Saturnino P. Javier, MD, FPCP, FPCC, FACC
Nagasaki, Japan — Institutional review boards (IRBs), institutional ethics committees (IECs) or ethics review committees (ERCs) are units that are usually based in a hospital, institution or facility which are tasked to assess the ethical aspects of any protocol or study dealing with human participants. There are currently more than 200 such IRBs in the country.
One of the most vital issues that research ethics committees always need to assess is the risk involved to patients or participants. There are protocols that carry high risks to patients – risks related to adverse events or side effects of the drugs that can lead to significant morbidity and even death or risks related to pregnancy and the unborn child, among others. There are protocols likewise that carry low or minimal risks – those that one encounters during ordinary activities of daily living.
As an example, a protocol involving a drug that can cause serious heart ailment or liver abnormalities is a high risk study while one that carries risk for slight itchiness or pruritus is low risk. Protocols involving prospective administration of drugs or injections to children or infants, or women in their child-bearing age are considered high risk. Protocols involving review of hospital records or charts of previously admitted patients are considered low risk.
Generally, studies that require administration of a new drug or use of a new device are considered high risk whereas those that involve no such administration, infusion or application are considered less risky protocols. Surveys, interviews, or questionnaires are generally considered low risk studies. But not always.
Questionnaires are usually viewed as harmless and low risk tools for qualitative and quantitative surveys. Quantitative surveys include those that provide important data related to incidence, prevalence and other demographic variables. However, the qualitative surveys that utilize open-ended questions can provide a more in-depth and insightful take on the issues being studied.
Such qualitative instruments can carry some potential risks. Consider a KAP questionnaire (knowledge, attitudes and practice) involving minors with HIV positive status. Any manner in which their privacy and confidentiality is violated can ultimately lead to societal stigmatization – resulting in mental and emotional trauma which may otherwise not have surfaced if not for the protocol being pursued.
Or a questionnaire assessing bullying behaviors among elementary students. Such questionnaires about bullying can elicit negative emotional and mental reactions particularly among the affected students who would otherwise block off all those negative insights had it not been for a survey which can actually revive and refresh the sore wounds of the trauma. One should also consider the impact of the instruments on those singled out as school bullies and their ‘retaliatory’ response by way of inflicting more harm on their bullying targets.
Ethics committees must determine that such studies provide a mechanism to support those who may be affected – either via counseling or referral to appropriate centers or physicians.
Facebook once came to intense criticism and scrutiny when it conducted an experiment on its users or account holders by exposing them to negative thoughts or emotions. The researchers, who were affiliated with Facebook, Cornell, and the University of California–San Francisco, tested close to 700,000 users whether or not reducing the number of positive postings made those people less likely to post positive comments as well. The same was done for negative comments.
In their conclusions, the authors claimed to have shown in a study involving more than 680,000 users that emotional states can be transferred to others via emotional contagion, leading people to experience the same emotions without their awareness.
The study published in the Proceedings of the National Academy of Sciences (June 2014) revealed that Facebook seemed to have intentionally manipulated the news posts of almost 700,000 users by feeding them positive or negative news in order to study “emotional contagion through social networks.” As many research ethics advocates have maintained, when one exposes people to something that can cause a change in psychological status, that is experimentation. James Grimmelmann from the University of Maryland averred – “This is the kind of thing that would require informed consent.”
What the critics of the survey deplored was that Facebook researchers deliberately tried to make people sad without their knowledge. Consent of a study participant is always a vital tool to ensure that the study is being conducted on ethical grounds. The study authors countered that the research proceeded with careful attention to all the ethical requirements – one that many proponents of research ethics certainly disagree with and adamantly refute.
What the issue highlighted is that a seemingly innocuous posting on Facebook – like a seemingly harmless questionnaire issue or item – can have an emotional impact on an individual. It is when such is done deliberately under the guise of a research protocol without full knowledge and informed consent of the participant that the study becomes ethically tenuous and flawed.
Vital Signs Issue 83 Vol. 4, January 1-31 2016