Cod et al: I MIGHT Have been Wrong about NIH/FOIA of Raw Data



Well I wanted to do some more research but instead I'm going to give
you the basic links and let you forge ahead.

The A-110 circular appears to make raw data available, FOIAble.

I don't know what would be considered the operative date for the
purpose of obtaining such data from the Klempner study--the date the
study began or ended etc.

But here is the basic info:

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H.R. 88: Research Data Available under the Freedom of Information Act

Statement on H.R. 88: Research Data Available under the Freedom of
Information Act by Harold Varmus, M. D.
Director, National Institutes of Health
U.S. Department of Health and Human Services

Before the House Committee on Government Reform, Subcommittee on
Government Management, Information and Technology
July 15, 1999


--------------------------------------------------------------------------------

Chairman Horn, Mr. Turner and other members of the Subcommittee on
Government Management, Information and Technology. I am Harold Varmus,
the Director of the National Institutes of Health. I am pleased to be
here today to testify about H.R. 88, a bill authored by your colleague
George Brown, the Ranking Member of the Science Committee, and a
long-time advocate of openness in scientific research.

I too am an advocate for openness in scientific research. Exchanging
ideas and sharing data are absolutely vital to the success of
biomedical research. They are the hallmarks of the success of the NIH
research programs. The true understanding of the breakthroughs we are
making in genetics research, medical imaging, clinical research, and
all other scientific investigation funded by NIH could not be
accomplished without public access to methods and data.

Openness has many virtues. It fosters trust in scientific outcomes as
well as trust in the use of federal dollars to conduct biomedical
research. It engenders faith that human subjects and animals
participating in research trials are adequately protected. And it
sparks technological innovations that help us find the answers to
public health problems. However, we know that the requirements in
different scientific fields vary and that great care must be taken in
crafting such strategies. There are many examples of responsible
data-sharing at NIH. The remarkable strides we are making in our
understanding of the genetic components of various diseases would not
be possible without the sharing of data. Also, NIH's firm stance
regarding the patenting of early DNA sequencing data has ensured that
such data are easily available to the scientific community.

And we require that coordinate data developed by x-ray
crystallographers be made available at the time of publication in a
peer reviewed journal. In these cases, and many others, we promote
openness.

But a word of caution. I think it would be a mistake to open all
underlying scientific data to public scrutiny simply because of the
concept that all openness is good. There are pitfalls in unrestrained
openness, including unwarranted violations of privacy, the potential
harassment of scientific investigators and the chilling effect that
inappropriate public scrutiny could have on the free exchange of ideas
and the willingness to take risks to find answers.

The amendment to OMB circular A-110 contained in Public Law 105-277
could have unintended, but nonetheless grave consequences. The
regulatory requirements embodied in the law are far more complex than
the apparently simple mandate to share data. The kind of widespread
access to data envisioned by the Act could result in unforeseen abuses.
Unless otherwise protected, patient privacy rights could be violated.
The willingness of scientists to speak openly about new ideas and take
experimental risks could be fettered by unrestricted data access.
Further, I am concerned that inappropriate sharing of preliminary data
could lead to misinterpretation of results. Finally, the new
requirements could undercut the ability of researchers to build private
sector partnerships that now lead to the eventual marketing of
products.

It is because of these concerns that we at NIH have taken the position
that, while expanded access to scientific data should be encouraged,
the A-110 amendment may be a poor vehicle to achieve this goal. I am
particularly concerned about the legislation's requirement that the
Freedom of Information Act (FOIA) be the tool of regulatory
implementation. FOIA was not designed to accommodate the
confidentiality requirements of the most sensitive scientific data.
Consequently, without additional protections, it would be possible for
the privacy of patients to be compromised or individual scientists to
be harassed by selected interests opposed to their work due to moral or
financial concerns. Such intrusions could stop promising scientific
research in its tracks, and the mere threat of such intrusions could
impede the Nation's efforts to recruit its most talented students into
publicly-supported research.

For example, imagine what would happen if HIV-infected patients thought
their condition might be revealed by someone using the new requirements
to examine raw experimental data. Patients would not participate in
clinical trials if they believed there was an opportunity for their
infected status to be revealed. Progress toward treatment of the
disease would be stymied.

Under this new application of FOIA embodied in the A-110 amendment, a
request for research data would be directed to federal agencies, such
as NIH. We would be required to forward the request to grantee
institutions and to the scientists with direct responsibility for the
data. Their data often contains information about individuals who
entered into the research project under a promise of confidentiality.
This information would be forwarded from grantee institutions to
federal agencies, who would be responsible for determining what to
release and what to exempt.

It may sound simple to make that determination, but it is not. FOIA
would allow the government agency to remove obvious identifiers such as
name, Social Security number, telephone number, but in a given data set
it is quite feasible to identify subjects using other information. If
the requestor knew a few items about an individual's history, such as
place of birth, education, occupation, marital history, or other
general information, an individual could be identified. Such
identification would then open up the whole research record, including
personal medical information to the requestor.

While there are many aspects of the A-110 amendment that trouble us,
there is a particular provision that presents a new challenge to those
who would make their data accessible. I am thinking about the
multiplicity of partnerships between public sector researchers and
private companies, non-profit organizations, and even foreign
governments. Some of these partnerships make strict requirements on the
researcher not to share data further. Without such agreements, private
researchers would not participate in these partnerships.

In regard to proprietary data, the Bayh-Dole Act specifically provides
protections for the intellectual property of individual researchers.
But the A-110 amendment threatens these protections for our partners.
Industry scientists may avoid collaborations with publicly-funded
institutions, including universities, if they believe they can no
longer protect their data from exposure.

The A-110 amendment will lead to increases in administrative burdens
and cost for granting agencies, such as NIH, but also for grantees.
Universities and other institutions that receive Federal grants will
need to create formalized procedures to respond to FOIA requests.
Increased administrative costs are not in themselves a reason not to
move forward with policies in the public interest, but we would like to
ensure that the benefits are commensurate with the costs. Increased
administrative costs will come at the expense of research, in both
dollars and in investigator time. The paperwork that requests will
generate is enormous and counter to the reduction in paperwork efforts.
Entire staffs will have to be recruited to make the decisions that will
have to be made, with consequent increases in costs of conducting
research.

In addition to the administrative burdens, the A-110 amendment is
likely to lead to the filing of lawsuits by individuals or
organizations whose requests for data are rejected, which would be
costly to the government and private institutions that perform
publicly-funded research.

I am aware that the Administration is working to implement the A110
amendment in the least intrusive manner possible. However, it is my
view that on balance, you should support H.R. 88 and repeal the A-110
amendment. Taking such action will not mean the end of data access. It
will signal the beginning of efforts to establish a more responsible
approach to data sharing, one that will protect the rights of
individuals, recognize the proprietary interests of commercial
enterprises, and consider the needs of the scientific community. I
pledge to work with you and your colleagues toward those efforts. I
would be pleased to answer any questions you may have.


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NIH: Institutes, Centers & Offices: Freedom of Information Act Office

http://www.nih.gov/icd/od/foia/

The NIH FOIA Staff welcomes you to the NIH FOIA Home Page. We hope you
will find this site informative and that it will give you a better
understanding of NIH's public information programs. We will continue to
improve this site to bring you current program information.


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NIH FOIA Staff
Susan R. Cornell, Freedom of Information Officer, NIH
Brenda J. Butler, FOIA Specialist, NIH
Connie A. Caldwell, FOIA Specialist, NIH
Catherine M. Papoi, FOIA Specialist, NIH



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Welcome
The NIH FOIA office handles three different categories of requests:

requests for information maintained by the Office of the Director, NIH
requests that will involve responses from more than one NIH Institute
or Center
requests for information that will not be released because it is
protected by one or more of the FOIA's nine exemptions or three
exclusions

While all requests may be sent to the NIH FOIA Office, each of NIH's
separate Institutes and Centers has its own FOIA Coordinator.
Requesters should direct requests for information about a specific NIH
component to that component. A list of the FOIA Coordinators for each
component is available at this site for your convenience.

Background/Overview

The Freedom of Information Act ("FOIA"), 5 U.S.C. 552, provides
individuals with a right to access to records in the possession of the
federal government. The government may withhold information pursuant to
the nine exemptions and three exclusions contained in the Act. The
Electronic FOIA ("E-FOIA") Amendments which President Clinton signed
into law in 1996, amended the law in several ways, including:


extend from 10 to 20 business days (excluding holidays) the time
agencies must respond to requests for information;
require agencies to make reasonable efforts to make records available
in formats desired by requesters;
require agencies to submit the NIH FOIA Annual Report by fiscal year;
require agencies to make the reports available to the public by
computer telecommunications or other electronic means;
require agencies to list their major information systems, record
locator systems, and a reference guide or guide for obtaining
information; and
require agencies to establish electronic reading rooms that include
agency policies, staff manuals, opinions made in the adjudication of
cases, and an index of records released by FOIA that are likely to
become the subject of subsequent FOIA requests.
these amendments have to be implemented by specific dates.

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Guide for Submitting FOIA Requests



Before submitting FOIA requests, individuals should ensure that the
information they seek is not already in the public domain. Each of
NIH's components has information available in both published format and
electronically. A search of the NIH Home Page can assist requesters in
locating information and lists of available publications. Such a search
can also help requesters identify the component(s) most likely to have
responsive documents so FOIA requests can be sent to the appropriate
component for response. A list of the NIH Institutes and Centers is
available at this site to assist you. A list of the FOIA Coordinators
for each component also is available at this site for your convenience.
FOIA requesters interested in obtaining information on federally funded
biomedical research projects should consult the Computer Retrieval of
Information on Scientific Projects (CRISP) database. This will enable
requesters to identify the grant number and the component funding the
research in their FOIA request.


In 1999 the Office of Management and Budget issued final revisions to
Circular A110 to provide for access to data produced under grants
awarded by the National Institutes of Health and other federal awarding
agencies. To the extent you are interested in requesting data produced
under a National Institutes of Health grant pursuant to the provisions
of Office of Management and Budget (OMB) Revised Circular A110, please
understand that the provisions of Revised Circular A110 apply to data:


first produced under a new or competing continuing grant awarded after
the Department of Health and Human Services amended 45 C.F.R. 74 to
incorporate the changes mandated by the Revised Circular (April 17,
2000); and
cited publicly and officially by the Federal Government in support of
an agency action that has the force and effect of law.

In addition, if the data you request are already available to the
public through an archive or other source, we will not process your
request under the FOIA. In that situation, we will refer you to the
archive or other source.


More information regarding NIH implementation of Revised Circular A110
may be found at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.


With all FOIA requests, if the information you are interested in is not
in the public domain, please follow the suggestions listed below when
preparing your FOIA request:

identify the records requested (be as specific as possible, i.e.,
describe the subject matter of the records, and, if known, indicate the
dates of the records, the places where they originated, and the names
of the originating persons or offices);
state that the records are requested under the Freedom of Information
Act;
include daytime telephone numbers in case additional information is
needed before answering requests; and
forward all requests either to the appropriate FOIA Coordinator or to
the NIH FOIA Office by one of the methods listed below:
if you are requesting data produced under an NIH grant, include the
following information in your request:
the federal regulation or administrative order that cited the data
being requested;
the publication and/or reference cited in the federal regulation;
the grant number under which the data were produced (this information
can be obtained from the CRISP database;
a description of the data sought; and
a statement that the data are being requested under OMB Revised
Circular A110.
Mail the request (mark the outside of the envelope, "FOIA Request")
either to the appropriate FOIA Coordinator or to the NIH FOIA Office:

Freedom of Information Office, NIH
Building 31, Room 5B35
9000 Rockville Pike
Bethesda, MD 20892
OR Fax the request to the FOIA Office at (301) 402-4541.
If the requester knows which component has responsive documents, the
FOIA request should be sent directly to the FOIA Coordinator for that
component. A list of the FOIA Coordinators for NIH components and their
addresses is included at this site.

Individuals with questions concerning their requests may call the NIH
FOIA Staff at (301) 496-5633.

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Guide for Submitting FOIA Appeals
FOIA requesters may appeal the denial of information within 30 days of
receipt of letters from the agency. Appeals should state the following
information:

the reasons why the requested information should be released under the
Act; and
why the denial may be in error.
FOIA requesters should attach copies of their original requests and
response letters to all appeals, clearly mark the letters and the
outside envelopes, "FOIA Appeal, " and mail appeals to the following
address:

Deputy Assistant Secretary for Public Affairs (Media)
U.S. Department of Health and Human Services
Parklawn Building, Room 17A-46
5600 Fishers Lane
Rockville, MD 20857



Fees
The Freedom of Information Act provides for the agency to recover part
of the cost associated with responding to a request. The Department
Regulations set out the specific rules for fees and for requesting a
fee waiver or a reduction in fees. Some general principles apply to all
requests such as:

if you are going to request a fee waiver or a reduction in fees, you
must do so when you file your initial request for documents.
you may be charged for search time even if we do not locate any
documents responsive to your request or if the documents we locate are
denied to you under one of the FOIA's exemptions.
there will not be a charge if the cost of responding to your request is
less than $25.
If a determination is made that fees will be charged, the following fee
schedule will be used to calculate the exact cost of search and review
time:

if the work is performed by an agency employee Grade 1-8, you will be
charged $4.75 for each 15 minutes worked.
if the work is performed by an agency employee Grade 9-14, you will be
charged $9.50 for each 15 minutes worked.
if the work is performed by an agency employee Grade 15 or above, you
will be charged $17.25 for each 15 minutes worked.
In addition, if you are requesting data produced under a NIH grant
under the provisions of OMB Revised Circular A110, you will be charged
a reasonable fee equaling the full incremental cost of obtaining the
data. This fee will reflect the costs incurred by NIH, the grantee
institution and the grantee investigator. These fees will be in
addition to any fees assessed by NIH under the FOIA.


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Exemptions
The Freedom of Information Act provides that the agency will provide
access to identifiable documents within our possession unless one of
nine exemptions or three exclusions applies. The exact language of the
exemptions can be found in the Freedom of Information Act. Additional
guidance on the exemptions and how they apply to certain documents can
be found in the Department Regulations implementing the FOIA.


NIH Reading Rooms

On-Site Reading Room
The NIH On-Site Reading Room (RR) contains a variety of documents that
come from several of the Institutes and Centers at the NIH. The
documents are indexed with an identifying number to assist users in
locating the document(s) of interest. The Index of Documents is
available at this site for your convenience. Documents cited with an
asterisk (*) are available for viewing in the RR, which is located in
Building 31, Room 5B-35. The hours of operation are 10:00 a.m. to 4:00
p.m, Monday through Friday (closed on Federal holidays). A copy machine
is available for users to duplicate documents of particular interest.
Documents without an asterisk are presently stored off-site and can be
retrieved for viewing upon specific request. Please contact the FOI
Office to make arrangements to view one or more of these documents.

Index of Documents



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Electronic Reading Room
In addition, the following documents are available in electronic format
at this site:


NIH FOIA Forms
Conflict of Interest Information and Resources
Dr. Zerhouni's Letter to The Honorable Diana DeGette and The Honorable
Michael Castle regarding Human Embryonic Stem Cell (hESC) Research
(Download Adobe Acrobat Reader)
Dr. Zerhouni's Letters to Congress regarding review of NIH Grants on
Human Sexuality (Download Adobe Acrobat Reader)
January 2004 Settlement Agreement between the National Cancer
Institute and Dairy Management, Inc. (Download Adobe Acrobat Reader)
NIH Purchase Card List
This list will be updated the first week of each month. PLEASE NOTE:
Many of the individuals on this list are scientists engaged in
research. Many consider it very disruptive to their work to receive
telephone solicitations or unannounced office visits. Please respect
their need to work without interruption when marketing your products.
Thank you.
Selected Institute and Center Directors' Meeting Minutes
CellPro Documents
NIH FOIA Annual Reports
NIH Telephone Directory


An NIH Search Engine is available at http://search.google.cit.nih.gov/.


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Reference Guide How to File a Request
How to File an Appeal
Fees
Exemptions
Policies
Major Information Systems


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Description of Publicly Available Information
The NIH has a wealth of information available to the public both in
printed form and electronically. Each of NIH's separate Institutes and
Centers maintains it's own list of publications and this information
can be accessed from their Home Pages. A list of the components is
available. If you do not know which component has information of the
subject you are interested in, you may run a search from the NIH Home
Page.

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Other Public Information Servers
Government Interactive Locator System (GILS). This system locates and
provides assistance in obtaining Federal public information, including
NIH specific documents.
National Technical Information Services (NTIS)
National Library of Medicine
U.S. Superintendent of Documents
All documents at the U.S. Superintendent of Documents are shelved by
government organization and not by subject matter. The documents
include information about U.S. Government laws, regulations,
statistics, maps, and bibliographies.
Records that are "promptly published and offered for sale" are not
subject to the requirements of FOIA, 5 U.S.C. 552(a) (2). These
published materials are not required to be placed in agency
conventional/electronic reading rooms.


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Major Information Systems MEDLINE: This database of more than 12
million references to articles published in 4600 biomedical journals is
maintained by the National Library of Medicine and may be accessed free
of charge on the World Wide Web. Two Web-based products, PubMed and the
NLM Gateway provide this access.
CRISP: This is a searchable database of federally funded biomedical
research projects conducted at universities, hospitals, and other
research institutions. The database is maintained by the Office of
Extramural Research at the National Institutes of Health.
PubMed: This is a comprehensive database of article titles and
abstracts.
NLM Gateway: The NLM Gateway allows users to search in multiple
retrieval systems at the U.S. National Library of Medicine (NLM.)


NIH's major information and record locator systems are identified under
the Government Interactive Locator System (GILS)

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Policies and Administrative Manuals that Affect the Public FOIA
Policies
The Freedom of Information Act (5 USC 552)
Electronic Freedom of Information Act Amendment of 1996
Regulations 45 CFR Part 5, Public Information
Privacy Act of 1974 (and Amendments)

Department of Justice
DOJ's Freedom of Information Act Guide, May 2002
FOIA Post






This page was last reviewed on January 21, 2005 .




To NIH Grantees and Applicants: Notice Of Amendment To A-110
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

To NIH Grantees and Applicants: Notice Of Amendment To A-110
Introduction
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access under some circumstances to research
data through the Freedom of Information Act (FOIA). The effective date
of the revised Circular is November 8, 1999; the guidance that NIH will
impose on grantees became effective on April 17, 2000 with the
publication of the interim final rule amending agencies' codifications
of Circular A-110. Amended A-110 is applicable to new and competing
continuation awards made after that date. It is important for grantees
to understand the basic scope of this amendment and to plan for
implementation. NIH encourages sharing of research data. Nothing in the
A110 amendment should affect ongoing data sharing plans.

The revised circular applies to data that are (1) first produced in a
project that is supported in whole or in part with Federal funds, and
(2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law.

The guidance presented below explains how access would be achieved when
a request is made under this amendment. We will use the News Flash page
of the NIH web site to update information as we gain experience with
the implementation process. (See http://www.nih.gov/grants/news.htm

Below we provide additional information related to this amendment on:


Applicability
Definitions
Overview of Process
Frequently Asked Questions (FAQs)
To see the full text of the A-110 amendment, see Federal Register,
Volume 64(195) at
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&docid=99-26264-filed

Applicability:

The amendment to OMB Circular A-110 applies only to data produced with
Federal support that are cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law.

Agency actions that have the force and effect of law include:

Regulations
Administrative orders
This amendment applies to data that are first produced in a project
that is supported exclusively with Federal funds or in a project with
both Federal and non-Federal support.

The amendment applies only to data first produced under a competing
award issued after the effective date.

It applies to data collected by institutions of higher education,
hospitals, and non-profit institutions that receive grants and other
financial assistance provided by Federal agencies.

It does not apply to data collected by commercial organizations.
It does not apply to most data collected by State and local
governments.
It applies to new and competing continuation awards that are made after
the effective date of the amendment. This is to say, it applies to Type
1 and Type 2 grants (i.e., new and competing continuations) as well as
Type 3 (competitive supplements) awards made after the effective date.
It does not apply to Type 5 (i.e., non-competing continuations) awards.
Amended A-110 does not apply to data collected under contracts, but
contract data can be accessed through FOIA (independent of A-110) if in
the possession of a government agency.

For data that are already available to the public through an archive or
other source, requestors will be referred directly to the public
source.

Definitions:
The term, Research Data, is defined as the recorded factual material
commonly accepted in the scientific community as necessary to validate
research findings.

It does not include:


preliminary analyses
drafts of scientific papers
plans for future research
peer reviews
communications with colleagues
physical objects (e.g., laboratory samples, audio tapes, video tapes)
trade secrets
commercial information
materials necessary to be held confidential by a researcher until
publication in a peer-reviewed journal
information which is protected under the law (e.g., intellectual
property)
personnel and medical files and similar files, the disclosure of which
would constitute unwarranted invasion of personal privacy
information that could be used to identify a particular person in a
research study.
Published is defined as when either:


research findings are published in a peer-reviewed scientific or
technical journal; OR
a Federal agency publicly and officially cites the research findings in
support of an agency action that has the force and effect of law.
Overview of Process:


The requestor prepares a FOIA request. The request must include:

The specific regulation or administrative order citing the data being
requested;
The publication cited in the regulation or administrative order;
The grant number under which the data were produced;
(Information on grants, including grant numbers, is available on
the NIH web site in CRISP)
A specific description of the data being sought;
A statement that the data are being requested under the amendment to
Circular A-110 (45 CFR 74.36).

NIH asks the requestor to send the request to the FOIA coordinator for
the NIH Institute or Center (IC) funding the grant. A list of IC FOIA
coordinators is provided on the NIH FOIA web page. (See
http://www.nih.gov/icd/od/foia/index.htmm)
The FOIA coordinator for the funding IC processes the request.
The FOIA coordinator notifies the funding IC's grants management
office and sends a letter to the Office of Sponsored Research at the
grantee institution with a copy to the Principal Investigator notifying
them about the request. Included with that letter will be guidance
provided by the NIH FOIA office on how to

respond to this request.

If the data are already available to the public through an archive or
other source, the A-110 amendment allows the FOIA coordinator to direct
the requestor to the public source. And the process stops here.
However, if the data are not publicly available, the process continues
as follows.
The amendment to A-110 provides for a reasonable fee to cover costs
incurred in responding to the request. The fee will include both the
costs to the NIH and the costs incurred by the grantee institution,
which will be accounted for separately. To accomplish this, the FOIA
coordinator:

Asks the grantee institution to estimate cost of providing the data;
and
Tells the requestor the estimated cost of producing the data.
If the requester has a history of not paying for costs related to
either FOIA or A-110 or if the estimated cost is greater than $250,
then prepayment will be requested.

Under the A-110 amendment, the grantee institution and the investigator
are required to provide data that are consistent with the definition of
research data (see definitions above) and deemed responsive to the
request.
Prior to sending the data to the appropriate NIH FOIA coordinator, the
grantee institution and the investigator redact the data to remove
personal identifiers and other information in accordance with amended
A-110 definitions (see above) and FOIA procedures.
The grantee institution transmits the data to the FOIA coordinator of
the funding IC along with an accounting of all associated costs.
NIH will develop guidance on how to estimate associated costs.
The FOIA coordinator and a knowledgeable program official from the
funding IC review the submitted data.
The FOIA coordinator responds to the requestor, issues a final invoice
for the fees, and transmits the data.
Frequently Asked Questions:

Q: For the past five years, an NIH-supported study has been
collecting data on traffic-related deaths. In June, 1999, this study
was cited in a federal regulation. Can the underlying data be requested
under the A-110 amendment?
A: No. Only data collected under grants awarded after the
effective date of the amendment are affected.

Q: How should telephone calls requesting data under the A-110
amendment be handled?
A: All investigators are free to share their data if they so
choose. In doing so, all parties should be aware of the need to adhere
to human subjects protections, including the >protection of
confidentiality. However, when a request will be addressed through
amended A-110, the caller should be referred to the FOIA office at the
funding NIH Institute or Center.

Q: Do Certificates of Confidentiality protect against a request
for data under FOIA or the A-110 amendment?
A: No. A Certificate of Confidentiality protects identifying
information of subjects. It does not exempt the entire data set.
However, it should be noted that identifying information is also
protected under FOIA as well as under the A-110 amendment.

Q: Are data collected under an SBIR or STTR accessible through
the A-110 amendment?
A: No, commercial organizations are exempted.
Q: What happens if a FOIA request is made for data that are
available to the public in an archive?
A: The FOIA officer will refer the requester to the archive where
the data are available.

Q: I am an investigator working on a topic that is often cited in
regulations. Therefore, I would like to plan to archive the data to be
collected in my next project. Can I request funding in the application
to archive the resulting data?
A: Yes. You should describe the archiving plan in the study
design and include information about this in the budget justification
section of the application.

Q: Besides archiving, what other things should I be thinking
about?
A: You may also want to think about how to structure informed
consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.

Q: How long does NIH require data to be stored after a project is
completed?
A: For three years after the submission of the financial status
report.

Q: Does that mean that data are only accessible for three years
after the close out of the grant?
A: No. If an investigator or grantee institution chooses to keep
records longer than three years, then they must be made available in
response to a request under the A-110 amendment.

Q: What happens if the PI has moved?
A: Research grants are awarded to Institutions, not individuals.
The FOIA office will send the request for data to the Office of
Sponsored Research at the grantee institution and will send a copy to
the PI. The FOIA office will work with the grantee institution to
locate PI and to fulfill the request for data.

Q: What happens if either the investigator or grantee institution
refuses to comply with the request?
A: This would be viewed as a material failure to comply with the
terms and conditions of award, and NIH would initiate appropriate
enforcement action. This could result in withholding of future support
or imposing additional restrictive terms and conditions of award to the
grantee institution.

Q: A research project has just received a very small amount of
support from the NIH as well as a much larger award from a private
foundation. Thus, the data will be produced with the combined support.
Would the data be accessible under the A-110 amendment?
A: Yes. As long as the data collection occurred with some Federal
support, regardless of level or amount, the grantee institution would
be required to provide those data.

Q: Can data collected under a training grant be requested under
the A-110 amendment?
A: This is a complex issue, and so the answer is maybe.
Fellowships are awarded to individuals, not institutions. Therefore,
data collected under fellowship grants may be exempted. If data are
collected under a training grant awarded to an institution of higher
education, hospital, or other non-profit institution, are published,
and are cited in a regulation, the data would be accessible under the
A-110 amendment. If a trainee works on a research project that is not
Federally funded, the data associated with that non-Federal award could
not be requested under the amendment to A-110.

Q: A competing continuation for a longitudinal study will be
renewed after the effective date or the A-110 amendment. This will pay
for years 9 through 12 of data collection. Are the data collected in
years 1 through 8 accessible under this amendment?
A: No. The only data that are accessible are those collected
under the award issued after the effective date of the A-110 amendment.


Q: The State Health Department received a grant to study
emphysema. Are the resulting data accessible under amended A-110?
A: If the State Health Department collected those data, they are
not accessible under this specific provision. However, if the State
Health Department contracted data collection to an institution of
higher education or other non-profit organization, then the data would
be accessible.

Q: An abstract was published in the Report of 10th Annual Meeting
of Snail Physiologists and cited in a Federal regulation. Are those
data accessible under amended A-110?
A: It depends. If the abstract is based on preliminary analyses
(as abstracts often are), then the data would be excluded since they do
not fit the amended A-110 definition of research data. However, if the
abstract is not based on preliminary analyses and is cited by a Federal
agency in a regulation, then the data may be accessible.









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