Year: 2015

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Comment on Proposed Rules for Protection of Human Subjects

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UPDATE: The proposed rulemaking comment period has been extended to January 6, 2016.

I would like to draw your attention to proposed revisions to the federal policy for the protection of human subjects, often referred to as the Common Rule. Even if you’re not currently involved in human subjects research activities, your research might be affected by the proposed changes.

The modifications are intended to enhance the ability of individuals to make informed decisions about participating in clinical research and also to modernize and streamline the regulatory approval process. One of the major reforms would expand the definition of human subjects research to include the secondary use of human biospecimens, regardless of identifiability. Some of the other proposed changes would affect the processes for obtaining informed consent and for determining the exemption status of human subjects research activities.

I encourage you to review the notice of proposed rulemaking and submit comments by the December 7, 2015, deadline. Please note that each proposed change described in the document includes specific questions for public comment.

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Wanted: Pharmacology, Physiology, and Biological Chemistry Division Director

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Search Committee Members:

Helen Sunshine, National Institute of General Medical Sciences, Chair

René Etcheberrigaray, Center for Scientific Review

Irene Glowinski, National Institute of Allergy and Infectious Diseases

Sherry Mills, Office of Extramural Research, NIH

Philip Cole, Johns Hopkins University School of Medicine

Judith James, University of Oklahoma Health Sciences Center

Scott Miller, Yale University

With the recent retirement of Dr. Michael Rogers, the search is now open for an outstanding individual to serve as director of our Division of Pharmacology, Physiology, and Biological Chemistry (PPBC).

This position offers significant opportunities to set scientific priorities, lead change and improve the biomedical research enterprise.

PPBC has a very broad scope, ranging from basic science to clinical areas. It supports research in fields including chemistry, biochemistry, chemical biology, enzymology, glycoscience, biotechnology, pharmacology, pharmacogenomics, anesthesiology, sepsis, trauma, burn injury and wound healing.There are tremendous opportunities to build bridges among these scientific disciplines, such as employing chemical methods to build tools for the life sciences and medicine, understanding fundamental biochemistry in its in vivo context and using systems approaches to solve physiological and pharmacological problems.

The division is organized into two branches, one focused on biochemistry and biorelated chemistry and the other on the pharmacological and physiological sciences. PPBC has 11 scientific staff members who serve as program officers.

The PPBC division director reports to the NIGMS director and is a member of our senior leadership team, which helps set policies and priorities for the Institute. There are also opportunities to participate in and advise on NIH-wide activities and collaborations with other federal agencies and scientific organizations.

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Lasker Award Recognizes Sustained Effort to Understand DNA-Damage Response

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We congratulate our long-time grantee Steve Elledge of Brigham and Women’s Hospital on being recognized with the 2015 Albert Lasker Basic Medical Research Award Link to external web site for “discoveries concerning the DNA-damage response—a fundamental mechanism that protects the genomes of all living organisms.” He shares the honor with Evelyn M. Witkin of Rutgers University.

For a quarter century, we’ve funded Elledge’s investigations of the molecular underpinnings of this fundamental biological process. While working with the yeast model system in the 1990s, his group showed that the Rad53 kinase plays an important role in coordinating DNA repair with progression through the cell cycle.

More recently, Elledge and his team have identified over 1,000 candidate proteins that may participate in the mammalian DNA-damage response. They are now seeking to uncover the precise functions of these proteins.

The Lasker Award is a fitting occasion to reflect on how far we’ve come in this field and the exciting opportunities that lie ahead.

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Early Career Investigators to Join Advisory Council Deliberations

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Beginning at this month’s meeting of the National Advisory General Medical Sciences Council, some of the ad hoc Council members will be early career investigators. We expect to benefit from their ideas and insights, and we also hope that they will get a better understanding of the workings of Council and share what they learn with peers.

As most of you know, the Advisory Council provides the second level of review required before any grant can be funded. The Council also advises the Institute on policy and scientific matters. Regular Council members are appointed by the HHS Secretary, but for most meetings, we invite ad hoc consultants to expand the Council’s breadth of expertise. Both regular and ad hoc members are typically at fairly senior career levels—often full professors or deans. We think there is value in inviting one or two early career investigators to each Council meeting as ad hocs to provide a greater diversity of views.

We’ve identified a perfect pool to draw from: the Early Career Reviewers who have participated in a study section for NIH’s Center for Scientific Review. If you are interested in applying to this CSR program, see How to Apply.

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Clarifying the Due Date for MIRA Applications from New and Early Stage Investigators

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The September 9 receipt date for the Maximizing Investigators’ Research Award (MIRA) for New and Early Stage Investigators (R35) is just one week away! We recommend that applicants submit a few days early to give themselves time to check that their applications as received by NIH are complete and correct.

A few points of clarification about the deadline:

  • If you’re planning to submit an AIDS or AIDS-related application for the later receipt date of November 19, 2015, please contact me immediately to discuss whether the MIRA grant mechanism is appropriate. It may not be when only part of the research is AIDS-related.
  • The expiration date for the funding opportunity announcement is listed as November 20, 2015. This is not the receipt date. Do not be misled by this or any reference to a closing date on forms downloaded from Grants.gov.
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Outcomes Analysis of the NIGMS Postbaccalaureate Research Education Program (PREP)

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We recently analyzed the educational and career outcomes of scholars who participated in the NIGMS Postbaccalaureate Research Education Program (PREP). The goal of this program, which we started in 2000, is to prepare recent baccalaureate graduates from groups that are underrepresented in the biomedical sciences for entry into—and completion of—rigorous Ph.D. training programs. PREP is part of a larger effort at NIGMS to support the development of a highly skilled, creative and diverse biomedical research workforce.

PREP grants are awarded to research-intensive institutions. Each grant supports five to 10 scholars who spend 75 percent of their time as apprentice scientists pursuing a mentored discovery research project and the remainder engaged in academic and professional development activities. These include a program of study to enhance their academic record and workshops to improve their writing and presentation skills.

Our assessment of PREP outcomes is based on various educational and career metrics for PREP scholars supported from 2001 to 2014 through 41 institutional programs. For more details about the analysis, read the report [PDF].

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NIH Common Fund Glycoscience Program Seeks Fresh Approaches for Developing Tools and Technologies

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As we enter the second year of the NIH Common Fund Glycoscience program to develop accessible tools for carbohydrate research, we encourage those who are new to carbohydrate chemistry and biology to bring their fresh perspectives to bear on difficult challenges in this field by applying through one of the following funding opportunity announcements (FOAs). While we continue to welcome applications from carbohydrate scientists, we hope to see new ideas from synthetic chemists and technology developers from other fields. Our goal is to enable researchers in all biomedical fields to study the roles of carbohydrates in health and disease, so approaches from outside the established glycoscience community are of particular interest.

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Training Career Outcomes

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Last week, I wrote to NIGMS-funded T32 program directors to encourage them to inform students about trainee career outcomes. Because this topic is also relevant to the broader community, I’d like to share the message here.

Dear NIGMS T32 Training Grant Program Director:

At the June 2015 meeting of NIGMS training, workforce development, and diversity program directors, Peter Preusch, Dick Okita and I discussed the importance of making post-training career outcomes available to current and prospective students. The goal of collecting and sharing data on Ph.D. career outcomes is consistent with recommendations of the Biomedical Research Workforce Working Group of the Advisory Committee to the Director, NIH. This topic has also been addressed by the Association of American Medical Colleges, the Council of Graduate Schools Link to external web site and a recent Molecular Biology of the Cell article.

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Becoming a Peer Reviewer for NIGMS

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NIH’s Center for Scientific Review (CSR) is not the only locus for the review of grant applications–every institute and center has its own review office, as well. Here at NIGMS, the Office of Scientific Review (OSR) handles applications for a wide variety of grant mechanisms and is always seeking outstanding scientists to serve as reviewers. If you’re interested in reviewing for us, here’s some information that might help.

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Comment on Proposed Framework for NIH-Wide Strategic Plan

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NIH is currently gathering input from the scientific community, including stakeholder organizations, on the proposed framework for its 5-year strategic plan. Responses are due by August 16, 2015.

We’ve been asked to share this message from NIH Principal Deputy Director Larry Tabak about the call for comments and suggestions:

In order to advance the NIH mission, the NIH is developing an NIH-wide Strategic Plan. The goal of this 5-year plan is to outline a vision for biomedical research that ultimately extends healthy life and reduces illness and disability. NIH senior leadership and staff have developed a proposed framework for the Strategic Plan that identifies areas of opportunity across all biomedicine and unifying principles to guide NIH’s support of the biomedical research enterprise. The aim is to pursue crosscutting areas of research that span NIH’s 27 Institutes, Centers, and Offices.

I invite you to review the framework in our Request for Information and on the NIH website, and to provide your feedback via the RFI submission site. I encourage stakeholder organizations (e.g., patient advocacy groups, professional societies) to submit a single response reflective of the views of the organization/membership as a whole. We also will be hosting webinars to gather additional input. These webinars will be held in early to mid-August.

Your input is vital to ensuring that the NIH Strategic Plan positions biomedical research on a promising and visionary path. I appreciate your time and consideration in assisting us with this effort.

The webinars Link to external web site mentioned in Larry’s message are scheduled for August 5, 11 and 13.