Record Retention and Confidentiality of
Data
Record
Retention
Requirements for record retention vary with the type of
research conducted and provisions of the investigator’s
funding source. The HSPC highly recommends that investigators
clearly understand the retention requirements of their sponsor.
UCLA policy requires that investigators maintain research records
for at least three years after completion of the research. All
records must be accessible for inspection and copying by
authorized representatives of the HSPC, department or agency
supporting the research. The conditions for maintaining
confidentiality of the subjects and the research records are
required for the life of the data. These rules apply equally to
research conducted by students and faculty.
Protocols conducted with FDA regulated articles must be kept
in accordance with current FDA regulations. Current FDA policy
states that investigators are required to maintain records for
the longest of either:
- A period of at least two years following the date on
which the results of the clinical investigation are
submitted to the FDA in support of an application for a
research Investigational
New Drug Number or Investigational
Device Exemption or marketing permit; or
- A period of at least two years following the date on
which an application for research or marketing permit (in
support of which the results of the clinical
investigation were submitted to the FDA) is approved by
the FDA; or
- Two years after the investigation is discontinued and FDA
is notified of that fact.
OPRR guidelines for federally funded research stipulate that
records pertaining to the research are required to be retained
for three years after 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 [45 CFR
46.115(b)]. The HSPC encourages investigators to maintain
research records for longer periods, if practicable.
Confidentiality
Investigators are required to maintain and protect the privacy
and confidentiality of all personally identifiable information of
all human subjects participating in research, except as required
by law or released with the written permission of the subject.
Subjects, including children, have the right to be protected
against invasion of their privacy, to expect that their personal
dignity will be maintained, and that the confidentiality of
private information will be preserved. The more sensitive the
research material, the greater the care required in obtaining,
handling, and storing data.
Information through which subjects may be identified include
their names, student identification numbers, hospital ID numbers,
social security numbers, driver’s license numbers, home
addresses, photographs, videotapes, and the like. Individuals
also may be identified by description, for example, as the
personnel manager in a particular company, the sixth grade
teacher in a certain school, or the pediatric nurse at a local
hospital. If information or data to be collected may be traced
back to individual subjects, safeguards should be provided to
ensure confidentiality.
Guidelines
for Protecting Confidentiality
- Limit recording of personal information to that which is
absolutely essential to the research;
- Store personally identifiable data securely and limit
access to the principal investigator and authorized
staff;
- Code data as early in the research as possible, and plan
for the ultimate disposition of the code linking the data
to individual subjects;
- Apply for federal Certificates of Confidentiality (see
below) in all situations for which certificates are
reasonable and available;
- Do not disclose personally identifiable data to anyone
other than the research team without the written consent
of the subjects or their legal representative.
(Exceptions may be made in case of emergency need for
intervention or as required by regulatory agencies).
Certificates
of Confidentiality
Data collection about sensitive issues (such as illegal
behavior, alcohol or drug use, or sexual practices or
preferences) requires the protection of confidentiality beyond
preventing accidental disclosures. Under federal law, researchers
can obtain an advance grant of confidentiality, known as a
Certificate of Confidentiality, that will provide protection
against compulsory disclosure, such as a subpoena, for research
data.
The investigator should delineate in the HSPC application any
conditions under which confidential information might be
disclosed and create an informed consent document that accurately
reflects those conditions, including any voluntary disclosure by
the researcher. The HSPC is required to determine whether the
risks to subjects are minimized, informed consent is appropriate,
and privacy and confidentiality protections are adequate.
The UC Counsel has informed the OPRS that the California State
Penal Code for reporting of child/elder abuse
is interpreted to include researchers. The Certificates of
Confidentiality were developed to encourage participation in
research by granting certain protections to a subject divulging
possible compromising information. The Certificates, however, do
not exempt investigators from performing ethical research nor do
they allow investigators to abdicate their responsibility to act
in the public good. Though Certificates of Confidentiality can be
used to defend against compelling a researcher to disclose
child/elder abuse,
they do not address the principal ethical issue, i.e., the
responsibility of an investigator to act in the public good which
logically extends to the protection of victims of abuse. As a
result, the HSPCs expect investigators to act in an ethical
manner and therefore comply with State law by informing subjects
in the consent form of the obligation of a researcher to obey the
law.
Incomplete disclosure or the use of deception cannot be used
as a means to secure the participation of subjects in research.
The federal regulations indicate that effective informed consent
requires complete disclosure of all information that a subject
could use to decide whether to participate in research. In
addition, the regulations do not allow a waiver of the conditions
of informed consent because the conditions are difficult or
because the conditions make it difficult to enroll subjects into
the research. The HSPC is required to consider whether the
withheld information would influence the decision of potential
subjects to participate in the research. Therefore,
investigators are required to include a statement in the consent
form that alerts potential subjects of the legal and ethical
mandate compelling researchers to report known or suspected child/elder abuse.
Investigators who are likely in the course of their research,
to become aware of a possible danger to an individual are
responsible for creating a mechanism that will both protect the
subject and comply with all incumbent moral and legal
responsibilities. The HSPC may require a modification to the
Certificate of Confidentiality if an investigator may be informed
of child/elder abuse. (Please see Chapter
4, "Informed Consent Requirements: Confidentiality"
and Chapter 10, "Special State
of California Requirements: Reporting Suspected Abuse of
Children, Elderly Individuals, and Others" for more
information.)
Investigators should contact the following appropriate
official in order to obtain a Certificate of Confidentiality:
Primary Contact
Ms. Olga Boikess
Office of Resource Management
National Institute of Mental Health
6001 Executive Boulevard, Room 8102
Mail Stop: MSC 9653
Bethesda, MD 20892-9653
Telephone: (301) 443-3877
Fax: (301) 443-2578
E-Mail: oboikess@mail.nih.gov
Food and Drug Administration
Matthew J. Tarosky, R.Ph.
Program Management Officer
Division of Scientific Investigations
Office of Medical Policy
Center for Drug Evaluation and Research
Food and Drug Administration
7520 Standish Place, HFD-45
Rockville, MD 20855
Phone (301) 827-5459
Fax (301) 594-1204
E-mail: taroskym@cder.fda.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Ms. Susan Farrell
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 402
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-1274
Fax: (301) 443-7043
E-Mail: sfarrell@willco.niaaa.nih.gov
National Institute on Drug Abuse (NIDA)
Ms. Jacqueline R. Porter
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158
Mail Stop: MSC 9547
Bethesda, MD 20892-9547
Telephone: (301) 443-2755
E-Mail: jporter@nida.nih.gov
For information about certificates for research
projects funded by the Centers for Disease Control and Prevention (CDC),
and Agency for Toxic Substances and Disease Registry (ATSDR):
Ms. Betsey Dunaway
MASO, M/S E-11
Centers for Disease Control
1600 Clifton Road NE
Atlanta, GA 30333
Telephone: (404) 639-2942
Fax: (404) 639-0445
E-Mail: basl@cdc.gov
For information about certificates for research
projects funded by Health Resources and Services Administration (HRSA):
Dr. Lewis Emmet Mahoney
Health Resources and Services Administration
Parklawn Building, Room 9-05
5600 Fishes Lane
Rockville, MD 20857
Telephone (301) 443-0458
Fax: (301) 443-0192
E-Mail: lmahoney@hrsa.gov
For information about certificates for research
projects funded by the Substance Abuse and Mental Health Services
Administration (SAMHSA):
Dr. Dorita Sewell
Substance Abuse and Mental Health
Services Administration
Parklawn Building, Room 12C-26
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-7023
Fax: (301) 594-6159
E-Mail: dsewell@samhsa.gov
For information about certificates for research
projects funded by the National Cancer Institute (NCI):
Dr. Susan Sieber
National Cancer Institute
Building 31, Room 11A48
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-5946
Fax (301) 496-2471
E-Mail: siebers@ephdce.nci.nih.gov
For information about certificates for research
projects funded by the National Heart, Lung and Blood Institute (NHLBI):
Mr. David Whitmer
National Heart, Lung and Blood Institute
Building 31, Room 5A33
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-5931
Fax: (301) 402-0299
E-Mail: Dave_Whitmer@nih.gov
Certificates of Confidentiality for biomedical,
behavioral, clinical, or other research that does not fall into
these categories are issued by the Assistant Secretary for Health
and are available for: (1) direct federal activities (i.e.,
intramural research); (2) federally-funded activities; and (3)
research in the United States that has no federal funding.
Certificates are issued only "when the research is of a
sensitive nature where the protection is judged necessary to
achieve the research objectives." The PHS policy defines
"sensitive" research as involving the collection of
information falling into any of the following categories:
- Information relating to sexual attitudes, preferences, or
practices;
- Information relating to the use of alcohol, drugs, or
other addictive products;
- Information pertaining to illegal conduct;
- Information that if released could reasonably be damaging
to an individual’s financial standing,
employability, or reputation within the community;
- Information that would normally be recorded in a
patient’s medical record, and the disclosure of
which could reasonably lead to social stigmatization or
discrimination;
- Information pertaining to an individual’s
psychological well-being or mental health.
Information in other categories, not listed, may also be
considered sensitive because of specific cultural or other
factors, and protection can be granted in such cases upon
appropriate justification and explanation.
Additional policy considerations apply to research that
involves the collection of data that relates to communicable
diseases. The Assistant Secretary for Health has issued a policy
granting certificates of confidentiality to projects that
"intend routinely to determine whether its subjects have
communicable diseases and that are required to report them under
State Law." Certificates will be issued:
- where the referring treating physician assures the
project director that they have complied with reporting
requirements; or
- where there is no referring physician, the investigator
has reached an agreement with the health department about
how s/he will cooperate with the department to help serve
the purposes of the reporting requirements (unless the
investigator can show why such cooperation is precluded);
and
- only where disclosures of identifiable information about
subjects comply with regulations on subject protection
and are explained clearly to subjects prior to their
participation.
Contact OPRS
October 29, 2004
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