(NB) IRB

Research Ethics: The IRB Application Process

Introduction to IRB and Research Ethics

Research involving human subjects in psychology must adhere to strict ethical guidelines to protect participants' rights, safety, and welfare. The Institutional Review Board (IRB) oversees this process, ensuring that all research proposals meet federal and institutional standards.

• IRB (Institutional Review Board): A committee that reviews research proposals to ensure ethical treatment of human subjects.

• Research Ethics: Principles and standards that guide researchers in conducting studies responsibly and ethically.

• Human Subjects Research Office (HSRO): The administrative office supporting IRB functions at RIT.

IRB Structure and Branches

Organization of the IRB at RIT

The IRB at RIT consists of two main branches, each responsible for reviewing different types of research activities:

• NTID IRB: Reviews research focused on Deaf and hard of hearing populations.

• RIT IRB: Reviews general research activities from other colleges at RIT.

Members of the IRB come from diverse backgrounds, ensuring a well-rounded review process in accordance with federal guidelines.

Types of IRB Review

Categories of Review

The type of IRB review required depends on the level of risk and the nature of the research:

• Exempt Review: For research with no more than minimal risk, such as studies involving educational practices or public behavior observation.

• Expedited Review: For research with minimal risk that fits specific expedited categories, such as surveys or interviews.

• Full Board Review: Required for studies involving greater than minimal risk, including those with vulnerable populations or sensitive topics.

Examples of Exempt Review Categories

• Research in educational settings involving typical practices

• Educational tests, interviews, or observation of public behavior

• Study of existing, publicly available data that is not identifiable

• Evaluation of public benefit or service programs

Examples of Expedited Review Categories

• Research on individual or group characteristics or behavior

• Surveys, interviews, human factors evaluation

• Continuing research previously IRB-approved

• Clinical studies of drugs/medical devices

Full Board Review Requirements

• Inclusion of vulnerable populations (children, pregnant persons, prisoners, individuals with cognitive impairment, students, or employees)

• Studies in foreign countries with limited human subject protections

• Research where information may require mandatory reporting (e.g., child or elder abuse, illegal activities)

• Deception studies involving more than minimal risk

The Belmont Report: Ethical Principles

Key Principles for Human Subjects Research

The Belmont Report (1979) established foundational ethical principles for research involving human subjects:

• Beneficence: Do no harm; maximize possible benefits and minimize possible harms.

• Respect for Persons: Recognize autonomy and obtain informed consent.

• Justice: Ensure equitable distribution of risks and benefits.

IRB Application Process

Required Materials and Steps

To obtain IRB approval, researchers must submit a comprehensive application including:

• Completed IRB Form A (application form)

• Abstract summarizing the research

• Supplemental forms (e.g., consent form, debriefing materials)

• All materials/stimuli to be used in the study

• IRB Submission Checklist

Researchers must not begin data collection until IRB approval is granted. Initial feedback may require revisions and resubmission.

IRB Form A: Key Sections

Project Information

• Project title, investigator contact information, supervisor, funding details

• Anticipated start and data collection dates

• Required signatures and attachments

Research Problem and Benefits

• Describe the research problem and its significance (1-2 paragraphs with citations)

• Explain expected benefits and knowledge to be gained

• Address how the study fills a gap in existing research

Participants and Recruitment

• Anticipated number of participants and selection criteria

• Inclusion/exclusion rationale (e.g., color vision, age)

• Recruitment methods (SONA, social media, ads)

• Incentives (credit, extra credit, gift cards, cash)

Vulnerable Populations

• Rationale for including vulnerable groups

• Researcher expertise and facility safety

• Number of subjects (supported by power analysis or literature)

Data Collection and Confidentiality

• Methods, instruments, materials, and stimuli used

• Site of data collection (if outside RIT, provide details)

• Confidentiality vs. Anonymity:

  • Anonymity: No one, including the researcher, can link responses to participant identity.

  • Confidentiality: Researcher can link responses to identity but will not disclose information.

• Data organization (e.g., coded by numbers/letters, consent forms stored securely)

Risks and Precautions

• Describe potential risks (psychological, physical, social, legal)

• Assess likelihood and seriousness (minimal, moderate, high)

• Outline precautions to minimize risks

• Provide examples (e.g., temporary anxiety during a task)

IRB Review Timeline and Recommendations

Planning for IRB Review

• IRB meetings may take several weeks to schedule

• Investigators should plan data collection start dates accordingly

• Additional review may be required to address IRB questions

Summary Table: IRB Review Categories

Review Category	Risk Level	Examples	Review Process
Exempt	Minimal	Educational practices, public behavior observation, non-identifiable data	Reviewed by HSRO Director
Expedited	Minimal	Surveys, interviews, human factors, clinical studies	Reviewed by HSRO and additional reviewers
Full Board	Greater than minimal	Vulnerable populations, sensitive topics, foreign studies	Reviewed by convened IRB Board

Key Equations and Concepts

• Power Analysis: Used to determine the appropriate sample size for a study. $n = \frac{(Z_{\alpha/2} + Z_{\beta})^2 \cdot 2\sigma^2}{\Delta^2}$ Where: $n$ = sample size, $Z_{\alpha/2}$ = critical value for significance level, $Z_{\beta}$ = critical value for power, $\sigma^2$ = variance, $\Delta$ = effect size.

Additional info: The notes are based on a college-level psychology course (PSYC 251-01) focusing on research ethics and the IRB application process. The content is suitable for exam preparation and understanding the ethical requirements for conducting psychological research involving human subjects.