EXEMPT RESEARCH and NOT HUMAN SUBJECTS RESEARCH DETERMATION FORM

INSTRUCTIONS:

EXEMPT RESEARCH and NOT HUMAN SUBJECTS RESEARCH DETERMATION FORM All human subjects research must be reviewed by the SJMHS IRB and receive either an exemption determination or approval prior to being conducted.

This form is ONLY to be used for exempt research projects and not human subjects research determinations. You may also use the Quality vs Research Determination checklist (see IRB website) to self- declare that a project is quality (no IRB determination letter will be issued). The quality determination checklist is not appropriate for projects that meet a definition of "research", but not the definition of "human subjects"; these projects must be reviewed by the IRB via this Exempt Research and NHSR Determination form. Got questions? (734) 712-5470 About the IRB: The primary responsibility of the IRB is to protect the rights and welfare of human subjects in research by upholding all applicable federal, state, local, and tribal research and HIPAA laws and regulations. At Saint Joseph Mercy Health System (SJMHS) all research involving human subjects must be reviewed by IRB #1, IRB # 2, or by an external IRB if delegated by an IRB authorization agreement. SJMHS IRB#1 is the IRB of record for the following locations: Trinity Health system-level research (directly involving Trinity Health patients, employees or clinical operations or using Trinity Health data that: (1) is led or sponsored by a system office colleague, or (2) involves at least three Ministries); and the Ann Arbor, Chelsea, Livingston, St. Mary’s Livonia Hospital locations. SJMHS IRB #2 is the exclusive single IRB for the Michigan Cancer Research Consortium. Forms, policies, and tools:  Please visit the Research Compliance Department's internal SharePoint site for helpful guidance, tools, and resources.  Visit the IRB public Internet website for policies and forms: http://www.stjoesannarbor.org/irb How to submit: Submit all of the following as separate attachments within one e-mail to [email protected]:  Scanned PDF of the typed Exempt Research and Not Human Subjects Research Determination form with CITI records (CITI only required for exempt research studies)  Protocol with appendixes  If applicable, informed consent document, assent document (may use SJMHS template and must submit as a Word document)  If applicable, signed Waiver of HIPAA form  Individual FCOI Disclosure forms for all research members (exempt research only)  All other pertinent documents such as:  Questionnaires and surveys (as a Word document)  Recruitment script (as a Word document)  Data collection forms  Advertisements  Letters to research participants, etc. (as a Word document)  All questions must be answered; comments such as, "see protocol" are not sufficient. This form may be sent back if questions are not answered and review delays will occur.  For research: this form must be signed by the Principal Investigator, all sub-investigators, and by the Department Chair/Head as acknowledgment of study conduct.  For research: If the proposed study involves other departments within the health system, approval must be obtained from the department Director in advance (e.g., Quality Institute involvement must include signoff/approval, etc.).  Submit all of the above via e-mail to [email protected]

The IRB will determine if your submission meets a) any definition of research and b) if so, if it meets the criteria for a particular exemption category. Please NOTE: If your submission is determined to be human subjects research, but does NOT meet an exemption category this application will be returned to you and you will be instructed to complete the New Project Application for expedited and full board review. Submission Deadlines: There are no deadlines for this type of submission. Response from the IRB: Your submission will be pre-reviewed by a Research Compliance staff member to assure completeness. If pre-review identifies issues or missing information, then a delay in IRB review will occur. When complete, your submission will then be reviewed by an IRB member. A response from the IRB will be emailed to the investigator and submitter in approximately 7 to 10 working days. Need Help? Please call (734) 712-5470 or e-mail us at: [email protected] or stop by- we are located on the 2nd floor of the Reichert Health Building in Suite 2018.

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 2 of 20 EXEMPT RESEARCH and NOT HUMAN SUBJECTS RESEARCH DETERMATION FORM

STUDY INFORMATION

Title of your study: Principal Investigator's (PI) full name and academic degree:

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 3 of 20 PI's title, department, and Institution: PI's status- please check all that apply: SJMHS/Trinity employee or affiliate Staff External researcher (non-SJMHS/Trinity or affiliate) Graduate Student Physician Undergraduate Student Resident or Fellow Other: PI's address: This address will be used for all correspondence PI's e-mail:

PI's telephone numbers: Work: Pager: FAX: Other:

Attach a current curriculum vitae Attached detailing the PI's N/A- This is not human subjects research expertise to conduct this research Sponsor of the project: None

Is this study conducted or Yes: supported by any No Federal dept.? Research/Study None or N/A Coordinator(s) name(s): E-mail & phone #: Name and position of person PI Research or Study Coordinator completing this form: E-mail & phone #: Correspondent contact name- Research or Study Coordinator optional (cc: on correspondence) E-mail:

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 4 of 20 CONFLICT OF INTEREST DISCLOSURE

N/A- Not conducting human subjects research. Skip to the next section (green heading section: "Reviews and Signature").

Conflict of interest (COI) can be defined as any situation in which financial, professional or personal obligations may offer opportunity to compromise or present the appearance of compromising an individual’s professional judgment in designing, conducting and analyzing or reporting research. Each investigator, sub-investigator and all research team members must disclose all significant financial interests that would reasonably appear to be directly and significantly affected by the research activity to comply with federal and state regulations, specifically including 42 CFR Part 50, Subpart F -responsibility of applicants for promoting objectivity in research for which PHS funding is sought. “Significant financial interest” means anything of monetary value exceeding $5,000.00 that includes the investigator, sub-investigator, research team member or member of his/her immediate family. Examples include but are not limited to; payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). 1. Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real significant financial conflict of interest that requires disclosure? Disclose to the IRB any further (bonus) funding for patient accrual. This may be allowed but may require disclosure of the funding in the consent form. A disclosure of any new reportable significant financial interest is required to be submitted to the IRB at the time of the change. Yes No PI initials: ______If yes, provide a detailed description of the financial disclosure:

2. Is this a Trinity Health system-level research project? System-level means any research directly involving Trinity Health patients, System Office employees or clinical operations or using Trinity Health data that is (1) led or sponsored by a System Office colleague or (2) involves at least three or more Ministries.

No - continue to the next question Yes - If yes, are you from SJMHS? Yes - continue to the next question (#3)

No - complete training requirements and form located at link, below, and then skip ahead to the next section. Link to form: http://uco.che.org/phyclinalign/edu/research/Research %20Program%20Policies%20%20Landing%20pages/5%20Trinity%20SFI%20Disclosure%20statement %2010.10.15.pdf

3. Have you already submitted an Annual Financial Interest Disclosure Form for the current year (May through May)? PI initials: ______No - STOP - you must complete and submit an updated Disclosure form with this application: http://www.stjoesannarbor.org/IRBForms

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 5 of 20 Yes - If yes, is the Disclosure form current? Yes No - submit form with this application. 4. Is there a financial disclosure that exceeds $5,000.00? Yes No PI initials: ______If yes, complete a Conflict Avoidance Statement and submit with this application: http://www.stjoesannarbor.org/documents/irb/ConflictAvoidance.doc

5. Do you have any other types of conflicts of interest (e.g. personal, owner of device, honorarium, etc.)? Yes No PI initials: ______If yes, provide a detailed description of the conflict: 6. Have all of the other SJMHS research team members submitted current FCOI disclosure forms to the SJMHS IRB or their institution within the reporting year? PI initials: ______Yes No - STOP- this must occur in order to submit this application

REVIEWS AND SIGNATURES N/A- Not conducting human subjects research. Skip to the next section (green heading, below). 1. Is the PI an external PI (external to SJMHS, Trinity Health, and their subsidiaries)? No Yes - you must collaborate with the locations where the research is being conducted and include site professional staff as a sub-investigator(s). You may wish to decided such things as authorship rights, data ownership, funding, etc.

2. Will a Research Site Agreement or a Facility Letter be signed prior to study initiation? Yes No - skip to PI signature section If yes, has the appropriate document been reviewed by the SJMHS Legal Department? Yes - date of review: No

3. Does the SJMHS Office of Grants and Contracts have a copy of the contract? Yes N/A No - state why:

PI SIGNATURE By signing below, the Principal Investigator has read the SJMHS IRB Policies and Procedures and individually accepts sole responsibility for conducting this project in accordance with SJMHS and/or Trinity Health Research Policies, applicable regulatory requirements that you agree to follow the protocol as written.  Agree to conduct the study in accordance with the current protocol and will only make changes in the protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of participants;  Agree to personally conduct or supervise the described investigation; Agree to report to the sponsor/funding body and IRB any unexpected, unanticipated adverse experiences that occur in the course of this investigation, including risks to

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 6 of 20 participants or to others;  Ensure all research team members are informed about their obligations in meeting all commitments;  Agree to maintain adequate and accurate records in accordance with applicable regulations and to make those records available for inspection as requested;  Ensure that the IRB complies with the applicable regulations; Agree to report promptly to the IRB all changes in research activity as indicated in the IRB policies and procedures;  Agree to comply with all other applicable policies and regulations. Your signature(s) on this application will also attest to the accuracy of your significant financial interest disclosure and compliance with HIPAA privacy laws for protected health information (PHI). Principal Investigator: Printed Name: Signature: Date

SJMHS and private entities on the SJMHS campus: The Department Head (Required): Department Head signs as awareness of the conduct of the study in their department and acknowledges that resources are available for study conduct. W hen the Dept. head and PI are the same person, someone senior in rank to the PI must sign for this role to ensure accountability and that leadership is informed.

Printed Name (cannot be the PI) Signature Date

Name of Department For SJMHS research only : Other SJMHS Department Involvement--required if applicable: signing as awareness and approval of their role in conduct of study in their department (e.g., data pulls by Trinity Health or St Mary’s must include approval from Dept Head). Without approval you may not conduct your study, even if the IRB has approved this study. ______Printed Name Signature Date

Name of Department For SJMHS Research Only: Sub- Investigator(s) and Research Coordinator(s)- By signing below SJMHS Sub-Investigators and Research Investigators are indicating that they have read the SJMHS IRB Policies and collectively and individually accept responsibility for conducting this project in accordance with SJMHS IRB Policies; applicable regulatory requirements, state, federal, and tribal laws; and that you agree to follow the protocol as written. Your signature(s) on this application will also attest to the accuracy of your significant financial interest disclosure and compliance with HIPAA privacy laws for protected health information (PHI). See website for additional signature pages: http://www.stjoesannarbor.org/IRBForms a) Printed Name and degree of Sub-I Signature Date

Institutional Affiliation Dept

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 7 of 20 b) Printed Name and degree of Sub-I Signature Date

Institutional Affiliation Dept Primary Research Coordinator for this study: ______Printed Name Signature Date Additional Research Coordinator for this study: ______Printed Name Signature Date

Additional Research Team Members- state role: c) ______Printed Name Signature Date

Institutional Affiliation Dept Role in research d) ______Printed Name Signature Date

Institutional Affiliation Dept Role in research e) ______Printed Name Signature Date

Institutional Affiliation Dept Role in research >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> 4. Was this study reviewed by a Research Review Committee? Note, certain Research Review Committees require their review (Oncology Research Committee, Saint Mary Mercy Livonia, Michigan Heart, System Office Research Committee and others)—check with the appropriate departments. This review must be completed prior to submitting to the IRB. Yes: indicate the name of the committee and date of review: No, a review was not done and this study is not being conducted at or by a PI from oncology, SMML, System Level, or Michigan Heart.

5. Please either list all submitted documents or attach a separate list (list exactly as you would like them to appear on the IRB determination letter):

6. If you are not affiliated with SJMHS or Trinity Health: N/A- I am affiliated a) Provide the rationale for conducting the research at SJMHS or Trinity Health locations or for using SJMHS or Trinity Health data in your research:

b) For research conducted at SJMHS only: If you are not affiliated with SJMHS, then endorsement from a SJMHS physician and /or department chair is required, as well as review

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 8 of 20 from research committees with in SJMHS (e.g. oncology, research committee, or departmental committee) prior to IRB review. Has the appropriate SJMHS Research Committee reviewed this study proposal? Yes - provide the name of the committee and date of review: No - explain: 7. IRB Invoice Contact (if applicable). Please include name, address, phone number, facsimile number, and email. NOTE: The contact provided will be used for all IRB fee correspondence.

8. Have you attached current CITI human subjects training completion records for the PI, all sub-Is, all research coordinators and all others on the study? See IRB Internet website for CITI instructions. Yes, all personnel’s current CITI completion reports are attached No - STOP: do not submit this form until training is complete. 9. Will/has another IRB review and approved this research? Yes - attach a copy of the approval letter and state name(s) of other IRB : No

10.Have you ever or were you part of a research team that ever received a sanction or disciplinary action for a research project or activity? Yes: please explain when and where this occurred: No 11.Have you been a PI before? No – skip ahead to next section Yes - have you previously conducted research at SJMHS? Yes: when was the last study approved by the SJMHS IRB? No

MEETING THE DEFINITION OF HUMAN SUBJECTS RESEARCH

1. Do you believe this project to meet the definition of human subjects research? Yes- skip to the next section Not sure No

2. Generalizable knowledge may be the result of the collection of data where the information gained could apply to a larger population or disease, in general, rather than one individual participant. Could generalizable knowledge be gained? Yes No: why not? 3. Is this a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge? Yes No 4. Is there intent to publish or present outside of the location(s) where the data will be collected? Yes No 5. Will the research team obtain information or biospecimens through intervention or interaction with the participants and use, study, or analyze the information or biospecimens? Yes No 6. Will the research team obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens? Private information or biospecimen for which the identity of the subject

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 9 of 20 is or may readily be ascertained by the investigator or associated with the information or biospecimens. Yes No If no, confirm that the Research/Project team does NOT have any access to a link for coded de- identified information, or have access to any Protected Health Information (PHI- see list on p. 17, section H, q. 2), or have a way to reasonably ascertain the identity of participants either alone or in combination with other information? Yes, this is correct No, this is not true – STOP, you must answer "yes" to Q 6, above. 7. Is this a Public health surveillance activity (includes the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority)? Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). Yes No EXEMPTION CATEGORY

1. Are you conducting human subjects research? Yes Unsure of whether this would be considered research or not No – skip ahead to next section (next green heading) 2. Will the proposed research include activities that are more than minimal risk or involve discomfort beyond what is normally experienced in daily life? For the definition of minimal risk see IRB policy Initial Review of Research –Expedited and Full Board Review here: http://www.stjoesannarbor.org/body_annarbor.cfm? id=1033&fr=true Yes - STOP, complete the New Project Application (for expedited and full board review No research) instead of this form. 3. Indicate if there is the potential for the enrollment of prisoners in this study? Status unknown or not targeted (only incidentally included with broader population) No Yes- STOP- you must submit this study using the New Project Application. Please contact the Research Compliance Dept. before submitting this to the IRB.

4. You must select the applicable exemption category for the proposed research from the following list, below (the IRB will make the final determination): (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: Select criteria that is met:

(i) research on regular and special education instructional strategies, or

(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 10 of 20 (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior. Answer the 2 questions below:

 Will the information obtained be recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects? No Yes

If yes, is it possible that any disclosure of the human subjects' responses outside the research (such as a breach, etc.) could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation? No Yes - STOP, you may not use this category

 Are children involved as participants? No Yes

If yes, what does the research involve? Involves survey or interview procedures– STOP, you may not use this category Only educational tests will be used or The observation of public behavior where the research team does NOT participate in the activities being observed. Other - STOP, you may not use this category

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under (2), above, where either of these two options are true:

(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, where by:

(i) The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the participants. or (ii) The source is publicly available

(5) Research and demonstration projects which are conducted by or subject to the approval of Federal department or Federal agency heads, and which are designed to study, evaluate, or otherwise examine:

(i) Public benefit or service programs;

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 11 of 20 (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.

(6) Taste and food quality evaluation and consumer acceptance studies if either of the two options are true, below: (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.

None of the above – STOP- complete the New Project Application or contact the SJMHS Research Compliance Dept for help in determining which form to complete. This form is only for not human subjects research determinations and for research that meets one of the above exemption categories.

A. STUDY OVERVIEW

1. This form does not supersede or replace a formal written protocol; it is in addition to the study protocol. This is a requirement for both projects that do and do not meet the definition of research. See the IRB website for a suggested (not required) research template: http://www.stjoesannarbor.org/IRBForms The protocol is attached with the submission I don't have a protocol –STOP: this is a requirement in order to submit. 2. Protocol Summary: Please provide a brief executive summary of the project:

3. State the research hypothesis and objectives or the project aims:

4. Describe the background literature and the subsequent rationale for the project. Why is this research needed to advance the field of study or why is this not human subjects research project being done? Explain how (or if) this study builds upon the existing research and is a viable next step.

5. Where will the project be conducted: a) Type of location- Select all that apply N/A – this is a retrospective study or other inpatient unit outpatient clinic private practice office emergency department

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 12 of 20 long term care administrative offices other: b) List every site by name and address, indicating if they are SJMHS, Trinity Health or other external locations:

B. STUDY POPULATION

1. Describe all of the groups of participants. For each group, provide: number, age range, ethnic background, health status (e.g., healthy participants, participants with diabetes, Residents, etc.):

2. List the inclusion criteria for participants in each group. 3. List the exclusion criteria for participants in each group. 4. Participants screened and/or recruited for the project: (a) What is the source of each participant group (how will they or the charts be selected)? Screening for listed inclusion and exclusion criteria in the medical record Entire group will be approached (e.g., all 1st year internal medicine residents) Other:

(b) List all methods of recruitment for each participant group: Research team member will approach participants after screening for eligibility (attach recruitment script if using one). Will not approach participants (e.g., retrospective chart review). If research, submit Waiver of HIPAA form- you do not need to complete the waiver of consent portion. Flyer, poster, e-mails, letters, announcements. Scripts and ALL recruiting/advertising materials must be attached. Other: Multiple participant groups: indicate which methods will be used with each group: 5. Are there any state, federal or tribal laws that need to be considered for the project? If yes, state how the project meets the law(s) (these must be addressed or your project will be delayed). See IRB policy: Michigan Laws: http://www.stjoesannarbor.org/body_annarbor.cfm?id=1033&fr=true No or this is not human subjects research- beware that many of these laws still apply to quality State of Michigan HIV/AIDs law: State of Michigan substance abuse law: Federal substance abuse laws: Psychotherapy notes laws: Other:

C. METHODOLOGY

1. Are you looking at or collecting any of these variables? HIV status, Aids status Alcohol use or abuse

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 13 of 20 Drug abuse Other substance abuse Mental illness- treatment, diagnosis, services Psychotherapy notes No

2. Is this study entirely a review/collection of chart data/EMR that presently already exists? Yes, this is a retrospective chart/data review study/project No

3. Is this study entirely a review/collection of chart data/EMR that does not currently exist, but will exist/be collected in the future? Yes, this is a prospective chart/data review study/project No

4. Either list ALL of the data variables that will be collected or attach the data abstraction tool (if this is research and you will screen in or use, access, or disclose information from the medical health record, then attach a Waiver of HIPAA Authorization form located here: http://www.stjoesannarbor.org/IRBForms/):

5. Indicate the types of records, in what format, and the nature of the information or data to be reviewed (e.g., medical record, pathology report, surgical notes, etc.): Electronic medical record

6. Will the participants complete any questionnaires/surveys or diaries? No Yes - Attach a copy of each questionnaire and answer the following: a) List type, nature, and title: b) How frequent will the participant have to complete: c) How long will each take and what is the total time: d) Provide information regarding the validity and reliability of tool:

7. Data collection methods and analysis: a) Indicate all types used: Qualitative Quantitative Mixed Quality improvement methods

b) Describe the data collection methods and the data analysis to be used in detail (e.g., retrospective chart review and type of statistical tests, focus group and recursive abstraction, etc.):

8. Who will carry out the data extractions/collections and/or administration/collection of surveys, etc.? N/A Research team

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 14 of 20 Other:

D. RISKS AND BENEFITS OF THE RESEARCH

N/A- Not conducting human subjects research. Skip to the next section (informed consent, below).

1. What are the potential risks to participants, including those whose data is collected? Risks can be physical, psychological, social, economic, or legal. Breach of confidentiality (select if keeping identifiers) Minimal discomfort with answering questions Psychological: Other: None

2. What steps will be taken to minimize each of these risks? Identifiable data protections described previously Other: Other: No risks were identified

3. What are the potential benefits, if any, to the research participants? N/A - only using specimens or existing data None Other:

4. What are the potential benefits, if any, to society? None N/A - only using specimens or existing data Other:

E. INFORMED CONSENT

1. Will informed consent be sought from each participant? Yes – attached consent document(s) and/or script or letter. No or N/A –HIPAA may still apply; skip to the next section 2. How will informed consent be obtained? Information sheet/letter (no documentation of signature) Verbal consent Written or electronic informed consent document with signature - see web for sample template http://www.stjoesannarbor.org/IRBForms.

3. Who will conduct the consent process with participants? List everyone who is involved: Research team members listed on this form Other:

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 15 of 20 F. MONITORING/ASSURANCE

N/A- Not conducting human subjects research. Skip to the next section, below (data security).

1. Describe the process for assuring that the study is implemented according to the protocol (i.e. monthly monitoring meetings, review of computer input, occasional review of adherence to protocol, supervision/oversight methods):

a) How often will the study procedures be reviewed?

b) Who will conduct periodic monitoring of this study?

c) How will this be documented?

Please note: if, after IRB approval/determination, you revise your protocol in a manner that violates the exemption category that was met (refer to IRB determination letter that you will receive), you must come back to the IRB.

G. DATA SECURITY AND PARTICIPANT PRIVACY N/A- Not conducting human subjects research. Skip to the next section, below. 1. Provide the measures that will be taken to assure privacy and/or anonymity and confidentiality of the participant records. Check all that apply. Note: Anonymity refers to the situation where no one, not even the researcher, knows what information came from which respondent. Confidentiality refers to the researcher’s promise not to provide to others any individual responses, which might be identifiable. Research/Project team will not have any access to identifiable information, including Protected Health Information (PHI), and no way to reasonably ascertain the identity of participants. Data will be recorded in such a way that the identity of the participant is not linked to their answers or information. Data that has any identifiable information and the link will be stored separately from the coded de- identified information. Participant binders/folders will use a code, rather than contain any identifiable information. Only the research team members will have access to the code and to the identifiable information. Research results will be presented so that there is no way to reasonably ascertain the identity of the participants (including when there is a small sample size within the demographic information breakdown). Other: 2. Does the research team anticipate that any of the participants will be personally known to them, excluding patients (i.e., residents recruiting residents)?

No Yes - If yes: a) Please explain why: b) What measures that will be taken to increase their privacy:

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 16 of 20 3. How will the data be stored and maintained? Include all locations where data will be stored. Stored on a SJMHS/Trinity Health/Private Practice secure server only (NOTE: data cannot be stored on jump drives or mobile devices/computers that leave premises) Stored in hard copy in locked drawer or locked office at this SJMHS/Trinity Health location(s): [provide name of location(s)]. Other: 4. Who will collect or abstract the data? N/A Names: What is their affiliation?

5. Other than the IRB, OHRP and the FDA, who will have access to the identifiable data, participant data and/or patient's records?

No identifiable info will ever be accessed, used or disclosed, including Protected Health Info. PI Sub-investigators, study coordinators Sponsor Other Institution(s): Other:

6. Does the PI and study team have permission from the database/listserv/etc. owner to have access to the records? N/A Yes – if using listserv, provide letter/e-mail granting permission No, please explain:

H. HIPAA and MEDICAL RECORDS

 Protected health information (PHI) may be used and disclosed for Treatment, Payment, Operations and certain other uses and disclosures without authorization (consent) from the patient.  Research does not fall under these uses. Research uses and disclosures of PHI must conform to an exception permitted by HIPAA or be authorized by the patient.  Additionally, only the minimum information reasonably necessary for a specific research purpose may be used or disclosed.  The signatures on the IRB application attest that the information listed in the HIPAA section for use and disclosure of PHI is accurate and all members of the study team will comply with the HIPAA regulations and the exception criteria.

1. Will any Protected Health Information (PHI) be accessed, used or disclosed or will any health or medical records be accessed, used or disclosed for research purposes ? Answer "no" if not conducting research; answer "yes" if conducting research using only decedents info. Yes No- you are finished with this form

2. Indicate all of the Protected Health Information (PHI) to be accessed, used or disclosed: Name Account numbers Geographic information smaller than Certificate of license numbers

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 17 of 20 state (i.e., city, zip code) Vehicle identifiers and serial numbers Device identifiers and serial numbers including license plate Web Universal Resource Locators (URLs) Electronic mail addresses Internet Protocol (IP) address numbers Telephone numbers Medical Record numbers and FIN Fax Numbers Biometric identifiers, including finger Health plan beneficiary numbers and voiceprints Social Security number Any other unique identifying number, Full face photographic images and characteristic, or code comparable images Elements of dates (except year) for all dates directly related to an individual including birth date, admission date, date of death, discharge date & all ages 89 yrs of age+ including year or anything indicative of age (but may use single category of "over 89yrs")

None of the above listed variables will be used, disclosed or accessed – you are finished with this form 3. Is this the minimum necessary use and disclosure of PHI? Yes No – STOP, must be minimum or must obtain HIPAA authorization from each individual 4. Disclosures for research operating under an authorization exception are subject to HIPAA’s disclosure accounting requirement. This means that you must complete an accounting disclosure form when the number of records used and disclosed is 50 or less. Contact the Research Compliance Department for a copy of the Accounting Disclosure Form. I plan on using 50 or less records and will maintain the required accounting of disclosure information and submit this to the HIPAA Privacy Officer. I plan on accessing greater than 50 records.

5. Additional permission must be sought each time the health information is to be reused for a different purpose or is to be disclosed to any other person or entity. I agree that the research team will not reuse or disclose information for a different purpose without obtaining permission in advance from the IRB (who is also the Privacy Board for research use and disclosure of PHI). Note, disclosure of PHI is permitted to a person subject to the jurisdiction of the FDA for quality, safety or effectiveness review (review, not research).

6. Select the HIPAA option you wish to request for permission to access, use or disclose PHI for research purposes (below) by indicating what you will be doing, then complete that section: Retrospective data/chart review– complete the separate Waiver of HIPAA form (website) and submit. You are finished with this form. Screening in the medical record only– complete A. Review Preparatory to Research if everyone screening is part of the SJMHS or Trinity Health cover entity. Complete a Waiver of HIPAA form if people conducting the screening are not part of the SJMHS covered health entity. Will obtain HIPAA Authorization from each participant- Attach (use SJMHS template). If this is the only option you are requesting, then you are finished with this form. Only need this info: - complete C. Limited Data Set section, below.  Zip code  Date of birth or date of death

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 18 of 20  Date(s) of service  Geographical subdivision (city) Using various PHI for research purposes – complete the separate Waiver of HIPAA form (website) and submit. You are finished with this form. Only looking at decedents records – complete B. Decedent’s section below.

A. Review Preparatory to Research – Complete this section if screening in patient medical records to determine eligibility or/and to obtain contact information. For internal investigators, only.

1. Are the research team members who will access, use, or disclose the PHI part of the SJMHS covered health entity and is sought solely to review protected health information as necessary to prepare for the research or for similar purposes preparatory to research? Yes No - STOP -preparatory to research cannot be granted 2. The protected health information for which use or access is sought is necessary for the research purposes: to screen in record for eligibility and exclusion criteria. to obtain contact info for the purposes of contacting the people to ask them to be in the research (and get HIPAA Authorization if any other medical record info will be used or disclosed). Other- STOP- Prep to research cannot be granted 3. Will any protected health information be removed from SJMHS/Trinity Health by the research team during the course of the research (may be released if and after you obtain HIPAA Authorization from each individual)? No Yes - preparatory to research cannot be granted

B. Research on Decedent’s Information – Complete if ONLY using decedent’s information. 1. Is use or disclosure being sought solely for the purpose of research on the protected health information of decedents? Yes No – STOP this option cannot be granted 2. Will documentation of the death of such individuals be provided, upon request of the IRB? Yes No– STOP this option cannot be granted 3. Is the protected health information for which use or disclosure is being sought necessary for the purposes of research? Yes No– STOP this option cannot be granted

C. Limited Data Set Use - Information used will be made “anonymous” but not completely “de- identified”, see below.

1. Will all of the following PHI listed below be removed when creating the limited data set- this includes the patient, relatives of the patient, employers of the patient, and household members of the patient? Yes No- STOP- cannot use a Limited Data Set  Names  Health Plan ID Numbers  Addresses other than city, state, zip  Account numbers

SJMHS Research Compliance Dept. Version: 1-19-2018a Page 19 of 20  Telephone numbers  Certificate/license numbers  Device and vehicle identifiers and serial numbers  E-mail addresses  URLs  Social Security numbers  IP addresses  Medical record numbers  Biometric identifiers including  Full face photos and other comparable images finger prints

2. Will your Limited Data Set include only one or more of the following:  Zip code  Date of birth or date of death  Date(s) of service  Geographical subdivision (city) Yes No- STOP, cannot use a Limited Data Set

3. To provide a limited data set to a sponsor, other external researcher, other covered entity, or any other non-covered entity, a Data Use Agreement between St. Joseph Mercy Health System or Trinity Health (for system level research) and the sponsor must be used. The Data Use Agreement must:  List the permitted uses and disclosures of it  Establish who is permitted to use or receive it  Provide that the recipient will:  Not use or further disclose the information other than as in agreement or as required by law  Use appropriate safeguards  Report to Saint Joseph Mercy Health System or Trinity Health (for system level research) any inappropriate uses or disclosures  Ensure that anyone to who he/she provides the data agrees to the same restrictions  Not identify the information or contact the individuals

4. Do you have a Data Use Agreement, including the above listed criteria, in place? Yes In process of obtaining No- not releasing externally No - STOP- a Limited Data Set cannot be granted

5. The PI will need to verify their identity if he/she is not already known to the Research Compliance Dept. or IRB. We know lots of people, but we will contact you if this is the case.

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