Important Clarifying Questions

Important Clarifying Questions: What is the nature of the retrospective review?

☒ 1. Researchers will have direct access to identifiable records from which they will abstract study data.

☐ 2. Researchers will obtain a data set from the data owner that contains none of the 18 elements of protected health information (PHI). If #2, STOP here and submit a request for a Determination of Not Human Subjects Research.

Does the research involve only the study of data, documents, records, pathological specimens or diagnostic specimens that are already in existence as of today’s date?

☒ Yes ☐ No If no, stop here. Your study is not retrospective. Submit an Application for Expedited Review. Indicate Category 5, which applies prospective data/specimen research.

A. Basic Information Protocol Title:

Principal Investigator

Protocol Number, Version and/or Date:

05/14/2015 KUMC – HRPP Page 1 of 5 B. Introduction - Background and Rationale 1. Study Significance: introduction, what the proposed research is intended to accomplish and the importance of the results 2. Explain how the background information from the literature supports the current proposed hypothesis(es). 3. Explain how this study might improve the diagnosis or treatment of the disease being studied (if applicable), or advance knowledge in the field.

C. Hypotheses / Objectives 1. Clearly state the hypothesis(es), listing them by number if there is more than one. 2. Clearly state the objectives, listing them by number if there is more than one. (NOTE: the Department of Biostatistics is available to assist with study design, sample size calculation, and statistical analysis matters. Contact 588-4795 or see Consulting and Collaboration at Department of Biostatistics

D. Subject Criteria 1. State the criteria for inclusion in the study in a specific and detailed manner. 2. Age Range:

Note: With regard to research involving pregnant women, prisoners, or minors, the IRB must review the study in accordance with Subparts B, C or D of the federal regulations. If it can be presumed that the subjects are not pregnant, incarcerated, or under the age of 18 during the conduct of the chart review, the Subparts do not apply. If, however, during the course of the chart review, the investigator becomes aware that the subjects meet one or more of these conditions, the PI must either exclude such subjects from the dataset, or the IRB must promptly re-review the proposal in accordance with the requirements of Subparts B, C or D.

Check all categories that apply to the target population for this study:

☐ Healthy volunteers ☒ Adults 65 years and older ☒ Patients ☐ Comatose/traumatized ☐ Children/Minors (under 7 years of age) ☒ Terminally ill ☐ Children/Minors ( 7 - 17 years of age) ☐ Prisoners ☐ Pregnant women ☐ Persons w/ active psychiatric disease ☐ Cognitively impaired ☐ KUMC Employees ☐ Males only ☐ KUMC Students/Residents/Fellows ☐ Females only

E. Date Range and Type of Proposed Chart Review 1. Provide the date range (Beginning to end date in which the data you are seeking was recorded in the medical record). In order to be considered retrospective, the end date must come before the IRB submission date: 1/1/2008 to 7/1/2016 2. Describe the type of records / specimens you wish to use

F. Study Methods 1. Source (location) of records to be reviewed (Who holds the records / specimens you wish to access (clinic, hospital, collaborator, etc)? If records do not belong to KU, we need an assurance from that institution approving the waiver of HIPAA authorization to release the records for research purposes and the assurance they will comply with the appropriate accounting of disclosures.

2 2. For what purpose were the data, records, specimens, etc. originally created? 3. Describe how the charts to be reviewed will be identified: 4. Describe who will identify charts to be reviewed: 5. Number of subjects you plan to study: 6. Number of charts you need to review in order to find appropriate subjects 7. Do you intend to submit the results of your study to the FDA for any reason? Yes No. if yes, please explain.

G. Waiver of Consent Explain why the research meets the following four criteria for waiving consent: Why is the research no more than minimal risk to subjects?

Why are the rights and welfare of subjects not adversely affected by waiving consent? Why can the research not practicably be carried out without a waiver of consent?

Are there any circumstances in which you would provide the subjects with additional pertinent information after your analysis?

H. Confidentiality of Data 1. Specify which members of the study team will be accessing the medical records: 2. Describe how research data (both paper and electronic) will be stored to safeguard confidentiality of the research records (e.g. in a locked cabinet, password protected computer): 3. Which individual identifiers or demographics below will be retained in the research records?

Names ☐ Ages over 89 years ☐ Street address, city, county, precinct or zip ☐ code Initials ☐ Identifying # or code # ☒ Health plan # or other account # ☐

Phone ☐ Other unique descriptor ☐ Vehicle identifier, serial #, license plate, etc. ☐

Fax ☐ Facial photos/images ☐ Biometric identifiers (finger/voice/retina) ☐

E-mail ☐ Social Security Number ☐ Device identifiers or serial numbers ☐

URL ☐ Certificate/License #s ☐ Date of birth, date of death, admit/discharge ☒ date IP ☐ Medical Record #s ☒ Other date related to the person (except year ☒ address only) None of the identifiers listed above will be included with the records used for research ☐

4. Do you plan on sharing the data with anyone outside KUMC? ☐No ☒Yes If yes, please explain the parties with whom the data would be shared and what demographic elements would be shared. (If the shared dataset contains elements of PHI, a data use agreement will be required.) 05/14/2015 KUMC – HRPP Page 3 of 5 5. How do you plan to protect identifiers from improper use and disclosure during data collection and analysis?

6. When will it be feasible to destroy the list that links the subject’s identity to the study data?

7. What is the plan to ensure that identifiable health information will not be reused or disclosed to other persons or entities?

8. Where will electronic study data be housed? (Check all that apply)

☐ Web server hosted by sponsor, collaborator or data coordinating center ☐ KUMC CRIS system ☒ KUMC REDCap server ☐ KUMC-supported network drive (e.g., S: drive, K: drive) ☒ University-owned laptop, tablet or iPAD ☐ Other servers, devices or drives: specify

Conflict of Interest for All Study Team Members

Prior to IRB approval, an annual COI disclosure form must be on file for all study personnel. The following questions relate to the study described in this application. NOTE: Principal Investigators are responsible for addressing these questions on behalf of the entire study team.

(a) ☐ Yes ☒ No Do any of the investigators or their immediate family* have financial arrangements with the sponsoring company or the products or services being evaluated, including:  receipt of honoraria  income, or  stock/stock options as payments in the past year or will be expected during the course of the project, that are:  not publicly traded, or  whose value may be affected by the outcome of the research?

(*Immediate family is defined as spouse, children, siblings, parents, equivalents by marriage [in-laws], or other household members)

(b) ☐ Yes ☒ No Do any investigators, study personnel, or their immediate family listed on this application have:  consulting agreements  management responsibilities  ownership interests, or  equity holdings or options (regardless of value) in the sponsoring company, the providers of the products or services being evaluated, vendors, provider(s) of goods, or subcontractors?

(c) ☐ Yes ☒ No Is any investigator, or their immediate family:  a paid or unpaid member of an advisory or executive board, or  have a paid or unpaid executive relationship with the sponsoring company or the providers of the products or services being evaluated? 4 (d) ☐ Yes ☒ No Do any investigators or their immediate family receive:  gift funds  educational grants, or  subsidies or other remuneration from the sponsoring company? (e) ☐ Yes ☒ No Do any investigators or their immediate family have an ownership or royalty interest in any intellectual property utilized in this protocol?

(f) ☐ Yes ☒ No Does KUMC or the KUMC Research Institute have an ownership or royalty interest in any intellectual property utilized in this protocol?

(g) ☐ Yes ☐ No For drug/device studies only: is the sponsor of the study a different party than the manufacturer of the drug or device?

(h) If you answered “Yes” to any of the questions about conflict of interest above, please describe in detail. Affirmative answers will be used for conflict of interest evaluation.

Thank you for your submission. If you have any questions, please contact the KUMC IRB office at (913) 588-1240 or [email protected]

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