ࡱ>  8bjbj.. =D_D_C; 8t05 DP(xxx4444444$8;4E4xxH4 xx4 4 {0#2~1k4500551< <,#2#2<724 44 05< X V: MORAVIAN UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB) EXEMPTION REQUEST FORM This form must be completed for any research activity involving human participants for which the researcher wants to claim exemption from the IRB review process. All researchers should review the ̽ Human Subjects Research Policy found at  HYPERLINK "/irb" /irb before submitting their proposals. Submit electronic copies of your completed Exemption Request Form as well as a copy of all of your instruments (surveys, tests, etc.) to:  HYPERLINK "mailto:hsirb@moravian.edu" hsirb@moravian.edu We require all forms and surveys to be submitted as Word or PDF documents (no documents shared via Google Drive). However, you may provide links to instruments if they will be accessible online. Please make sure that the file name clearly indicates the proposers name and the content of the file. So, for example, please call your document something along the lines of wilkenfeld.exemptionform.docx and wilkenfeld.survey.docx. Questions: contact Executive board members Dr. Sarah Johnson, Department of Psychology:  HYPERLINK "mailto:johnsons@moravian.edu" \h johnsons@moravian.edu Dr. Debra Wetcher-Hendricks, Department of Sociology:  HYPERLINK "mailto:wetcherhendricksd@moravian.edu" \h wetcherhendricksd@moravian.edu Dr. David Wilkenfeld, Department of Rehabilitation Sciences:  HYPERLINK "mailto:wilkenfeldd@moravian.edu" \h wilkenfeldd@moravian.edu Part I: Basic Proposal Information 1. Proposer: 2. Department: 3. E-mail address: 4. Phone: 5. List of Co-investigators with emails; include institution for non-̽ co-investigators [Note: CITI training is not required for approval of an exemption request]: 7. Title of Proposal: 8. Faculty Advisor (if applicable): 6. Research Start/End Dates: Format as month, day, year. Please allow at least 1 week between the date you submit your request and your proposed start date (actual turnaround time may be shorter or longer than 1 week). Proposed start date: Proposed end date: 9. Funding/compensation: a. List the research funding sources, if any. b. Is compensation being provided to participants? If so, briefly describe and state the source of the compensation funds. 10. The results of this research will be published. _____ Yes _____ No _____ Uncertain If you marked yes or uncertain, please provide a brief description of the possible forum of publication (for example, peer-reviewed journal, conference presentation, etc.) in the space below: 11. Brief description of target participant pool and estimated number of participants intended: 12. Proposal description (please be brief): 13. List of instruments (surveys, tests, inventories) that are being used (and please attach all surveys, etc. If you cannot attach them, please explain why not):  Part II: Exemption Categories Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review. These categories are taken from  HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-a-46104/index.html" 45 CFR 46.104 from the U.S. Department of Health & Human Services. If you need help Please check those items that apply to your research.  FORMCHECKBOX  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.  FORMCHECKBOX  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 HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.111(a)(7)" 46.111(a)(7). NOTE for research involving CHILDREN: Sections i and ii of this section only may apply to children if the research involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Section iii of this section may not be applied to research with children.  FORMCHECKBOX  (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 HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.111(a)(7)" 46.111(a)(7). (ii) For the purpose 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 behavioral 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 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. NOTE: This exemption category does not apply to research involving children.  FORMCHECKBOX  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 investigators 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 2002, 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, 5 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.  FORMCHECKBOX  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 or 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 sections 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 publicly 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. (ii) [Reserved]  FORMCHECKBOX  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.  FORMCHECKBOX  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 HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.111(a)(8)" 46.111(a)(8).  FORMCHECKBOX  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 HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.116(a)(1)" 46.116(a)(1)through HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.116(a)(4)" (4), HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.116(a)(6)" (a)(6), and HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.116(d)" (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.117" 46.117; (iii) An IRB conducts a limited IRB review and makes the determination required by HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html" \l "46.111(a)(7)" 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 HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-a-46104/index.html" \l "46.104(8)(i)" (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. Part II Cont d: Exemption Categories If you do not qualify for exemption under any of the categories above, but believe your research should still qualify as exempt, please explain your reasoning here:  FORMTEXT       Part III: Privacy How will privacy of participants be maintained (specify whether you will provide full anonymity vs. confidentiality, and how)?  FORMTEXT       Explain criteria for participant selection/method of participant recruitment:  FORMTEXT       Will consent be obtained?  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FORMCHECKBOX  Written  FORMCHECKBOX  Verbal Attach a copy of the consent statement or a script that will be used to verbally request consent. Any additional comments re: privacy?  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