What’s new for Hospital accreditation

Major steps designed to modernize the accreditation process

Agency for Healthcare Research and Quality’s homepage for information on Bioterrorism planning and response.

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.”

A Centers for Disease Control and Prevention web-site on emergency preparedness and management

This white paper addresses enhancements that NEMA considers to be vital in a nationwide strategy for catastrophic disaster preparedness.

Information on the standards that are still in draft form awaiting approval

Joint Commission Calls For Community Mobilization To Develop Emergency Response Capabilities For Terrorist Attacks

Guidelines for hand washing in a healthcare setting

The Joint Commission homepage for hospitals

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.

Implementation tips for compliance with the prohibited abbreviations requirement of the National Patient Safety Goals are now available on the Joint Commission website

Information on infection control initiatives

Infection Control addressed through a variety of Joint Commission initiatives

A position statement by the Joint Commission on medical errors

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.

Joint Commission whitepaper offering solutions to nursing shortages posing serious healthcare risk Understanding the On-site Survey Process

Information on the Joint Commission’s ORYX performance measurement initiative, requirements, Core Measures, Glossary of Terms, etc.

The Joint Commission focuses on Pain Management

Extensive information on the new accreditation process

Information on the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery TM

Information on purchasing the current Standards for all the types of healthcare organizations that the Joint Commission accredits

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 healthcare errors by becoming active, involved and informed participants on the healthcare team.

Describes HIPAA authorizations and provides sample language

Provides guidance regarding when IRB review is required for stand-alone HIPAA authorizations

Describes the role of privacy boards in relation to HIPAA

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

The Office of the National Coordinator's (ONC) operating plan detailing implementation dates for various provisions outlined in the American Reinvestment and Recovery Act (a.k.a the Stimulus Act) and the Health Information Technology for Economic and Clinical Health (HITECH) Act

Specifies "cost principles" for determining allowable research costs by hospitals

Article detailing steps for conducting an audit of research grants

Contains NSF policies and procedures for grants

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

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

Audit report from HHS Office of Inspector General into Grant reports from Northeastern University

Specifies "cost principles" for determining allowable research costs by educational institutions

Specifies "cost principles" for determining allowable research costs by state, local, and federally-recognized Indian tribal governments

Establishes consistency and uniformity among Federal agencies in the management of grants and cooperative agreements with State, local, and federally-recognized Indian tribal governments

Specifies administrative requirements for institutions receiving grants.

Specifies "cost principles" for determining allowable research costs by nonprofit organizations other than educational institutions and hospitals

This is the "uniform audit" guide for institutes of higher education and other nonprofit organizations

Listing of government-wide common rules for administrative requirements of federal award recipients

Table of contents for OMB A-133

An example of the various roles and responsibilities in research at Oregon Health Sciences University

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

Summarizes the three basic ethical principles for the protection of human research subjects

An international standard for ethical and human rights considerations in medical research

Ten ethical principles guiding the use of human subjects in research

List of the categories of research approved by HHS for expedited IRB 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"

OHRP guidance on the use of expedited review procedures by IRBs

Guidance regarding informed consent from non-English speaking subjects

Describes HHS regulations regarding additional protections for 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)

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

Decision trees from OHRP to assist in determining if human subject research regulations apply

OHRP Guidance on the HHS 45 CFR 46.407 Review Process

Guidance on reporting incidents (serious problems, non-compliance, etc.) to OHRP

Compilation of human subjects laws, regulations and guidelines by country

Guidance to Institutional Review Boards (IRBs) for the review of information provided to potential research subjects through clinical trial websites.

General information about FWAs (from the OHRP website)

Provides answers to frequently asked questions about FWAs (from the OHRP website)

Describes terms of the FWA for domestic and international institutions (from the OHRP website)

Instructions for completing a domestic FWA

Instructions for completing an international FWA

FWA Form for domestic institutions

FWA Form for international institutions

Terms of the FWA for both domestic and international institutions

Lists the categories of research approved by FDA for expedited IRB review

Describes significant differences in the FDA and HHS human protections regulations

Provides guidance on general topics relating to human subjects research regulated by the FDA

Describes Good Clinical Practice international ethical and scientific guidelines for human subjects research, as adopted by ICH

FDA regulation on the protection of human subjects in research

FDA regulation on 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

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

Draft Guidance Only: Discusses the roles, responsibilities, and operating procedures for 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

Final Rule allowing FDA approval for certain drugs for human use based on animal efficacy data alone

Updated Animal Efficacy Rule relating to the approval of certain biological products based on animal efficacy data alone

Updated Animal Efficacy Rule relating to the approval of certain drugs based on animal efficacy data alone

Regulation on CMS coverage of costs related to invetigational device trials

CMS policy regarding coverage of routine costs in clinical trials for Medicare recipients

Claims Processing Instructions for claims submitted for Medicare Beneficiaries participating in Qualifying Clincal Trials

Explanation of CMS expanded coverage of routine costs for Category A Device Trials

Education article explaining CMS coverage of Category A device trials

Manualization of instructions in the Medicare Claims Processing Manual and previously issued program memorandums for payment of Qualifying Clinical Trials

Regulation detailing procedures and requirements for the use of investigational new drugs and the filing of IND's with the FDA

Regulation providing procedures for the conduct of clinical investigations of devices and the filing of IDE's with the FDA

Form completed by each principal investigator conducting research with FDA-regulated investigational drugs or biologics

Form filed with the FDA to request permission to test investigational drug in humans

Instructions for completing the FDA 1571 (IND)

Instructions for submitting an IND for a biological product

Overview of entire IDE application process and responsibilities

Instructions for completing an IDE application -- Includes administrative checklist to ensure application is complete

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

Describes acceptable approaches to monitoring clinical investigations

Describes HIPAA authorizations and provides sample language

Provides researchers with a basic understanding of the Privacy Rule and how it may affect health research

Provides guidance regarding when IRB review is required for stand-alone HIPAA authorizations

Describes the role of privacy boards in relation to HIPAA

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

Describes how the HIPAA privacy rule affects research

Describes how the HIPAA privacy rule affects research involving records within repositories and databases

Provides guidance on the HIPAA privacy rule and its effects on clinical research

Guidance document created by the University of Pennsylvania to complement the consent template. Used with the permission of UPenn.

Template created by the University of Pennsylvania for developing informed consent documents. Used with the permission of UPenn.

The official general Medicare form for giving patients advance notice when a service will not be covered by Medicare

Public Health Service (PHS) regulation regarding financial conflicts of interest in research

PHS requirements for promoting objectivity by PHS contractors

Form submitted to FDA with marketing application certifying that financial arrangements of investigators have been disclosed

Form to submit to the FDA disclosing financial interests of an investigator participating in a clinical trial

Provides guidance on the FDA requirements for financial disclosure of clinical investigators in research

Report of a review of financial conflicts of interest issues, including a review of five university policies

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

Covers the NSF's requirements for institutions applying for or receiving NSF grants, including information on NSF's conflict of interest policy

NIH statement of issues that should be considered in regards to financial conflicts of interest

NIH Conflict of Interest Policy

Guidelines for managing individual and institutional financial conflicts of interests at universities to ensure research integrity

The policy statement that describes the terms and conditions of NIH grants awards

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

Interim Final Rule that proposes requirements to address ethical issues at NIH

Description of prohibited outside activities for NIH employees

NIH News Release describing publication on ethics reform interim final rule

Answers to frequently asked questions regarding the interim final rule

Update on filing deadline extension for financial disclosure report for NIH employees

Publication of the OSTP Federal Policy on Research Misconduct

The ORI's position on 28 significant issues related to inquires and investigations into scientific misconduct

ORI guidance for adhering to the PHS requirement to protect whistleblowers

A sample policy provided by ORI that institutions can use as a model to create their own misconduct policies

Provides advice to institutions on methods for handling allegations of misconduct and conducting inquiries and investigations into suspected 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

Report of a review group assembled to evaluate HHS procedures related to research misconduct

Proposed rule to modify PHS research misconduct policies

Final Rule issuing revised research misconduct policies for all PHS supported research -- incorporates OSTP Federal Misconduct Policy

Guidance published by ORI to assist institutions in meeting their obligations under the new final rule

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