U9D1-60 S1 - Ethics: Protection of Human Participants - See Detail Questions.

Assessing Risk in Research Guidance for Doctoral Learners Version 1.1 Effective February 2016

Capella University 225 South Sixth Street, Ninth Floor

Minneapolis, MN 55402

ASSESSING RISK

Table of Contents

Assessing Risk ........................................................................................................ 3 Minimal Risk and Greater than Minimal Risk Designations ................................................ 3 Types of Potential Risks Associated with Research .......................................................... 3

Inconvenience 4 Physical harm 4 Economic/Financial Harm 4 Psychological Harm 5 Legal Harm 5 Social Harm 5 Loss of Confidentiality & Privacy 5 Group Harms 6

Determining Risk Levels .............................................................................................. 6 Magnitude and Probability of Risk 6

Assessing Risk ........................................................................................................... 7 Disclosing Risk ........................................................................................................... 7 Minimizing Risk .......................................................................................................... 8 Greater than Minimal Risk Studies ................................................................................ 8

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ASSESSING RISK All research involves some potential risks. It is the role of the IRB to evaluate all potential risks and ensure that the potential benefits justify the potential risks. It is important for researchers to understand the difference between ‘every day risks’ and ‘risks presented by research’. Every day risks are risks that individuals face regardless of their participation in research; the risks that we face going through life on a daily basis. For example, an individual could be in an accident on their way to participate. These types of risks do not need to be disclosed to the IRB and not considered as part of the IRB’s risk assessment. However, risks introduced by the research must be disclosed to and considered by the IRB. For example, if interviewing individuals about infidelity in their long-term relationships, the researcher could inadvertently violate the privacy of their participants by leaving a voicemail confirming their participation in the research.

Minimal Risk and Greater than Minimal Risk Designations Per the federal regulations (aka the Common Rule), there are two categories of risk1:

1. Minimal Risk 2. Greater than minimal risk

However, only minimal risk is “clearly” defined:

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests (45 CFR 46.102 LINK)

Greater than minimal risk is not defined by the regulations. Therefore, if a study’s potential risks do not meet the criteria for minimal risk, it is determined to be greater than minimal risk. Capella University applies the universal standard when defining daily life. The universal standard compares the potential for negative effects for the research participants to the potential for negative effects of everyday life or routine physical or psychological examinations or tests or a population of normal healthy individuals.

Types of Potential Risks Associated with Research Often times when individuals think of risk in research, they think of the physical risks associated with biomedical research when testing an experimental drug, device, or

1 There is a third designation of risk but it applies only to research with children and the types of research conducted by Capella University researchers do not qualify for this designation.

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treatment. However, there are other types of risks associated with research and these are the types of risks that effect most research at Capella University:

• Inconvenience • Physical Harm • Economic/Financial Harm • Psychological harm • Legal harm • Social harm • Loss of privacy and confidentiality • Group harms

Inconvenience

A great deal of research involves merely the possibility of inconvenience to participants. Participation in research requires time, effort, and sometimes financial expenditures. Arranging transportation or day care so as to participate in the study, fighting traffic to travel to a research site, setting aside social engagements or taking time away from one’s family or work is often a hassle. While some protocols require as little as fifteen minutes to complete an on-line survey, others may entail greater investments of time, and may present a significant burden or commitment for the participant.

Physical harm

Physical harm includes: • Discomfort • Pain • Injury, Illness • Disease • Life-threatening injury/illness

A great deal of research that occurs both in the U.S. and internationally involves clinical trials and medical procedures. This is important research that entails the potential risk for physical harm. Some studies may entail simply the risk of discomfort. An example might be a study that involves a blood draw. Others might entail more significant risks, and in some cases even involve procedures or medications that could be life-threatening. Because the research conducted at Capella is social, behavioral and educational, such risks are seldom encountered.

Economic/Financial Harm

Economic/Financial Harm may include: • Loss of wages, money • Loss of economic opportunity, income • Loss of credit, insurance, job

Economic and Financial Harm may also be a risk of research. Some risk may result simply from the costs of participation, particularly if participation will be time-intensive or require expenditures for travel, daycare, and parking or time away from work. Research may also pose a risk to employment if, for example, the research centers on job performance or workplace habits. Recent attention has been paid to the possible impact on credit,

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insurability and employability that a breach of confidentiality could present to research participants who disclose engagement in risky behaviors, or challenge workplace practices.

Psychological Harm

Psychological harm includes: • Worry, anxiety, stress • Discomfort • Confusion • Distress, fear • Depression • Embarrassment, shame, guilt

Research involving interactions with participants around sensitive topics often presents the risk of psychological harm. Participants may experience distress or anxiety in discussing a sensitive or personal topic. Research on particularly vulnerable populations who have experienced trauma has the potential to result in re-traumatization or trigger symptoms of depression, PTSD, etc.

Legal Harm

Legal Harm includes: • Involvement with law enforcement or social services • Civil or criminal prosecution, subpoena • Misdemeanor or felony conviction

Research may also result in legal consequences, particularly if a study involves disclosures relating to criminal behaviors. Certain populations, such as those on parole, those embroiled in custody hearings or working with social services agencies may be particularly susceptible to such harms. It is important to note that confidentiality in research does not extend to legal proceedings. Therefore, Capella University’s IRB rarely approves studies in which there is a significant potential for legal harm to participants. Any researcher considering a topic that may poses these risks must consult with the IRB Office early on in their dissertation process.

Social Harm

Social Harm includes: • Social embarrassment • Loss of respect or reputation • Loss of social standing or status • Stigma

Many participants worry about the confidentiality of their disclosures. One reason is concern over social harm that could result from a breach of confidentiality. Embarrassment or loss of standing within one’s family, workplace, or community present significant risks.

Loss of Confidentiality & Privacy

Loss of Confidentiality & Privacy includes: • Invasion of privacy

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• Disclosure of Personal Identifying Information, Public Information, Educational Records

• Identity theft Privacy refers to the individual’s identify and confidentiality refers to data. The loss of privacy and confidentiality can expose the participant to risks discussed previously such as financial, social, legal, and psychological harms.

Group Harms

Some studies pose a risk to the entire community or group. Such studies often present the possibility of group stigma and stereotyping. Examples of studies that could present group harms:

• A study of the educational achievement gap within the African American community • A study of alcoholism within a tribal community • A study comparing girls and boys achievements on standardized math tests • A study focusing on the ethical behaviors of accountants

Any study whose findings might lead to generalizations across an entire population has the potential to present group harms. Therefore, risks to the community or group must also be assessed and addressed.

Determining Risk Levels As all research involves some risk, the potential for risk alone does not mean that a study will be considered greater than minimal risk. Moreover, risk is somewhat subjective and determining if a study is greater than minimal risk often times requires multiple perspectives. Therefore, the IRB ensures that multiple IRB members weigh in on any study that may potentially be greater than minimal risk before determining that a study is greater than minimal risk. In making its risk assessment, the IRB considered the magnitude of potential risks and the probability of the participant experiencing these potential risks.

Magnitude and Probability of Risk

Magnitude of risk relates to the potential for negative effects or harms. The magnitude of the risk is impacted by:

• Duration: how long will the participant experience the negative effect? • Intensity: where on the spectrum of inconvenience-discomfort-distress-harm might

the negative effect fall? • Reversibility: Can the negative effect be reversed? Is it transient or permanent?

Responsible practices for risk assessment entail attention to the various types of risks a study might present followed by an assessment of their magnitude. Magnitude refers to the degree of negative impact or effects. Researchers should consider several factors:

• First, Duration – how long will the negative effect last? • Next, Intensity – How strong will the negative effect be? • Finally, Reversibility – Can the negative effect be reversed? Is it permanent or

transient?

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The probability of harm or discomfort refers to the likeliness or chance that the participant will experience negative effects from participation in the research activity. Probability refers to the rate at which something is likely to occur. The regulations require that the IRB consider the probability as it makes the risk assessment. Additionally, researchers should consider the probability that the risk will be encountered. Probability refers to how likely it is that the participant will experience the negative effect. While often a “common sense” reflection concerning probability is adequate, some topics require more in-depth analysis to determine actual probability. A researcher planning to interview participants experiencing PTSD should note, for example, that 80% of those diagnosed experience other forms of anxiety.

Assessing Risk The IRB is responsible for assessing risk to identify the type of risk and the magnitude and probability of the negative effect

• Assess personal bias prior to risk assessment; seek consultation as needed to manage bias

• Assess whether risk is comparable to those encountered in daily life • Consider the types of risk presented by the research • Weigh magnitude and probability of risk • Take systematic approach, avoiding “what if” scenarios • Consider whether risk can be minimized • Conduct risk/benefit analysis

The Institutional Review Board performs a risk assessment as part of IRB review. It is important for researchers to perform this same risk assessment and to anticipate and address concerns that may be identified by the IRB. Risk assessment should involve the following steps:

• Assess any personal bias you might bring to the topic and seek consultation if necessary to manage the bias.

• Assess whether the risk is comparable to those encountered in “daily life.” • Consider the types of risk the participant may encounter. • Weigh the probability and magnitude of the risk. • Consider whether the risk can be minimized. • Consider whether the risk might be justified based on the study’s potential benefits.

Disclosing Risk Risks should be disclosed as part of the IRB Application and in the informed consent documents

• Researchers should disclose the types of risks a participant may encounter • Researchers should reflect on the probability and magnitude of the risks and

highlight those risks that are more likely to occur and of greater magnitude • Researchers should explain in concrete terms plans for minimizing risks

Researchers sometimes worry that acknowledging that a study presents potential risks means that the IRB will not approve the study. However, the IRB is far more concerned when apparent risks are not disclosed. Researchers who carefully disclose and thoughtfully analyze potential risks are generally able to make modifications to the design or incorporate additional safeguards in order to minimize the risk to acceptable levels. Researchers who

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hide or efface risks rather than disclosing and managing them generally undermine not only their ability to protect participants, but ultimately the overall success of their study.

Minimizing Risk Once a risk has been identified, it should be minimized:

• Adequate informed consent allows participants to make a decision guided by clear and accurate information

• Psychological harm can be mitigated and perhaps reversed by debriefing, counseling, provision of resources

• Social harm can be minimized by careful attention to privacy and confidentiality and good data security plans

• Debriefing, counseling, provision of resources • Careful attention to privacy and confidentiality and good data security plans • Small participant incentives

Greater than Minimal Risk Studies Most research Capella University researchers do falls into the minimal risk category and the potential risks are relatively easy to mitigate. However, when selecting a topic, it is important to understand which populations may be considered vulnerable and which topics are considered sensitive. Studies involving vulnerable populations or sensitive topics may be determined to be greater than minimal risk, which means they are subject to more robust IRB review. If the study involves both vulnerable populations and sensitive topics, the level of risk increases and these studies likely will be determined greater than minimal risk. While robust review ensures the adequacy of participant protections, it can also be very time consuming, require multiple revisions to the research plan, and require more than a quarter to navigate. Researchers engaged in research with potentially vulnerable populations or sensitive topics should be prepared for this level of review. Additionally, the more risk associated with the study, the more likely the researcher will encounter challenges recruiting participants. The regulations include additional protections for prisoners and parolees, children and minors, and pregnant women. Additional populations are described as potentially vulnerable to research risks. Such individuals may be more likely to experience coercion or undue influence to participate in the research, may have limited capacity to consent to participation, or may be at increased risk of adverse events such as psychological distress. Whether or not an individual is considered vulnerable is determined on a case by case basis and may also depend on the nature of the research topic and methodology. Sensitive topics include ones that are more likely to lead to participant distress or result in participant risks such as social stigma, risk to employability, or legal consequences.

• Review Examples of Vulnerable Populations. • Review Examples of Sensitive Topics.

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