Privacy Impact Assessment for the Medical and Research Study Records of Human Volunteers

On this page:

• I. Data in the System
• II. Access to the Data
• III. Attributes of the Data
• IV. Maintenance of Administrative Controls

I. Data in the System

1. Generally describe what data/information will be collected in the system.

   EPA Human Studies Division is a human research facility in ORD that collects demographic and medical information on subjects who volunteer to participate in research.

2. What are the sources and types of the information in the system?

   The subjects themselves are the sources of information. Types explained above.

3. How will the data be used by the Agency?

   To conduct safe, ethical human research.  Aggregate research results are used by the agency to address regulated pollutants.

4. Why is the information being collected? (Purpose)

   Above.

II. Access to the Data

1. Who will have access to the data/information in the system (internal and external parties)? If contractors, are the Federal Acquisition Regulations (FAR) clauses included in the contract (24.104 Contract clauses; 52.224-1 Privacy Act Notification; and 52.224-2 Privacy Act)?

   Medical staff and investigators listed on IRB-approved protocols.

2. What controls are in place to prevent the misuse of data by those having authorized access?

   Data collected at HSD kept under lock and key. Data collected in the field is protected by IRB-approved good research practices.

3. Do other systems share data or have access to data/information in this system? If yes, explain who will be responsible for protecting the privacy rights of the individuals affected by the interface? (i.e., System Administrators, System Developers, System Managers)

   Other systems outside of the research team do not have access.

4. Will other agencies, state or local governments share data/information or have access to data in this system? (Includes any entity external to EPA.)

   No.

5. Do individuals have the opportunity to decline to provide information or to consent to particular uses of the information? If yes, how is notice given to the individual? (Privacy policies must clearly explain where the collection or sharing of certain information may be optional and provide users a mechanism to assert any preference to withhold information or prohibit secondary use.)

   Yes. Informed consent is required for the information to be collected and for what it will be used.

III. Attributes of the Data

1. Explain how the use of the data is both relevant and necessary to the purpose for which the system is being designed.

   To conduct safe, ethical, scientifically valid human research.

2. If data are being consolidated, what controls are in place to protect the data from unauthorized access or use? Explain.

   As above (II-2).

3. If processes are being consolidated, are the proper controls remaining in place to protect the data and prevent unauthorized access? Explain.

   NA

4. How will data be retrieved? Can it be retrieved by personal identifier? If yes, explain. (A personal identifier is a name, Social Security Number, or other identifying symbol assigned to an individual, i.e. any identifier unique to an individual.)

   Data is retrieved by name and/or study number.

5. Is the Web privacy policy machine readable? Where is the policy stated? (Machine readable technology enables visitors to easily identify privacy policies and make an informed choice about whether to conduct business with that site.)

   NA

IV. Maintenance of Administrative Controls

1. Has a record control schedule been issued for the records in the system? If so, provide the schedule number. What are the retention periods for records in this system? What are the procedures for eliminating the records at the end of the retention period? (You may check with the record liaison officer (RLO) for your AA-ship, Tammy Boulware (Headquarters Records Officer) or Judy Hutt, Agency Privacy Act Officer, to determine if there is a retention schedule for the subject records.)

   EPA Records Schedule 566

2. While the data are retained in the system, what are the requirements for determining if the data are still sufficiently accurate, relevant, timely, and complete to ensure fairness in making determinations?

   Records are kept as updated as possible to maintain accuracy and completeness while subjects are actively enrolled or attempting to re-enroll in study protocols.

3. Will this system provide the capability to identify, locate, and monitor individuals? If yes, explain.

   Yes, the research record in an integral part of the study activities.

4. Does the system use any persistent tracking technologies?

   NA

5. Under which System of Records (SOR) notice does the system operate? Provide the name of the system and its SOR number if applicable. For reference, please view this list of Agency SORs. (A SOR is any collection of records under the control of the Agency in which the data is retrieved by a personal identifier. The Privacy Act Officer will determine if a SOR is necessary for your system.)

   EPA-34