I.2 Policy Arguments Favoring Data Access

I.2.1 Background

I.2.2 Principles of Open Government

I.2.3 Benefits to Government Decision Making

I.2.4 Enhancements to the Scientific Enterprise

I.3 Current Agency Policies and Other Data Access Precedents

I.3.1 U.S. Government Executive Branch Policies

I.3.1.a Presidential Executive Order on Children's Health
I.3.1.b Food and Drug Administration
I.3.1.c National Science Foundation
I.3.1.d National Center for Health Statistics
I.3.1.e Public Health Service of HHS
I.3.1.f National Institutes of Health
I.3.1.g National Aeronautics and Space Administration
I.3.1.h National Institute of Justice of the Department of Justice

I.3.2 Professional Organizations and Journals

I.3.2.a National Research Council
I.3.2.b Institute of Medicine
I.3.2.c American Physical Society
I.3.2.d American Sociological Association
I.3.2.e American Society for Microbiology
I.3.2.f American Statistical Association
I.3.2.g International Statistical Institute
I.3.2.h American Chemical Society Journals
I.3.2.i The British Medical Journal
I.3.2.j Cell
I.3.2.k Cancer Research
I.3.2.l Journal of the American Medical Association
I.3.2.m Nature
I.3.2.n Proceedings of the National Academy of Sciences
I.3.2.o Science

I.3.3 Professional Commentary

I.3.4 Academic and Research Institutions

I.3.4.a Duke University
I.3.4.b Massachusetts Institute of Technology
I.3.4.c Mount Sinai School of Medicine
I.3.4.d University of California at San Francisco
I.3.4.e University of Minnesota
I.3.4.f University of New Mexico
I.3.4.g University of Pennsylvania

I.3.5 State Legislation

I.3.5.a California
I.3.5.b Massachusetts
I.3.5.c Michigan

PART TWO -- Addressing Concerns Over Data Access

II.1 Introduction

II.2 FOIA Exemptions Provide Broad Protection Against Harmful Disclosures

II.2.1 Protection of Privacy Rights

II.2.2 Intellectual Property Protection

II.2.2.a Introduction
II.2.2.b Protection for Pending Patents and Copyrights
II.2.2.c Exemption for Trade Secrets
II.2.2.d Exemption for Confidential Commercial Information
II.2.2.e Relationship to Circular A-110
II.2.2.f Reverse FOIA Proposal

II.2.3 National Security Exemption

II.2.4 FOIA Procedures and Logistics

II.3 Ethical Standards and Practices Protect Patient Confidentiality

II.4 Procedural Concerns Relating to Issuance of Revisions

II.5 Notice to Awardees at Time of Award

II.6 Definitions

II.6.1 Data

II.6.2 Published research findings

II.6.3 Produced under an award

II.6.4 Used

II.6.5 Developing policy or rules

II.6.6 Within a reasonable time

II.7.1 Introduction

II.7.2 Recommendations Regarding User Fees

II.8.1 Data Retention

II.8.2 Attestation

II.8.3 Final Disclosure Determinations

II.8.4 Agency Enforcement

II.9.1 Privacy Rights

II.9.2 Intellectual Property Rights

II.9.3 Administrative Costs and Other Burdens on Awardees

II.9.4 Definition of "Data"

II.9.5 Definition of "Published"

II.9.6 Definition of "Used"

II.9.7 Relationships with Private Funding Sources

II.9.8 Retroactivity

II.9.9 Burden on Agencies