Potential risks fall into five broadly-defined categories. Research Compliance Services and the CPHS/IRB will weigh the potential risks of research against the potential benefits as part of the review process. Researchers are expected to take steps to minimize potential risks.
Physical risks
Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric magnetic or gravitational fields, etc. Engaging a subject in a social situation which could involve violence may also create a physical risk.
Psychological risks
Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Sensory deprivation, sleep deprivation, use of hypnosis, deception or mental stresses are examples of psychological risks.
Social/Economic risks
Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include payment by subjects for procedures not otherwise required, loss of wages or other income and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.
Loss of Confidentiality
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the rights to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data. In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity. If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized staff may access it. Identities of individual subjects must never be released without the express consent of the subject. In addition, if an investigator wishes to use data for a purpose other than the one for which it was originally collected and the data are still identifiable (e.g. a code list for the data still exists), the investigator may need to obtain consent from the subjects for the new use of the data.
Legal risks
Legal risks exist when the research methods are such that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable.
Certainly! As an expert in research ethics and compliance, I've worked extensively with Institutional Review Boards (IRBs) and understand the critical balance between potential risks and benefits in research involving human subjects. I'll break down the concepts outlined in the article to provide a comprehensive understanding.
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Physical Risks: These pertain to any discomfort, injury, or illness resulting from research procedures. This can include exposure to various physical stimuli like noise, heat, or electromagnetic fields. Even situations involving potential violence in a social setting can pose physical risks to subjects.
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Psychological Risks: Research methods can induce negative psychological states such as anxiety, depression, or altered behavior. Techniques like sensory deprivation, sleep deprivation, hypnosis, or deception might lead to such risks.
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Social/Economic Risks: These risks involve the potential alterations in relationships or economic status of subjects due to research participation. This encompasses embarrassment, loss of respect, labeling, or financial costs incurred by the subjects.
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Loss of Confidentiality: Ensuring confidentiality is crucial in research involving human subjects. It involves protecting identifiable information and preserving the dignity and privacy of participants. Careful collection, storage, and access control of personal data are essential to mitigate the risk of loss of confidentiality.
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Legal Risks: These risks arise if research methods could potentially lead to subjects or others engaging in unlawful activities, making them liable for civil or criminal offenses.
In summary, research compliance services and IRBs evaluate studies to assess and mitigate these five types of risks. Researchers are expected to take steps to minimize these risks while maximizing the potential benefits of the research. This includes ensuring confidentiality, minimizing physical and psychological harm, avoiding legal complications, and mitigating any adverse social or economic impacts on participants.
