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Institutional Review Board & HIPAA FormsMED 8101-04 Clinical Epidemiology

James Beal, Ph.D.Family & Community Medicine777-3272james.beal@med.und.edu

Institutional Review Board (IRB)• Research - Research means a systematic investigation, including

research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

• Human Subject - Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains– data through intervention or interaction with the individual, or– identifiable private information.

• If you plan to conduct "Human Subject Research", submit the appropriate form to the IRB for review and approval before beginning the research

Types of IRB Review• Exempt -information is recorded by the

investigator in such a manner that subjects cannot be identified – Numbers or codes

• Age, gender, Length-of-stay

• No medical record number or names

– Minimal or No dates recorded• Such as birth date, admission, departure

• Expedited– Survey or Direct Observational Study

• Full Board– Drug study or Clinical trial

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IRB Approval Requiredprior to data collection

• UND IRB Approval• Exempt Form• Student Consent Form• Letter of Assurance• Key Personnel Form• HIPAA Compliance Form

• Hospital IRB Approval

IRB and Methods

• Your IRB Protocol can go a long ways towards writing your Methods section

• IRB application– Written in future tense

• “We plan to conduct a chart review…” or “We plan to collect data on…”

– Need to provide estimate of number of subjects, i.e. patients included

• Methods– Written in past tense

• “We conducted a chart review…” or “We collected data on…”

Clinical Protocol

• Who

• What

• Where

• When

• How

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Guidelines to Clinical Protocol:What to Include?

• Abstract of Introduction and background Information: (Approx. 200 words).

• Include an explanation of why you are undertaking this research

• What’s in the literature/previous studies

• Purpose of the study:• Explain the specific questions you hope to answer

or specific hypotheses you plan to test

Guidelines to Clinical Protocol• Selection of participants and gathering

information:• Where or how will you get the information?

– Medical records or dataset?

• What are the disease of interest and exposure?

– ICD-9 codes and/or CPT codes

• What is the timeframe for including patients?– Ex. All TKR/THR patients from Jan 1., 2015 – Dec. 31, 2015.

• What are your criteria for selecting participants and for excluding people from the study?

– ICD codes? Race? Gender? Age?

• How will you record information?– Briefly describe the procedures and techniques that will be used

Guidelines to Clinical Protocol

• How will the results of the research be detected and measured?– What methods and criteria will be used to measure the major

variables and effects in the research design?

– What strategies of data analysis (such as statistical methods) do you plan to use?

– How will records of the research be maintained? • In what form?

• Where?

– References: What prior published research provides the major context or precedents for this proposal?

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Example

Protocol-Purpose

4. With increasing focus being paid to conserving resources and time in the emergency department (ED), the process of triaging illness appropriately has become critical. This involves assigning an Emergency Severity Index (ESI) score based on vital signs and presenting symptoms to determine urgency and treatment priority. While this system is effective, it is inherently dependent on the medical personnel doing the assessment. Racial disparities have been frequently reported in ED care. The purpose of this study is to determine the association of race on ED triage assessment.

Protocol-Data Source

5-7,9. I will conduct a retrospective analysis of adults diagnosed with chest pain, abdominal pain, or back pain–the three most common presenting chief complaints –utilizing the 2011 National Hospital Ambulatory Medical Care Survey (NHAMCS) Emergency Department Patient records data set. I will compare the average ESI scores for each of these diagnoses amongst three racial groups: White, Black or African American, or Other (to include Asian, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native).

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Protocol-Inclusion

The inclusion criteria will be adult men and women of any race, ages 18 and older, presenting with and/or diagnosed with chest pain (ICD-9 code 786.5), abdominal pain (789.0), or back pain (724.5). Exclusion criteria will be patients under age 18 and patients 18 or older with any diagnosis other than the aforementioned diagnoses.

Protocol-Data Recorded

Data to be recorded will include: age, gender, race, insurance status, hospital ownership type (for-profit, government, nonprofit), region of US (Northeast, West, South, Midwest), MSA (uban or not), hospital teaching status (patients seen by a resident physician), initial vital signs, triage level, pain scale, reason for visit, and provider’s diagnosis for visit.

Protocol-Statistics

SPSS 24.0 for Windows will used to analyze demographic and clinical characteristics of patients. Frequencies and relative percentages will be computed for each categorical variable. Chi-square tests or Fisher’s exact tests will be performed to determine which categories were significantly different from one another, and t-test will be used to compare continuous variables. All p-values will be two-sided, and p-value < 0.05 will be considered significant. Missing data will be excluded from analysis.

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Protocol-Confidentiality

• 8 & 10: For the purpose of this study, there will be no physical interaction between the principal investigators and the patients whose charts are being reviewed. Furthermore, no procedures will be performed nor will direct interaction occur with patients of this study. Data will be stored securely on password-protected computers and files. The data file will not contain any identifying information such as patients’ names or medical record numbers. Only those involved in the research project will be able to access the data. Data will be stored in the Department of Family and Community Medicine at the UND School of Medicine and Health Sciences for a period of six years after analysis.

ICD-9 Codes & ICD-10 codes

• ICD-9CM codes– http://icd9.chrisendres.com/– http://www.cms.gov/medicare-coverage-

database/staticpages/icd-9-code-lookup.aspx– PDF files on Epidemiology Schedule Page

• ICD-10 – http://www.icd10data.com/

• ICD-9 to ICD-10; vice versa– http://www.icd10data.com/Convert– http://www.icd10codesearch.com/

IRB Process• Download forms from the Epi Schedule page,

http://med.und.edu/education-resources/epidemiology/schedule.cfm

• Complete UND and Hospital Forms

– Each group member listed as PI AND must sign forms

– Type each form- handwritten forms not accepted

• Write the Protocol

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IRB Process• October 23: E-mail IRB Forms and Protocol Due

to Dr. Beal

– Email completed IRB Forms and Protocol-word documents

– Fax or scan e-mail signature pages only

• i.e., no need to fax every page-send it via e-mail

IRB Process• Dr. Beal reviews forms and Protocol for

November group meetings

• Once Protocol is finished

– Dr. Beal signs both UND and Hospital IRBs as faculty advisor

UND IRB: Necessary Forms

• Data Exempt Form (IRB Application)

• Student Consent Form

• Letter of Assurance• Key Personnel

• HIPAA Compliance Form

• Hospital required additional forms– Permission to conduct research

– Key Personnel

– Data request form

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IRB Forms - UND

• Exempt Certification Form– Page 1

• Principal Investigators – all group members

• Project Title

• Contact Information

– Pages 2-3• List the Hospital/Clinic and

• Date submitted to Hospital IRB-pending

• Question 4-11: Do not Answer=Protocol answers them

• Every group member must sign it

IRB Protocol• Separate Page

– Title

– PIs-Group Members

– 4-5 paragraphs• Background & Purpose statement/Question

• Subjects, Disease (ICD-9/10 codes), time-frame, & inclusion/exclusion

• Data to be /recorded collected

• Statistical Analysis-copy from one of the Protocol examples on Epi. Schedule page

• Confidentiality Statement-Copy

IRB Forms - UND• Letter of Assurance

– Every Group Member must be • Name

• Signature

– Can be one sheet or separate sheets

• Student Consent– Project Title

– Student ID#

– Name

– Signature (Can be one or separate sheets

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IRB Forms - UND• HIPAA Form

– P.1 • List every PI-Group Member• Title

– P. 4, Section H, item 1• Replace [INSERT: Relevant Variable] with

variables listed in Protocol– P. 4, Section H, item 2.E

• Replace [INSERT: Topic and/or exposure] with topic and exposure. Copy from Purpose Statement in Protocol

– Section I• Every Group Member Sign it=1st and last pages

Hospital IRBs: Each is Unique• Sanford-Bismarck/Fargo

– Submit a copy of UNDs IRB application

– Data Request Form

– Receive approval letter

• Altru-similar to UNDs• St. A’s-

• Forms submitted electronically via IRBNet• required to submit forms 2wks in advance• present to full board

– Only meets 1 time per month

• Trinity-Similar to St. A’s

IRB Contacts UND

Dr. Beal I need to sign it as student

advisor Michelle Bowles, IRB

Coordinator 777-4079

Altru Health System Marie-Laure Reese mreese@altru.org 6th floor, P.O. Box 6002

Grand Forks, ND 58206-6002 701-780-6161

Cindy Flath Altru Research Center Building 1

860 South Columbia Road

Grand Forks, ND 58201

701-780-1750

Sanford Health System Renee Schievelbein Renee.Schievelbein@SanfordHealth.org IRB Coordinator for IRB #1 & #3 Sanford Health Human Research

Protection Program (605) 312-6432

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IRB Contacts St. Alexius

Joan Galbraith, BS, RPhjgalbraith@primecare.orgClinical Research ManagerClinical Research ServicesDivision of St. Alexius Medical Center810 E. Rosser Ave Suite 202Bismarck ND 58501701-530-6950Fax: 701-530-6970

Trinity Health Cindy Nordquist

Cindy.Nordquist@trinityhealth.org

Medical Staff Coordinator

Trinity Health

PO Box 5020

Minot, ND 58702-5020

701-857-5118 – phone

701-857-5117 - fax

Due Dates

• October 23, 2018 - IRB Forms

• November 9 & 13 -Group Meetings

• January 8 – Introduction & Methods

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University of North Dakota Exempt Certification Form – SEPTEMBER 2015 VERSION Research Involving Existing Records or Data

Complete this form if you are requesting permission to review existing records or conduct analysis of existing datasets. All research with human participants conducted by faculty, staff, and students associated with the University of North Dakota, must be reviewed and approved as prescribed by the University’s policies and procedures governing the use of human subjects. No activities are to be initiated without prior review and approval by the Institutional Review Board. Please answer the following questions regarding your research. Handwritten forms are not accepted – responses must be typed. 1. Are the data existing? Existing means the data are ‘on the shelf’ (i.e., they were collected prior to this research

proposal). Yes No If you answered “No” to the above question, this research does not qualify as exempt. Please fill out and submit a “Human Subjects Review Form”. If you answered “Yes”, continue to question 2. 2. Will there be any contact with the subjects? Yes No If you answered “Yes” to the above question, this research does not qualify as exempt. Please fill out and submit a “Human Subjects Review Form”. If you answered “No”, continue to question 3a. 3a. Are the data publicly available? Yes No If you answered “No” to the above question, please continue to question 3b. If you answered “Yes”, skip question 3b and provide the information requested below. 3b. Will the data be documented in a manner that subjects cannot be identified, either directly or through

identifiers linked to the subjects (e.g., subject name, social security number, birth date, coding, etc.) ? Yes No If you answered “No” to the above question, this research does not qualify as exempt. Please fill out and submit a “Human Subjects Review Form”. If you answered “Yes”, please provide the information requested below:

If the research involves the use of audio, video, digital or image recordings of subjects, this research does not qualify as exempt. Please fill out and submit a “Human Subjects Review Form”.

Principal Investigator:

Telephone: E-mail Address:

Complete Mailing Address:

School/College: Department:

Student Adviser (if applicable): James R. Beal, Ph.D.

Telephone: 701-777-3272 E-mail Address: james.beal@med.und.edu

Address or Box #: 1301 N Columbia Rd, 9037

School/College: School of Medicine Department: Family & Community Medicine

*** All IRB applications must include a Key Personnel Listing

Project Title:

Proposed Research Beginning Date: Exempt research will be approved for 3 years from the original approval date.

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Funding agencies supporting this research: NA

(A copy of the funding proposal for each agency identified above MUST be attached to this proposal when submitted.)

YES or NO

Does any researcher associated with this project have a financial interest in the results of this project? If yes, submit on a separate piece of paper an additional explanation of the financial interest. The Principal Investigator and any researcher associated with this project should have a Financial Interests Disclosure Document on file with their department.

YES or NO Will any research participants be obtained from another organization outside the University of North Dakota (e.g., hospitals, schools, public agencies, American Indian tribes/reservations)?

YES or NO Will any data be collected at or obtained from another organization outside the University of North Dakota?

If yes to either of the previous two questions, list all institutions: Letters from each organization must accompany this proposal. Each letter must illustrate that the organization understands its involvement and agrees to participate in the study. Letters must include the name and title of the individual signing the letter and should be printed on organizational letterhead. Does any external site where the research will be conducted have its own IRB? YES or NO If yes, does the external site plan to rely on UND’s IRB for approval of this study? YES or NO (If yes, contact the UND IRB at 701 777-4279 for additional requirements)

If your project has been or will be submitted to other IRBs, list those Boards below, along with the status of each proposal. Date submitted: Status: Approved Pending

Date submitted: Status: Approved Pending

(include the name and address of the IRB, a contact person at the IRB, and a phone number for that person) Type of Project: Check “Yes” or “No” for each of the following.

YES or NO New Project YES or NO Dissertation/Thesis/Independent Study

YES or NO Continuation/Renewal YES or NO Student Research Project

YES or NO Is this a Protocol Change for a previously approved project? If yes, submit a signed Protocol Change Form, along with a signed copy of this form with the changes bolded or highlighted.

Provide additional information regarding your research by responding to questions 4-11 on a separate sheet of paper. 4. In non-technical language, briefly describe the purpose of the study and state the rationale for this research.

5. In non-technical language, describe the study procedures.

6. What is (are) the type(s) of records to be reviewed (medical records, data sets, etc.)? 7. Describe what data will be recorded, including the date range of the files/records you will be reviewing. 8. How will data be stored?

Note: Must state that data will be stored for a minimum of three years after data analysis is complete, or for a period of time sufficient to meet federal, state, and local regulations, sponsor requirements, and organizational policies and procedures.

Revised 9/102015 3

9. If data are not publicly available, please provide a letter of support from the agency, or IRB approval from the

agency. 10. Describe procedures you will implement to protect confidentiality and privacy of participants. 11. If the project involves medical record information, complete the HIPAA Compliance Application and submit it

with this form. Necessary attachments: Signed Student Consent to Release of Educational Record Form (students and medical residents only); Investigator Letter of Assurance of Compliance; Key Personnel Listing; Advertisements. NOTE: The UND IRB requires that all key personnel involved in the research complete human subject education before IRB approval to conduct research can be granted. *************************************************************************************************** By signing this form, I certify that the above information is accurate, and that this research will be conducted in accordance with the statements provided above. The investigators will not intervene or interact with identified research subjects in the conduct of this research project.

(Principal Investigator) Date:

(Student Adviser) Date:

**All students and medical residents must list a faculty member as a student adviser on the first page of the

application and must have that person sign the application.**

Submit the signed application form and any necessary attachments to the Institutional Review Board, 264 Centennial Drive Stop 7134, Grand Forks, ND 58202-7134; or bring it to Twamley Hall, Room 106.

Revised 9/102015 4

INVESTIGATOR LETTER OF ASSURANCE OF COMPLIANCE WITH ALL APPLICABLE FEDERAL REGULATIONS FOR THE

PROTECTION OF THE RIGHTS OF HUMAN SUBJECTS I _ ____________________________ (Name of Investigator) agree that, in conducting research under the approval of the University of North Dakota Institutional Review Board, I will fully comply and assume responsibility for the enforcement of compliance with all applicable federal regulations and University policies for the protection of the rights of human subjects engaged in research. Specific regulations include the Federal Common Rule for Protection of the Rights of Human Subjects 45 CFR 46. I will also assure compliance to the ethical principles set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research document, The Belmont Report. I understand the University’s policies concerning research involving human subjects and agree to the following: 1. Should I wish to make changes in the approved protocol for this project, I will submit them

for review PRIOR to initiating the changes. (A proposal may be changed without prior IRB approval where necessary to eliminate apparent immediate hazards to the subjects or others. However, the IRB must be notified in writing within 72 hours of any change, and IRB review is required at the next regularly scheduled meeting of the full IRB.)

2. If any problems involving human subjects occur, I will immediately notify the Chair of the

IRB, or the IRB Coordinator. 3. I will cooperate with the UND IRB by submitting Research Project Review and Progress

Reports in a timely manner. I understand the failure to do so may result in the suspension or termination of proposed research and possible reporting to federal agencies. ______________________________________ _ _________________ Investigator Signature Date

Revised 9/102015 5

STUDENT RESEARCHERS: As of June 4, 1997 (based on the recommendation of UNDLegal Counsel) the University of North Dakota IRB is unable to approve your project unlessthe following "Student Consent to Release of Educational Record" is signed and includedwith your IRB application.

STUDENT CONSENT TO RELEASE OF EDUCATIONAL RECORD1 Pursuant to the Family Educational Rights and Privacy Act of 1974, I hereby consent to the

Institutional Review Board’s access to those portions of my educational record which

involve research that I wish to conduct under the Board’s auspices. I understand that the

Board may need to review my study data based on a question from a participant or under

a random audit. The title of the study to which this release pertains is

. I understand that such information concerning my educational record will not be released except on the condition that the Institutional Review Board will not permit any other party to have access to such information without my written consent. I also understand that this policy will be explained to those persons requesting any educational information and that this release will be kept with the study documentation. ID # Printed Name

Date Signature of Student Researcher 1Consent required by 20 U.S.C. 1232g.

Protocol: The association between use of antihypertensive medications and the recurrence of prostate cancer

after radiation therapy. Thomas Grindberg, MS3 Sadi Skarloken, MS3 and ErinWenzel, MS3

Faculty Advisors: James R. Beal, Ph.D. Abe E Sahmoun, Ph.D.

Question 4: Prostate cancer is the most common non-cutaneous cancer among men in the United States. In 2010, 196,038 men were diagnosed with and 28,560 died from prostate cancer in the US alone.1 Radiation therapy (RT) is one of the potentially curative treatment modalities for localized prostate cancer, but recurrence can often still occur. It is desirable to find secondary prevention strategies in the management of prostate cancer long-term. Beta-blockers are commonly used drugs to treat hypertension, congestive heart failure, and angina. Recent animal studies have shown beta-blockers to inhibit the development of metastases from breast and prostate cancer, and to prevent stress-induced tumor growth and angiogenesis in ovarian carcinoma models.2 Use of beta-blockers was as-sociated with lower primary prostate cancer risk in two of the three largest observational studies on anti-hypertensive drugs and prostate cancer.3-5 The purpose of this study is to determine the association between hyper-tensive medication use and reoccurrence of prostate cancer after radiation therapy. Questions 5-7, 9: We will conduct a retrospective chart review of men, 40 years and older, diagnosed with prostate cancer (ICD-9 Code 185) between January 1, 2006 and December 31, 2008 at Sanford Health, Fargo, ND. Patients included will be those that received external beam radiation as primary prostate cancer treatment. Patients will be reviewed for prostate cancer recurrence for 5 years from the first day after radiation therapy to the occurrence end of 5 years of follow-up or death, whichever comes first. Prostate cancer recurrence will be defined as the earliest of the following outcomes: (1) biochemical recurrence, defined as a rise in PSA by 2 ng/ml or more above the nadir PSA after radiation therapy based on the 2005 Phoenix definition6; or (2) clinical disease progression, defined as use of salvage chemotherapy, diagnosis of metastatic disease or prostate cancer-related death. Diagnosis of metastatic dis-ease will included ICD-9 codes 196.x, 197.x, 198.x, and 199.x and/or noted in the medical records. Cases will be men with prostate cancer with recurrence within five years. Controls will be men with prostate cancer without re-currence. The inclusion criteria for cases will be men, 40 years and older, with histologically confirmed prostate cancer as a primary site diagnosed between 2006 and 2008 using a pathology report present in the medical records. Exclusion criteria will be: 1. race other than white as <6% of residents of Fargo-Moorhead are non-White; 2. diagnosis of any cancer other than primary prostate cancer; 3. those with stage IV disease or unknown stage; 4. those who received radical prostatectomy prior to radiation therapy; 5. those who had no PSA test in the year following radiation thera-py or had less than 2 PSA tests within 5 years after radiation therapy; and 6. Men starting hypertensive medication after the date of diagnosis. Hypertensive medications will include ACE inhibitors, angiotension receptor blockers, beta-blockers, calcium-channel blockers, and/or thiazide diruretics. For hypertensive medication use we will follow Li et al.7, classifica-tions. Current users will be those who ever used these medications for 6 months or longer and were currently using them within 6 months of their diagnosis date. Former users will be patients who ever used these medications for 6 months or longer who last used them more than 6 months prior to their reference date. Short-term users will be men who used these medications for less than 6 months regardless how close to diagnosis date Data to be recorded will include: age at prostate cancer diagnosis, BMI , race/ethnicity, time between prostate cancer diagnosis to radiation therapy, histology, cancer stage, Gleason score, pre-radiotherapy PSA level, time between radiation therapy and prostate cancer recurrence, hypertensive medication use prior to/during/or after radiation ther-apy, duration of hypertensive medication use, type of hypertensive medication, dose of hypertensive medication, NSAIDs, statins use, vitamin supplements, heart disease(ICD-9 414.9, ), hypertension (ICD-9 401.9), diabetes (ICD-9 250.00), hypercholestorlemia, and smoking (ICD-9 305.1). SPSS 21.0 for Windows will used to analyze demographic and clinical characteristics of patients. Frequencies and relative percentages will be computed for each categorical variable. Chi-square tests or Fisher’s exact tests will be performed to determine which categories were significantly different from one another, and t-test will be used to

Protocol The association between race and ED triage assessment.

Jordan Bleth, MSIII Faculty Advisors: James R. Beal, Ph.D. & Abe E Sahmoun, Ph.D.

4: With increasing focus being paid to conserving resources and time in the emergency department (ED), the process of triaging illness appropriately has become critical. This involves assigning an Emergency Severity Index (ESI) score based on vital signs and presenting symptoms to determine urgency and treatment priority. While this system is effective, it is inherently dependent on the medical personnel doing the assessment. Racial disparities have been frequently reported in ED care. The purpose of this study is to determine the association of race on ED triage assessment.   5‐7, 9:  I will conduct a retrospective analysis of men and women diagnosed with chest pain (ICD‐9 code 786.5), abdominal pain (789.0), or back pain (724.5) – the three most common presenting chief complaints – the 2011 National Hospital Ambulatory Medical Care Survey (NHAMCS) Emergency Department Patient records data set. I will compare the average ESI scores for each of these diagnoses amongst three racial groups:  White, Black or African American, or Other (to include Asian, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native).   The inclusion criteria will be adult men and women of any race, ages 18 and older, presenting with and/or diagnosed with chest pain, abdominal pain, or back pain. Exclusion criteria will be patients under age 18.   Data to be recorded will include: age, gender, race, insurance status, hospital ownership type (for‐profit, government, nonprofit), region of US (Northeast, West, South, Midwest), MSA (uban or not), hospital teaching status (patients seen by a resident physician), initial vital signs, triage level, pain scale, reason for visit, and provider’s diagnosis for visit.   SPSS 23.0 for Windows will used to analyze demographic and clinical characteristics of patients. Frequencies and relative percentages will be computed for each categorical variable.  Chi‐square tests or Fisher’s exact tests will be performed to determine which categories were significantly different from one another, and t‐test will be used to compare continuous variables.  All p‐values will be two‐sided, and p‐value < 0.05 will be considered significant.  Missing data will be excluded from analysis.   8 & 10:  For the purpose of this study, there will be no physical interaction between the principal investigators and the patients whose charts are being reviewed.  Furthermore, no procedures will be performed nor will direct interaction occur with patients of this study.   Data will be stored securely on password‐protected computers and files.   The data file will not contain any identifying information such as patients’ names or medical record numbers.   Only those involved in the research project will be able to access the data.  Data will be stored in the 

Department of Family and Community Medicine at the UND School of Medicine and Health Sciences for a period of six years after analysis. References:  

- Schrader CD, Lewis LM. Racial disparity in emergency department triage. J Emerg Med. 2013 Feb;44(2):511‐8. doi: 10.1016/j.jemermed.2012.05.010. Epub 2012 Jul 19. 

- Qiao WP, Powell ES, Witte MP, et al. Relationship between racial disparities in ED wait times and illness severity. Am J Emerg Med. 2016 Jan;34(1):10‐5. doi: 10.1016/j.ajem.2015.08.052. 

- Vigil JM, Alcock J, Coulombe P, et al. Ethnic Disparities in Emergency Severity Index Scores among U.S. Veteran's Affairs Emergency Department Patients. PLoS One. 2015 May 29;10(5):e0126792. doi: 10.1371/journal.pone.0126792. eCollection 2015. 

 

compare continuous variables. All p-values will be two-sided, and p-value < 0.05 will be considered significant. Missing data will be excluded from analysis. Questions 8 & 10: For the purpose of this study, there will be no physical interaction between the principal investi-gators and the patients whose charts are being reviewed. Furthermore, no procedures will be performed nor will direct interaction occur with patients of this study. Data will be stored securely on password-protected computers and files. The data file will not contain any identifying information such as patients’ names or medical record num-bers. Only those involved in the research project will be able to access the data. Data will be stored in the Depart-ment of Family and Community Medicine at the UND School of Medicine and Health Sciences for a period of six years after analysis. References: 1. Prostate Cancer, National Cancer Institute <http://www.cancer.gov/cancertopics/types/prostate>. 2. Grytli HH, Fagerland MW, Fossa SD, Taskén KA. Association between use of β-blockers and prostate cancer-

specific survival: a cohort study of 3561 prostate cancer patients with high-risk or metastatic disease. Eur Urol. In press. http://dx.doi.org.ezproxy.undmedlibrary.org/10.1016/j.eururo.2013.01.007.

3. Ronquist G, Rodriguez LA, Ruigomez A, Johansson S, Wallander MA, Frithz G et al (2004) Association be-tween captopril, other antihypertensive drugs and risk of prostate cancer. Prostate 58(1):50–56. doi:10.1002/pros.10294.

4. Perron L, Bairati I, Harel F, Meyer F (2004) Antihypertensive drug use and the risk of prostate cancer (Canada). Cancer Causes Control 15(6):535–541. doi:10.1023/B:CACO.0000036152.58271.5e.

5. Vezina RM, Lesko SM, Rosenberg L, Shapiro S (1998) Calcium channel blocker use and the risk of prostate cancer. Am J Hypertens 11(12):1420–1425. doi:10.1016/S0895-7061(98)00176-9M.

6. Roach 3rd, G. Hanks, H. Thames Jr, et al., Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO phoenix consensus conference, Int. J. Radiat. Oncol. Biol. Phys. 65 (4) (2006) 965–974.

7. Li CI, Daling JR, Tang MT, Haugen KL, Porter PL, Malone KE. Use of antihypertensive medications and breast cancer risk among women aged 55 to 74 years. JAMA Intern Med. 2013 Sep 23;173(17):1629-37. doi: 10.1001/jamainternmed.2013.9071.

Position Highest Academic Degree Licenses/Certifications

First Name Last Name (select from drop‐down menu) (High School, B.S, M.A., Ph.D., M.D., etc.) (if applicable) Consent Subjects Recruit Subjects Research Design Intervention Data Analysis

1

2

3 James Beal Faculty Ph.D.

4 Abe Sahmoun Faculty Ph.D.

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* Attach proof of education in human subjects research for all non‐UND personnel

Names of Research Personnel Responsibilities (check all that apply)

INSTITUTIONAL REVIEW BOARD

KEY PERSONNEL LISTING

UNIVERSITY OF NORTH DAKOTA

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HIPAA Compliance Application Institutional Review Board, Research Development and Compliance, University of North Dakota 264 Centennial Dr. Stop 7134, Twamley Hall, Rm. 106, Grand Forks, North Dakota 58202 FWA-00000376/IRB-00001040 Phone: (701) 777-4279/ Fax: (701) 777-6708 http://und.edu/research/resources/human-subjects/

PROJECT TITLE

PRINCIPAL INVESTIGATOR Name (Last, First)

Please complete this form if you intend to use/disclose protected health information (PHI) in your research. PHI is health information transmitted or maintained in any form or medium that: identifies or could be used to identify an individual; is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual An investigator may access PHI using one or more of the following methods. Unless otherwise noted, you should complete this entire form as applicable. A. Please check the appropriate box(es) for your specific research.

1. De-identified Information: De-identified Information is health information that cannot be linked

to an individual. Research which involves the use of “de-identified” PHI is exempt from HIPAA requirements. The HIPAA Privacy Rule regulations [45 CFR 164.514(b)] lists 18 specific identifiers that must be removed from the health information before the researcher obtains the information for it to be considered not identifiable. The list includes: Name/initials; Street address, city, county, precinct, zip code and equivalent geocodes; All elements of dates (except year) directly related to an individual (date of birth, admission date, discharge date, date of death); Elements of date, including year, for persons 90 or older; Telephone number; Fax number; Electronic mail address; Social Security Number; Medical record numbers; Health plan identification numbers; Account numbers Certificate/license numbers; Vehicle identifiers and serial numbers, including license plate numbers; Device identifiers and serial numbers; Web addresses (URLs); Internet IP addresses; Biometric identifiers, including finger and voice prints; Full face photographic images and any comparable images; Any other unique identifying number, characteristic or code.

If the research does not include access to any of the above identifiers, sign the certification at the bottom of the page. The HIPAA privacy regulations do not apply and you are not required to complete the rest of the application.

(Sign and Date this section only if the research involves De-Identified Information) I certify the PHI received or reviewed by research personnel for the research referenced above

does not include any of the identifiers listed above. Principal Investigator Signature Date

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2. Limited Data Set: A limited data set is a subset of information (PHI) that only contains the following identifiers linked to the subject: city, state, zip code, or elements of date such as date of birth, death or service. The other specific identifiers included in the list above may not be included in the health information that is being received by the research team. The use of a Limited Data Set requires a Data Use Agreement to be in place. The Data Use Agreement is a legal contract between the covered entity and the recipient.

3. Patient Authorization: A patient authorization is a document, signed by the subject that gives the

researcher permission to use/disclose PHI collected during the research study for defined purposes. An Authorization Form needs to be prepared in addition to the Informed Consent Document. The authorization information may also be addressed in the consent form. Please prepare the Authorization Form and submit it with your IRB application. (See sample Authorization Form)

4. Waiver/Alteration: A waiver/alteration is a request to forgo the authorization requirement based

on the fact that the use and/or disclosure of PHI involves minimal risk to the subject’s privacy and the research cannot be practically done without this waiver/alteration and access to/use of PHI. Refer to Section H to see if you may qualify for a waiver/alteration. Please designate if a waiver is being sought for initial recruitment purposes or for the entire research protocol.

Once a waiver of Authorization is granted, contact your source of PHI (i.e. Health Information

Management) to ensure that you follow the accounting procedures established as required by the Privacy Rule. Per the Privacy Rule, the covered entity must receive documentation of the waiver/alteration before PHI can be used or disclosed for the research.

The categories listed below are additional opportunities allowed under the HIPAA Privacy Rule to view/record PHI without prior individual authorization. 5. Reviews Preparatory to Research: Preparatory work is when PHI is reviewed for the purpose of

designing a research study or identifying potential subjects. No information may be removed from the records.

6. Research on Decedent’s Information: Decedent research is when PHI is collected from deceased

(prior to the study) patients/subject’s records.

B. Provide a description of the Protected Health Information (PHI) to be used or disclosed for your research:

Review of hospital/medical records to record de-identified data.

C. Source and Data Collection

1. Indicate your sources of health information:

Data containing no health information* Hospital/medical records (in and out patient)

Physician/clinic records Psychotherapy Notes

Lab, pathology and/or radiology results Data previously collected for research purposes

Biological samples Billing records

Interviews/Questionnaires Other (describe below)

*If the research does not include PHI, the HIPAA Privacy Rule regulations do not apply to this research study and you do not need to finish this form. Please be sure to note on your initial review protocol application that the research does not include PHI.

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2. Indicate how the research team will access and/or receive health information:

With limited identifiers: ZIP codes, geocodes, dates of birth, or other dates only. The study qualifies as a Limited Data Set and requires a Data Use Agreement. With a code that can be linked to the identity of the subject.*

The research includes PHI because the research team will have health information with identifiers. With unrestricted identifiers. * *Requires Consent and Authorization from the subject or a Waiver of Consent and Waiver of Authorization

from the IRB. 3. Indicate how the research team will record health information:

Without any direct or indirect identifiers – as a de-identified data set With limited identifiers: ZIP codes, geocodes, dates of birth, or other dates only.

With a code that can be linked to the identity of the subject. With unrestricted identifiers

D. Summary: Briefly summarize the collection, use and sharing of PHI for this research study.

Recorded data will not include name and medical record number. Data will be password protected. Only the principal investigators and faculty student advisors will have access to the recorded de-identified dataset.

E. Recruitment: Please mark all that apply:

1. PI/collaborators will recruit his/her/their own patients.

2. PI will send an IRB approved letter to colleagues asking for referrals of eligible patients. The treating physician will make initial patient contact. If the patient is interested, the patient will contact the PI.

3. PI will send an IRB approved letter to colleagues asking the physician to send out IRB approved

general “Dear Patient” letters describing the research study. The PI may draft the letter with the treating physicians’ signature, but may not have access to the patient names or addresses for mailing. If the PI wants the letters to be personalized (Dear Mr. Doe), the personal information would have to be entered by the treating physician.

4. Advertisements/media. All recruitment materials must have IRB approval.

5. The PI requests an initial Waiver of Authorization for the purpose of identifying subjects for

recruitment purposes including (with permission of the patient) the treating physician will invite the PI/research team to talk with the patient about enrollment. Be sure and complete section H.

6. Other , please specify:

F. PHI Sharing: 1. Indicate who may receive PHI during the course of the research study.

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Statistician Consultants

Colleagues (s) / Collaborators Data, Tissue, Specimen Registry(s)

Other Research Laboratory (s) Sponsor / Funding Agency

Study Data Coordinating Center Publication (s)

Other. please specify: Student/Faculty Advisor: James R. Beal, Ph.D.

2. Indicate how the data will be shared or disclosed.

Without any identifiers. With a linked code*.

With identifiers*. As a Limited Data Set*. * In this format, Authorization must specifically note who data will be shared or disclosed to. G. Data Security: Describe how the data will be secured. Please mark all that apply. 1. Electronic data:

secure network password access coded, with a master list secured and kept separately

other (specify): 2. Hardcopy data:

locked suite locked office locked file cabinet

data coded by PI or research team with a master list secured and kept separately.

data de-identified by PI or research team

other: (specify) H. Waiver/Alteration of Authorization [Complete this section to request a waiver of authorization for the

entire research protocol, for recruitment purposes, or to request an alteration of authorization process such as no signed documentation]. 1. Describe the protected health information (PHI) for which use, access, or disclosure is necessary. Include

a detailed list of the PHI and also a list of the sources. Data will be recorded without name and medical record number. Data to be recorded will include [INSERT: Relevant

Variables]. 2. Criteria for Waiver/Alteration of Authorization:

A. Explain how the use and disclosure of the information presents no more than minimal risk to the privacy of the individual.

Data will be recorded in a de-identified manner.

B. Describe the plan to protect the identifiers from improper use and disclosure (i.e., where will the

identifiers will be stored and who will have access).

NA

C. Describe the plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research. If there is a health or research justification for retaining identifiers or if such retention is required by law, please provide this information as well. NA

D. Explain why the research could not be practicably conducted without the alteration or

waiver.

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Most of the institution/hospitals do not have the medical records staff and time to provide students with limited or de-identified data sets so principal investigators/students have to review the charts. Also, most data is only available via chart review.

E. Explain why the research could not be conducted without access to and use of the PHI. There is no way to investigate [INSERT: Topic and/or exposure] without examining case histories derived from patients’ charts.

F. The Privacy Rule requires that when a waiver is granted that only the minimum necessary health information be used/disclosed. Therefore, provide justification that the PHI being requested is the minimum necessary information reasonably necessary to accomplish objectives of the proposed research. The variables being recorded are necessary to obtain valid results and draw conclusions of the study. The PHI will only be seen during the chart review and most data will be recorded as de-identified data.

STOP Continue to Section I The University of North Dakota IRB determined that this waiver request satisfies all of the requirements of the HIPAA Privacy Rule in 45 CFR 164.512(i)(2)). [ ] The proposed research activity will present no more than minimal risk to the privacy of the human subjects. [ ] There is an adequate plan to protect the patient identifiers from improper use and disclosure. [ ] There is an adequate plan to destroy the patient identifiers at the earliest opportunity and/or by the end of the

research study, or there is a health, research or legal justification for retaining the patient identifiers. [ ] There are adequate assurances that the requested information will not be reused or disclosed to any other

person or entity, except as required by law, for authorized oversight of this research study, or for other research for which the use or disclosure of the requested information would be permitted by the Privacy Rule.

[ ] The research could not be practicably conducted without the Waiver for Patient Authorization to access and use the requested PHI.

[ ] The approval process was conducted by normal review procedures. _____________________________ ___________________ Signature of IRB Chair or Member Date

I. HIPAA Privacy Rule Assurance

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The information listed in the application is accurate and all research staff (investigators, key research personnel) that are involved in the research will comply with the HIPAA regulations. Further, I assure that all research staff will have completed the UND IRB research training requirement prior to research participation.

I assure that the information obtained as part of this research (including protected health information) will not be reused or disclosed to any other person or entity other than those identified on this form, except as required by law. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entities I will seek approval by the UND IRB.

Principal Investigator Signature Date