National Academies Press: OpenBook

On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition (2009)

Chapter: Human Participants and Animal Subjects in Research

« Previous: Responding to Suspected Violations of Professional Standards
Suggested Citation:"Human Participants and Animal Subjects in Research." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2009. On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition. Washington, DC: The National Academies Press. doi: 10.17226/12192.
×
Page 24
Suggested Citation:"Human Participants and Animal Subjects in Research." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2009. On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition. Washington, DC: The National Academies Press. doi: 10.17226/12192.
×
Page 25
Suggested Citation:"Human Participants and Animal Subjects in Research." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2009. On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition. Washington, DC: The National Academies Press. doi: 10.17226/12192.
×
Page 26
Suggested Citation:"Human Participants and Animal Subjects in Research." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2009. On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition. Washington, DC: The National Academies Press. doi: 10.17226/12192.
×
Page 27

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

24 On Being a S c i e n t i s t 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 fed- eral, 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 re- quirements 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). IRBs must approve all research covered by the Com- mon 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 re- search 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 While IRBs are independent, they are local review committees that fall under the jurisdiction of the funded research institution.

Responding t o S u s p e c t e d V i o l a t i o n s 25 Tests on Students For his dissertation project in psychology, Antonio is studying new approaches to strengthen memory. He can apply these techniques to cre- ate 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. 1. Should Antonio seek IRB approval for his research project with human participants? 2. What do students need to be told about Antonio’s project? Do they need to give formal informed consent? 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 popula- tions? 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 hu- mans 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. Pub- lic Health Service’s Policy on the Humane Care and Use of Laboratory Ani-

26 On Being a S c i e n t i s t A Change of Protocol Hua is doing a postdoctoral fellowship in a laboratory that studies cancer treatment. In the experiment she is overseeing, a cancer-prone strain of mice is allowed to develop visible tumors and then receives experimental drugs to observe the effects on the tumors. Hua notices that the tumors are interfering with the ability of some of the mice to eat and drink. She also notices that some of the mice are weaker and more emaciated than the others, which she suspects is a consequence of their feeding difficulties. The protocol for the experiment states that the mice will be treated only if they exhibit obvious signs of pain or discomfort. When she mentions her concerns to another postdoctoral fellow, he suggests not raising the issue with the rest of the lab. The mice will be euthanized as soon as the experiment is over, and their nutritional status probably has little or no effect on the drug treatment. Furthermore, if it proved necessary to change the experimental protocol, the previous work would be invalidated and the Institutional Animal Care and Use Commit- tee would need to be notified. 1. What can Hua do to get more information about the issue? 2. If she decides to raise the issue with others, what is the best way to do so? 3. Should the original protocol have been approved? mals, 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 alterna- tives: reduction in the numbers of animals used, refinement of tech- niques 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

Responding t o S u s p e c t e d V i o l a t i o n s 27 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 ac- credit research institutions using existing regulations and the guide as standards.

Next: Laboratory Safety in Research »
On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition Get This Book
×
Buy Paperback | $17.95 Buy Ebook | $14.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The scientific research enterprise is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct.

On Being a Scientist was designed to supplement the informal lessons in ethics provided by research supervisors and mentors. The book describes the ethical foundations of scientific practices and some of the personal and professional issues that researchers encounter in their work. It applies to all forms of research--whether in academic, industrial, or governmental settings-and to all scientific disciplines.

This third edition of On Being a Scientist reflects developments since the publication of the original edition in 1989 and a second edition in 1995. A continuing feature of this edition is the inclusion of a number of hypothetical scenarios offering guidance in thinking about and discussing these scenarios.

On Being a Scientist is aimed primarily at graduate students and beginning researchers, but its lessons apply to all scientists at all stages of their scientific careers.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!