Items for Consideration

Data, Documents, Records and Human Biological Specimens

Data, Documents or Records

Investigators should consider the following when using private data in their research:

What method will be used to collect data - video or audio taping?
Will data be supplied by another investigator? (May require IRB approval from that institution).
Will the data be identified in such a manner that it can be readily associated with an individual?
Will data be coded to protect privacy?
Who is responsible for the code key?
Where will the data be stored during the study?
What provisions will be made for controlling access to the data? Who will have access to the data and/or to the codes?
If data with subject identifiers will be released, to whom will the information be released?
How will the data be handled or disposed of when the research has been completed? What will happen to the identifiers?
Is a Data Management Plan (DMP) required?
Is the data subject to the DHHS Health Insurance Portability and Accounting Act (HIPAA)?
Will the data be used for any other purpose than this study?
Will a new database be created from the information gathered during this study that could be used for other research purposes?
Has justification been provided in the consent for the use of identifying data, such as Social Security numbers and names?
Is a Certificate of Confidentiality needed to protect sensitive data such as drug use, sexual practices, etc. from disclosure?

Research which includes the review of private records involving access to and/or recording of identifiable information generally requires prior written consent from the subject. The review of pre-existing public records does not require prior consent.

Records considered private based on federal and state statutes, including medical, insurance, and educational records, require written release by the individual subject or by the custodian of the record and IRB approval to be used in research. Where appropriate, HIPAA regulations for protection of records must be considered and adhered to.

Record Retention

Requirements for record retention vary with the type of research conducted and provisions of the investigator's funding source. The IRB recommends that investigators clearly understand PNNL and client requirements for records retention. The conditions for maintaining confidentiality of records are required for the life of the data.

OHPR guidelines for federally funded research stipulate that records are retained for three years following completion of the research. All records must be accessible for inspection and copying by authorized representatives of the department or agency supporting or conducting the research at reasonable times and in a reasonable manner.

At PNNL, all 1830 records must be stored indefinitely. The IRB maintains all human subject records permanently and encourages investigators to do the same.

Biological Materials Derived from Humans

Biological materials derived from humans includes organs, tissues, biofluids, (e.g., urine, blood, blood products) specimens, (e.g., skin, hair, teeth) cells or cell lines (e.g., primary or established cell cultures); sub-cellular (e.g., organelles) or molecular (e.g., DNA, RNA, protein) constituents.

Investigators should consider the following when using human biological materials for research purposes.

Are the specimens clearly described?
How and from whom will the specimens be obtained?
- Directly from subjects?
- From another investigator?
- If from an FDA or IRB approved commercial vendor?
How will specimens be collected and recorded?
Will the specimens be identified with an individual?
Will the specimens be coded to protect privacy?
Where will the specimens be stored during the study? How will they be secured?
How long will the specimens be retained?
What will happen to them when the research has been completed? What is the method of disposal?
Will the specimens be used for any other purpose than this study?
Does this study involve long-term storage or "banking" of specimens? If yes, explain how they will be handled if:
- A subject wishes to withdraw from the study after it has begun.
- Another investigator wants to use the specimens for the same research purposes.

Genetic research involves additional ethical concerns that may not apply to other types of research with biological specimens such as the potential for discrimination with regards to employment or insurability, for instance.

Research using cell lines that identify or link to coded information of a donor is considered human subject research and requires IRB review. If the investigators sign a Specimen or Data Transfer Agreement stating that the identifying information will not be released by the provider or exchanged under any circumstances and that the research will be conducted within the terms of their respective Federal Wide Assurances, the IRB may determine that an exemption is appropriate.

Investigators use the Specimen or Data Transfer Agreement form (.doc) to obtain the agreement, which must be included in their application for review.

The IRB uses the guidance found in the "Determination of Exemption Worksheet" (.pdf 56kb) to determine when research qualifies for exemption (or not).

Data or specimens are considered anonymous when there is no way to identify or link them with the subjects. For instance, data are not anonymous if anyone, or any procedure such as accessing a computer database, can identify or link the data or specimens to the subject. In most instances, the omission of specific identifiers, such as name, Social Security number, or patient number, is sufficient to qualify as anonymous. Sometimes an investigator may preserve a subject's anonymity while still retaining data on individual characteristics such as age, gender, ethnic origin, occupation, or diagnosis. However, when the number of participants is small and/or the research setting is identified, anonymity can be threatened or compromised even when identifiers have been removed from the data.