Which right of research participants applies when a researcher is able to identify a particular persons responses but undertakes not to do so publicly?

The terms anonymity and confidentiality are frequently confused in human subjects research. The distinction between the two terms, however, is critical in the design of protocols that protect participant privacy and provide for adequate informed consent.

Confidentiality refers to a condition in which the researcher knows the identity of a research subject, but takes steps to protect that identity from being discovered by others. Most human subjects research requires the collection of a signed consent agreement from participants, and the collection of other personally identifiable data, and thus researchers are aware of the identity of their subjects. In such cases, maintaining confidentiality is a key measure to ensure the protection of private information.

Researchers employ a number of methods to keep their subjects' identity confidential.  Foremost, they keep their records secure through the use of password protected files, encryption when sending information over the internet, and even old-fashioned locked doors and drawers. They frequently do not record information in a way that links subject responses with identifying information (usually by use of a code known only to them). And because subjects may not be identified by names alone, but by other identifiers or by combinations of information about subjects, researchers will often only report aggregate findings, not individual-level data, to the public.

Anonymity is a condition in which the identity of individual subjects is not known to researchers. Because most human subjects research requires signed documentation of consent, subject anonymity is not as common in human subjects research.  Federal law does allow an IRB to waive the requirement for signed consent documents in cases where the collection of that document is the only identifying information linking the subject to the project.  Such documentation is most often waived for projects such as online survey that present no more than minimal risk to subjects.

As you develop your human subjects review application, please be certain you understand the distinction between confidentiality and anonymity, and that you use the appropriate terms in your project description and consent documents.

Abstract

Informed consent is the most essential part of research ethics. The requirement to explain an experiment to the participants who provide tissues/information in order to obtain their voluntary consent is absolutely necessary in any research project. It is an expression of respect regarding the autonomy of the person who participates in the experiment. Why and how is informed consent required and what if some information is intentionally withheld to facilitate the participation? This paper will briefly review the history of informed consent, discuss the components of an ethically valid informed consent and examine deception in research. Sometimes, deception is used in Social, Behavioral and Educational Research (SBER) in order to obtain accuracy information. Can this be justified? There is no doubt that, for some psychological and sociological experiments, the less the subjects know the better. The Bystander Apathy Experiment and the Milgram Experiment will be used here as examples that are discussed and analyzed. In general, deception is not acceptable in human studies. Occasionally, it is necessary to mislead the participants who are subjects of a study in order to obtain unbiased information. The Institute Review Board (IRB) must review very carefully the proposals that use deception or misrepresentation. The reasons that deception is necessary for the study purpose need to be justified in depth and there must be provision in the procedures to protect the participants. When the study is completed, it is essential that a debriefing by the investigator is provided that explains any deception or incomplete disclosure involved; this should also help the subjects to deal with any distress or discomfort experienced in the research.

Keywords

Autonomy

Debriefing

Deception

Informed consent

Copyright © 2012 Published by Elsevier B.V.