An IRB’s primary responsibility is to review planned research studies before they are conducted. This review aims to ensure a favorable balance of risk and benefits; minimization of risks to participants; fair recruitment practices that do not exploit particular groups; and adequate plans to secure valid, voluntary, informed consent when necessary. No recruitment, enrollment, or data collection may begin until an IRB reviews the research study.
In the United States, if research is conducted or supported by a federal government agency (such as the National Science Foundation or the Department of Education), or if data collected will be submitted to the Food and Drug Administration (FDA), then IRB review is required by law. However, academic research institutions almost always require that all human research conducted by students, faculty, and staff members undergo some type of IRB review, regardless of funding source or type.
Because federal research regulations and professional codes do not dictate specific requirements for all situations in research, institutions that conduct research also develop and disseminate their own detailed policies. These policies must be consistent with the federal regulations; but they may include additional requirements, some of which are more stringent than the federal regulations. Researchers are expected to follow their institution-specific policies in addition to the federal regulations.
More questions? See #6, #10, and #81.
Question #10 When I Begin Developing My Research, What Ethical Issues Should I First Consider?
This book provides tips for addressing specific ethical issues that may arise in social and behavioral sciences research, but how do you know which issues are relevant to your research? For all your studies, you must first and foremost demonstrate respect for participants. This may be accomplished by obtaining informed consent for participation, although consent may take a variety of forms, and in some cases, may not be required. More on this in Part 5. You must also ensure that your research has the potential to do more good than harm. Research poses a variety of risks. More on this in Part 2. You must ensure that you are fair in your selection of research participants. This is covered in Part 6. Where to begin!? Consider your topic area, target population, methods, and data sources. Here are some questions to help you get started.
What is the focus of your research, and what kinds of information do you want to collect? Will you be asking about or be in a position to observe illegal or socially stigmatized behavior? Will you learn information about people that they might not want shared with others? Even if you’re not asking people about illegal or stigmatized behaviors, you might be asking them to tell you information that they consider personal and private. What people perceive as personal and private varies greatly, so avoid making assumptions about participants’ needs. In any study, regardless of the topic, researchers must follow best practices to protect participants’ privacy and the confidentiality of their data. More on this in Part 3.
Who is your target population? Might some or all of the individuals you want to recruit have difficulty understanding what the research is about and their rights as participants (including the right to say “no”) because of either cognitive deficits, limited English proficiency, or young age? Might some have a difficult time saying “no” to participating because you are in a relationship with unequal power? More on ethical considerations and best practices for research with a variety of vulnerable populations in Part 4.
How will you find your participants? What research method (or methods) do you plan to use? Self-administered online surveys, face-to-face or telephone interviews, focus groups, or observations? Each poses unique ethical challenges. For example, focus groups limit your ability to maintain participants’ privacy and the confidentiality of their data. Using deception in research may help you to collect more reliable information from participants, but you must consider ethical trade-offs. More on ethical issues to think about when designing your research in Part 6 and implementing your research in Part 10.
What will be your primary sources of data? Surveys? Observations? Data that exist in cyberspace? More on unique ethical challenges posed by different types of data sources in Parts 7 and 9.
Lastly, as you begin thinking about conducting a research study, you must find out the requirements and process for ethical review at your institution. More on the institutional review board submission process in Part 8.
More questions? See #11, #18, and #34.
Question #11 What Is Risk, and What Are the Risks in Social and Behavioral Sciences Research?
Risk is defined as the possibility of something happening that is in some way harmful. Risk has two parts: the magnitude or degree of harm that might occur, and the probability that it will occur.
In research, risks are harms or discomforts that study participants could potentially experience from taking part in the research. As in life, where individuals experience some level of risk every day, participating in research always has risks. In most social and behavioral sciences research, the probability of harm is low, and the magnitude of potential harms is small. Therefore, most social and behavioral sciences research meets the definition of minimal risk research (see Question #13), which may affect certain requirements for institutional review board oversight and informed consent. However, despite the fact that risk is generally low, it is important for all social and behavioral sciences researchers to carefully assess risk in each study, no matter what their discipline, topic, method, or target population.
When thinking about types of risks in research, we often think first of physical harms, such as pain or bruising from having blood drawn or unpleasant side effects from taking an experimental drug. For research in the social and behavioral sciences, physical harm from study participation is usually not a concern. However, researchers in the social and behavioral sciences must think about other types of risks, including potential psychological, economic, legal, social, and dignitary harms. Potential group-level harms should also be considered.
Some harms may occur during the collection of research data. For example, psychological harms are emotional responses such as sadness, anxiety, or embarrassment that may result from sharing information with researchers.
Other types of harms may occur if a research participant’s sensitive personal information is revealed to people outside of the study (see Part 3: Protecting Privacy and Confidentiality). Informational and identity breaches may result in economic, legal, or other social harms. Economic harms include negative effects on employment, such as loss of employment, or on future employability. For example, an employer may develop a negative perception of a participant because of inappropriately disclosed research findings and therefore not hire him or her. Economic harms may also include loss of business or sales, for example, if customers learn from inappropriately disclosed research findings that a business owner previously engaged in illegal behavior.
Legal harms could include arrest, imprisonment, or other legal action such as losing custody of one’s children. For example, mandatory reporting laws require individuals in certain professions, such as teachers and social workers, to report any known child abuse. If research participants disclose to a mandatory reporter during research that they are neglecting their children, researchers are required to report them to the appropriate authorities.
Social harms occur when participants’ relationships with others or their reputations are negatively affected because of the research. For example, if a woman is participating in a research telephone interview and her husband overhears responses to questions about her sexual history, this could damage trust between them.
Research may also include the risk of dignitary harm. This refers to the idea that people can be “wronged” without actually suffering tangible harm. For example, some people may feel violated