On October 26th, Harvard submitted comments to HHS' proposed changes to the federal Common Rule governing human subjects research.  The comments were the result of meetings with IRB leadership, faculty researchers in various schools and departments and review by the university-wide Human Research Protection Program Coordinating Committee.

For more information on HHS' proposed changes, visit the Common Rule ANPRM website.

The US Department of Health and Human Services (HHS) today released a Final Rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors. The Rule implements changes to regulations last updated in 1995 that govern the relationships between PHS-funded investigators and industry.  

The University Financial Conflict of Interest Policy, approved in May 2010 anticipated and accommodates many of the changes published in the Final Rule, which goes into effect in August, 2012. The text of the full Rule can be found here. 

Working with the University Standing Committee on Conflict of Interest, the Office of the Provost will assist Schools as they implement plans to ensure that all new requirements are satisfied.

On Friday, July 22nd, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking ("ANPRM") to revise the feederal regulations governing research with human subjects, otherwise known as the Common Rule.  HHS rules governing research with human subjects were simulatneously adopted by 14 agencies 20 years ago.  The ANPRM represents the first major development in the federal oversight of human subjects research since the adoption of the Common Rule.  HHS is soliciting comments on how such regulations might be modernized and revised to be more effective.  The ANPRM can be found here.

Colorado Democratic Representative Diana Degette re-introduced the Stem Cell Research Advancement Act with Republican support from Pennsylvania Representative Charlie Dent.  The bill seeks to provide legislative support for President Obama's 2009 Executive Order and the NIH Guidleines promulgated pursuant to it.

Sandeep R. Datta, M.D., Ph.D., Assistant Professor of Neurobiology at Harvard Medical School and Wendy S. Garrett, M.D., Ph.D., Assistant Professor of Immunology and Infectious Diseases at the Harvard School of Public Health, were recently named 2011 Searle Scholars. Over the past 30 years, the Searle Scholars Program has awarded grants in support of research in medicine, chemistry, and biological science. Fifteen Scholars were named from a pool of 180 recently appointed assistant professors nominated by 126 universities and research institutions. This year’s Scholars have already demonstrated innovative research with the potential for making significant contributions to biological research over an extended period of time.

On Tuesday, March 15th, two disease-specific stem cell lines, HUES PGD 13 and HUES PGD 3, were approved under the NIH Guidelines for inclusion on the NIH Human Embryonic Stem Cell Registry. As a result, research using these lines will be eligible for NIH funding. The embryos from which the disease-specific Harvard lines were derived were determined through preimplantation diagnosis (“PGD”) to be affected with Spinal Muscular Atrophy and Duchene Muscular Dystrophy, respectively. Disease-specific embryonic stem cell lines are of particular value to researchers because they provide greater insight into the manifestation and development of disease. Additionally, such lines are particularly useful in drug testing. HUES PGD 13 and HUES PGD 3 are the first disease-specific lines to be added to the NIH Registry since 42 disease-specific lines derived by the Reproductive Genetics Institute (“RGI”) in Chicago were rejected last June for failure to meet NIH informed consent requirements. Prior to the rejection of the RGI lines, only one disease-specific line was approved for federal funding. Further information is available on the NIH website.

For HUES PGD 13: http://grants.nih.gov/stem_cells/registry/current.htm?id=469 and for HUES PGD 3: http://grants.nih.gov/stem_cells/registry/current.htm?id=102

From the Association of American Medical Colleges (AAMC): "The Institute for Laboratory Research (ILAR) of the National Academies has released the final version of the 8th Edition of The Guide for the Care and Use of Laboratory Animals, an internationally accepted primary reference on the humane treatment of animals in research, testing, and teaching.  Last updated in 1996, this new edition of the Guide integrates recently published data, scientific principles, and expert opinion to recommend practices for responsible laboratory animal use. AAALAC is expected to issue revised accreditation guidelines in the next few months, which will incorporate the Guide revisions."

To ease administrative burdens and limit the exposure of high-risk data, the University has issued a new Financial Policy on Human Subjects Payments effective January 1, 2011.  Pursuant to the new policy, PIs, researchers or other designees conducting research need not collect social security numbers or other high-risk confidential information such as individual financial accounts, driver's license, state ID, or passport numbers, or a name in conjunction with biometric information about the named individual when issuing payments of $100 or less to research subjects.  For further information on the policy, including a decision tree and other training materials, click here:  http://eureka.harvard.edu/eureka/course_content/financial/hspp.ppt.

The National Science Foundation posted new data sharing requirements for grant proposals.  Pursuant to the new requirements, investigators are expected to share the primary data, samples, physical collections and other supporting materials created or gathered in the course of work funded by NSF grants, at no more than incremental cost and within a reasonable time.  Pursuant to this policy change, all proposals submitted to NSF must include a supplementary document of no more than two pages labeled "Data Management Plan," describing how the proposal will conform to NSF policy on the sharing and dissemination of research results.  In drafting the Data Management Plan, investigators should follow program-specific guidance, or, if no such guidance is available, the general requirements laid out in the Grant Proposal Guide.  According to the 2011 Grant Proposal Guide, Fastlane will no longer permit submission of proposals without a Data Management Plan.  A statement that no detailed plan is necessary will suffice as a valid Data Management Plan, as long as there is clear justification provided.  For more information, see: http://www.nsf.gov/pubs/policydocs/pappguide/nsf11001/gpg_2.jsp#dmp

A new report, authored by members of the committee that wrote the influential 2005 report Rising Above the Gathering Storm, highlights the rapidly deterioating climate for American competitiveness and innovation.

The Harvard Corporation has adopted a University-wide conflict of interest policy, the first time such a policy has been crafted to cover faculty members across the entire campus.

The Department of Health and Human Services issued a proposed rulemaking to address the increasingly complex interactions between research institutions, government, and the private sector in the areas of biomedical and behavioral research and the need to strengthen accountability.