ࡱ> vystu/ wbjbjNN oF,bh,bho'!@ @ """Tvvvvb`^(_______$Zbe`"e#G@e#e#`-`&&&e#8"_&e#_&&jY ] +c$BQ[2_2`0b`[*e%ed]]8e"]5 |& d!P``_&jb`e#e#e#e#e@ X : 91Ϣ of Health Sciences Institutional Review Board 16200 E Amber Valley Drive Whittier, CA 90604 Phone: 562 947 8755 Fax: 562 947 5724  91Ϣ of Health Sciences Exemption from IRB Review OR Expedited Review Request Form and Application Statement of Policy: 91Ϣ of Health Sciences (SCU) has an approved policy for the protection of human subjects from research risk as set forth in Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46). It is the policy of SCU that, except for those categories specifically exempted by 45 CFR 46 (see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), all research covered by this assurance will be reviewed and approved by the Institutional Review Board (IRB) established under the policy, regardless of the source of funding of the research. Studies meeting exemption criteria are considered human studies research. As such, the IRB policy requires that exemptions be determined by the IRB and not by the Investigator. A study qualifying for an exemption is of minimal risk to participants and exempt from further review by the IRB. However, should an Investigator amend the study once it receives an exemption, the IRB recommends that the Investigator confirm with the IRB that the study still meets the initial exemption criteria. Currently, there are eight categories of exemption; the four most common to SCU educational research are listed below. 46.104Exempt research (a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category. (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1)Subpart B.Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. (2)Subpart C.The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners. (3)Subpart D.The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D. (c) [Reserved] (d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy: (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 46.111(a)(7). (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 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. (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 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. 3501et 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 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] (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 46.111(a)(8). (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 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 46.117; (iii) An IRB conducts a limited IRB review and makes the determination required by 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. 45 CFR 46.110 Expedited Review Procedure Applicability Research activities that (1) present no more than minimal risk to human subjects, and (2)involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. The categories in this list apply regardless of the age of subjects, except as noted. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The expedited review procedure may not be used for classified research involving human subjects. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB. Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Research Categories Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html" \l "footnote2" [2], considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c)permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html" 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) Collection of data from voice, video, digital, or image recordings made for research purposes. 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 research in this category may be exempt from the HHS regulations for the protection of human subjects. HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html" 45 CFR 46.101(b)(2)and (b)(3). This listing refers only to research that is not exempt.) Continuing review of research previously approved by the convened IRB as follows: where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.  HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html" \l "backfootnote1" [1]An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html" 45 CFR 46.110.  HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html" \l "backfootnote2" [2]Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html" 45 CFR 46.402(a). Source: HYPERLINK "https://www.hhs.gov/ohrp/news/federal-register-notices/federal-register-11-09-1998-vol-63-no-216/index.html" 63 FR 60364-60367, November 9, 1998. Instructions: Please be certain to provide all requested data. Instructions listed in red font indicate a need for an attachment. Please submit this document, along with the check list and any necessary attachments, electronically. In addition, please mail a signed hardcopy to the address located at the top of this form to the attention of Christine Lemke, Chair, Institutional Review Board. Declaration of Exempted or Expedited Status Please check the category of exemption or expedited status (from page one) that you feel this study qualifies for: Exempted CategoryCategory 1Category 2Category 3Category 4Category 5Category 6Category 7Category 8 ExpeditedCategoryCategory 1Category 2Category 3Category 4Category 5Category 6Category 7Category 8Category 9 Instructions: Please be certain to provide all requested data. Instructions listed in red font indicate a need for an attachment. Please submit this document, along with the check list and any necessary attachments, electronically. In addition, please mail a signed hardcopy to the address located at the top of this form to the attention of Christine Lemke, Chair, Institutional Review Board. Section 1 Project Identification Table 1 Complete this table for all investigators NameTitle & DepartmentAcademic Degree(s)TelephoneEmail AddressCompleted Human Subjects Protections Training (date) Table 2 Submission DateTitle of Project In the space below, describe the expected duration of project through data analysis: Start Date: _________________ End Date:___________________ Table 3 Other Review Boards Involved (include copies of other IRB approvals/denials as an appendix to this application): InstitutionIRB Contact NamePhone NumberEmail (if applicable) Section 2 Description of the Project List the Hypotheses: Describe the specific aims of this project: Describe the currently available research on this subject (include evidence if a review of the literature as an appendix to this application): Description of project protocol & methods: (or include on separate document) Will the human subjects complete questionnaires? If yes, specify their nature, duration and frequency of their administration. (Include the questionnaire/survey as an appendix to this application.) State the significance of this project to the health and welfare of the general public: Describe the risks to the participants and how those risks will be minimized: List who outside of the investigators has peer-reviewed this project: List all funding resources and protocols (grants or other funding): Section 3 Description of the Human Subjects of the Research Estimated number of individuals to be enrolled: ____________ Description of target demographics: List the inclusion criteria for the subjects/records: List the exclusion criteria for the subjects/records: Section 4 Description of the Recruitment Procedures Please explain recruitment procedures in detail (please note: all advertisements must be IRB approved prior to use. Please include a copy of all proposed recruitment materials (brochure, flyer, email, poster etc.) as an appendix to this application. Future and altered recruitment ads can be submitted with a modification request at a later date if needed.): Will the subjects include pregnant women, neonates, human fetuses, children, or prisoners? Describe the provisions for subject ability to decline participation: Expected dates for recruitment period: Start:_________ End:_________ Expected duration of participation of each subject: Indicate the source of subject recruitment (clinics, hospital, general public, campus): Will the subjects receive payments or other compensation (free clinic visit, course points, tied to course grade, etc) for participating? If yes, indicate amounts: Section 5 Description of Informed Consent and HIPAA Authorization Procedures Will this be a survey study using a web-based survey instrument that is completely anonymous and include a request for a waiver of informed consent? If yes, answer yes on this question and continue to question 8. Please be sure to include a consent statement at the beginning of your survey instrument (include the copy with this proposal). Is the investigator requesting a waiver of any required element of informed consent? If yes, full waiver or waiver of documentation (signature)? Please summarize your reason for seeking the waiver and complete the SCU IRB Informed Consent Waiver Request Form and submit with the proposal. Will Personal Health Information be accessed and/or utilized for this research? If so, please describe. Is a HIPAA Waiver of Authorization being requested? If yes, please summarize your reason for seeking the waiver and complete the SCU HIPPA Waiver Request Form and submit with the proposal. Describe how the consent of the human subjects will be obtained: (include a copy of the written consent documents as an appendix to this application) Describe the circumstances under which consent will be sought and obtained: Describe the method of documenting consent (who will be obtaining the consent, how will it be recorded and stored, who has access to this documentation, etc): Is classroom time being used for any part of the study? If yes, please indicate how much course time will be used and what activity is planned for non-participants during the class session in order to preclude the pressures to participate. Section 6 Data Collection, Storage, Destruction How will data be collected? Please check all that apply: ___ Interviews ___ Questionnaires/surveys ___ Focus groups ___ Public records ___ Medical records ___ Biological specimens ___ Registries ___ Other (describe) Will these data contain any personal identifiers? If yes, please also describe the methods that will be used to protect the data. If data are de-identified, will study personnel have any links/keys to identifiers? Who will de-identify the data? If data are not de-identified, when & how will identifiers be removed from the data? Section 7 Costs of the Research Funding: Title of Grant or Funding Application: ______________________________________________________ Number of Grant (if applicable): ___________________ Table 8 Source of fundingSpecifyAmount per YearPeriod of supportInternalFederalPrivateFellowshipCorporateOther Will participants incur any expenses in conjunction with this research? If yes, identify each cost item, and for each indicate amounts and whether the written consent form discloses this potential liability, and justify the assignment of the burden: Will the subjects receive payments or other compensation (free clinic visit, course points, tied to course grade, etc) for participating? If yes, indicate amounts: Do you have an economic interest in this research external to SCUHS? If yes, please explain. Section 8 Signatures (please provide a signed hardcopy of this document to the IRB chair): Principal Investigators Name: _________________________________________________________________ Signature of PI:: ________________________________________________ Date: _____________________ BOX FOR COMMITTEE USE ONLY ___________________________________________ _____________ Human Subjects Review Committee Signature Date Exempted Category: ________ Expedited Category: ________ Approve ___ Disapprove, requires review ___ Subject to the following conditions: _____________________________________________________ ____________________________________________________________________________________ Period of approval is one year, from_____________________ through________________________ *VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED     PAGE 1 PAGE 4 IRB USE ONLY Project ID: _____ 2Mh{    & ' 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