What action must a researcher take if an Institutional Review Board (IRB) identifies ethical concerns with a proposed study?

During the institutional review, an Institutional Review Board (IRB) may identify ethical concerns or questions about a proposed study. Researchers must respond to these inquiries in good faith and without delay, which may require them to make additional modifications to their research design and procedures to better protect participants prior to resubmitting their protocol.

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Before beginning a study, researchers must secure formal permission from their institution or course instructor, following specific local policies. This procedure typically requires submitting a detailed research protocol to an oversight committee, like an Institutional Review Board (IRB), to confirm that the proposed study adheres to ethical standards and adequately safeguards participants.

Institutional Approval

An institutional review board is a committee required by federal regulations for universities, hospitals, and other institutions receiving federal support. Its responsibility is to review research protocols for potential ethical problems, ensuring that risks are minimized, benefits outweigh risks, research is conducted fairly, and informed consent procedures are adequate. The board must consist of at least five people with diverse backgrounds, including scientists and nonscientists, men and women, various professions, and at least one person unaffiliated with the institution.

Institutional Review Board

A research protocol is a detailed, formal document outlining a proposed scientific study that investigators must submit for institutional approval. It comprehensively describes the study's core objectives, methodological design, step-by-step procedures, risk-benefit assessment, strategies to minimize potential participant harm, and plans for obtaining informed consent and conducting debriefing.

Research Protocol

After identifying potential hazards, researchers can often eliminate or reduce them by altering the research design. This risk minimization strategy can involve simplifying the study procedure to avoid participant frustration or replacing highly offensive and upsetting stimulus materials with milder alternatives, ensuring the study remains effective while subjecting participants to less stress.

Minimizing Risks through Research Design Modification

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Researchers should view the institutional approval process not as a bureaucratic hurdle, but as a constructive opportunity to thoroughly consider the ethical dimensions of their study. This process encourages consultation with committee members and peers who can offer diverse perspectives and extensive experience, thereby enhancing the research's ethical foundation.

Value of the Institutional Approval Process

Addressing IRB Concerns

A researcher's ethical obligations do not end once a study receives institutional approval. It is critical to adhere strictly to the submitted research protocol throughout the study. If any adjustments beyond minor changes are required, the researcher must seek additional approval from the institutional review board before implementing those modifications.

Adhering to the Protocol

What is the primary purpose of securing institutional approval before beginning a research study?

An experimental psychologist wants to investigate the impact of stress on problem-solving abilities. Below are two potential procedures for the study. As a member of the committee that reviews research proposals to ensure participant safety and ethical conduct, which procedure would you approve? Justify your decision by referencing at least two distinct ethical principles that guide such reviews.

Ethical Review of a Research Proposal

A psychologist proposes a study to examine the effects of 48 hours of continuous sleep deprivation on the problem-solving skills of student volunteers. The proposal states that participants will be compensated and that the findings could have important implications for understanding workplace safety. When this proposal is submitted for review, what is the most critical issue the review committee responsible for protecting human participants will focus on?

An informed consent form is a formal written document that participants review and sign to officially agree to partake in a study. It comprehensively outlines the research procedures, potential risks and benefits, and the participant's right to withdraw, adhering to specific ethical standards (such as APA Standard $$8.02$$a). To ensure comprehension, researchers typically supplement this form with a clear verbal explanation of the study.

Informed Consent Form

Minimal risk describes a level of potential harm in research that does not exceed the risks individuals ordinarily experience in their daily lives or during routine physical or psychological evaluations. Establishing this threshold is essential for institutional review boards (IRBs) to determine the necessary level of oversight, such as qualifying a study for expedited review.

Minimal Risk

Expedited research involves studies that pose a somewhat higher risk than exempt research but still expose participants to no more than minimal risk, which is defined as risks encountered by healthy individuals in daily life or during routine examinations. Because the risk is minimal, expedited review can be conducted by just one member of an institutional review board or by a separate committee under the board's authority, rather than the full committee.

Expedited Research

In federal research regulations, exempt research represents the lowest level of risk and includes studies such as the evaluation of normal educational activities, the use of standard, non-sensitive psychological measures that maintain confidentiality, or research utilizing existing public data. Once this type of research receives initial approval, it is considered exempt from regular, continuous review by an institutional review board.

Exempt Research

What is the primary responsibility of an Institutional Review Board (IRB)?

Which of the following best describes a research protocol?

A prominent example of modifying a research design to reduce participant risk is Jerry Burger's $$2009$$ replication of Stanley Milgram's obedience study. To avoid the severe psychological stress caused by the original experiment, Burger stopped the procedure just before participants administered a $$150$$-volt shock, rather than allowing them to proceed to the $$450$$-volt maximum. This modification was effective because past data showed that participants who reached $$150$$ volts typically continued to the maximum, allowing Burger to validly compare obedience rates while minimizing harm.

Burger's Modification of Milgram's Study

A foundational moral principle in psychological research is that a study is only ethical if its potential benefits outweigh its risks. This ethical evaluation can be challenging, as the risks and benefits are often not directly comparable and may affect different groups; for instance, a study might pose significant risks to the research participants while offering substantial benefits primarily to the scientific community or society.

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