IRB Harms

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Kent State University
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Division of Research and Graduate Studies

Physical, Psychological, Social, Economic Harms

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Physical Harms   
Some research involves exposure to minor pain, discomfort, or injury from invasive medical procedures, strenuous exercise, or harm from possible side effects of drugs. Procedures commonly used in medical research often result in no more than minor discomfort (e.g., temporary dizziness, the pain associated with venipuncture).   

This "injury paragraph" should be included in the consent form for projects with a possibility of injury or harm: 

Emergency medical treatment within the limits of that normally  offered by the University Health Center (telephone 672-2322)  will be provided for physical injuries occurring on the Kent State University main campus. No other medical treatment or  financial compensation for injury for participation in this  project is available. 

Psychological Harms    
Participation in research may result in undesired changes in thought processes and emotion (e.g., episodes of depression, confusion, or hallucination resulting from drugs, feelings of stress, guilt, and loss of self-esteem.)  Stress and feelings of guilt or embarrassment may arise simply from thinking or talking about one's own behavior or attitudes on sensitive topics such as drug use, sexual preferences, selfishness and violence.  These feelings may be aroused when the subject is being interviewed or filling out a questionnaire.  A list of agencies where the subjects who may be affected by this type of research should be provided.  The researchers should also provide his/her telephone number and a detailed explanation to the HSRB of what he/she will do if a subject becomes upset.  Stress may also be induced when the researchers manipulate the subjects' environment - as when "emergencies" or fake "assaults" are staged to observe how passersby respond.  More frequently, however, the HSRB will confront the possibility of psychological harm when reviewing behavioral research that involves an element of deception, particularly if the deception includes false feedback to the subjects about their own performance. 

Invasion of Privacy  
Invasion of privacy is a risk of a somewhat different character.  In the research context, it usually involves either covert observation or "participant" observation of behavior that the subjects consider private.  The HSRB must make two determinations: 1) is the invasion of privacy involved acceptable in light of the subjects' reasonable expectations of privacy in the situation under study; and 2) is the research question of sufficient importance to justify the intrusion?  The HSRB should also consider whether the research design could be modified so that the study can be conducted without invading the privacy of the subjects. 

Breach of Confidentiality 
Breach of confidentiality is sometimes confused with invasion of privacy, but it is really a different problem.  Invasion of privacy concerns access to a person's body or behavior without consent; confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another. 

Social and Economic Harms 
Some invasions of privacy and breaches of confidentiality may result in embarrassment within one's business or social group loss of employment, or criminal prosecution.  Areas of particular sensitivity are information regarding alcohol or drug abuse, mental illness, illegal activities, and sexual behavior.  Some social and behavioral research may yield information about individuals that could "label" or "stigmatize" the subjects (e.g., as actual or potential delinquents or schizophrenics).  Confidentiality safeguards must be strong in these instances. 

Participation in research may result in additional actual costs to individuals.

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This page was last modified on October 17, 2006

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