Jhsph Irb Application for Disclosure of Johns Hopkins Medicine(Jhm)

To be completed by the Principal Investigator

JHSPH IRB APPLICATION FOR DISCLOSURE OF JOHNS HOPKINS MEDICINE(JHM)

PROTECTED HEALTH INFORMATION (PHI)

(based on JHSPH IRB Policy on Use of PHI in Research)

PI Name
IRB Number
Study Title

JHM Protected Health Information for Living Participants (For Decedents, go to Section V)

Identify the specific JHM Covered Entity[1]and JHM Departments from which the PHI will be obtained:

The Johns Hopkins Hospital The Johns Hopkins Bayview Medical Center
Howard County General Hospital JH Community Physicians
Suburban Hospital Sibley Memorial Hospital
All Children’s Hospital JH Pharmaquip
JH Pediatrics at Home Priority Partners Managed Care Organization
JH University School of Medicine Johns Hopkins Employee Health Plans, e.g. EHP
JH University School of Nursing JH Home Health Services
Other Hopkins Providers (specify):
List the specific JHM department(s) from which the PHI is sought:

Select the personal identifiers you seek to access/use in your research project.

Name / Certificate or license numbers
Geographic information smaller than State, including city, county, and zip code and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:
(1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and
(2)The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. / Vehicle identifiers and serial numbers, including license plate numbers
All elements of dates except years (e.g., birth date, admission date, date of death, age by year if >89 years of age) / Device identifiers and serial numbers
Telephone numbers / Web URLs
FAX numbers / Internet Protocol (IP) address
Email address / Biometric identifiers, including finger and voice prints
Social Security Number / Full face photographic images and comparable images
Medical record numbers / Health Plan beneficiary numbers
Account numbers / Any other unique identifying number, characteristic or code

Describe specifically the types of health information you will collect (e.g. diagnosis, test results, treatments, etc.)

Identify how you will access the JHM PHI you want to use in your study. Choose all that apply.

Directly from the study participant with a signed JHSPH IRB Approved Consent/HIPAA Privacy Authorization Form

What type of form do you plan to use?

Combined consent/HIPAA authorization document
Stand-alone Medical Records Release form with HIPAA authorization document
Stand-alone HIPAA authorization document

From electronic medical/billing records via a credentialed JHHS Workforce Member
From electronic medical/billing records via a JHU student (SOM, SON, and/or SPH) working under the direction of a credentialed JHHS workforce member and who have signed a HIPAA Workforce Agreement either for this study or as part of their patient care responsibilities.
From electronic medical/billing records via JHU-employed research personnel (including faculty and staff) working under the direction of a credentialed JHHS workforce member, and who have signed a HIPAA Workforce Agreement for this study.
From electronic medical/billing records via a JHM Privacy Office certified Honest Broker*

Will you use PHI to identify and/or contact potential participants for your research?

Yes No

If yes, complete the sections below.

Will you access PHI to identify potential participants for the study?

Yes No

If yes, you must confirm the following:

i.You will only obtain the “minimum necessary” PHI;

ii.The PHI will not leave the JHM covered entity or, if electronic, go outside JHM firewalls;

iii.The PHI will not be used or disclosed to anyone outside the approved recruitment plan; and

iv.All PHI will be destroyed after it has been used for recruitment purposes.

Confirm

Please identify the individual(s) who will access PHI to identify potential participants for your research.

Role / Name(s)
JHHS Credentialed Workforce Member(s) with treatment relationship to potential participants
SPH, SON or SOM student(s) who has signed a HIPAA Workforce Agreement as part of patient care responsibilities.
SPH Student(s) who hassigned HIPAA Workforce/Confidentiality Agreement for this study.
JHU Researcher(s)who has signed HIPAA Workforce Agreement
JHHS Certified Honest Broker

Will you use PHI to contact(in person or via mechanism like mail or phone) potential participants for the study? Note: Successful recruitment will require a signed consent/authorization from participants who join the study.

Yes No

If yes, please check all that apply.

i.Will a clinician with a treatment relationship obtain verbal permission from the potential participant to provide name and contact information to the researcher so the researcher may directly contact the potential participant from within the JHM covered entity?

Yes No

If yes, confirm the following:

That you are a HIPAA Workforce Member (need signed HIPAA Workforce Agreement)
That the clinician will note the verbal permission in the medical record.
That contact with the individual will take place in person within the JHM covered entity.
That the PHI is the “minimum necessary” and will not leave the JHM covered entity.
That if the potential participant agrees to participate, you will obtain consent and authorization.

Confirm

ii.Will the clinician with a treatment relationship with the potential participant contact that individual in person or via mail, phone, email, or other mechanism to obtain permission to share contact information with the researcher so that the researcher may contact the potential participant from outside JHM to explain the study?

Yes No

If yes, confirm the following:

That the clinician will obtain the verbal permission from the individual allowing the researcher to contact the individual, and will note that verbal permission in the medical record.
That the clinician who is recording the note in the medical record will be added as a co-investigator to the study.
That the PHI given the researcher is the “minimum necessary” to make the contact.
That the PHI used for recruitment purposes will be destroyed after contact for those individuals who do not respond or who decline participation.
Those individuals who agree to join the study will sign a consent/authorization.
That the PHI for those who agree to participate will be retained in accordance with the HIPAA Authorization signed by the study participant.

Confirm

Are you requesting a Waiver of the HIPAA Authorization requirement?

Yes No

If yes, answer the sections below

1.Check off the purpose for which you seek the waiver:

For study recruitmentbecause it is impracticable to have the clinician with a treatment relationship with the potential participants involved in the recruitment contact? [Note: The IRB will grant a waiver for recruitment in rare circumstances; its expectation is that the researcher’s activities will follow the recruitment requirements provided in Section II, above.]

Yes No

For secondary data analysis or a broad program evaluation?

Yes No

2.Explain why the research and/or recruitment could not practicably be conducted without the waiver. Be as specific as possible.

3.Explain why the research and/or recruitment could not practicably be conducted without access to/use of the PHI. Be as specific as possible.

4.Confirmthat the use of PHI pursuant to the waiver involves no more than minimal risk to the privacy of the study participant.

Confirm

5.Confirm that if you plan to enroll, or do enroll, 49 or fewer participants from JHM, you will “track” the disclosuresof PHI to you, as required, in the SPH Johns Hopkins HIPAA Compliance System. The database may be accessed at

Confirm

6.When will you destroy the identifiers? (Must be at earliest opportunity)

LIMITED DATA SETS

Do you intendto use a Limited Data Set produced by a JHHS Certified Honest Broker or other HIPAA Workforce Member?

Yes No

If Yes, identify the person who will create the Limited Data Set:
Please identify the individual(s) who will access prepare, and/or use the Limited Data Set:

Role / Name(s)
JHHS Credentialed Workforce Member(s) with treatment relationship to potential participants
SPH, SON or SOM student(s) who has signed a HIPAA Workforce Agreement as part of patient care responsibilities.
SPH Student(s) who has signed HIPAA Workforce/Confidentiality Agreement for this study.
JHU Researcher(s) who has signed HIPAA Workforce Agreement
JHHS Certified Honest Broker

Note:A limited data set may include only the following identifiers:

Dates, such as admission, discharge, service, DOB, DOD;
City, state, five digit or more zip code or any other geographic subdivision, such as state, county, city, precinct and their equivalent geocodes except street addresses; and
Ages in years, months, days, or hours (with ages >89 aggregated into a single category of 90 or older).

Have you obtained a Data Use Agreement from the Johns Hopkins Privacy Office?

Yes No

If yes, attach or upload a copy of the Data Use Agreement to this Application.

If no, contact the Johns Hopkins Privacy Office for a Data Use Agreement.

DECEDENTS-ONLY PHI

Do you seek to access and use JHM PHI from Decedents Only?

Yes No

If yes, please answer the following questions.

Please describe the research purposes for which the researcher intends to examine records/specimens of deceased individuals.

Please identify the source of the records/specimens of deceased individuals the researcher intends to study.

If yes, confirm the following:

The use or disclosure of PHI is sought solely for research on the PHI of decedents. No living individuals will be included.
If the IRB requests it, the researcher will provide documentation as to the death of the individuals.
The PHI is necessary for the research purposes.
The PHI will be obtained through a HIPAA Workforce Member.

Confirm

Please identify the individual(s) who will access, prepare, and/or use the decedent PHI.

Role / Name(s)
JHHS Credentialed Workforce Member(s)
SPH, SON or SOM student(s) who has signed a HIPAA Workforce Agreement
SPH Student(s) who has signed a HIPAA Workforce/Confidentiality Agreement for this study.
JHU Researcher(s) who has signed a HIPAA Workforce Agreement for this study
JHHS Certified Honest Broker

Confirm the following: The PHI will not be reused or disclosed to any other person or entity, except:

As required by law
For authorized oversight of this research
For other research for which use or disclosure of PHI is permitted under HIPAA. I will not proceed with any such use without consultation with the Johns Hopkins MedicineHIPAA Privacy Office.

Confirm

______

Signature of Principal Investigator Date

*“Honest Broker” is someone who is authorized to create large datasets for analysis, but is not involved in the analysis.

07Mar2018 – JHM Application

[1] An updated list of Johns Hopkins Medicine covered entities may be found at: