The NIH is has launched a new Web site, Medical Research with Animals: For Researchers and Institutions, as part of our work to support NIH-funded scientists using animal models.

Vaccines, medicines, therapies, surgical interventions, and preventive health care are all essential to maintaining high standards of health worldwide. Medical research that uses animals makes a tremendous contribution to the development of new and life-saving interventions, as well as to our overall understanding of human and animal physiology. Like all NIH-funded research, medical research involving animals must go through a strict peer review and approval process based on federal regulations to ensure the protection of animal welfare.

As the Deputy Director for Extramural Research, I care deeply about the well-being of NIH-supported researchers, animals used in medical research, and institutions with animal programs. One of my chief concerns since joining OER has been the creation of a proactive and supportive environment for researchers and institutions with NIH-supported animal research programs. NIH-funded scientists engaging in this type of research dedicate themselves to supporting the welfare of animals in the critically important medical research that protects and promotes the health of humans and animals alike.

The majority of Americans support carefully regulated and appropriate use of animals in medical research benefitting human and animal health. But some people do not believe that animals should be used in medical research. NIH-supported projects have sometimes been opposed through legal protests that are protected by free speech. Unfortunately, there also exists the threat of violence against individuals and institutions whose research involves the use of animals. Just in the past year, NIH-supported researchers and their families have been subject to threats, harassment, and acts of domestic terrorism. Important research institutions have also been threatened.

When threats or incidents of violence occur, it is critical that institutions and researchers are prepared and able to respond quickly. To that end, OER has created a resource for researchers, and institutions that use animals in NIH-supported science. A new Web site, Animals in Medical Research: Resources for Researchers and Institutions, provides guidance for preparedness and crisis management by researchers and institutions, and information on how NIH can help. It also provides quick access to funding opportunities focused on animals in research, resources to assist with grant writing, and training and education for animal care and use, models, and science and ethics. A sister site designed for the general public is set to be launched in the near future.

The Medical Research with Animals: For Researchers and Institutions site is just beginning. It will continue to evolve and improve over time with your suggestions and experiences, so please use the “Contact Us” link to submit your questions and comments.

— Norka Ruiz Bravo, Ph.D.
OER Director and NIH Deputy Director for Extramural Research

As I have discussed before in this space (January and May 2008 Nexus issues), ensuring that research is conducted objectively and without bias is of paramount importance to maintaining the public’s trust in our activities. This necessitates an ongoing and robust collaboration with you the investigators and your institutions. In February 2008, I appointed a task force to conduct a comprehensive review of the regulations governing extramural Financial Conflicts of Interest (FCOI) and the policies and procedures that have been put in place to comply with those regulations, both at the NIH and in the wider community. As a result of the task force’s activities, we have identified and are reviewing several areas for oversight enhancement. These include consistency of Institutional FCOI policies with the regulation; full implementation of those policies by the Institutions; reporting of all identified FCOIs to the NIH; complete disclosure of relevant financial interests by Investigators to their Institutions; and development of additional guidance and training for NIH staff on how to handle Institutional reports of FCOI.

We are instituting a variety of measures to address these issues quickly and carefully. First, we are embarking on an enhanced outreach and education campaign to raise the awareness of the importance of proper identification and management of FCOI in the extramural community. We have posted an expanded FAQ document about the relevant regulations on the OER Web site (http://grants.nih.gov/grants/policy/coifaq.htm) and will soon publish a Web-based Tutorial that will thoroughly review the roles and responsibilities of the NIH, the awardee Institutions and the Investigators. I encourage you to consult regularly these resources and additional information on the OER Conflict of Interest Web site (http://grants.nih.gov/grants/policy/coi/index.htm) and to contact FCOICompliance@mail.nih.gov with any questions. Second, to improve our ability to monitor FCOI reports, we have developed a Web-based reporting and tracking tool that provides a central place for collection of all FCOI reports received across the NIH. This tool has been in use by NIH staff since March and will be rolled out to the extramural community later in the year. Third, we are developing detailed internal procedures and training modules to ensure that all NIH staff is able provide appropriate oversight of FCOI issues. Finally, we are considering gathering public comment on whether to modify the FCOI regulation (42 CFR Part 50, Subpart F).

As we develop these measures, I will continue to update you about our progress on these activities.

— Norka Ruiz Bravo, Ph.D.
OER Director and NIH Deputy Director for Extramural Research

NIH Director Elias A. Zerhouni, M.D., announced June 6 the next phase of the peer review enhancement process. In a memorandum explaining the goals of the NIH review of peer review, Dr. Zerhouni articulated the two principles that helped shaped the process: First, to ensure that any changes to the peer review system add value and maintain a viable cost-benefit balance; and second, that any changes continue to maximize the freedom of exploration NIH-funded scientists enjoy. These two goals support the original charge of the review of the peer review process, which was “to fund the best science, by the best scientists, with the least administrative burden.”

There has been a widespread, positive response to the NIH Director’s call-to-action last year for a review of the peer review process. Collaborative teams of internal and external participants spent the past year collecting and analyzing input on the peer review process. From their efforts came a comprehensive strategic plan to be implemented over the next 18 months.

The Implementation Plan Report has the following four priorities as outlined by Dr. Zerhouni:

1. Engage the best reviewers: Increase flexibility of service, formally acknowledge reviewer efforts, compensate time and effort, and enhance and standardize training.
2. Improve quality and transparency of reviews: Shorten and redesign applications to highlight impact and to allow alignment of the application, review, and summary statement with five explicit review criteria; and modify the rating system.
3. Ensure balanced and fair reviews across scientific fields and career stages: Support a minimum number of early stage investigators and investigators new to NIH and emphasize retrospective accomplishments of experienced investigators. To encourage and expand the transformative research pathway, NIH will create a new investigator-initiated Transformative R01 Award program funded within the NIH Roadmap with a planned commitment of $250 M over five years.
4. Develop a permanent process for continuous review of peer review

For more information about enhancing peer review at NIH and to learn about the plan, please visit http://enhancing-peer-review.nih.gov .

The NIH Public Access Policy applies not just to awardees, but to anyone supported by NIH funds, including NIH staff. A recent memo was distributed to all staff, clearly stating the requirements: “As of April 7, 2008, all NIH employees must comply with the NIH Public Access Policy...We must have 100 percent compliance.”

The Policy applies to all peer-reviewed articles that NIH employees author or co-author as part of their official NIH duties, even if the corresponding author or other authors are not supported by NIH. The Public Access Web site provides NIH employees with information about complying with the Policy, including a publishing Cover Sheet for NIH employee authors.

These materials are being made available for reference to the wider research community and institutions as they develop policies and procedures to comply with the NIH Public Access Policy.

How many people notice when NIH issues new Web-based training? Quite a few! OER’s new “Protecting Human Research Participants” (PHRP) tutorial, launched on March 1, 2008, registers an average of 450 new users every day. In less than four months the course approached 50,000 registrants, with over 41,000 registrants successfully completing it. OER’s PHRP tutorial registrants hail from nations around the globe, including countries as diverse as India, Australia, and Kenya, to name a few. All told, more than 4,000 researchers from outside the U.S. have taken the course.

Registrants take the course for a variety of reasons. One key motive is that since 2000, the NIH has required education on the protection of human research participants for all recipients of NIH funding for research with human subjects. While the NIH does not require that researchers complete NIH-developed training courses to qualify for funding, the popularity of such NIH training is increasing exponentially.

There are many other reasons for obtaining training in Human Research Protections. Academic faculty, for example, find it useful to assign students such NIH training to help them learn in greater depth about protecting human research participants. Research institutions and industries may also mandate education for staff performing research that is not funded by the NIH.

We all owe a debt of gratitude to research participants for making the choice to contribute to the advancement of biomedical and biobehavioral knowledge. OER is proud to promote the highest quality research models, and that means placing a priority on providing all appropriate protections for volunteers in clinical research studies.

At the discretion of NIH, grant applicants are at times allowed to submit materials for peer review that are in addition to the originally submitted application. While often good news for applicants, the policy also prompts further questions on submitting such materials. For example:

Q.  Who do I contact if I need to submit important additional material before the peer review meeting?
A.  Applicants are instructed to contact the assigned NIH Scientific Review Officer (SRO). Acceptance of additional materials is at the discretion of the SRO.

Q: Are there any deadlines for submitting additional materials before the peer review meeting?
A: The deadline for receipt of additional materials is 30 calendar days prior to the peer review meeting.

To provide guidance for questions, consistency in the peer review process and to clarify existing policy, NIH has developed a set of Best Practice Guidelines for accepting additional grant application materials. The guidelines also remind applicants that the opportunity to submit additional material should not be used as a means to circumvent submission deadlines, page limitations or content requirements. The final decision to accept additional material before peer review rests solely with the Scientific Review Officer.

For more information, read the NIH Guide Notice on NIH Policy on Submission of Additional Grant Materials and the related NIH Best Practice Guidelines for Accepting Additional Grant Materials housed on the Peer Review Policies and Practices page.

On July 15, 2008, the Federal government will sponsor a public consultation meeting to engage the scientific community and research organizations in a discussion of a framework for the oversight of dual use research proposed by the National Science Advisory Board for Biosecurity (NSABB). The proposed framework, which has been formally submitted by the Board to the Federal government for its consideration, outlines key features of oversight of dual use research, including criteria for identifying dual use research of concern, local oversight, evaluation and risk assessment of research with dual use potential, responsible communication of research with dual use potential, considerations in developing codes of conduct, and the need for outreach and education. The proposed framework also outlines the roles and responsibilities of key individuals and institutions in managing dual use research, including researchers, research institutions, institutional review entities, the NSABB, and the Federal government.

Any groups or individuals who cannot attend the meeting are encouraged to submit in advance of the meeting written comments on the questions found in Appendix 2 of the NSABB’s report to: nsabb@od.nih.gov . Due to limited space, pre-registration is encouraged. To register for the meeting, please go to: http://www.capconcorp.com/meeting/lifesciences2008/ . More information about the NSABB is available at http://www.biosecurityboard.gov/.

NIH is currently seeking a Director for the Office of Research Information Systems (ORIS). ORIS is the NIH focal point for Electronic Research Administration, the Enterprise system that supports all NIH grants business and publishes all statistical and analytical reports regarding federally supported research. Job duties include providing executive leadership, vision, management oversight, and expertise in the direction of the NIH electronic extramural activities. The Director will also develop and provide authoritative advice on broad scope information systems policies and strategies that shape the direction of NIH corporate grant business.

For more information on this position, please visit http://grants.nih.gov/grants/oer_vacancies.htm.