Research Ethics and Inclusion

Questions and Answers

An increase in cost is an acceptable reason for excluding women, minorities, and their subpopulations in clinical research.

False

The Code of Federal Regulations (45 CFR 46.111), the U.S. Food and Drug Administration (FDA) and the National Institutes for Health (NIH) address the inclusion of women and minorities in research.

True

A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.

True

All research is expected to include both sexes and members of every racial/ethnic group and subpopulations as participants.

False Signup and view all the answers

What are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice Signup and view all the answers

What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

The study has a maximization of benefits and a minimization of risks. Signup and view all the answers

What aspect does the Belmont Report indicate is necessary to avoid conflicts of interest?

It indicates that it is necessary to rigorously avoid conflicts of interest. Signup and view all the answers

The history of ethical regulations in human subjects research began with which document?

Nuremberg Code Signup and view all the answers

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (Select all that apply)

Faculty Advisor/Research Mentor Signup and view all the answers

Which elements must be included in an informed consent?

All foreseeable risks and discomforts. Signup and view all the answers

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt Signup and view all the answers

How can faculty researchers avoid coercion of student subjects?

Avoid using their own students in their research Signup and view all the answers

What type of review would a study that involves a survey without identifiable information be categorized as?

Exempt Review Signup and view all the answers

What type of review would a dissertation study involving interviews and identifiable information be categorized as?

Full Board Review Signup and view all the answers

What category does a study involving junk food inquiries that do not collect identifiers fall under?

Not Human Subjects Signup and view all the answers

Which studies need IRB approval?

Studies collecting data about living individuals. Signup and view all the answers

What is the Institutional Review Board (IRB) charged with? (Select all that apply)

Protecting the rights and welfare of human subjects. Signup and view all the answers

What action can a professor expect from the IRB when submitting a biography research proposal?

The IRB will not review this study because it is not research as defined by the federal regulations. Signup and view all the answers

Which of the following studies meets the definition of research with human subjects? (Select all that apply)

Videotaping interactions between toddlers and caregivers. Signup and view all the answers

According to federal regulations, what is defined as human subjects?

Living human beings about whom an investigator obtains data through interaction or intervention with the individual or identifiable private information. Signup and view all the answers

Which study meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine effective intervention methods. Signup and view all the answers

A medical record is an example of what?

Private information. Signup and view all the answers

When must continuing review of an approved and ongoing protocol occur?

Must occur within 12 months of the approval date. Signup and view all the answers

Under what condition can the expedited review process be utilized?

When the study procedures pose no more than minimal risk. Signup and view all the answers

In addition to pregnant women, fetuses, and neonates, which other vulnerable population is provided protections by DHHS regulations?

Prisoners Signup and view all the answers

Research is eligible for exemption if it falls into what?

The research falls into one of six categories of research activity described in the regulations. Signup and view all the answers

Which statement about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval. Signup and view all the answers

What is the primary purpose of a Certificate of Confidentiality?

Protect identifiable research information from compelled disclosure. Signup and view all the answers

What would be most helpful if the consent form is the only record linking a subject to research that could be potentially harmful?

Obtain a waiver of documentation of informed consent. Signup and view all the answers

What is a likely additional risk for subjects in research studying generational differences in coping mechanisms?

Experience emotional or psychological distress. Signup and view all the answers

What is the most accurate statement about risks in social and behavioral sciences research?

Risks are specific to time, situation, and culture. Signup and view all the answers

Identify an example of when situation and time is key to assessing risk of harm in a research study.

Asking women if they have had an abortion. Signup and view all the answers

Risk of harm in social and behavioral sciences generally falls into how many categories?

Three categories: invasion of privacy, breach of confidentiality, and study procedures. Signup and view all the answers

Which statement about parental permission in research with children is correct?

The parents of the children might feel pressure to give permission to the therapist to use their children's data. Signup and view all the answers

What is an example of exculpatory language in a consent form?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. Signup and view all the answers

Study Notes

Inclusion in Research

Excluding women and minorities from clinical research due to increased costs is unacceptable.
The Code of Federal Regulations, FDA, and NIH emphasize the importance of including women and minorities in research studies.

Minority Groups

Definition: A minority group is an identifiable subset of the U.S. population distinguished by racial, ethnic, and cultural heritage.

Belmont Report Principles

The Belmont Report highlights three core principles: Respect for Persons, Beneficence, and Justice.

Ethical Guidelines

The Principle of Beneficence in research ensures maximization of benefits and minimization of risks.
The Belmont Report emphasizes the need for rigorous avoidance of conflicts of interest.

Research Ethics History

The Nuremberg Code marks the beginning of ethical regulations in human subjects research.

Informed consent must include all foreseeable risks and discomforts involved in a study.
Exempt review does not require full IRB approval but does require an IRB determination for certain studies.

Research Categories

Student researchers can find IRB approval resources through Faculty Advisors and the IRB Office.
Studies collecting data about living individuals mandate IRB approval.
Research categorization: Exempt Review for studies with no identifiable information; Full Board Review for studies collecting identifiers.

IRB Responsibilities

The IRB is responsible for protecting human subjects' rights and welfare, ensuring compliance with regulations, and reviewing recruitment materials and strategies.

Definition of Research with Human Subjects

Research is defined as any study obtaining data through interaction or intervention with living individuals or identifiable private information.

Vulnerable Populations

Additional protections under DHHS regulations extend to prisoners, alongside pregnant women, fetuses, and neonates.

Certificate of Confidentiality

The primary purpose is to protect identifiable research information from being disclosed involuntarily.

Risks in Research

Risks can lead to emotional or psychological distress, particularly in sensitive topics (e.g., abuse).
Risks specific to social and behavioral sciences research depend on time, situation, and cultural context.
Categories of risk in research: invasion of privacy, breach of confidentiality, and study procedures.

Parental Permission

Researchers must be cautious about the pressure parents might feel to give permission for their children's data use in research settings.

Informed consent must avoid exculpatory language that waives a subject's legal rights or releases researchers from liability related to negligence.

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Description

This quiz explores the ethical principles guiding research, including the importance of including women and minorities in clinical trials. It covers key documents like the Belmont Report and historical guidelines such as the Nuremberg Code, emphasizing their relevance in today's research practices.