Part 3 – Risk and Confidentiality

As stated earlier, risk in social science research is very different from risk in biomedical procedures. The three primary risk factors in social research with human subjects are invasion of privacy, breach of confidentiality and the study procedures themselves.

Before defining these risks, it is important to note that privacy indicates an individuals ability to control the availability of their person and personal information, and confidentiality is the treatment of information gathered from an individual in making sure it is not divulged to others.

Learning Objectives

After taking this course, learners will be able to:

• Identify the characteristics and qualities of confidential information acquired in research
• Distinguish between private information, privacy and confidentiality
• Understand and identify common risks to confidential information
• Be familiar with reporting requirements in relation to confidential information

Invasion of privacy can be done directly and indirectly. Examples include gaining information from subjects they do not wish to be used in a study (direct) or accidentally causing the subject to reveal information about themselves to their peers (indirectly). As an example for the latter, if a lab building is known to be hosting a study on LGBTQ+ studies, subjects are still having their private information made public by entering the building, , even if the lab keeps all information recorded secure.

Breach of confidentiality involves the leaking of sensitive information that may harm the subject. For instance, studies involving information on undocumented individuals or illicit drug use can cause serious repercussions for respondents if information is leaked, and studies on domestic violence may cause retaliation from abusers if the subjects are discovered to be a part of the study.

Study procedures can present dangers when they can endanger the privacy or well-being of respondents. Studying PTSD related concerns need to be safeguarded in a way that will not cause re-traumatization, and further, even confidential interviews of questionnaires can be compromising for individuals if conducted in a venue where information may be overheard or seen.

Informed Consent and Mandatory Reporting

Factoring this in, all risks, including asking embarrassing or distressing information, must be clearly outlined in the informed consent document clearly, as to abide by the key ethical principle of respect for persons.

There are several activities that are mandated reporting categories by state law and therefore supersede study confidentiality and certificates of confidentiality.  This can include: specific communicable diseases, child abuse, elder abuse and risk of self-harm. This mandated reporting should be included in the informed consent if it is at all likely to come up during the study procedures.

Securing of data

In instances where the primary risk is a subject being identified as part of the study (such as for gang violence or previous criminal activity), research may apply for documenting informed consent to be waived. This does not mean informed consent is waived – participants must be provided or read a written outline or otherwise informed of study procedures exactly as they would with an informed consent document, and must agree all the same. The only difference is a signed document will not be retained.

Means of protecting subject data can include assigning codes to participant names and other identifiers and keeping the code key in a separate, secure area. Also, removing all unnecessary identifiers where practical to the study, password protecting documents and making sure written records are stored in locked containers all are safeguards that can be taken.

In order for a study to be considered ethical, it must assess both the probability of harm to its participants and the magnitude of that harm, and compare that to the benefits of the information gained from the research. The IRB is assigned as the impartial agent to make that judgment.

In situations with particularly damaging information gathered in a study, a Certificate of Confidentiality may be requested from the National Institutes of Health to protect documents from legal, criminal and administrative subpoenas and guarantee the data gathered is only for research purposes. This is usually acquired for topics such as drug use, criminal activity and genetic information.