Irb Health Insurance Portability & Accountability Act Compliance Application (Page 3 of 5) in pdf

Irb Health Insurance Portability & Accountability Act Compliance Application Page 3

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.

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.

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:

Irb Health Insurance Portability & Accountability Act Compliance Application Page 3