investigators develop new approach for using rna ...forms.research.chop.edu/btob/aug06btob.pdfsachin...

BenchR T C’ H P

to BedsideAugust 2006

HAVE NEWS? Contact Jennifer Long at ext. 4-2105 or by e-mail at [email protected].

Read this and previous versions of Bench to Bedside online at http://stokes.chop.edu/intranet/pubs/

Investigators Develop New Approach for Using RNA Interference

Pursuing accreditation through the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is a major initiative not only for the Institutional Review Board (IRB) but for all those involved in human research at The Children’s Hospital of Philadelphia. The success of this initiative depends largely on the level of awareness and support within the research community, and feedback from the research community is critical as the Hospital prepares for accreditation.

This issue of Bench to Bedside highlights the Hospital’s efforts to date in pursuit of accreditation in order to keep investigators, coordinators and staff aware and informed.Feedback and questions about the Hospital’s AHRPP initiative and other changes affecting research involving human subjects may be directed to Lynn Bevan, director of Research Regulatory Affairs, at [email protected].

The IRB reviews various types of research studies. Some studies are considered exempt from further IRB review and oversight, some are eligible for expedited (administrative) review, and some require review by the full board.The number of protocols requiring review by the full board of the IRB decreased from 172 in fiscal year to 2005 to 105 in 2006. This decrease is attributable to several factors, including a decrease in trials sponsored by pharmaceutical companies and a decrease in protocols from the University of Pennsylvania (reviewed under the cooperative agreement). In addition, new protocols from the National Cancer Institute’s (NCI) Children’s Oncology Group, of which the Hospital’s Division of Oncology is a member, are now reviewed by the NCI. The streamlined process enables the Hospital’s IRB to rapidly approve NCI-sponsored studies, allowing for more effective collaboration and reducing administrative burdens on the IRB. The process also enhances the protection of research participants by providing consistent IRB review at the national level before protocols from the Children’s Oncology Group are distributed to investigators around the country.While the number of protocols requiring full review has declined, the number eligible for review using expedited procedures has continued to increase. The number of such protocols has grown to 318 in fiscal year 2006 from fewer than 100 in the year 2000. In response to the current trends, the IRB decreased the number of full-board committees from three to two and has increased its capacity to perform expedited reviews.The following tables and graphs illustrate recent IRB submission and review trends:

In keeping with its overall commitment to excellence, the Hospital’s human research protection program strives for performance standards that surpass state and federal requirements, while allowing investigators to conduct the highest quality of research. As announced in May, the Hospital continues to work toward the accreditation of its human subjects protection program as an intermediate step in its overall pursuit of excellence in clinical research. In addition to strengthening the national credibility of the Hospital’s human research activities, accreditation will benefit investigators in these ways:● improving the support services for processing and monitoring protocols● clarifying roles and responsibilities for administration of protocols involving human subjects● improving education programs available to investigators and research staffIn conjunction with representatives from Huron Consulting Group, a small team of IRB personnel and senior administrators are preparing the preliminary application for submission to AAHRPP. Established in 2001, AAHRPP’s goal is to foster and advance the ethical and professional conduct of persons and organizations that engage in research with human participants. Over the past few months, the Hospital’s efforts have resulted in the following improvements to its human research protection program:● Updating existing and developing new policies and operating procedures related to human research protections.● Redesigning the IRB Web site to incorporate accreditation-related resources and information for investigators and coordinators.

● Initiating the Web-based Collaborative IRB Training Initiative (CITI) program to replace the existing human research protections training for investigators and staff● Reconfiguring the Hospital’s IRBs to facilitate improved protocol review and turnaround times● Selecting an electronic management system to provide a paperless protocol and grant submission and review system (The Hospital will implement the system by the start of the next fiscal year.)

An AAHRPP Accreditation Update

Compliancewith

FederalRegulations

AAHRPP

Excellence

IRB Submissions FY05 and FY06

Exemptions Expedited Review

Full Board Review

Total Reviews

FY 2005 FY 2006

FY 2005

Exemptions8%

ExpeditedReview

Full BoardReview

FY 2006

Exemptions9%

ExpeditedReview

Full BoardReview

New submissions by Type: FY 2005 and FY 2006

R at The Children’s Hospital of Philadelphia

Bioinformatics Specialist

Jonathan Bradfield

Clinical Research Assistants

Samantha DuvalDiana HarrisAllison HatchettJordan Silberman

Clinical Research Coor-dinators

Walter CooperAnupriya GroverJacob McGrath

Counselor

Keila Vargas

Director – LAF

Rebecca Wiltshire

Health Educators

Geraldine McGinleyEbony Settles

Operations Coordinator

Linda Pedersen

Research Assistants

Tina AhmadinejadSachin DaxiniCara DiCristinaQuan Zhao

Research Associates

Jessica Mei NgTae-Ju parkAlexander Schlachterman

Research Technicians

Asen BagashevValeria FeltonLu Mei HeErin JurgensenRachel LaxtonTimothy LiuNina MartinJustin MathewDavid Piel Jr.Jacqueline ReynerElizabeth RickenbacherLi SongAndrea Wittenborn

School Readiness Specialist

Stacey Mellinger

Scientist

Craig Brumwell

Social Worker

Kimberly Sterner Stein

Staff Accountant

Renae Fultz

Technical Director

Struan GrantLisa Speicher

New Research Employees (July 2006)We welcome the following new research employees:

The Joseph Stokes, Jr. Research Institute is planning to launch an electronic, paperless management system to provide a cross-functional platform to facilitate the administrative, regulatory, contractual and reporting obligations related to Stokes research activities. Once implemented, this system will be used by both members of the Stokes research community and those involved in research administration. The research community consists of those individuals who submit grant proposals, IRB and Institutional Animal Care and Use Committee (IACUC) protocols, and clinical trial agreements for review, and includes principal investigators, study coordinators, research assistants, administrative assistants, and other support staff that facilitate the operations of research and aid in the preparation of documents. The staff of the IRB, IACUC, Research Administration, and Research Compliance will be able to access all documents required for review and approval of research protocols and will submit their reviews directly into the system. Click Commerce is the vendor who will provide and support this new system. The company’s eResearch Portal supports a comprehensive suite of Web-based solutions that streamline research administration, integrate compliance oversight processes and enable users to track a study from inception to completion. The eResearch Portal also provides tools to facilitate the compliance process for both human and animal subjects. eResearch Portal modules cover IRB, IACUC, grants and contracts management, clinical trials participant tracking, clinical trials discovery, conflict of interest and incident management.Phase one of the implementation process is scheduled to begin within the next two months. Future announcements to the research community will update investigators, coordinators and research staff on the progress of this initiative.

Paperless Management System Coming to StokesAAHRPP requires accredited institutions to have policies and procedures covering a broad range of issues related to human subject protections. Those issues include research protocol development, protocol review, informed consent processes and documentation, conflicts of interest disclosure and management, problem reporting and management and the protection of vulnerable subjects. To meet AAHRPP’s requirements, members of the Hospital’s IRB and Office of Research Regulatory Affairs are collaborating with senior hospital administrators to write and revise a variety of Hospital and IRB policies and procedures related to human subjects research. The IRB has also developed many new forms and checklists for investigators and for IRB members.Further incentive for developing and refining the Hospital’s human subjects-related policies and procedures comes from publicized reports from site visits by the U.S. Department of Health and Human Services’ Office for the Protection of Human Subjects (OHRP). During those visits OHRP reported numerous problems at IRBs across the country, including inadequate policy and procedure documentation to support protocol approval processes. Going beyond the relatively small number of topics and documenting procedures addressed in the federal regulations to cover a broader range of topics will help Children’s Hospital ensure consistent decision-making processes within the IRB on a wider range of issues. Additionally, new policy and procedure documents will help both IRB members and investigators in identifying the “least burdensome approach” to each issue and aid in streamlining the IRB review process. The Hospital is developing nine new institutional policies that will affect its human research protection program. Four policies (Investigational Drug Research, Investigational Device Research, Investigator Record-Keeping Responsibilities, and Investigator-Initiated IND and IDE Research) address the federal, state and Hospital requirements related to investigator responsibilities in the conduct of human subject research. The remaining five will address Hospital processes (including administrative and compliance responsibilities) related to IRB authority and independence, roles and responsibilities of the institutional official for the human research protection program, investigating potentially serious or continuing non-compliance, suspensions and terminations of research previously approved by the IRB, and reporting to federal regulatory agencies and sponsors.See http://stokes.chop.edu/intranet/departments/irb/irb10.html for a list of the SOPs currently under development. While intended primarily for reference by IRB members and staff, draft versions of the SOPs are posted on the IRB Web site as a guide to investigators, coordinators and research staff to illustrate the IRB’s position on various topics related to human research protections.

To date, 40 standard operating procedures have been developed, covering such areas as: ● Human research oversight ● IRB composition and management activities● IRB office administration● IRB review of research● Special population of research participants● IRB management systems ● Participant recruitment and informed consent processes● Investigator responsibilities● Research compliance activities

Feedback from investigators, coordinators and research related to these drafts is encouraged, and will aid in the refinement of the documents to make them as informative and user-friendly as possible. Please contact Lynn Bevan at [email protected] with any questions, comments or feedback related to the new Institutional policies and procedures.

Hospital Developing New Policies, Procedures for Human Subjects Research

The National Institutes of Health has announced the availability of educational loan repayment under two programs: the NIH Extramural Loan Repayment Program for Clinical Researchers and the NIH Extramural Pediatric Research Loan Repayment Program.The programs each provide for the repayment of up to $35,000 of the principal and interest of educational loans for each year of service. Participation in the loan repayment program is open to those with M.D.s, Ph.D.s and other terminal degrees who agree to dedicate at least 50 percent of their work schedule to clinical research or pediatric research for at least two years. Applications will be accepted from Sept. 1 through Dec. 1, 2006. Awards are expected to be made between July and September of 2007. Applications must be submitted through the NIH Loan Repayment Web site at http://www.lrp.nih.gov/.

For more information, visit http://grants.nih.gov/grants/guide/pa-files/PA-06-517.html.

NIH Announces Loan Repayment Programs

Lynn Bevan, CIP, director, Research Regulatory Affairs, and Mark Schreiner, M.D., chair, Committee for the Protection of Human Subjects, are working toward a restructured IRB Web site on the Stokes intranet (http://stokes.chop.edu/intranet/departments/irb/irb01.html).

Some of the new additions to the site include:● Updated standard operating procedures on the Committee Policies and Procedures page (http://stokes.chop.edu/intranet/departments/irb/irb10.html)● An AAHRPP link on the IRB site, which has updates on the status of the accreditation initiative (http://stokes.chop.edu/aahrpp.html)● A section on frequently asked questions section within the AAHRPP link (http://stokes.chop.edu/aahrpp_faq.html)● Archived presentations, publications and correspondence relevant to the Hospital’s AAHRPP accreditation activities

Investigators and staff will also notice on the Web site that the IRB is creating new and revising existing forms as part of the AAHRPP accreditation process. This initiative will also facilitate the transition to an electronic IRB submission and management system.

IRB Web Site Modified, Improved Several changes have been made to the monthly faculty luncheon series to include a wider range of scientific presentations to appeal to investigators and interested research staff. Both clinical and laboratory research will be featured in the revamped series, which will also include presentations by fellows. The luncheons will focus exclusively on scientific presentations without an administrative session after the presentations. Research Education is working with Marc Yudkoff, M.D., who has played an integral role in organizing the luncheon series over the past several years, to ensure a broad range of scientific topics and a variety of speakers to engage investigators and enhance collegiality. The next faculty luncheon is scheduled for Friday, Sept. 8, at noon in Abramson 123. Contact Research Education at [email protected] withquestions or for more information.

Stokes Faculty Luncheon Revamped