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Certificates of Confidentiality
Application Instructions
The Secretary of Health and Human Services may issue
Certificates of Confidentiality under Section 301(d)
of the Public Health Service Act (42 USC 241(d)).
These Certificates are intended to protect researchers
from compelled disclosure of the identities of research
subjects. The Secretary has delegated the authority
to issue these Certificates to all Public Health Service
agencies.
The Health Resources and Services Administration
issues Certificates for research that is supported
by HRSA funds or related to HRSA programs.
To apply for a HRSA Certificate, the investigators
should submit an application letter, on the host research
institution’s letterhead, containing the following
information, organized into paragraphs according to
the numbering scheme shown below. Please write in
complete sentences, concisely providing each item
of information required in narrative format in the
body of the letter. Portions of this narrative will
be used verbatim to describe the research project
in the Certificate that might be issued.
It is a good idea to consult with the Certificate
of Confidentiality Coordinator, prior to submitting
the formal application letter.
Please include the following in your application
letter:
- Name and address of the applicant institution
that will sponsor and oversee the study. This is
the institution with which the applicant is affiliated
and the recipient of grant support for the research,
if there is any.
- Name, title, mailing and email addresses, telephone
and fax numbers of the applicant as well as the
name and title of other key personnel. Include
brief summary of the relevant training and experience
and/or curriculum vitae of the applicant and key
personnel.
- Title of the research project. If the project
title on the Institutional Review Board (IRB) form
is different from the title given here, then the
applicant must document that the IRB approval pertains
to this project.
- Source and number of any Federal grant or contract
that supports the research directly or indirectly
(e.g. "This research is supported by SPNS Grant
BRH-xxxxxx from the Health Resources and Services
Administration;" if none, state "This
study is not supported by Federal funds").
- Name and location where the research will be conducted
and a brief description of the facilities available
for the conduct of the research. Please indicate
if this is a multi-site project. The lead site of
a multi-site project should apply for a single Certificate
to protect participants enrolled at all sites. However,
multi-site applicants must list each participating
unit, its address and project director. If any
new sites are added after the certificate is issued,
the lead site should provide HRSA with an updated
list and the cover letter should include a statement
by the lead site that IRB approval has been given
at the new site and that the lead site is maintaining
a copy of that approval.
- A Certificate of Confidentiality will not be issued
to an applicant conducting research involving human
subjects unless the project has IRB approval. The
approving IRB must be in compliance with applicable
Federal requirements. If the applicant institution
is receiving DHHS funding for research involving
human subjects, an Office for Human Research Protections
(OHRP) approved IRB for that institution must approve
the project for which a Certificate of Confidentiality
is sought.
If the applicant institution does not receive DHHS
funding for this research involving human subjects
but has an IRB that complies with the requirements
for IRB’s imposed by another Federal agency, that
IRB must approve the research. If the applicant institution
does not have an IRB, the project should be reviewed
by an IRB in accordance with 45 CFR Part 46.
Documentation of IRB Approval: Attach a formal
letter or form signed by an authorized IRB representative.
Approval must be current and unconditional, or conditioned
only upon the issuance of a Certificate of Confidentiality
and documented by a letter or form signed by an authorized
IRB representative. If this is a multi-site project,
only the lead site IRB approval needs to be submitted;
however, the lead site must maintain a copy of the
IRB approval from each site, which must be made available
to the HRSA upon request.
If the project is exempt from IRB oversight and
approval, the applicant should attach justification.
If such an exempt project is supported by HRSA funds,
please attach a statement demonstrating compliance
with Program Protection of Human Subjects Participating
in Research Programs Conducted or Supported by HRSA
policy.
Documentation of IRB Qualifications: For all
projects, submit for the IRB that reviewed the project
the Federal wide Assurance number assigned by OHRP
or statement of qualifications that the IRB complies
with the applicable Federal regulations governing
research involving human subjects and the appropriate
IRB number associated with the FWA number.
If this is a multi-site project, the lead site must
maintain the OHRP assurance number for the reviewing
IRB at each site, which must be made available to
the HRSA upon request.
Attach copies of the informed consent forms to be
used in the study, as approved by the IRB. The informed
consent form must include a description of the protections
and limitations of the Certificate of Confidentiality,
including the circumstances in which the investigators
plan to disclose voluntarily identifying information
about research participants (e.g. child abuse, harm
to self or others, etc.).
Sample language provided below.
If significant changes are made to the informed
consent form, the applicant should contact the Certificate
of Confidentiality coordinator who issued the Certificate
and submit a copy of the revised consent form.
- Beginning and expected end dates of the project.
The Certificate of Confidentiality will state the
date upon which it becomes effective and the date
upon which it expires. A Certificate of Confidentiality
protects all information identifiable to any individual
who participates as a research subject (i.e. about
whom the investigator maintains identifying information)
during any time the Certificate is in effect. The
protection afforded by the Certificate is permanent.
- Concise description (1-2 paragraphs) of the project
aims and research methods. Please state the number,
source and description of the human subjects. If
significant changes are made to the project aims
or methods during the course of the study, the applicant
should contact the HRSA Certificate of Confidentiality
Coordinator. The coordinator will determine if
the Certificate can be modified or if the applicant
will need to submit an amended application.
- Justification for requesting a Certificate of
Confidentiality (e.g. will collect sensitive information,
identifying information on subjects, etc.). Include
a brief description of the sensitive and identifying
information to be collected.
- Concise description of the means used to protect
subjects' identities (e.g., coded identifiers, record
access restricted to trusted staff, locked files
and secured computer data storage, etc.).
- Assurances of compliance with HHS requirements.
The following assurances are required and the following
information must be inserted verbatim into the Certificate
of Confidentiality application letter. Both the
Principal Investigator and Institutional Official
must sign this letter. The name and title of the
Institutional Official should be typed below the
signature line.
Assurances that the investigators, the responsible
institution, and all collaborating institutions (if
applicable) will ensure:
- that all personnel involved in the conduct
of the research will comply with all the requirements
of 45 CFR Part 46, "Protection of Human Subjects."
(Projects not supported by DHHS must certify compliance
with 45 CFR 46.103(c) and document legally informed
consent in a manner consistent with the principles
stated in 45 CFR 46.111);
- that the Certificate of Confidentiality will
not be represented as an endorsement of the project
by the Secretary of HHS or be used to coerce individuals
to participate in the research project;
- that the recipient of the Confidentiality Certificate
will use its authority to protect the identity
of research subjects;
- that all subjects will be informed that a certificate
has been issued and that subjects will be provided
with a description of the protection covered by
the certificate; and
- that subjects who enter the project after expiration
or termination of the certificate will be informed
that the protection afforded by the certificate
does not apply to them
This letter request must be signed by the individual
primarily responsible for the conduct of the research
and by an appropriate institutional official authorized
to bind the host institution. In doing so, they are
agreeing to the assurances as stated in the application
letter.
If the research project will not be completed by
the expiration date and/or an amendment is necessary,
the Certificate holder should submit a written request
for an amendment of the Certificate 3 months prior
to the expiration date. Any such request should include
the justification for the amendment/extension, documentation
of the most recent IRB approval, and the expected
date for completion of the research project.
Any request will be processed as rapidly as possible.
However, if all of the items of information requested
above are not provided in the letter, issuance of
your certificate will be delayed.
Note to Applicant:
- If this is a multi-site project, with the application
the lead site must indicate acknowledgement and
agree to be sure that all sites have copies of the
Certificate and agree to the assurances. Once the
Certificate is issued, the lead site obtains signed
copies of the assurances from each site and maintains
them in its files.
- The Certificate of Confidentiality protects against
the involuntary disclosure of information that could
identify subjects. It does not govern the voluntary
disclosure of identifying characteristics of research
subjects. Researchers are not prevented from the
voluntary disclosure of matters such as child abuse
or a subject’s threatened violence to self or others.
However, if a researcher intends to make such voluntary
disclosures, the consent form should clearly indicate
this.
Send letter to:
Amber Berrian
HRSA Center for Quality
Parklawn Building 7-100
5600 Fishers Lane
Rockville, MD 20857
INFORMED CONSENT
NOTE: When a researcher obtains a Certificate
of Confidentiality, the research subjects must be
told about the protections afforded by the certificate
and any exceptions to that protection. That information
should be included in the informed consent form.
Examples of appropriate language follow. Researchers
may adapt the language to the needs of the research
participants and to the subject matter of the study.
However, the language used must over the basic points.
Researchers should also review the language about
confidentiality and data security that is routinely
included consent forms to be certain that it is consistent
with the protections of the Certificate of Confidentiality.
The Office for Human Research Protections provides
guidance on the content of informed consent documents.
Additional
information
Sample Language:
A Certificate of Confidentiality has been obtained
from the Federal Government for this study to help
insure your privacy. This Certificate means that
the researchers cannot be forced to disclose information
that may identify you, even by a court subpoena, in
any federal, state, or local civil, criminal, administrative,
legislative or other proceedings. But, if you request
disclosure, we can release the information.
The Certificate cannot be used to resist a demand
for information from personnel of the United States
Government that is used for auditing or evaluation
of federally funded projects or for information that
must be disclosed in order to meet the requirements
of the federal Food and Drug Administration (FDA)
[The researchers should include language such as
the following if they intend to make voluntary disclosure
about things such as child abuse, intent to hurt self
or others, or other voluntary disclosures.] The Certificate
of Confidentiality does not prevent the researchers
from disclosing voluntarily, without your consent,
information that would identify your as a participant
in the research project under the following circumstances.
[The researchers should state here the conditions
under which voluntary disclosure would be made. If
no voluntary disclosures will be made, the researchers
should so state.]
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