3. IRB Certification Form - Exempt Review

IRB EXEMPT CERTIFICATION FORM Note to Investigators: Certification of exemption is determined by the Institutional Review Board only Certifications are not to be determined by Investigators or Department Heads Street Address: Community Medical Centers Institutional Review Board (IRB) UCSF Fresno Building 155 N Fresno St., Suite 290 Fresno, CA 93701 Office Contact for questions: Office: (559) 499-6553 Facsimile: (559) 499-6633 e-mail: IRB@communitymedical.org PART 1: ADMINISTRATIVE REQUIREMENTS A Study Title: Study Title: Department: Application Type: [ ] New Category 1, 2, 3, 4, or please circle) [ ] Modification / Update [ ] Re-certification B PRINCIPAL INVESTIGATOR: Name: E-mail Address: Department: Phone Number: Co-Principal Investigator: Name: Department: Mailing Address: Phone Number: E-mail Address: Additional Contact Person (if any): Name: Department: Mailing Address: Send correspondence to (check one): UCSF Sites (Check all that apply): [ ]UCSF [ ]Cancer Center [ }Other: Phone Number: [ ]PI only [ ]CRMC E-mail Address: [ ]PI and Co-PI [ ] CCH [ ]PI and Additional Contact Person [ ] FH&SH [ ] UMC B Funding: If this study is eligible for “Just in Time” NIH review, not submit your application to the CHR until you have received notification from the federal granting agency that your study appears to be in a fundable range If this study is federally funded please complete section B.6 Check all that apply: Type of funding: Source of funding: Funds will be awarded to/through: [ ]Contract/Grant [ ]Subcontract [ ]Drug/device donation [ ]Student project [ ]Other: Have funds been awarded? [ ]Yes [ ]Pending [ ]No [ ]Federal Government* [ ]Other Gov (e.g., State, local) [ ]Industry** [ ]Other Private [ ]Campus/UC-Wide program [ ]Departmental Funds [ ]Other: Award No.: Sponsor Name: IRB Exempt Certification Form Version date 01Sep2016 Dept./ORU: Institution Federal Wide Assurance (FWA) No [ ]UCSF 00000068 [ ]CCFMG [ ]CMC……………………………………… 00000927 [ ]FH&SH…………………………………… 00011614 Page of Proposal Express number(s): **UCSF (or affiliate) financial contact person for IRB review recharge: Grant Title and PI (if different from above): Protocol/Federal Grant or Contract Comparison If this study is federally funded, please submit one copy of one of the following documents (unless there is more than one grant or contract involved; in that case, submit one copy for each associated grant or contract) Please indicate which document you have attached: [ ] The human subjects section of your NIH grant, or [ ] For other federal proposals (contracts or grants), the section of the proposal describing human subjects work, or [ ] The section of your progress report if it provides the most current information about your human subjects work Note: If there are any significant discrepancies between the grant or contract and this CHR application please explain here: Secondary sponsors: If there are multiple sources of funding for this study, please describe the additional funding: C Key Personnel: All key personnel including the PI and Co-PI must be listed below along with a brief statement of their qualifications Please note: All Key Personnel at UCSF or affiliated sites must complete the UCSF Collaborative Institutional Training Initiative (CITI) online module Investigator (and institution): Qualifications: D Statement of Financial Interest: Does the PI or any investigator have any financial interests related to this clinical study? [ ]Yes [ ]No If Yes, Attach Conflict of Interest E Principal Investigator's Certification:  I certify that the information provided in this application is complete and correct  I accept ultimate responsibility for the conduct of this study, the ethical performance of the project, and the protection of the rights and welfare of the human subjects who are directly or indirectly involved in this project  I will comply with all CMC/UCSF policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human subjects in research  I will ensure that the personnel performing this study are qualified and adhere to the provisions of this CHR-certified protocol  I will not modify this CMC/UCSF-certified protocol or any attached materials without first submitting an amendment to the previously approved protocol Principal Investigator's Signature Date PI completed training [ ] Yes [ ] No CoPI completed training [ ] Yes [ ] No PART 2: STUDY SPECIFIC INFORMATION Complete this part for research eligible under Exempt Category #1, 2, 3, 4, 5, 6: Complete this part for research eligible under Exempt Category #1, 2, 3, 4, 5, 6: Category #1 Research conducted in established or commonly accepted educational settings, involving normal education practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods IRB Exempt Certification Form Version date 01Sep2016 Page of Category #2 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior, except when: a Information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; AND b Any disclosure of this information outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability or reputation; or However, CMC/UCSF requires Expedited Review and in some cases Full Committee Review —and does not exempt—research in this category under the following circumstances: • The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol AND will not be conducted in an anonymous fashion, or • The study involves any of the following subject populations: o patients at UCSF or an affiliated institution o children (people under 18 who not have the legal right to consent for themselves or o prisoners Category #3 The research involves the use of educational tests, survey or interview procedures, or observations of public behavior when the human subjects are elected or appointed public officials or candidates for public office Category #4 Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects Category #5 Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs Category #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 For survey and interview research that is exempt, CMC/UCSF requires that the request for exemption describe how subjects’ consent will be obtained with or without out collecting identifiers The application should include a consent form, information sheet, or script that will be used to obtain consent Items addressed in the consent process should include but are not limited to: • purpose of the study and that the activity involves research, • name and contact information for who is conducting the study, IRB Exempt Certification Form Version date 01Sep2016 Page of • • • • • why or how the subjects were selected, that participation is voluntary, types of questions that will be asked, how long the subjects participation will take, and how confidentiality of the research data will be maintained If any of the above is not applicable you must submit an application for Full Committee or Expedited Review In non-technical language briefly describe the study purpose and activities: How the study activities differ from standard practice? Describe the population that will be evaluated: Will subjects be contacted for the study? [ ] Yes [ ] No If “Yes”, please answer the following questions a How will subjects be contacted? b How will subjects be informed about the research nature of the project? c How will subjects have the ability to opt out of the study? (Note: Please attach a copy of any written material that will be given out for any of the above purposes.) What types of instruments will be used? (Check all that apply.) [ ] Interviews* [ ] Educational tests [ ] Questionnaires/Surveys* [ ] Observation [ ] None [ ] Other: *Copies of any survey instruments or interview guides used for the study must be attached to this application At minimum, attach a representative list of sample questions How will the information obtained be identified? [ ] No Identifier are associated with the information obtained [ ] Names and other identifying information is obtained but is not shared with anyone except the study staff [ ] Names and other identifying information is obtained and potentially used in publications (Please note this is only allowed if you are applying for category 3.) Data Security: Identifiable data should not be stored on laptops, PDA’s or other portable devices Please indicate how the identifiable data are kept secure Check all that apply: [ ] Data are coded; data key is destroyed at end of study or provide date: [ ] Data are coded; data key is kept separately and securely [ ] Data are kept in locked file cabinet [ ] Electronic data are protected with a password [ ] Data are kept in locked office or suite [ ] Data are stored on a secure network I certify that the information provided in this form is complete and correct _ Signature of Principal Investigator IRB Exempt Certification Form Version date 01Sep2016 Date Page of IRB Exempt Certification Form Version date 01Sep2016 Page of ************************************ IRB Office Use Only ***************************************** Study # Initial Review Date: Certification of Exempt Status On the basis of the information presented here, this research activity is exempt from 45CFR46 The only involvement of human subjects will be in: _ Category 1: Research conducted in established or commonly accepted educational settings, involving normal education practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods _ Category 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior, except when: • Information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; AND • Any disclosure of this information outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability or reputation; or • The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol AND will not be conducted in an anonymous fashion, or • The study involves any of the following subject populations: - patients at CMC/UCSF or an affiliated institution, - children (people under 18 who not have the legal right to consent for themselves, or - prisoners _ Category 3: The research involves the use of educational tests, survey or interview procedures, or observations of public behavior when the human subjects are elected or appointed public officials or candidates for public office _ Category 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects _ Category #5 Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs _ Category #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 IRB Exempt Certification Form Version date 01Sep2016 Page of _ This study does not qualify for human subjects review by Exempt Status as defined by the UCSF and/or CMC Policies and Procedures Exempt Certifications are valid for three years from the date of certification The study must be re-certified by the expiration date if work is to continue Also, re-certification is required before implementing any changes involving human subjects Chair or Designated IRB Member Certification Date Expiration Date Exempt Project Number CHR EXEMPT PROJECT NUMBER: IRB Exempt Certification Form Version date 01Sep2016 Page of ... subjects Chair or Designated IRB Member Certification Date Expiration Date Exempt Project Number CHR EXEMPT PROJECT NUMBER: IRB Exempt Certification Form Version date 01Sep2016 Page... of IRB Exempt Certification Form Version date 01Sep2016 Page of ************************************ IRB Office Use Only ***************************************** Study # Initial Review Date: Certification. .. the U.S Department of Agriculture IRB Exempt Certification Form Version date 01Sep2016 Page of _ This study does not qualify for human subjects review by Exempt Status as defined by the UCSF