Request for Partial Waiver of Authorization for Recruitment

1.This form is to request a Partial Waiver of Authorization (PWA) to use and/or disclose individually identifiable health information, i.e., protected health information (PHI), for recruitment purposes.
SECTION 1.0: Study Information
1.Protocol No.: / 2. Principal Investigator:
3.Sponsor: / 4.Name of HIPAA Covered Entity:
SECTION 2.0: Partial Waiver of Authorization Request
1.For what recruitment method(s) is the PWA being requested? Check all that apply:
Phone screening / Accessing an existing database or records (paper or electronic) to obtain potential study subjects’ PHI
Internet screening / Adding potential study subjects’ PHI to an existing recruitment database with their verbal permission
Mail screening / Creating a new recruitment database to retain potential study subjects’ PHI with their verbal permission
Other:
2.Describe in detail all PHI which will beused or disclosed for recruitment purposes. Completea. and b.:
Note: Health Information is individually identifiable when it is labeled with one or more of the HIPAA identifiers or derivative(s) thereof (such as initials).
  1. HIPAA Identifiers (check all that apply):

Names
Geographic subdivision smaller than a state
(e.g., address, county, zip code)
Date(s) (except year) related to the individual
(e.g., birthday, admission/discharge date, ageif > 90)
Telephone numbers
Fax numbers
Electronic mail addresses
Social Security numbers
Medical Records numbers
Health Plan Beneficiary numbers / Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic or code
Describe:
  1. By checking here, I confirm that Individually Identifiable Health Information to be used or disclosed for recruitment purposes involves only that which is contained in the study’s inclusion/exclusion criteria.

3.What is the plan to protectthe health information from improper use or disclosure? Check all that apply:
Confidentiality agreements with study staff
Policies and procedures relating to privacy and confidentiality
Initial and continuing staff education on the HIPAA Privacy Rule/ Final Omnibus Rule and/or subject privacy and confidentiality
Other:
4. Identifiers must be destroyed at the earliest opportunity. When will identifiers of potential subjects be destroyed?
Identifiers will be destroyed immediately upon the individual’s request.
Identifiers will be retained until potential subjects come to the study site to sign a HIPAA Authorization and complete screening.
Identifiers will be destroyed with the study records, as defined by federal, state and/or local laws and regulations.
Identifiers will not be destroyed at the earliest opportunity.Provide a health, research and/or regulatory/legal justification for retaining the Identifiers:
5. What steps will be taken to ensure that the PHI will not be reused or disclosed to any other person or entity?
Check all that apply:
Limited access to only individuals who need to know the information.
Electronic safeguards where only study staff has access to electronic study information. Describe the electronic safeguards in place (e.g., password protection, data encryption, firewall, automatic shutdown of unused screen, electronic system will not transmit data outside the covered entity [if so, explain protective measures]):
Physical safeguards where only study staff has access to areas with study information. Describe the physical safeguards in place (e.g., locked cabinets, locked filing room, security system):
Other:
6. Explain why it is not practicable (feasible) to recruit for this study without access to and use of the PHI.
Access to and use of PHI is necessary to contact potential subjects and/or be contacted by potential subjects to screen them for the study to help determine possible eligibility for study participation.
Other:
Note: Practicability (feasibility) should not be determined solely by considerations of convenience, cost or speed.
7. Explain why it is not practicable (feasible) to recruit potential subjects in order to conduct this study without a PWA. Check all that apply:
Potential subjects will be contacting the site by telephone or internet and, therefore, will not be available to sign a HIPAA Authorization.
The study staff will be contacting potential subjects, e.g., via telephone, e-mail, or mail, to inform them of the study and conducting telephone and/or internet screening and, therefore, potential subjects will not be available to sign a HIPAA Authorization.
Other:
Note: Practicability (feasibility) should not be determined solely by considerations of convenience, cost or speed.
SECTION 3.0: Investigator Certification & Signature
My signature below indicates my assurance that the answers provided on this form are complete, true and accurate. I further provide assurance that I will collect only the minimum necessary PHI for the purposes of recruitment; that I will limit access to PHI as described above; and that the PHI will not be reused or disclosed to any other person or entity, except as required by law. By submitting this form, I am confirming that I am the Principal Investigator (PI) or the PI's designee authorized to submit on behalf of the PI.
Principal Investigator or Designee Signature / Signature Date (mm/dd/yyyy)
Principal Investigator or Designee Name & Title
Version: January2015* / © 2015 Copyright SCHULMAN / Page 1 of 2