The Apus Institutional Review Board (IRB) Reviews And Approv

The Apus Institutional Review Board Irb Reviews And Approves All Res

The APUS Institutional Review Board (IRB) reviews and approves all research involving human subjects to ensure that it is conducted in accordance with all federal, institutional, and ethical guidelines. If the research involves APUS faculty, staff, and/or students, this research may also need approval of the Internal Research Review Board (IRRB). All human subject research under the aegis of APUS, regardless of funding source, must be reviewed and approved by the IRB before research can begin. Research reviewed by the APUS IRB must meet these criteria: · The research is sponsored by APUS. · The research is conducted or directed by any employee or trainee of the university in connection with his or her APUS responsibilities. · The research involves access to any property or facility of APUS. · The research involves APUS faculty, staff, and/or students.

This research may also need approval of the Internal Research Review Board (IRRB). How is a Human Subject Defined? A human subject is defined by federal regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (45 CFR 46.102(f)). Human subjects may participate in a study different ways: · They may be actively involved in the research process, such as responding to surveys or being interviewed. · Data about human subjects may be gathered from other sources, such as public records, existing datasets, medical records, or other sources. Research reviewed by the IRB · Involves living individuals about whom "an investigator conducting research obtains data through intervention or interaction with the individual." · Contains "identifiable private information" (Title 45 CFR, Part 46.102.f). · Includes secondary analysis of existing datasets where participants are individually identifiable. IRB Review Types Exempt A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories outlined in federal law 45 CFR 46.101(b). Briefly described, these categories are: 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. 2. Research using anonymous or no-risk tests, surveys, interviews, or observations. (Note that anonymous is not the same as confidential). You can learn more about this topic in your CITI training. 3. Most research involving public officials. 4. Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified. 5. Research examining public benefit or service programs. 6. Taste and food quality evaluation and consumer acceptance studies. Expedited A research design plan may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. The most common types of studies considered for expedited review include the following: 1. Collection of data from voice, video, digital, or image recordings made for research purposes. 2. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior), or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: some of this research may be considered exempt according to criteria above). 3. The collection of physical data through non-invasive procedures such as height and weight; MRI, ECG, ultrasound; moderate exercise; collection of blood samples by heel stick or finger stick. See a full list of procedures at 45 CFR 46.110. Full Board Research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process as this review type may take longer than the prior review processes. The following categories of research require full IRB approval: 1. Projects for which the level of risk is determined by the IRB Chair to be greater than minimal. 2. Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants. 3. Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals). 4. Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal). On your application, you should choose the type of review you believe is most appropriate for your project. The IRB Chair, with consultation from board members, can then revise your choice if necessary. Not Human Subjects Research According to federal guidelines, oral history is not required to undergo IRB review if it meets the ethical guidelines of the Oral History Association, including their ethical requirement to gain informed consent prior to conducting an interview, and a signed legal release at the conclusion of the interview. These issues are codified in the Oral History Association's Principles and Standards and Evaluation Guidelines. IRB Resources · U.S. Department of Health & Human Services Policy & Guidance Index

Paper For Above instruction

The Institutional Review Board (IRB) at APUS plays a critical role in safeguarding ethical standards in research involving human subjects. Its primary purpose is to review and approve all research activities to ensure compliance with federal, institutional, and ethical guidelines. This oversight helps protect the rights and welfare of participants, uphold the integrity of research, and maintain institutional accountability. The IRB's responsibilities extend to projects involving APUS faculty, staff, or students and may also involve the Internal Research Review Board (IRRB) when internal approval is required.

Understanding what constitutes human subject research is fundamental for researchers. According to federal regulations (45 CFR 46.102(f)), a human subject is a living individual about whom data is obtained through intervention or interaction, or whose private identifiable information is accessed. Participants can be involved actively, such as through surveys, interviews, or experiments; conversely, their information might be collected indirectly from various sources like medical records or public datasets. The scope of research reviewed by IRB includes studies involving living individuals, identifiable private information, or secondary analysis of existing but identifiable datasets.

The IRB categorizes research review types into exempt, expedited, and full board reviews. Exempt status applies to low-risk research, such as studies conducted in established educational settings, anonymous surveys or observations, and research using publicly available data. These activities meet specific federal criteria outlined in 45 CFR 46.101(b). Researchers need to be familiar with the criteria for exemption, often accessed through training modules like CITI.

Expedited review is suitable for minimal-risk research involving non-invasive procedures, collection of digital or visual data, or studies on behavior, perception, or social interactions that do not involve sensitive populations. Examples include recordings for research, surveys, and measurements like height, weight, or non-invasive imaging techniques. Such studies must still meet criteria for minimal risk and appropriate consent procedures.

Research involving greater than minimal risk, vulnerable populations such as children, prisoners, or individuals with disabilities, require a full IRB review. This comprehensive review considers the risk level, the use of intrusive procedures, and ethical considerations regarding the population involved. Researchers planning to undertake such studies should allocate sufficient time for the review process, which is typically longer than expedited or exempt reviews.

In addition, special considerations are made for research like oral history projects. These are generally exempt from IRB review if they adhere to the ethical standards of the Oral History Association, including obtaining informed consent and signed legal releases from participants.

IRB resources include federal policies and guidance from the U.S. Department of Health & Human Services, accessible through their Policy & Guidance Index. These resources support researchers in understanding compliance requirements and ethical standards for human subjects research.

In conclusion, the IRB's oversight ensures that human research conducted at APUS conforms to ethical principles protecting participants while allowing the university's research endeavors to proceed responsibly. Researchers must carefully determine their project's review category and adhere to approved procedures, ensuring that ethical considerations remain central throughout the research process.

References

  • Department of Health & Human Services. (2018). Human Subjects Research. Office for Human Research Protections. https://grants.nih.gov/policy/humansubjects.htm
  • 45 CFR 46, Department of Health & Human Services. (2018). Protection of Human Subjects. https://www.ecfr.gov/current/title-45
  • Council for International Organizations of Medical Sciences (CIOMS). (2016). International Ethical Guidelines for Health-Related Research Involving Humans.
  • Office of Research Integrity. (2019). Ethical Principles in Research. https://ori.hhs.gov/eti
  • National Institutes of Health. (2023). Human Subjects Research Policies. NIH.gov. https://grants.nih.gov/policy/human.subjects.htm
  • Levine, R. J. (2003). Ethics and Regulation of Clinical Research. Yale University Press.
  • American Psychological Association. (2017). Ethical Principles of Psychologists and Code of Conduct. https://www.apa.org/ethics/code
  • Fletcher, R. H., & Wagner, E. H. (1995). Evidence-Based Health Policy. JAMA, 274(19), 1547–1550.
  • Resnik, D. B. (2015). What's Wrong with Bioethics? Kennedy Institute of Ethics Journal, 25(1), 45–66.
  • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

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