A Diagnostics & Imaging Week

The National Institutes of Health (NIH; Bethesda, Maryland) has rolled out a pilot effort to shorten the times for research grant applications reviews so that the actual research can be launched more quickly.

This project was generated, the NIH said, because of concerns that current review times are too slow, thus “hindering the careers of promising researchers and the advancement of science and health.”

It said the effort especially would help a “vulnerable” group of researchers: new investigators applying for their first major NIH grant, an R01 grant. “R01 grants totaling about $10 billion support many of the best biomedical researchers at universities and medical centers across the country,” the NIH said in a statement.

The new director of the Center for Scientific Review (CSR), Toni Scarpa, MD, PhD, said, “We plan to use new electronic and management tools while preserving the rigor and fairness of NIH peer review, so we can identify the most promising medical research more rapidly.” The main goal is to cut the review process time in half.

The CSR will initiate the pilot in February in 40 of its scientific review panels, offering quicker reviews to new investigators who need to resubmit revised applications for their first R01 grant.

CSR’s process currently takes six months and involves more than 15,000 outside scientific experts. Resulting evaluations receive a second review, usually taking three more months. Outside experts on their advisory councils make final recommendations for final acceptance or rejection.

Among the project’s features:

  • Reviewers will have four weeks instead of the usual six weeks to review and critique R01 applications from new investigators.
  • Grant applicants will get the evaluation of their applications within a week of their peer review panel’s discussion, including a summary of the discussion and the written evaluations by the panel members.
  • New researchers in the trial will be given a special 20-day delay of the deadline for resubmitting revised applications for the next review cycle, thereby reducing the time for resubmission by four months.

NIH said that, if the pilot proves useful, it could be used to speed the reviews of all new investigator applications for R01 grants.

New electronic and management methods and new electronic research applications may enable CSR to use shortened cycles in reviewing all R01 applications and other applications as well. NIH has announced that on Dec. 1 it began phasing out paper applications and appendices.

BIO, others push SOX reform

The Biotechnology Industry Organization (BIO; Washington), along with a coalition of healthcare technology, high-tech and venture capital industries, submitted a letter to a Securities and Exchange (SEC) advisory committee recently requesting reform to the internal controls section of the Sarbanes-Oxley Act (SOX).

“We’re not proposing to change a single word of the Sarbanes-Oxley legislation,” said Jim Greenwood, BIO’s president and CEO. “But, complying with the Sarbanes-Oxley external auditor requirement can cost upwards of $1 million, often doubling a small firm’s operating costs. Unintended consequences of the cost burdens associated with a ‘one-size-fits-all’ approach [of the section] continues to hamper small companies’ ability to invest in research and development and to gain access to public capital markets.”

The coalition said it wants the SEC to ease disproportionate financial burdens on small public companies.

Coalition members working with BIO include the National Venture Capital Association, TechNet, the Advanced Medical Technology Association (Washington), the California Healthcare Institute and SEMI. The coalition represents more than 5,300 companies from 50 states and around the world.

Morrie Ruffin, BIO’s executive vice president of capital formation and business development, said, “We do not oppose government oversight; rather, we want to ensure that oversight is conducted in a manner that is fair to small biotech or high-tech businesses. Some of these cost burdens threaten to jeopardize the competitiveness of smaller companies that are the growth engines of the U.S. economy.”

The SEC formed the Advisory Committee on Smaller Public Companies to consider ways of improving the impact of Sarbanes-Oxley on small public companies, and it has been holding public hearings to seek recommendations from stakeholders. It has set a meeting at SEC headquarters on Wednesday to review those recommendations and prepare draft proposals for the SEC.

The coalition recommends that smaller public companies be:

  • Defined as the bottom 6%, based on a quarterly average, of the total U.S. public market capitalization or by a revenue threshold set by the average revenues of companies at the bottom 6% of total market capitalization.
  • Exempt from having external auditors attest to internal controls. This would not exempt small public companies from complying with SOX as a whole.
  • Allowed to take a risk-based approach to prioritizing their key financial controls and be allowed to alternate the frequency of control testing to every second or third year.