Tag Archives: Ethics

New article compares different approaches for notification and authorization in pragmatic clinical research

Dr. Kevin Weinfurt and colleagues in the Regulatory/Ethics Core of the NIH Collaboratory recently published an article in the American Journal of Bioethics regarding how acceptable different approaches to notification and authorization are to potential participants in pragmatic research. The authors conducted a series of interviews using 24 different hypothetical scenarios reflecting different types of studies and approaches to notification and authorization.

Key findings:

  • People have significant difficulty understanding 1) randomization and 2) that all the data are collected during routine care, and no extra visits or tests are required.
  • For some types of pragmatic research, many of the respondents viewed
    • Active alternatives to written consent—such as oral consent—as acceptable.
    • Less active approaches to notification—such as no notification ahead of time or broad notification—as unacceptable.
  • When using written consent in cases where researchers are testing accepted medical interventions that have known clinical risks but with no incremental risks of participating in the research, it was acceptable to omit the clinical risks from the consent documents, thereby shortening the forms.
  • A significant portion (28-49%) of respondents would decline to participate regardless of notification approach, which could lead to non-trivial consent bias (in other words, there could be significant differences in people who decline vs people who agree to participate).

Based on these findings, the authors suggest alternate approaches to notification and authorization should be further developed and tested.

Read the full article here.

2015 International Compilation of Human Research Standards Released


The 2015 edition of the International Compilation of Human Research Standards is now available. Compiled by the U.S. Department of Health and Human Service’s Office for Human Research Protections, the document indexes more than 1,000 laws, regulations, and guidelines governing human subjects research in over 100 countries.

The compilation includes direct links to many of the laws, regulations, and guidelines, and serves as a resource for researchers, institutional review boards (IRBs), research sponsors, and others involved in human subjects research worldwide.

The 2015 edition includes hundreds of updates, including the addition of six new countries (Ghana, Guinea, Liberia, Malaysia, Saudi Arabia, and Sierra Leone).

Access the 2015 compilation here

Content is organized in the following topics:
 1. General
 2. Drugs and Devices
 3. Research Injury
 4. Privacy/Data Protection
 5. Human Biological Materials
 6. Genetic
 7. Embryos, Stem Cells, and Cloning