Research Standards manual updated
No U.S. changes, but many elsewhere
The Office for Human Research Protections' 2014 Edition of International Compilation of Human Research Standards is available with hundreds of updates and three additional nations, including Cameroon, Mozambique, and Zambia.
The 129-page electronic PDF is available online at http://www.hhs.gov/ohrp/international/index.html.
The changes between the 2013 edition and the 2014 edition include hundreds of new bills, regulations, and guidelines internationally. There were no legislative or guideline updates or changes in the United States information.
The compilation features listings of more than 1,000 laws, regulations, and guidelines on human subject protections in 107 countries. It also includes standards, such as issues of informed consent, research ethics committee review, reporting requirements, and vulnerable populations issued by a number of international and regional organizations.
The listings are organized into seven categories: general research, drugs and devices, research injury, privacy/data protection, human biological materials, genetics, embryos, stem cells, and cloning.
Many listings feature a hyperlink that leads directly to the law, regulation, or guideline of interest. The compilation is available in both PDF and Word versions.
The compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world, and it was first published in 2005 with annual updates.
Among the changes from the 2013 edition are:
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The general international guidelines now list this reference: 3. Ethical issues in Patient Safety Research: Interpreting Existing Guidance (2013): http://apps.who.int/iris/bitstream/10665/85371/1/9789241505475_eng.pdf.
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Croatia, Denmark, and Bulgaria have new laws on medicinal products; Germany and Iceland updated their Medicinal Products Act from 2009.
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Finland has new regulations on consent for biobanks.
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France has a new law on embryos, stem cells, and cloning, and new Civil Code Articles on genetic research.
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Switzerland has a new Federal Act on Research Involving Human Beings, as well as three new ordinances:
- Ordinance on Clinical Trial (2014);
- Ordinance on Research Involving Human Beings, with the Exception of Clinical Trials (2014);
- Ordinance on the Organization of the Federal Act on Research Involving Human Beings (2014).
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Turkey created 2013 updates for its Guideline for Good Clinical Practice, Guidance on the Ethics of Pediatric Clinical Research, Drug Observational Studies Guide, and created these new guidelines:
- Guideline for Independent Data Review Committees;
- Guidance on Education Programs Related to GCP and Clinical Trials;
- Guidance on Archiving in Clinical Research;
- Guidance on Ethical Committee Submission;
- Guidance on Submission to the Turkey Pharmaceuticals and Medical Devices Agency in Clinical Trials;
- Guidance on Adverse Event Reaction Reporting in Clinical Trials.
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Australia updated its National Statement on Ethical Conduct in Human Research (previously 2009).
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Japan updated the Ethics Guidelines for Epidemiological Research (previously 2008), Good Clinical Practice Guidelines for Medical Devices (previously 2009), Guidelines for Clinical Research Using Human Stem Cells (previously 2010), Ethical Guidelines for Research on Assisted Reproductive Technology to Develop Human Fertilized Embryos (previously 2010), and Ethics Guidelines for Human Genome/Gene Analysis Research (previously 2008). Japan also passed a new Pharmaceutical Affairs Law (previously 2011) and created new Guidelines on Research on Producing Germ Cells from Human Induced Pluripotent Stem Cells or Human Tissue Stem Cells.
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South Korea's Food and Drug Administration is now named the Ministry of Food and Drug Safety. South Korea also passed a new Pharmaceutical Affairs Act and Bioethics and Safety Act and updated its Korean Good Clinical Practice (previously 2009) and the Enforcement Rule of the Protection of Personal Information Maintained by Public Agencies (previously 2008).
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Mexico passed a new General Health Law, Title V and enacted a new rule on Establishing Criteria for the Conduct of Health Research Projects (2012).
