| June 27, 2022 |
Comments on NIH Draft Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data NOT-OD-22-131
Submitted by the ISBER Science Policy Committee |
| February 25, 2022 |
Comments on Request for Information on the NIH Genomic Data Sharing Policy, NOT-OD-22-029
Submitted by the ISBER Science Policy Committee |
| September 27, 2021 |
Comments on NIH’s Request for Information: Developing Consent Language for Future Use of Data and Biospecimens, NOT-OD-21-131
Submitted by the ISBER Science Policy Committee |
| June 10, 2020 |
Responsible Data Sharing to Respond to the COVID-19 Pandemic: Ethical and
Legal Considerations (v 2.0): The Perspective of the Regulatory and Ethics Work Stream of the
Global Alliance for Genomics and Health
Submitted by the ISBER Science Policy Committee |
| April 29, 2020 |
Comments on Application of GDPR to Biomedical Research
Submitted by the ISBER Science Policy Committee |
| January 7, 2020 |
Comments on the Draft NIH Policy for Data Management and Sharing
Submitted by the ISBER Science Policy Committee |
| August 1, 2019 |
Comments on GA4GH Data and Security Policy
Submitted by the ISBER Science Policy Committee |
| February 11, 2019 |
Docket No. FDA-2018—N-2727, "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations" (83 Federal Register 57378)
Submitted by the ISBER Science Policy Committee |
| January 3, 2018 |
Comments relating to the Proposed Changes to TCPS 2 (2014) Guidance for Research involving Human Cells and Cell Lines
Submitted by the ISBER Science Policy Committee |
| February 29, 2016 |
Comments relating to the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
Submitted by the ISBER Science Policy Committee
|
| November 18, 2015 |
Comments on Notice of Proposed Rulemaking for Revisions to the Common Rule
Submitted by the ISBER Science Policy Committee
|
| November 16, 2015 |
Missed Opportunities and Lost Lives: Consequences of Some Proposed Changes to Regulations on Research with Human Tissues
Reprinted by permission from the American Association for Cancer Research: Grizzle WE.
Missed opportunities and lost lives: consequences of some proposed changes to regulations on research with human tissues. Clin Can Res. 2015 19. [Epub ahead of print]. doi:10.1158/1078-0432.CCR-15-2513. |
| June 11, 2015 |
Comments on the World Medical Association (WMA) Declaration of Ethical Considerations Regarding Health Databases and Biobanks
Submitted by the ISBER Science Policy Committee
|
| August 12, 2014 |
Comments on the Working Document on Research on Biological Materials of Human Origin to the Committee on Bioethics of the Council of Europe
Submitted by the ISBER Science Policy Committee |
| July 1, 2014 |
Comments on the International Code of Conduct for Genomic and Health-Related Data Sharing
Submitted by the ISBER Science Policy Committee
|
| November 20, 2013 |
Response to the Request for Public Comments on the Draft Genomic Data Sharing (GDS) Policy
Submitted by the ISBER Science Policy Committee
|
| July 8, 2013 |
Response to the U.S. Presidential Commission for the Study of Bioethical Issues Request for Comments on Issues Related to Incidental Findings
Submitted by the ISBER Science Policy Committee
|
| March 4, 2013 |
Response to the European General Data Protection Regulation Proposal
as provided by the European Parliament and the Council of the European Union, (Brussels, 4 December 2012)
Submitted by the ISBER Science Policy Committee
|
| January 12, 2012 |
Australian government National Health and Medical Research Council (NHMRC) proposed revisions to Chapter 3.4: human tissue samples and Chapter 3.6: Human stem cells of the National Statement on Ethical Conduct in Human Research
Submitted by the ISBER Science Policy Committee
|
| October 26, 2011 |
Federal Government of U.S.A. Health and Human Services Department (May 31, 2011) proposed changes to Common Rule
Submitted by the ISBER Science Policy Committee
|
