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Compliance Partners

Healthcare Financial Management Association -
New Jersey Chapter

Articles on HCCS, Health Care Compliance, and Computer Based Training.
Bill Sacks, Vice President, HCCS. Computer Based Training - One Solution to an Ongoing Problem.
Compliance Training for High Level Professionals and Staff: A talk given by Bill Sacks at the CHAA Conference, 4/13/00.
J.C. Kinnamon, Program Manager, Training Applications, Midi Corporation. What Is Interactive Training?
J.C. Kinnamon, Program Manager, Training Applications, Midi Corporation. Multimedia Learning - Reprint from: INTERACTIVE INSIGHTS VOLUME 6: ISSUE 1 January, 2003

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General Compliance

HHS - Office of Inspector General

Official Government Information

http://www.oig.hhs.gov

Authorities & Federal Register Notices

Regulatory Authority	HHS-OIG - Authorities & Federal Register Notices-Regulatory Authority
Federal Register Notices	HHS-OIG-Authorities & Federal Register Notices-Federal Register Notices

Publications

Workplan	HHS-OIG - Publications-Workplan
Semiannual Report	HHS-OIG - Publications-Semiannual Report
Orange Book	HHS-OIG - Publications-Orange Book
Red Book	HHS-OIG - Publications-Red Book
HCFAC	HHS-OIG - Publications-Health Care Fraud and Abuse Control Program Report
MFCU	HHS-OIG - Publications-Medicaid Control Fraud Units (MFCU)

Reports

Recent Audit Reports	HHS-OIG - Reports - Office of Audit Services
Recent Evaluation & Inspection Reports	HHS-OIG - Reports - Office of Evaluation and Inspections

Fraud Prevention & Detection

Safe Harbor Regulations	HHS-OIG-Fraud Prevention & Detection - Safe Harbor Regulations
Advisory Opinions	HHS-OIG-Fraud Prevention & Detection - Advisory Opinions
Fraud Alerts, Bulletins & Other Guidance	HHS-OIG-Fraud Prevention & Detection - Fraud Alerts, Bulletins and Other Guidance
Compliance Guidance	HHS-OIG-Fraud Prevention & Detection - Compliance Guidance
Exclusions Program	HHS-OIG-Fraud Prevention & Detection - Exclusion Program
Corporate Integrity Agreement	HHS-OIG-Fraud Prevention & Detection - Corporate Integrity Agreements
Self-Disclosure Information	HHS-OIG-Fraud Prevention & Detection - Self-Disclosure Information
Hotline	HHS-OIG-Hotline
Enforcement Actions	HHS-OIG-Fraud Prevention & Detection - Enforcement Actions

HIPAA

Describes HIPAA authorizations and provides sample language	Information for Covered Entities and Researchers on Authorizations For Research Uses or Disclosures of Protected Health Information
Provides guidance regarding when IRB review is required for stand-alone HIPAA authorizations	Guidance for Industry IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations
Describes the role of privacy boards in relation to HIPAA	Privacy Boards and the HIPAA Privacy Rule
Describes an IRB's role in relation to the HIPAA privacy rule, and clarifies differences among HHS, FDA, and HIPAA regulations in relation to IRBs	Institutional Review Boards and the HIPAA Privacy Rule

Accreditation/Joint Commission

Accreditation	What’s new for 2004 Hospital accreditation http://www.jointcommission.org/AccreditationPrograms/
Agenda for Change	Major steps designed to modernize the accreditation process http://www.jointcommission.org/PerformanceMeasurement
AHRQ Bioterrorism Planning and Response	Agency for Healthcare Research and Quality’s homepage for information on Bioterrorism planning and response. http://www.ahrq.gov/prep/
AHRQ Disaster Planning Drills and Readiness Assessment	This web-site contains issue briefs on “Conventional Disasters versus Bioterrorism,” “Disaster Planning: An Ongoing Community Effort,” “Disaster Training and Evaluation,” and “Readiness Assessment for Hospitals.” http://www.ahcpr.gov/news/ulp/btbriefs/btbrief2.htm
CDC Emergency Preparedness & Response	A Centers for Disease Control and Prevention web-site on emergency preparedness and management http://www.bt.cdc.gov/
Domestic Preparedness White Paper	This white paper addresses enhancements that NEMA considers to be vital in a nationwide strategy for catastrophic disaster preparedness. http://www.jointcommission.org/NR/rdonlyres/FE29E7D3-22AA-4DEB-94B2-5E8D507F92D1/0/planning_guide.pdf
Draft Standards	Information on the standards that are still in draft form awaiting approval http://www.jointcommission.org/Standards/
Emergency Preparedness	Joint Commission Calls For Community Mobilization To Develop Emergency Response Capabilities For Terrorist Attacks http://www.jointcommission.org/NewsRoom/OnCapitolHill/testimony_101001.htm
Hand Washing	Guidelines for hand washing in a health care setting http://www.cdc.gov/handhygiene/
Hospitals	The Joint Commission homepage for hospitals http://www.jointcommission.org/
Hospital Emergency Incident Command System	HEICS III update project web-site homepage. Contains information on the HEICS project, an organizational chart, frequently asked questions and answers, and the ability to download the HEICS Plan. http://www.emsa.ca.gov/dms2/heics3.htm
Implementation Tips For Do Not Use Abbreviations	Implementation tips for compliance with the prohibited abbreviations requirement of the National Patient Safety Goals are now available on the Joint Commission website at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/abbr_tips.htm
Infection Control	Information on infection control initiatives http://www.jointcommission.org/GeneralPublic/PatientSafety/
Infection Control Initiatives	Infection Control addressed through a variety of Joint Commission initiatives http://www.jointcommission.org/GeneralPublic/PatientSafety/
Medical Errors	A position statement by the Joint Commission on medical errors http://www.jointcommission.org/SentinelEvents/errors.htm
National Emergency Management Association (NEMA)	NEMA is the professional association of and for state emergency management directors. NEMA’s mission is to provide national leadership and expertise in comprehensive emergency management, serve as a vital emergency management information and assistance resource and advance continuous improvement in emergency management through strategic partnerships, innovative programs, and collaborative policy positions. http://www.nemaweb.org/
Nursing Shortage	Joint Commission whitepaper offering solutions to nursing shortages posing serious health care risk http://www.jointcommission.org/NR/rdonlyres/5C138711-ED76-4D6F-909F-B06E0309F36D/0/health_care_at_the_crossroads.pdf
On-site Survey	Understanding the On-site Survey Process http://www.jointcommission.org/AccreditationPrograms/Hospitals/AccreditationProcess/onsite_qa.htm
ORYX	Information on the Joint Commission’s ORYX performance measurement initiative, requirements, Core Measures, Glossary of Terms, etc. http://www.jointcommission.org/AccreditationPrograms/HomeCare/ORYX/
Pain Management	The Joint Commission focuses on Pain Management http://www.jointcommission.org/JointCommission/Templates/GeneralInformation.aspx
Quality Check	A Joint Commission service to monitor improvement http://www.jointcommission.org/AccreditationPrograms/CriticalAccessHospitals/faqs.htm
Shared Visions-New Pathways	Extensive information on the new accreditation process http://www.jointcommission.org/Library/jconline/jo_04_07.htm
Terrorism Forces Us to Make a Choice	Ready.gov is the Department of Homeland Security’s web-site for the general public. It includes information on making a kit of emergency supplies, making a plan for what to do in an emergency and information about what might happen in different threat situations. http://www.ready.gov/
Universal Protocol	Information on the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery TM http://www.jointcommission.org/NR/rdonlyres/2020EE90-CBD6-482D-8FE3-24593431A313/0/wrong_site_brochure.pdf
Standards	Information on purchasing the 2004 Standards for all the types of healthcare organizations that the Joint Commission accredits http://www.jcrinc.com/77/
Speak Up Initiative	Brochures, posters, and buttons provided as part of a national campaign launched by the Joint Commission and the Centers for Medicare and Medicaid Services (CMS), to urge patients to take a role in preventing health care errors by becoming active, involved and informed participants on the health care team. http://www.jointcommission.org/PatientSafety/SpeakUp/speak_up_general.htm

Grants and Contracts

Specifies "cost principles" for determining allowable research costs by hospitals	Appendix E to Title 45 Part 74 of the Code of Federal Regulations
Article detailing steps for conducting an audit of research grants	Developing a Research Audit Plan
Contains NSF policies and procedures for grants	NSF http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpm
Contains the policy requirements that are the terms and conditions of NIH grant awards -- effective for all grants and agreements with budget periods beginning on March 1, 2001 through Nov. 30, 2003	NIH Grants Policy Statement (March 2001)
Contains the policy requirements that are the terms and conditions of NIH grant awards -- effective for all grants and agreements with budget periods beginning on or after Dec. 1, 2003	NIH Grants Policy Statement (Dec 2003)
NIH reminder regarding costs of IRB review	http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-042.html
Audit report from HHS Office of Inspector General into Grant reports from Northeastern University	Northeastern University DHHS Grant Costs
Specifies "cost principles" for determining allowable research costs by educational institutions	OMB Circular A-21- Cost Principles for Educational Institutions (08/08/2000)
Specifies "cost principles" for determining allowable research costs by state, local, and federally-recognized Indian tribal governments	OMB Circular A-87 - Cost Principles for State, Local and Indian Tribal Governments (05/2004)
Establishes consistency and uniformity among Federal agencies in the management of grants and cooperative agreements with State, local, and federally-recognized Indian tribal governments	OMB Circular A-102 - Grants and Cooperative Agreements with State and Local Governments (05/2004)
Specifies administrative requirements for institutions receiving grants.	OMB Circular A-110 - Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations (09/30/1999)
Specifies "cost principles" for determining allowable research costs by nonprofit organizations other than educational institutions and hospitals	OMB Circular A-122 - Cost Principles for Non-Profit Organizations (05/2004)
This is the "uniform audit" guide for institutes of higher education and other nonprofit organizations	OMB Circular A-133 - Audits of States, Local Governments, and Non-Profit Organizations (06/24/1997, includes revisions published in Federal Register 06/27/03)
Listing of government-wide common rules for administrative requirements of federal award recipients	OMB CIRCULARS AND COMMON RULES FOR GRANT MANAGEMENT
Clarifies the treatment of voluntary uncommitted cost sharing effort and tuition remission costs in accordance with	OMB A-21 OMB Memo: Clarification of OMB A-21 Treatment of Voluntary Uncommitted Cost Sharing and Tuition Remission Costs
Table of contents for OMB A-133	OMB A-133 Compliance Supplement
An example of the various roles and responsibilities in research at Oregon Health Sciences University	Oregon Health Sciences University -- Roles and Responsibilities in the Proper Conduct of Research and Administration of Sponsored Projects
Specifies "cost principles" for determining allowable research costs by commercial organizations and certain nonprofit institutions exempt from OMB Circular A-122, A-21, or Appendix E	Part 31 of the Federal Acquisition Regulations (FAR)

Human Subjects

Ethical Guidance Documents

Summarizes the three basic ethical principles for the protection of human research subjects	Belmont Report
An international standard for ethical and human rights considerations in medical research	Declaration of Helsinki
Ten ethical principles guiding the use of human subjects in research	Nuremberg Code

HHS-related Documents

List of the categories of research approved by HHS for expedited IRB review	List of HHS approved research for expedited review
HHS regulations for the protection of human subjects in research, includes Subpart A, "The Common Rule;" Subpart B, "Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research;" Subpart C, "Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects;" and Subpart D, "Additional Protections for Children Involved as Subjects in Research"	45 CFR 46: Protection of Human Subjects
OHRP guidance on the use of expedited review procedures by IRBs	Guidance on the Use of Expedited Review Procedures
Guidance regarding informed consent from non-English speaking subjects	Obtaining and Documenting Informed Consent of Subjects Who do not Speak English
Describes HHS regulations regarding additional protections for prisoners in research	OHRP Guidance on the Involvement of Prisoners in Research
Provides guidance to IRB's, institutions, and investigators engaged in research to consider whether financial interests in research may adversely affect the welfare of human subjects)	HHS Guidance: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 12, 2004)
Letter from the OHRP describing inspection findings of deficiencies in human subjects protections that resulted in a temporary restriction on the institution's federalwide assurance	OHRP Determination Letter to Weill Medical College at Cornell University (May 24, 2004)
Decision trees from OHRP to assist in determining if human subject research regulations apply	OHRP Human Subject Regulations Decision Charts (Sept 2004)
OHRP Guidance on the HHS 45 CFR 46.407 Review Process	Children Involved as Subjects in Research (May 2005)
Guidance on reporting incidents (serious problems, non-compliance, etc.) to OHRP	Guidance on Reporting Incidents to OHRP (May 2005)
Compilation of human subjects laws, regulations and guidelines by country	International Compilation of Human Subject Research Protections (Oct 2005)
Guidance to Institutional Review Boards (IRBs) for the review of information provided to potential research subjects through clinical trial websites.	Guidance on Institutional Review Board Review of Clinical Trial Websites (Sept 2005)

FWA Information

General information about FWAs (from the OHRP website)	Federalwide Assurance Information
Provides answers to frequently asked questions about FWAs (from the OHRP website)	IRB Registration and Federalwide Assurance Questions and Answers
Describes terms of the FWA for domestic and international institutions (from the OHRP website)	Federalwide Assurance of Protection for Human Subjects
Instructions for completing a domestic FWA	Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States (Jan 2005)
Instructions for completing an international FWA	Step-by-Step Instructions for Filing a Federalwide Assurance for International (Non-U.S.) Institutions (Jan 2005)
FWA Form for domestic institutions	Federalwide Assurance -- Domestic Institutions
FWA Form for international institutions	Federalwide Assurance -- International Institutions
Terms of the FWA for both domestic and international institutions	Terms of the Federalwide Assurance (Jan 2005)

FDA-related Documents
Lists the categories of research approved by FDA for expedited IRB review	List of FDA approved research for expedited review
Describes significant differences in the FDA and HHS human protections regulations	FDA Information Sheets (Appendix E): Significant Differences in FDA and HHS regulations for Protection of Human Subjects
Provides guidance on general topics relating to human subjects research regulated by the FDA	FDA Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators [General Section]
Describes Good Clinical Practice international ethical and scientific guidelines for human subjects research, as adopted by ICH	Guidance for Industry Good Clinical Practice: Consolidated Guidance
FDA regulation on the protection of human subjects in research	21 CFR Part 50: Protection of Human Subjects
FDA regulation on Institutional Review Boards	21 CFR Part 56: Institutional Review Boards
Document completed by each principal investigator participating in a clinical trial; By signing investigator agrees to comply with certain commitments as described in the document	FDA Form 1572: Statement of Investigator (Mar 2005)
Document completed by each principal investigator participating in a clinical trial; By signing investigator agrees to comply with certain commitments as described in the document	FDA Form 1572: Statement of Investigator
Draft Guidance Only: Discusses the roles, responsibilities, and operating procedures for Clinical Trial Data Monitoring Committees	FDA Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
Proposed rule that would require IRB's reviewing any research with products regulated by the FDA to register with DHHS	Proposed Rule: Institutional Review Boards; Registration Requirements (July 2004)
Final Rule allowing FDA approval for certain drugs for human use based on animal efficacy data alone	Animal Efficacy Rule: New Drug and Biological Drug Products: Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (May 2002)
Updated Animal Efficacy Rule relating to the approval of certain biological products based on animal efficacy data alone	Animal Efficacy Rule: Subpart H "Approval of Biological Products When human Efficcy Studies Are Not Ethical or Feasible" (April 2003)
Updated Animal Efficacy Rule relating to the approval of certain drugs based on animal efficacy data alone	Animal Efficacy Rule: Subpart I "Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible" (April 2004)


Clinical Trial Billing Documents
Regulation on CMS coverage of costs related to invetigational device trials	42 CFR 405, Subpart B: Medical Services Coverage Decisions That Relate to Health Care
CMS policy regarding coverage of routine costs in clinical trials for Medicare recipients	Medicare National Coverage Determination for Clinical Trials
Claims Processing Instructions for claims submitted for Medicare Beneficiaries participating in Qualifying Clincal Trials	Medicare Coverage - Clinical Trials: Program Memorandum
Explanation of CMS expanded coverage of routine costs for Category A Device Trials	Coverage of Routine Costs of Clinical Trials Involving Investigational Device Exemption (IDE) Category A Devices
Education article explaining CMS coverage of Category A device trials	Medlearn Matters: Coverage of Routine Costs of Clinical Trials Involving Investigational Device Exemption (IDE) Category A Devices
Manualization of instructions in the Medicare Claims Processing Manual and previously issued program memorandums for payment of Qualifying Clinical Trials	CMS Manual System Pub. 100-04 Medicare Claims Processing (Transmittal 487)

Investigator-Sponsored Research Documents
Regulation detailing procedures and requirements for the use of investigational new drugs and the filing of IND's with the FDA	21 CFR 312: Investigational New Drug Application (IND) (April 2004)
Regulation providing procedures for the conduct of clinical investigations of devices and the filing of IDE's with the FDA	21 CFR 812: Investigational Device Exemptions (IDE's) (April 2004)
Form completed by each principal investigator conducting research with FDA-regulated investigational drugs or biologics	FDA Form 1572: Statement of Investigator (Mar 2005)
Form filed with the FDA to request permission to test investigational drug in humans	FDA Form 1571: Investigational New Drug Application (IND) (Mar 2005)
Instructions for completing the FDA 1571 (IND)	Information for Sponsor-Investigators Submitting Investigational New Drug Applications (IND's) (Oct 2004)
Instructions for submitting an IND for a biological product	Information on Submitting an Investigational New Drug Application for a Biological Product (May 2005)
Overview of entire IDE application process and responsibilities	Information on IDE's (July 2003)
Instructions for completing an IDE application -- Includes administrative checklist to ensure application is complete	IDE Application Requirements (July 2003)
Provides guidance on medical devices, IRB review of medical device studies, distinguishing between significant and non-significant riks devices, and emergency use of investigational devices	FDA Guidance Document on Medical Devices (April 2001)
Describes acceptable approaches to monitoring clinical investigations	FDA Guideline for the Monitoring of Clinical Investigations (Nov 1998)

HIPAA-related Documents

Describes HIPAA authorizations and provides sample language	Information for Covered Entities and Researchers on Authorizations For Research Uses or Disclosures of Protected Health Information
Provides researchers with a basic understanding of the Privacy Rule and how it may affect health research	Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
Provides guidance regarding when IRB review is required for stand-alone HIPAA authorizations	Guidance for Industry IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations
Describes the role of privacy boards in relation to HIPAA	Privacy Boards and the HIPAA Privacy Rule
Describes an IRB's role in relation to the HIPAA privacy rule, and clarifies differences among HHS, FDA, and HIPAA regulations in relation to IRBs	Institutional Review Boards and the HIPAA Privacy Rule
Describes how the HIPAA privacy rule affects research	The HIPAA Privacy rule and research
Describes how the HIPAA privacy rule affects research involving records within repositories and databases	Research Respositories, Databases, and the HIPAA Privacy Rule
Provides guidance on the HIPAA privacy rule and its effects on clinical research	Clinical Research and the HIPAA Privacy Rule

Miscellaneous Documents

Guidance document created by the University of Pennsylvania to complement the consent template. Used with the permission of UPenn.	University of Pennsylvania Consent Guidelines
Template created by the University of Pennsylvania for developing informed consent documents. Used with the permission of UPenn.	University of Pennsylvania Consent Template

Conflict of Interest and Scientific Misconduct

Conflict of Interest

Public Health Service (PHS) regulation regarding financial conflicts of interest in research	42 CFR 50 Subpart F "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought "
PHS requirements for promoting objectivity by PHS contractors	45 CFR 94 Subpart A "Responsible Prospective Contractors "
Form submitted to FDA with marketing application certifying that financial arrangements of investigators have been disclosed	FDA Form 3454 -- Certification: Financial Interest and Arrangements of Clinical Investigators
Form to submit to the FDA disclosing financial interests of an investigator participating in a clinical trial	FDA Form 3455 -- Disclosure: Financial Interest and Arrangements of Clinical Investigators
Provides guidance on the FDA requirements for financial disclosure of clinical investigators in research	FDA Guidance: Financial Disclosure by Clinical Investigators
Report of a review of financial conflicts of interest issues, including a review of five university policies	GAO Report: Biomedical Research HHS Direction Needed to Address Financial Conflicts of Interest (Nov 2001)
A draft guidance document from the Department of Health and Human Services raising issues as to whether financial conflicts of interest in research affect the well-being of human subjects, and if so, what actions should be taken to protect them	HHS Draft Guidance: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (March 31, 2003);
Covers the NSF's requirements for institutions applying for or receiving NSF grants, including information on NSF's conflict of interest policy	National Science Foundation Grants Policy Manual (NSF GPM)
NIH statement of issues that should be considered in regards to financial conflicts of interest	NIH Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards
NIH Conflict of Interest Policy	NIH Guide: Objectivity in Research (July 1995)
Guidelines for managing individual and institutional financial conflicts of interests at universities to ensure research integrity	Association of American Universities (AAU) Task Force on Research Accountability: Report on Individual and Institutional Financial Conflict of Interest (Oct. 2001)
The policy statement that describes the terms and conditions of NIH grants awards	NIH Grants Policy Statement (Dec. 2003)
Provides guidance to IRB's, institutions, and investigators engaged in research to consider whether financial interests in research may adversely affect the welfare of human subjects	HHS Guidance: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 12, 2004)
Interim Final Rule that proposes requirements to address ethical issues at NIH	Supplemental Standards of Ethical Conduct and Financial Disclosure (Feb 2005)
Description of prohibited outside activities for NIH employees	Summary of NIH-specific Provisions in Interim Final Rule (Feb 2005)
NIH News Release describing publication on ethics reform interim final rule	NIH News Release: NIH Announces Sweeping Ethics Reform (Feb 2005)
Answers to frequently asked questions regarding the interim final rule	Questions and Answers for Employees Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements (Feb 2005)
Update on filing deadline extension for financial disclosure report for NIH employees	Conflict of Interest Regulations Update (March 2005)

Scientific Misconduct

Publication of the OSTP Federal Policy on Research Misconduct	Office of Science and Technology Policy (OSTP) Executive Office of the President; Federal Policy on Research Misconduct; Preamble for Research Misconduct Policy (12/06/00)
The ORI's position on 28 significant issues related to inquires and investigations into scientific misconduct	ORI Addresses Issues in Inquiries and Investigations
ORI guidance for adhering to the PHS requirement to protect whistleblowers	ORI Guidelines for Institutions and Whistleblowers: Responding to Possible Retaliation Against Whistleblowers in Extramural Research (Nov 1995)
A sample policy provided by ORI that institutions can use as a model to create their own misconduct policies	ORI's Model Policy for Responding to Allegations of Misconduct
Provides advice to institutions on methods for handling allegations of misconduct and conducting inquiries and investigations into suspected misconduct	ORI's Model Procedures for Responding to Allegations of Misconduct
SUSPENDED policy that would have required all institutions receiving PHS research funds to provide formal education in the responsible conduct of research to all affected employees	PHS Policy on Instruction in the Responsible Conduct of Research (RCR) (Dec 2000) -- SUSPENDED
Report of a review group assembled to evaluate HHS procedures related to research misconduct	Report of the Department of Health and Human Services Review Group on Research Misconduct and Research Integrity (July 1999)
Proposed rule to modify PHS research misconduct policies	42 CFR Parts 50 and 93: Public Health Service Policies on Research Misconduct; PROPOSED RULE (April 16, 2004)
Final Rule issuing revised research misconduct policies for all PHS supported research -- incorporates OSTP Federal Misconduct Policy	42 CFR Parts 50 and 93: Public Health Service Policies on Research Misconduct; FINAL RULE (May 2005)
Guidance published by ORI to assist institutions in meeting their obligations under the new final rule	Requirements for Institutional Policies and Procedures on Research Misconduct Under the New PHS Policies on Research Misconduct, 42 CFR Part 93 (Aug 2005)
Provides answers to frequently asked questions to assist Research Integrity Officers (RIOs), compliance officers, PHS researchers, and other interested parties in understanding their obligations under the new regulation and how the new regulation affects them	Questions and Answers regarding 42 CFR Part 93 (Aug 2005)