Assessing Risk- SBE

Identify the example of when situation and time are key to assessing risk of harm in a research study:

asking women if they had an abortion (Asking women if they have had an abortion would carry very different risks in a country where abortion is a routine medical practice, a country where it is illegal, and a country in which it is legal but the issue is fraught with religious and political controversy. Purchasing tobacco products is generally illegal for persons under 18 years of age, so any assessment of the risk for teenagers will have to consider that the research focuses on an illegal activity and is assessing the subject population, not situation and time. Similarly, a survey about sexually transmitted diseases would carry different risks for middle class suburban men, clergy, and gang members and is assessing risk through the idea of subject population, not situation and time. Research on the prevalence of harassment in different academic disciplines may stigmatize the community being studied in certain extreme cases, but the risk should be assessed as subject population, not situation and time either.)

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

both the magnitude (or severity) and the probability (or likelihood) of harm (Risk must be determined by assessing both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.)

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

experience emotional or psychological distress (Some subjects may experience emotional or psychological distress. The fact that the subjects have consented to participate in the study makes it unlikely that they would feel that their privacy was being invaded. Because confidentiality procedures have been built into the protocol it is also unlikely that the subjects might lose legal status or employment.)

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

invasion of privacy, breach of confidentiality, and study procedures (Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally fall in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.)

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

obtain a waiver of documentation of informed consent (If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research.)

The primary purpose of a Certificate of Confidentiality is to:

protect identifiable research information from compelled disclosure (Certificates of Confidentiality protect sensitive information provided by research subjects from civil, criminal, or administrative subpoena.)

What statement about risks in social and behavioral sciences research is most accurate:

risks are specific to time, situation and culture (Research in the social and behavioral sciences sometimes does pose risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive issue or topic at a given time and/or place may not be so at another time and/or place. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.)