Download Assessing Risk - SBE and more Study notes Design in PDF only on Docsity!
Assessing Risk - SBE
University of Wisconsin - Madison - UW Social & Behavioral Course
Switch View
Content Authors
Tracy Arwood, MS Clemson University Sangeeta Panicker, PhD American Psychological Association
Introduction
One of the most important and challenging tasks researchers and Institutional Review Boards (IRBs) face is identifying and evaluating risks of harm associated with participation in research. Unlike biomedical research studies and clinical trials in which the sources of risk may be more readily identi able and quanti able, potential harms associated with taking part in social and behavioral science research may be more ambiguous and less predictable, such as individual reactions to certain events or questions. However, identifying and assessing risks in such situations should be informed by a growing body of research literature on risks associated with research participation.
The risks of harm typically associated with social and behavioral research are social, psychological, economic, and legal in nature. However, in rare circumstances, the risks may involve physical harm. For example, those who study victims of domestic violence need to consider that individuals taking part in the study may become the victims of retaliatory violence if the subjects' involvement in the research is discovered.
It also is possible that when groups or communities rather than individuals are the focus of a study, the group as a whole may be at risk of harm. For example, research on the prevalence of individuals with HIV in communities may stigmatize the community being studied.
Identi cation, assessment, and minimization of risk are paramount to the conduct of ethical social and behavioral research.
Learning Objectives
By the end of this module, you should be able to:
Identify risks of harm associated with participation in social and behavioral sciences
Assessing Risk - SBE
research. Distinguish between probability and magnitude of harm when assessing risk. Apply the concepts of minimizing and managing risk.
Identifying Risks Associated with Participation in Social and Behavioral Sciences Research
Risks of harm in social and behavioral sciences generally fall into three categories:
Invasion of Privacy
Invasion of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. For example, if a researcher studying interaction patterns in an online support group joins the group and does not reveal her true identity online, the support group participants could feel that their privacy had been invaded by the researcher, if or when her true identity as a researcher is revealed to the group.
Invasion of privacy also can occur if a subject's participation in a study is revealed despite assurances that this would not happen. For example, a researcher is studying emotional reactivity in women who have experienced sexual abuse. The research is conducted in a designated university lab on a particular day each week. Another university sta person sees an acquaintance entering the meeting room and therefore discovers that the acquaintance has experienced sexual abuse.
Breach of Confidentiality
Perhaps the primary source of potential harm in the social and behavioral sciences is that information obtained by researchers could adversely a ect subjects if disclosed outside the research setting. Con dentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. For example:
are two distinct elements of risk that must be considered. One is the probability of harm - the likelihood that a speci c harm might occur. The fact that not all possible harms are equally probable should be taken into consideration when assessing risk. The second element of risk is the magnitude or severity of harm should it occur. The interaction between these two elements is a crucial factor in determining the level of risk of harm in a study.
Often there is disparity between the probability and the magnitude of risk of harm in a study. For example, a researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identi ers will not be collected; however, Internet Protocol (IP) addresses may be present in the data set. Although the probability that an individual subject could be identi ed is low, the magnitude of the possible risk of harm is high given the sensitivity of the information.
Situation and Time
Risks of harm in research participation are speci c to time, situation, and culture. What may be a socially sensitive issue or topic at one time or place may not be so at another time or place. For example, asking women if they have had an abortion would carry very di erent risks in a country where abortion is a routine medical practice, a country where it is illegal, or a country in which it is legal but the issue is fraught with religious and political controversy.
Subject Population
Risks of harm will di er according to the subject population, too. Consider this case: A study on the e cacy of a behavioral intervention for smoking cessation involves both adults and teenagers. Purchasing tobacco products is generally illegal for persons under 18 years of age. For adults, however, it is a health hazard, but not an illegal activity. Thus, any assessment of the risk for teenagers will have to consider that the research focuses on an illegal activity.
Similarly, a survey about sexually transmitted diseases may carry di erent risks for di erent subject populations.
Assessing Risk Objectively
It may be challenging for researchers or potential subjects to assess risk objectively.
Researchers
People, including researchers, may underestimate risks involved in activities with which they are familiar and overestimate the bene t of things that are important to them.
Potential Subjects
Regardless of the true probability of harm, research indicates that when potential harms are severe, people tend to overestimate the probability. When potential harms are less severe, such as embarrassment, people tend to underestimate the probability.
An independent assessment of risk is critical. One function of IRBs is to provide this independent assessment.
Balancing Risks and Potential Benefits
Federal regulations, based on the ethical principle of bene cence, require that risks of harm associated with research are reasonable in relation to the potential bene ts (Protection of Human Subjects 2018).
A great deal of research in the social and behavioral sciences o ers little potential for direct bene ts to the subjects themselves. The bene ts of the research often lie in the importance of the knowledge to be gained, the contributions it makes to science, or the contributions to society in general. There also might be cases in which a speci c community, rather than individual subjects, bene ts from the research. This should be balanced with the fact that most research in the social and behavioral sciences poses little or no risk of harm to the individual subject.
In addition, regulations stipulate that risks of harm must be minimized to the extent possible, consistent with sound research design (Protection of Human Subjects 2018).
In order to minimize risk, potential research subjects need to be given su cient information to make a decision about whether they are willing to accept risks and participate in the research. If research questions will be of a sensitive nature, subjects need to be forewarned. Subjects also need to know what steps will be taken to protect con dential information, including disposition of recorded material. Any limits to the extent to which a researcher can protect identi able personal information should be clearly explained. State and local laws may limit con dentiality, such as reporting requirements for child and elder abuse. Con dentiality cannot be guaranteed for information shared in a focus group.
Minimizing and Managing Risk
It is important to minimize and manage the risks of harm in the research study. Researchers and IRBs should assess the potential risks of harm in the study to determine the best minimization and management plan.
When the Primary Source of Risk Is the Data
When a possible disclosure of subject responses is the primary source of potential harm, collecting data anonymously may provide the best protection. For example, a mailed survey can be constructed without a follow up procedure, thereby negating the need for identi ers.
If, however, the study design makes the collection of identi ers necessary, for example a longitudinal study, safeguarding the data from unauthorized access can be
accomplished in various ways, including:
of child abuse or neglect, or any other state-mandated reporting requirements, such as elder abuse.
Other federal agencies, such as the Department of Justice, provide agency-speci c protections that apply to research conducted or funded by the agency.
Under a policy issued 7 September 2017 (e ective 1 October 2017), NIH-funded investigators do not need to apply for a Certi cate of Con dentiality, nor will they receive a document certi cate. The NIH issues Certi cates of Con dentiality automatically for “NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that collects or uses identi able, sensitive information” (NIH 2017). Certi cates of Con dentiality contain conditions for disclosure of the identi able, sensitive information that the investigator must comply with, including more restrictive requirements for disclosure in the new policy.
The Certi cates of Con dentiality policy remains the same for non-federally funded research, in that investigators must apply for a Certi cate of Con dentiality from the NIH or other HHS agency for speci c research studies.
Researchers must inform subjects about the protections and limitations provided with a Certi cate of Con dentiality.
When the Primary Source of Risk Is the Consent Document
Subjects may be placed at risk if others know they are taking part in a study of a stigmatizing or illegal activity. If the consent form is the only document that links the participants to the study, one way to diminish their risk of exposure is to consider applying to the IRB for a waiver of the requirement to document consent. A waiver of documentation of consent does not imply that any of the required elements of consent are waived. The elements of consent must be provided in some fashion such as in a cover letter, informational sheet, or verbal script.
Summary
Common social and behavioral sciences methodologies such as surveys, questionnaires, and interviews are considered (sometimes erroneously) low risk, because they do not involve physically invasive procedures with associated risk of physical harm. However, it is not the procedures per se that engender potential risks of harm, but the interaction of di erent factors. It is necessary to assess both the probability and magnitude of harm, as well as the context (situation, place, and time) of the research as it relates to the particular study population.
Assessing Risk
Reference
Cromer, Lisa DeMarni, and Elana Newman. 2011. Research ethics in victimization studies: widening the lens." Violence Against Women 17(12):1536-48. National Institutes of Health (NIH). 2017. “ Notice of Changes to NIH Policy for Issuing Certi cates of Con dentiality .” Accessed September 14. Protection of Human Subjects, 45 CFR § 46 (2018).
Original Release: January 2004 Last Updated: January 2019
