module 6

contributions to risk

Assessing Risk Objectively may be challenging for researchers or potential subjects People, including researchers, may underestimate risks involved in activities with which they are familiar and overestimate the benefit of things that are important to them. if Potential Subjects sees potential harms as severe, they tend to overestimate the probability. When less severe, like embarrassment, people tend to underestimate the probability. An independent assessment of risk is critical. One function of IRBs is to provide this independent assessment.

Risks of harm in social and behavioral sciences three categories:

1. invasion of privacy 2. breach of confidentiality 3. study procedures

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, apply 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.

information protected by Certificates of Confidentiality

Substance abuse or other illegal behaviors Sexual attitudes, preferences, or practices Genetic information Psychological health do not override the requirement to report the suspicion of child abuse or neglect, or any other state-mandated reporting requirements, such as elder abuse.

ways to safeguard data from unauthorized access

Use of as few direct identifiers as practical. Remove all direct identifiers as soon as possible. Substitute codes for identifiers. Maintain code lists and data files in separate secure locations. Use accepted methods to protect against indirect identification, such as aggregate reporting or pseudonyms. Use and protect computer passwords. Encrypt transmitted and stored data. Access and store data on computers without internet connections. Minimize procedures involving transferring direct identifiers between persons. Obtain a Certificate of Confidentiality.

studies where Certificates of Confidentiality may be granted

collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.

disparity between the probability and the magnitude of risk of harm in a study.

example, 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, Internet Protocol (IP) addresses may be present in the data set. Although the probability that an individual subject could be identified is low, the magnitude of the possible risk of harm is high given the sensitivity of the information

Invasion of Privacy

if personal information is accessed or collected without the subjects' knowledge or consent. example: a researcher studying interaction patterns in an online support group joins the group and does not reveal her true identity online can occur if a subject's participation is revealed despite assurances that this would not happen. example: researcher 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 staff person sees an acquaintance entering the meeting room and therefore discovers that the acquaintance has experienced sexual abuse.

Certificates of Confidentiality

issued by the National Institutes of Health (NIH) to protect identifiable research information from compelled disclosure. used for any research, regardless of funding, so long as the research is relevant to the mission of the NIH (an agency of the U.S. Department of Health and Human Services [HHS]). will allow the researcher, and others who have access to research records, to be protected from required disclosure of identifying information on research participants in: civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level.

ways to minimize risk

subjects need to be given sufficient 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. need to know what steps will be taken to protect confidential information, including disposition of recorded material. limits to the extent to which a researcher can protect identifiable personal information should be clearly explained. State and local laws may limit confidentiality, such as reporting requirements for child and elder abuse. Confidentiality cannot be guaranteed for information shared in a focus group.

what is Risks of harm specific to

time, situation, and culture and subject population ex; 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, or a country in which it is legal but the issue is with religious and political controversy. SP ex: A study on the efficacy 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. a survey about sexually transmitted diseases may carry different risks for different subject populations.