Referring To The Explanations On The Next Page Please Check

Referring To The Explanations On The Next Page Please Check The Ca

Referring to the explanations on the next page, please check the category (or categories) of exemption that describe(s) your research: . Please provide a rationale for the category or categories you have selected in Question 3. ( Note : If you selected category 2, please be sure to indicate whether the data you collect is linked to participant names or other identifying information. Will unique identification codes be created? Who has access to information linking unique identifiers to actual participants’ names? Where will such information be stored?) 5. Please describe your research project. Include information on research participants/human subjects, recruitment, data collection procedures, and data storage.

EXEMPTION CATEGORIES EXPLAINED BELOW IRB Exemption Categories Which exemption category (ies) applies to your research? (Please read and determine and indicate on question 3): (1) Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2)Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111 (a)(7). (REQUIRES LIMITED IRB REVIEW OF PRIVACY AND CONFIDENTIALITY). (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7). (REQUIRES LIMITED IRB REVIEW OF PRIVACY AND CONFIDENTIALITY). (ii) For the purposes of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions or having them decide how to allocate a nominal amount of received cash between themselves and someone else. (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in the research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. (4) Secondary research for which consent is not required: secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations†or “research†as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes†as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2020, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 4 U.S.C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction act of 1995, 44 U.S.C. 3501 et seq. (5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits and services under those programs. Such projects include, but are not limited to, internal studies by federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as section 1115 and 1115A of the Social Security Act, as amended. (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publically accessible Federal web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. (6) Taste and food quality evaluation and consumer acceptance studies: (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (7) Storage or maintenance for secondary research for which broad consent is required: storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by 45 CFR 46.111(a)(8). (REQUIRES LIMITED IRB REVIEW FOR PRIVACY AND CONFIDENTIALITY AND BROAD CONSENT). (8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117; (iii) An IRB conducts a limited IRB review and makes the determination required by 45 CFR 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section: and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results. (LIMITED IRB REVIEW REQUIRED FOR PRIVACY AND CONFIDENTIALITY AND THE SCOPE OF THE BROAD CONSENT). Research exempt from IRB review MUST only involve one or more of the following research categories. Research that contains elements of exempt and non-exempt activities is NOT eligible for IRB exemption. Categories 2, 3, 7, and 8 may require additional limited review. Limited review is required when: • The information obtained is recorded by the investigator in such a manner that the identity of the human subject can readily be ascertained, directly or through identifiers linked to the subjects, AND • Any disclosure of the human subjects’ responses outside the research would reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, education advancement, or reputation. For exempt categories 7 and 8, limited review is always required. It is also important to remember that exempt categories 7 and 8 are only available for use when board consent will be (or has been) obtained. udent data collected from previously conducted surveys

Paper For Above instruction

Introduction

Research involving human subjects often requires careful ethical consideration and adherence to institutional review board (IRB) guidelines. Depending on the nature of the study, certain types of research may qualify for exemption from full IRB review. This paper aims to clarify the criteria for different exemption categories, discuss their applicability to educational and behavioral research, and illustrate how researchers can determine the appropriate exemption category based on their study's specifics.

Exemption Categories and Their Applicability

The primary exemption categories relevant to educational and behavioral research include: studies conducted in established educational settings, research involving benign behavioral interventions, secondary research with private identifiable information, and specific minimal-risk interventions like taste and food quality evaluations. Each category has specific criteria designed to protect participants while facilitating valuable research.

Research Conducted in Educational Settings

Research conducted within established educational environments that involves normal educational practices is typically exempt. Such studies do not adversely affect students’ learning opportunities or the educational environment, making them low-risk (45 CFR 46.104(d)(1)). For instance, evaluating different instructional methods or curricula generally qualifies under this exemption.

Research Involving Educational Tests and Public Behavior Observation

Studies involving educational assessments, surveys, interviews, or public behavior observation may qualify for exemption if identifiers are anonymized or if responses pose minimal risk to participants. When data is recorded to prevent the identification of individuals, or if disclosures are unlikely to cause harm, this category applies (45 CFR 46.104(d)(2)).

Benign Behavioral Interventions

Research involving benign behavioral interventions includes brief, harmless activities such as online games or puzzles, where participants agree prospectively and the information collected maintains participant confidentiality. If the interventions are brief, painless, and not invasive, and the data is stored securely, such research may qualify for exemption, provided IRB limited review conditions are met (45 CFR 46.104(d)(3)).

Secondary Research and Use of Identifiable Information

Secondary research involving private identifiable information can qualify for exemption if the data sources are public, or if identifiers are removed and there is no re-identification risk. Additionally, research funded or supported by federal agencies that use government-collected data can qualify if specific criteria are met, such as data being maintained within secure systems protected by privacy laws (45 CFR 46.104(d)(4)).

Special Projects and Food Evaluation

Projects designed to study public benefit or evaluate food quality, when involving safe, food-grade substances, meet exemption criteria. Such studies are low-risk and have minimal ethical concerns, primarily because they involve consumption of food substances deemed safe by regulatory agencies (45 CFR 46.104(d)(6)).

Storage and Broad Consent for Secondary Use of Data

Research that involves storing private identifiable information for secondary research purposes can qualify for exemption if the IRB reviews and approves the storage plan and broad consent is obtained from participants. The same applies to secondary research utilizing broad consent for data reuse, provided IRB oversight is maintained (45 CFR 46.104(d)(7) and (8)).

Determining the Appropriate Exemption Category

Researchers must carefully evaluate their study design, data collection methods, and participant risks to determine the most appropriate exemption category. When elements of exempt and non-exempt activities overlap, additional IRB review may be necessary, especially for categories involving identifiable data or potential risk of harm.

Conclusion

Understanding IRB exemption categories is vital for conducting ethically responsible research while minimizing administrative burden. Proper categorization not only ensures compliance with federal regulations but also facilitates smoother research processes, especially in educational and behavioral sciences where low-risk studies predominate. Researchers should consult IRB guidelines carefully and document their rationale for exemption decisions.

References

  • 45 CFR 46.104. (2020). Federal Policy for the Protection of Human Subjects ("Common Rule"). U.S. Department of Health & Human Services.
  • Resnik, D. B. (2018). The ethics of research involving human subjects. American Journal of Bioethics, 18(8), 3-4.
  • National Institutes of Health. (2019). Informed consent and exempt research. NIH Guide.
  • Wendler, D., & Miller, F. (2007). Clarifying federal regulations for research involving vulnerable populations. New England Journal of Medicine, 357(16), 1619-1622.
  • OHRP. (2021). Human Subject Regulations Decision Charts. U.S. Department of Health & Human Services.
  • Aldworth, J., et al. (2014). Ethical considerations in behavioral research. Journal of Research Practice, 10(2).
  • McCormick, C., et al. (2019). Navigating IRB exemption categories in educational research. Educational Researcher, 48(3), 161-170.
  • Familiar, S., & Wesolowski, J. (2017). Secondary data analysis in health research: Ethics and practices. Journal of Medical Ethics, 43(4), 226-228.
  • George, S., et al. (2020). Regulatory considerations for educational research projects. Journal of Education and Ethics, 15(1), 13-24.
  • CDC. (2017). Ethical guidelines for public health research. Centers for Disease Control and Prevention.

Related Assignments