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ETHICS IN MEDICINE   University of Washington School of Medicine
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Research Ethics

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The ethical issues in human subjects research have received increasing attention over the last 50 years. Institutional Review Boards for the Protection of Human Subjects (IRB's) have been established at most institutions that undertake research with humans. These committees are made up of scientists, clinical faculty, and administrators who review research according to the procedures set out in the Federal Regulations at 45 CFR 46.

What are the main ethical issues in human subjects research?

There are several ethical issues that must be considered when designing research that will utilize participants who are human beings.
  • The primary concern of the investigator should be the safety of the research participant. This is accomplished by carefully considering the risk/benefit ratio, using all available information to make an appropriate assessment and continually monitoring the research as it proceeds.
  • The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing (although oral consents are sometimes acceptable) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent should be seen as an ongoing process, not a singular event or a mere formality.
  • The investigator must enumerate how privacy and confidentiality concerns will be approached. Researchers must be sensitive to not only how information is protected from unauthorized observation, but also if and how participants are to be notified of any unforeseen findings from the research that they may or may not want to know.
  • The investigator must consider how adverse events will be handled; who will provide care for a participant injured in a study and who will pay for that care are important considerations.
  • In addition, before enrolling participants in an experimental trial, the investigator should be in a state of "equipoise," that is, if a new intervention is being tested against the currently accepted treatment, the investigator should be genuinely uncertain which approach is superior. In other words, a true null hypothesis should exist at the onset regarding the outcome of the trial.

What are the main ethical principles that govern research with human subjects?

There are three primary ethical principles that are traditionally cited when discussing ethical concerns in human subjects research. (A more complete enumeration of these principles is available in the Belmont Report, written by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.)
  • The first ethical principle cited by the influential Belmont Report is autonomy, which refers to the obligation on the part of the investigator to respect each participant as a person capable of making an informed decision regarding participation in the research study. The investigator must ensure that the participant has received a full disclosure of the nature of the study, the risks, benefits and alternatives, with an extended opportunity to ask questions. The principle of autonomy finds expression in the informed consent document.

  • The second ethical principle is beneficence, which refers to the obligation on the part of the investigator to attempt to maximize benefits for the individual participant and/or society, while minimizing risk of harm to the individual. An honest and thorough risk/benefit calculation must be performed.

  • The third ethical principle invoked in research with human subjects is justice, which demands equitable selection of participants, i.e., avoiding participant populations that may be unfairly coerced into participating, such as prisoners and institutionalized children. The principle of justice also requires equality in distribution of benefits and burdens among the population group(s) likely to benefit from the research.

What are the components of an ethically valid informed consent for research?

For an informed consent to be ethically valid, the following components must be present:
  • Disclosure: The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research. There should also be a statement that describes procedures in place to ensure the confidentiality or anonymity of the participant. The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury. The document should make it clear whom to contact with questions about the research study, research subjects' rights, and in case of injury.
  • Understanding: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators. The informed consent document must be written in lay language, avoiding any technical jargon.
  • Voluntariness: The participant's consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation.
  • Competence: The participant must be competent to give consent. If the participant is not competent due to mental status, disease, or emergency, a designated surrogate may provide consent if it is in the participant's best interest to participate. In certain emergency cases, consent may be waived due to the lack of a competent participant and a surrogate.
  • Consent: The potential human subject must authorize his/her participation in the research study, preferably in writing, although at times an oral consent or assent may be more appropriate.

Is informed consent required by law?

According to 21 CFR 50.20,

"no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative."

The potential participant must be given the opportunity to give full consideration regarding the decision whether or not to participate in the research study without undue influence from his or her physician, family, or the scientific investigator. No informed consent may contain any exculpatory language by which the participant waives any legal rights or releases the investigator or sponsor from liability for negligence.

Can I use deception when doing research?

As a general rule, deception is not acceptable when doing research with humans. Using deception jeopardizes the integrity of the informed consent process and can potentially harm your participants. Occasionally exploring your area of interest fully may require misleading your participants about the subject of your study. For example, if you want to learn about decision-making practices of physicians without influencing their practice-style, you may consider telling them you are studying "communication behaviors" more broadly. The IRB will review any proposal that suggests using deception or misrepresentation very carefully. They will require an in-depth justification of why the deception is necessary for the study and the steps you will take to safeguard your participants.

I'm just doing a simple survey! Do I need IRB approval?

Some research with humans is eligible for "exempt" status from the Institutional Review Board (IRB). If your research is part of a routine educational experience, or if your participants will remain completely anonymous (with no identifying code to link them to their identity), you may apply to the IRB for a certificate of exemption. Your study proposal will still be reviewed by a member of the IRB, but the application process is considerably shorter.

Your study may also qualify for "expedited review" if an IRB reviewer determines that it meets assessment criteria for minimal risk, and involves only procedures that are commonly done in clinical settings, such as taking hair, saliva, excreta or small amounts of blood. A study that qualifies for expedited review is still held to the same standards used in full board review, but the approval process may take less time. Contact the University IRB if you have questions about the eligibility of your study.

 

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Core clerkship material for: ISMS Project


Timothy C. Callahan, PhD
Associate VP of Academics & Research
Bastyr University

and

Ron Hobbs, ND
IRB Member
Bastyr University


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Last date modified: October 21, 2010