Center for Clinical and Translational Science

In March, 2011, The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) announced that The Rockefeller University had been awarded Full Accreditation by the Council on Accreditation.  AAHRPP’s accreditation program is the field’s primary vehicle for setting uniform, high standards across the research enterprise -in both the private and non-profit sectors. Accreditation indicates that the institution’s human subject protection plan demonstrated its commitment to protect research participants and its ability to deliver on that promise.  According to the AAHRPP, “When an organization earns accreditation, the global benchmark for human research protection is raised.”

In January, 2012, AAHRPP informed us that Rockefeller University was one of the few organizations accredited in the last year to earn the honor of meeting Element I.1.F. with “distinction“ from the AAHRPP Council on Accreditation.  This element is, “The Organization has and follows written policies and procedures for reviewing the scientific or scholarly validity of a proposed research study. Such procedures are coordinated with the ethics review process.”  

 In citing Rockefeller University for this distinction, AAHRPP indicated that the University’s Center for Clinical and Translational Science Research Navigation Process was a crucial element as was the University’s “robust mechanism for scientific review of all human participant research.”   The Research Navigation Process is a comprehensive process that assists researchers in designing a clinical research protocol.  The Research Facilitation Office, led by Ms. Brassil, developed the process.  Although, initially focused on Clinical Scholars, the program expanded to include basic scientists beginning to develop clinical research projects and experienced clinical investigators who would benefit from expert multidisciplinary input into the development of their protocols.

The goal of Navigation is to facilitate the rapid development of an outstanding scientific protocol that:
1) addresses an important aspect of human biology and/or health
2) incorporates the highest standard of human subject protection
3) meets all of the bioethical, regulatory, and biostatistical requirements of Good Clinical Practice
4) meets the standards for participant safety of the Rockefeller University Hospital medical and nursing leadership; and
5) is highly likely to be approved by both the Advisory Committee and on Clinical and Translational Science (ACCTS) and the Rockefeller University IRB at the time of its first submission.

To accomplish this goal, the Navigator works closely with the investigator to refine the protocol by enlisting expert consultants, as needed, in the fields of scientific validity, study design, study plan formulation, research nursing, research pharmacy, regulatory guidance, biostatistics, bionutrition, bioinformatics, clinical medicine, contract negotiation, technology transfer, and protection of human subjects. This expertise is called on by the Navigator in the most efficient manner, varying from one-on-one meetings to small group meetings, to full multidisciplinary Navigation meetings tailored to the needs of the individual protocol.
Throughout the process, the investigator is informally educated about GCP standards and other regulations involving human subject protection.  After establishing the initial feasibility of a study, the ongoing needs assessment process continues throughout the process to insure the development of an optimal protocol.

In recognizing Rockefeller’s achievement and to showcase the Rockefeller Navigation process and acknowledge its contribution to achieving the highest standards for human research protection, AAHRPP formally invited Rockefeller to present the Navigation process at the upcoming AHRPP Annual Conference in Denver, CO on April 19, 2012.