what are the main ethical issues in human subjects research

8/12/2019 What Are the Main Ethical Issues in Human Subjects Research

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What are the main ethical issues in human subjects

research?

There are several ethical issues that must be considered whendesigning research that will utilize participants who are human

beings.

The primary concern of the investigator should be thesafety of the research participant. This is accomplished

by carefully considering the risk/benefit ratio, using allavailable information to make an appropriate assessment

and continually monitoring the research as it proceeds.

The scientific investigator must obtain informed consentfrom each research participant. This should be obtainedin writing (although oral consents are sometimes

acceptable) after the participant has had the opportunity

to carefully consider the risks and benefits and to ask anypertinent questions. Informed consent should be seen asan ongoing process, not a singular event or a mere

formality.

The investigator must enumerate how privacy andconfidentiality 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 unforeseenfindings from the research that they may or may not

want to know.

The investigator must consider how adverse events willbe 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 anexperimental 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 investigatorshould be genuinely uncertain which approach issuperior. 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 traditionallycited when discussing ethical concerns in human subjects

research. (A more complete enumeration of these principles is

available in theBelmont Report,written by The National

Case 1

Case 2

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Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research in 1979.)

The first ethical principle cited by the influentialBelmont Report is autonomy, which refers to the

obligation on the part of the investigator to respect eachparticipant as a person capable of making an informed

decision regarding participation in the research study.

The investigator must ensure that the participant hasreceived a full disclosure of the nature of the study, the

risks, benefits and alternatives, with an extended

opportunity to ask questions. The principle of autonomyfinds expression in the informed consent document.

The second ethical principle is beneficence, which refersto the obligation on the part of the investigator to attempt

to maximize benefits for the individual participant and/orsociety, while minimizing risk of harm to the individual.

An honest and thorough risk/benefit calculation must beperformed.

The third ethical principle invoked in research withhuman subjects is justice, which demands equitable

selection of participants, i.e., avoiding participantpopulations 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 thepopulation group(s) likely to benefit from the research.

What are the components of an ethically valid

informed consent for research?

For aninformed consentto be ethically valid, the following

components must be present:

Disclosure: The potential participant must be informedas fully as possible of the nature and purpose of the

research, the procedures to be used, the expected benefitsto the participant and/or society, the potential of

reasonably foreseeable risks, stresses, and discomforts,

and alternatives to participating in the research. Thereshould also be a statement that describes procedures in

place to ensure the confidentiality or anonymity of the

participant. The informed consent document must alsodisclose what compensation and medical treatment are
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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 whathas been explained and must be given the opportunity toask 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 participatein 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 giveconsent. 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 authorizehis/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 hasobtained the legally effective informed consent of the subject or

the subject's legally authorized representative."

The potential participant must be given the opportunity to givefull consideration regarding the decision whether or not to

participate in the research study without undue influence fromhis 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 theinvestigator 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


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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 reviewany 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 willtake 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

theInstitutional Review Board(IRB). If your research is part of

a routine educational experience, or if your participants willremain completely anonymous (with no identifying code to linkthem 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 isconsiderably shorter.

Your study may also qualify for "expedited review" if an IRBreviewer 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 expeditedreview 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 ofyour study.
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