MICROSOFT WORD 6.0 TUTORIAL MANUAL



HUMANRESEARCHPROTECTIONRequest for exempt category 4 determination -Secondary researchNumber311-4Version dateOCT 2020Resource typeFORMUse this form to request an IRB exempt category 4 determination.Email this completed form and all supplementary materials (e.g., 309 FORM Request for waiver of HIPAA authorization; 303 FORM & 401 CHECKLIST) via attachment toHRPO@Visit the HRPO website for current forms and checklists: NOTES: If your research involves activities in multiple exempt categories (i.e., not secondary research only) please complete the 311 FORM Request for exempt determinationFor secondary research involving Epic data, the IRB requests that researchers?engage the Analytics Center of Excellence (ACE) or Virtual Data Warehouse (VDW) to extract data for the study unless it is not obtainable via their services (e.g., information contained in notes fields). The IRB will accept hybrid extraction, e.g., if research needs information from notes, ACE/VDW should be engaged to provide?required data?from records with a link to?access notes data in the records.ServiceNow instructions for ACE requestsVirtual Data WarehouseIf your secondary research involves?ONLY de-identified?data obtained via ACE/VDW or other honest broker, the research?is NOT human subject research, i.e., not subject to IRB oversight?– do not complete this form. (see 398 FORM Not human subject research determination)Non-employees (e.g., NRCs) will NOT be granted access to Epic or PHI for secondary research.Do not add researchers that are external to Hennepin Healthcare to the personnel for this IRB submission; human subject activities for external researchers must be approved in accordance with their own institutional requirements. For data subject to HIPAA, any researcher(s) external to Hennepin Healthcare may only access/receive Hennepin Healthcare data that is de-identified in accordance with HIPAA; a data agreement?should be established (contact HHRI Grants and Contracts office). The federal single IRB requirement does not apply to multisite research approved as exempt.This is a Word fillable form – be sure to Enable EditingAre you requesting to transition a currently IRB-approved study to exempt?See 111 GUIDANCE Transitioning studies to 2018 Common Rule for more information FORMCHECKBOX NO FORMCHECKBOX YESIf YES, provide the HSR ID for the currently approved study: FORMTEXT ?????Study informationStudy Title FORMTEXT ?????Sponsor FORMTEXT ?????Is this an investigator-initiated study? FORMCHECKBOX YES FORMCHECKBOX NOPlanned start date FORMTEXT ?????Planned end date FORMTEXT ?????Hennepin Healthcare site PIName FORMTEXT ?????Email FORMTEXT ?????StatusPhone FORMTEXT ????? FORMCHECKBOX Hennepin Healthcare System employeeDept FORMTEXT ????? FORMCHECKBOX Hennepin Healthcare Research Institute employeeTerminal degree(s) FORMCHECKBOX MD FORMCHECKBOX DMD/DDS FORMCHECKBOX PhD FORMCHECKBOX PharmD FORMCHECKBOX DNP FORMCHECKBOX Other, specify: FORMTEXT ?????Or other degree(s) FORMCHECKBOX PA FORMCHECKBOX MA/MS FORMCHECKBOX RN/NP FORMCHECKBOX BA/BS FORMCHECKBOX Other, specify: FORMTEXT ?????Additional HENNEPIN HEALTHCARE study personnel FORMCHECKBOX 303 FORM Study personnel approval request is attached with this submissionOR FORMCHECKBOX The PI is the only personnel involved in this study for HENNEPIN HEALTHCAREOrganizational information FORMCHECKBOX YES FORMCHECKBOX NOHave you received approval from your Chief of Service/Department Head to conduct this research? FORMCHECKBOX YES FORMCHECKBOX NOIs this multisite research?Conflict of Interest AttestationDo any Hennepin Healthcare key personnel participating in this study or their spouse/domestic partner, and/or dependent child/children have a potential conflict of interest related to this research project?Key personnel are individuals engaged in human subject?research that are in a position to influence the study's design, conduct, and/or reporting.NOTE: Disclosures must include current relationships and arrangements and those that can be reasonably expected in the next 12 months. See the HHRI Conflict of Interest Policy for more information: FORMCHECKBOX A 300 FORM Conflict of interest disclosure is attached FORMCHECKBOX The PI attests that the HHRI Conflict of Interest Policy has been reviewed and there are no COI disclosure(s) for this research AcknowledgementPerson submitting this form FORMTEXT ?????email FORMTEXT ?????Phone number FORMTEXT ?????Date FORMTEXT ?????By submitting this form, I confirm that:I am the Principal Investigator (PI) or the PI’s designee authorized to submit on behalf of the PI The PI has full awareness of the information within this form The Department Head has approved the conduct of this researchThe information within this form is accurate and completeFor research subject to HIPAA:Researcher(s) will access, use, and/or disclose PHI only as allowed by HIPAA, state law, and Hennepin Healthcare policy Prerequisite information1. Will data from this research be submitted to the US Food and Drug Administration (FDA) or will researchers hold data from this research for inspection by the FDA? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, the proposed research is not eligible for exemption2. Does the research intend to include data and/or specimens from PRISONERS as research subjects (other than incidentally)?NOTE: Choose NO for research involving a broader subject population that may incidentally include prisoner data/biospecimens FORMCHECKBOX NO FORMCHECKBOX YESIf YES, the proposed research is not eligible for exemption3. Does this research involve?ONLY de-identified?data obtained via ACE/VDW or other honest broker? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, do not complete this form; see IMPORTANT NOTES section on page 1.4. Does this research involve sharing any data and/or specimens with researchers external to Hennepin Healthcare? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, you are responsible for contacting your HHRI Research Administrator to determine whether a data agreement is necessary. If you’re unsure who to contact, visit the Grant Administration Portfolio Assignments page for a listing.IMPORTANT: In accordance with Minnesota statutes, Protected Health Information may not be released to external researchers without explicit authorization from subjects.5. Does this research involve re-use of data that have been or will be collected for non-research purposes? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, identify the source(s); for any non-HHS source, describe permission to the data: FORMTEXT ?????6. Does this research involve re-use of data that were collected via a different research study than the one proposed? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, attach IRB approval and approved consent form (if applicable)7. Does this research involve re-use of specimens that have been or will be collected for non-research purposes? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, identify the source(s); for any non-HHS source, describe permission to the specimens: FORMTEXT ?????8. Does this research involve re-use of specimens that were collected for a different research study than the one proposed? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, attach IRB approval and approved consent form (if applicable)9. Will the researcher(s) have a key to link direct identifiers to the study data? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, describe how the key will be kept secure: FORMTEXT ?????Exempt category 4 (i – iv) -Secondary research on existing data or specimensCheck all that apply:Applicability:Secondary research for which consent is not required. Data do not need to be existing (“on the shelf”) at the time of the research study. Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria (i-iv) is met: FORMCHECKBOX (i) Identifiable private information or identifiable biospecimens are publicly available;Publicly available refers to data and/or specimens that are accessible to anyone in the general public, without the need for special permissions or privileges. In these cases, the subjects do not have a reasonable expectation of privacy of their data/specimens. FORMCHECKBOX (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;Example: Private information, which may or may not contain identifiers, that is not subject to HIPAA regulations.? Study team members?may access?identifiable private information but?cannot?record data in a way in which it could be linked back to identifiers, even temporarily. Any individuals accessing the identifiable data must already have access to that information (by means of their involvement with the original collection). FORMCHECKBOX (iii) Research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA (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); FORMCHECKBOX REQUIRED:309 FORM Request for HIPAA waiver or alteration of authorization for research is attached with this submissionREQUIRED: Describe how the method of data extraction will filter out patients’ records who have opted out of sharing their information for research: FORMTEXT ????? FORMCHECKBOX (iv) Research conducted by or on behalf of the federal government using information generated or collected by the government for non-research purposes, when the information is subject to other regulatory protections for data confidentiality (e.g., FISMA).Select the resources used to collect, store, and analyze study dataCheck all that apply: FORMCHECKBOX N/A – all study data is stored on paper FORMCHECKBOX Hennepin Healthcare RedCap FORMCHECKBOX HHS network FORMCHECKBOX HHRI network FORMCHECKBOX Cloud storage authorized by HHRI IT FORMCHECKBOX HHS-owned local storage device (e.g., desktop, laptop, tablet) FORMCHECKBOX HHRI-owned local storage device (e.g., desktop, laptop, tablet) FORMCHECKBOX Server hosted by a research sponsor or data coordinating center Provide HHRI GA contact for sponsored project agreement: FORMTEXT ????? FORMCHECKBOX External storage device – explain: FORMTEXT ????? FORMCHECKBOX Personal device - explain: FORMTEXT ????? FORMCHECKBOX Other - Specify: FORMTEXT ?????For Exempt Category 4(iii) ONLY:Select the type of PHI to be used (check all that apply): FORMCHECKBOX Names FORMCHECKBOX geographic subdivisions smaller than a state (e.g., street address, city, county, precinct, ZIP code, and their equivalent geocodes) FORMCHECKBOX elements of dates (except year) that are directly related to an individual (e.g., birth date, admission date, discharge date, death date) or year for ages over 89 that are indicative of such age FORMCHECKBOX Telephone numbers FORMCHECKBOX Vehicle identifiers and serial numbers, including license plate numbers FORMCHECKBOX Fax numbers FORMCHECKBOX Device identifiers and serial numbers FORMCHECKBOX Email addresses FORMCHECKBOX Web Universal Resource Locators (URLs) FORMCHECKBOX Social security numbers FORMCHECKBOX Internet Protocol (IP) addresses FORMCHECKBOX Medical record numbers FORMCHECKBOX Biometric identifiers, including finger and voice prints FORMCHECKBOX Health plan beneficiary numbers FORMCHECKBOX Full-face photographs or comparable images FORMCHECKBOX Account numbers FORMCHECKBOX Certificate/license numbers FORMCHECKBOX Any other unique identifying number, characteristic, or code; describe: FORMTEXT ?????Study detailsAre you attaching a separate protocol that provides all of the information requested in this Study details section? FORMCHECKBOX NO FORMCHECKBOX YESIF YES, you may skip this sectionIMPORTANT: If any information requested below that is not provided in an attached protocol will delay IRB processing and approval. All information provided on this form must be consistent with the protocol.Purpose of the research: FORMTEXT ?????Hypothesis: FORMTEXT ?????Objective(s)/Specific aim(s): FORMTEXT ?????Relevant previous research and gaps in current knowledge to support the proposed research: FORMTEXT ?????Planned number of patient records/specimens to be used for the study: FORMTEXT ????? Date range: FORMTEXT ?????Age range: FORMTEXT ?????Inclusion criteria: FORMTEXT ?????Exclusion criteria: FORMTEXT ?????List all the data elements and/or specimens that will be used for the study: FORMTEXT ?????Describe the data analysis plan: FORMTEXT ?????Describe the destruction of data and/or specimens after completion of the study: FORMTEXT ?????Describe the data management and security measures for data and/or specimens: FORMTEXT ?????Describe potential risks for human subject data and/or specimens: FORMTEXT ?????Describe potential benefits of the study: FORMTEXT ?????Will any results from this study be shared with human subjects? FORMCHECKBOX NO FORMCHECKBOX YESIf YES, describe what information will be shared and how contact will be made: FORMTEXT ????? ................
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