AADR Seeking Input on Human Research Subjects Regulations

HHS has issued A Notice of Proposed Rulemaking (ANPRM) outlining changes to regulations overseeing research utilizing human subjects. Before the changes are finalized, the agency is inviting public input on a host of related issues, including:

  • Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  • Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  • Updating the forms and processes used for informed consent.
  • Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  • Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  • Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  • Providing uniform guidance on federal regulations.

AADR requests member feedback, which may utilized in a response to HHS on behalf of the organization. Individuals interested in contributing to a potential AADR members are asked to submit information to Jonathan Nurse, AADR Director of Government Affairs, at jnurse@aadronline.org by September 9, 2011. AADR also encourages individuals to respond directly to HHS. A full copy of the HHS request is available here.

In Defense of Peer Review

AADR joined with the Coalition to Promote Research and 84 other organizations in a letter to the Chairman and Ranking Member of the House Appropriations Subcommittee that has jurisdiction over the NIH budget. The letter defends the NIH peer review process, which has recently been publicly questioned by an outside organization. Read the joint letter here.

HHS Seeking Comments on Proposed Human Subjects Regulations

The Department of Health and Human Services issued an Advance Noticed of Proposed Rulemaking (ANPRM) on Friday, which appeared in the Federal Register today. The notice details changes under consideration to “ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight,” and invites comments by 5pm on September 26th.  Continue reading

Key Issues Roundup: Money Matters

Budget Deal Remains Elusive- Inside the Washington beltway, yesterday, some saw signs of an end to the budget standoff that has been center stage in DC for the past few weeks. A bipartisan group of Senators announced a plan to cut spending and close tax loopholes over a 10-year period to cut the federal deficit by $3.6 trillion. It is unclear what the deal would mean for NIH and other research agencies. However, the spending bill that supports Labor-HHS-Education and some smaller related agencies would be expected to produce $70 billion is savings over 10 years. The House of Representatives has been noticeably cool to the Senate proposal, and some have stated that it may be too late to write a bill that can pass before the August 2nd deadline to raise the debt limit. President Obama indicated today that he may be open to a stopgap measure if it is clear that a long-term compromise is in the works.

House Takes Symbolic Vote- The House of Representatives approved a “Cut, Cap, and Balance” bill on Tuesday -largely along party lines. The bill would cut FY12 spending by $111 billion, reduce federal spending as a percentage of GDP over the next 10 years, and require passage of a balanced budget amendment in order to raise the nation’s debt ceiling. The legislation has no chance in the Senate, and the President has already stated that he would veto the bill if presented to him. According to the Obama administration, the legislation would “set unrealistic spending caps that could result in significant cuts to education, research and development, and other programs critical to growing our economy and winning the future.”

[**7/22 Update** As expected, the Senate voted down the “Cut, Cap, and Balance” bill today -party line vote.]

AADR On the Hill- AADR is continuing with advocacy meetings, in support of NIH/NIDCR, with members of the House and Senate appropriations committees. Meeting feedback suggests that the Senate is taking a “wait and see” approach to the FY12 budget; waiting to see what the White House is able to work out on deficit reduction/debt limit increase with House leaders, and what the House recommends for FY12. The House is moving forward with the regular appropriations process. If the current schedule is kept, as some House staffers suggest, by July 26th we may know the FY12 figure that is being advanced for NIH in the House. It remains a great time for members of the research community to reach out to their elected officials.

[**7/22 Update** The House has postponed consideration of the spending bill that funds NIH and several other agencies. The bill will not move forward until after the month-long August recess. More time for advocacy efforts!]

AADR will also offer input for the oral health component of a health disparities bill that is being reintroduced by Congresswoman Barbara Lee.

Defending NIH Grants- The NIH peer review process is again under attack by an outside group claiming that specific grant awards are of an ideological nature and limited in benefit to taxpayers. The group is administering an online petition to encourage President Obama to institute a grant moratorium at NIH to allow time for a special prosecutor to conduct a review. It is expected that certain Members of Congress will also raise issue with specific NIH grant awards, as legislation to fund the agency for FY12  is assembled in the coming days and weeks.

AADR is joining with much of the biomedical research advocacy community to defend the NIH grant peer review process. A letter is being drafted from our groups to House Appropriators asking that Congress refrain from undermining the peer review process by eliminating funding for specific awards. Although the targeting of NIH grants is not a new phenomenon and rarely seems to gain much traction, the other side of the story definitely needs to be told. Interested individuals are invited to contact AADR Government Affairs for a copy of the current draft letter in support of the NIH grant process .

Did You Know- During the August congressional recess, many Members of Congress hold town hall forums back in their home states/districts. These events provide an excellent opportunity to voice support for federal research investments. Visit the websites [House, Senate] of your elected officials and sign-up for their e-mail distribution lists, so that you can be notified of events in your area.

NSF Level Funded for FY12 in House Bill

The House Appropriations Committee has approved a Fiscal Year 2012 spending bill for Commerce-Justice-Science programs, which includes the National Science Foundation (NSF). The bill would provide NSF $6.9 billion or the same level of funding that it is receiving for the current (2011) fiscal year. According to the Committee, “NSF’s core research is increased by $43 million to enhance basic research that is critical to innovation and U.S. economic competitiveness.” While it is certainly encouraging to see NSF spared the budget axe and legislative language supporting research and development, it should be noted that funding the agency at the FY11 level is actually $53 million less than it received in FY10 and $907 million less than President Obama requested for FY12. The full House will vote on the bill later in the summer. Additionally, the Senate will put together it’s own version. Deficit reduction talks taking place at the White House may also impact the final FY12 budget for NSF.

Budget Negotiations Making Little Progress

With just a few days left before the nation faces a default on its debt, Members of the House leadership and the White House continue to clash over the composition of a deficit reduction plan. House leaders have made clear that they will accept no revenue enhancements as part of an agreement while the President has stated that spending cuts alone are unacceptable, producing a very real possibility that the two sides will be unable to reach a deal. President Obama has identified this Friday as the point by which congressional leaders need to make their final intentions known on a plan for deficit reduction and increasing the debt limit. Continue reading

IOM Report on Access to Oral Health Care Recommends Increased Research

In an event at the National Press Club, earlier today, the Institute of Medicine’s (IOM) Committee on Oral Health Access to Services released its final report.  The study, sponsored by the Health Resources and Services Administration and the California HealthCare Foundation, finds that millions of Americans fail to receive adequate dental care because of “persistent and systemic” barriers to access.  The report makes six primary recommendations to increase access, notably calling for new measures of quality and efficiency as well as increased research leading to new methods of delivery and care. According to the report:

“The committee identified a deficiency in the collection, analysis, and use of data related to oral health. For example, the paucity of oral health quality measures limits the findings that can be drawn regarding the relationship between specific services and procedures and longer-term oral health outcomes. Congress, federal agencies, including HHS, and private foundations should support oral health research and evaluation of: new methods and technologies for the delivery of oral health care to vulnerable and underserved populations; measures of access, quality, and outcomes; and payment and regulatory systems.”

In its conclusion, the Committee calls on leaders at all levels of government to work in concert with the oral health community to implement report recommendations. At numerous points during the question and answer period, panelists were asked to address the likelihood of implementing its recommendations in a climate that is hostile to increased spending and new initiatives. Panelists stated a belief that existing federal agency funds within the public health portfolio could be realigned to support many of the suggestions offered by the Committee. However, they acknowledged that the current fiscal and political climate in Washington, DC pose yet another challenge to access.

Key Member of Congress Urges Advocacy for NIH Budget

Today, Representative Rosa DeLauro (D-CT) who is Ranking Member of the House Appropriations Subcommittee that has jurisdiction over NIH funding met with the Ad Hoc Group for Medical Research. AADR is a participant in the coalition, which is housed within the Association of American Medical Colleges and consists of many biomedical research advocacy groups.

The congresswoman opened the conversation with passionate words in support of a strong NIH budget, tying in her personal battle with cancer and the hope that biomedical research brought to her own life. She explained the “what could have been” scenario for NIH from a FY11 budget proposal (H.R. 1) that passed the House earlier in the year, but was ultimately put aside in favor of a compromise with the Senate and White House. She articulated that the cuts would have resulted in a steep decline in the number of extramural grant opportunities offered by NIH, as well as an applicant success rate of only 12.5%. Congresswoman DeLauro closed her remarks by stating emphatically that research advocates need to be out making the case for sustained NIH funding to their elected officials. “Stand up, speak out, you are making the case for life,” she asked of participants in the meeting and their constituencies.

The White House continues to meet with congressional leaders to develop a deficit reduction plan that will set the framework for the FY12 budget and beyond, as well as trigger enough votes to pass an increase in the nation’s debt ceiling. The results of the negotiations will largely decide the trajectory of funding for NIH and the rest of the federal government. However, the annual budget process will ultimately proceed in some form, meaning that contacts with individual congressional offices are of significant importance. It is expected that the size of the NIH budget, relative to the other components of the Labor-HHS-Education appropriations bill, will make it a prime target when appropriators decide how to reach the budget cut targets set by congressional leaders and the White House.

What can you do? In addition to writing letters to your elected officials, you are encouraged to write op-ed pieces for your local papers, make a scheduled visit to the local or DC offices of your congressional delegation, and sign-up to be on the listserv for each member of your congressional delegation. One can typically sign-up for a listserv on a Member’s website. The listserv will provide information on townhall events and other meetings in district where constituents can voice their thoughts.

House Member Websites

Senate Member Websites