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Identifying Risks

 Potential Risks

 

Description IRB Analysis What IRBs may require

Physical Harms

Research can involve exposure to minor pain, discomfort, or injury from invasive medical procedures or activities designed to test biomechanical or ergonomic performance. Risks are very specific to the study; this is why IRBs need to see a detailed account of all of the tasks investigators will be asking subjects to perform and the environment in which they will be performed.  The IRB will want to review supporting evidence of a device’s commercial application and basic operating information from the manufacturer.

Psychological Harms

These run from temporary anxiety and distress to relapse and precipitation of behavioral disorders.  Discomfort may be associated with the questions in a survey or interview.  The IRB considers the range of reactions that are possible in response to the research and will ask researchers to design the study in a way that provides an adequate level of protection Giving subjects information on available counseling services.

Deception

Federal regulations permit but establish limitations on the use of deception in research.  Deception in research occurs when subjects are intentionally mislead or when information about the nature of the experiments is withheld.

 

IRBs will require that subjects are fully debriefed after the experiment is conducted.  Investigators will submit a debriefing document for review.  Subjects are given the opportunity to ask questions about the new information and given the chance to withdraw.  It is not permissible to use deception to obtain participants

Invasion of privacy

In the research context, it usually involves either covert observation or "participant" observation of behavior that the subjects consider private The IRB 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

 

Breach of confidentiality

Confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another.  A breach of confidentiality may result in psychological harm to individuals (in the form of embarrassment, guilt, stress, and so forth) or in social harm.

 

 

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. Confidentiality safeguards must be strong in these instances. For example, the fact that a person has participated in HIV-related drug trials or has been hospitalized for treatment of mental illness could adversely affect:



1.
present or future employment,

2.
eligibility for insurance,


3.
standing in the community,

4. relationships with family members