal Animal     Welfare Act seeks “to insure that animals intended for use in research     facilities … are provided humane care and treatment.” The U.S. Public     Health Service’s Policy on the Humane Care and Use of Laboratory Animals     , which applies to all animal research supported by the National     Institutes of Health , requires institutions “to establish and maintain     proper measures to ensure the appropriate care and use of all animals     involved in research, research training, and biological testing.” The     policy requires adherence with both the Animal Welfare Act and the Guide     for the Care and Use of Laboratory Animals, a document prepared and     regularly updated by committees under the National Research Council.     Guidance for researchers who use animals recommends that researchers     carefully consider the “three R’s” of animal testing alternatives:     reduction in the numbers of animals used, refinement of techniques and     procedures to reduce pain and distress, and replacement of conscious living     higher animals with insentient material. Anyone who plans to use animals in     research or teaching must be familiar with the relevant regulations and the     guide and must receive appropriate training before beginning work.     The Animal Welfare Act and the Policy on the Humane Care and Use of Laboratory Animals   both require institutions to have Institutional Animal Care and Use Committees (IACUCs), which include experts in the care of animals and members of the public. These committees review and approve research proposals using animals, oversee animal care programs and facilities, and respond to concerns about the use of animals in research. Also, private organizations like the American Association for the Accreditation of Laboratory Animal Care accredit research institutions using existing regulations and the guide as standards.                   2         While     IRBs are independent, they are local review committees that fall under the     jurisdiction of the funded research institution Tests on Students     For     his dissertation project in psychology, Antonio is studying new approaches     to strengthen memory. He can apply these techniques to create interactive Web-based instructional modules. He plans to test these modules with     students in a general psychology course for which he is a teaching     assistant. He expects that student volunteers who use the modules will     subsequently perform better on examinations than other students. He hopes to publish the results in a conference proceedings on research in learning, because he plans to apply for an academic position after he completes the doctorate. 2- What do students     need to be told about Antonio’s project? Do they need to give formal informed     consent?

Answer 1

Students should be told that they are going to undergo some techniques to strengthen the memory. The techniques are harmless and they will be helpful to get some sort of knowledge on Web-based instructional modules. The students should be instructed to inform Antonio any kind of disappointment any student feels during the session.

As the techniques used are not harmful physically or mentally to the students, no need of a formal informed consent. But if Antonio's any of the techniques involve any kind of psychological or physical distress, sure he needs to take the formal informed consent from students.