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UCLA Human Research Protection Program

 

Overview of UCLA

 

The University of California Los Angeles (UCLA) is a public university whose primary purpose is the creation, dissemination, preservation, and application of knowledge for the betterment of our global society. UCLA is one of the world’s great research universities, number 11 in London’s Times Higher Education rankings (2010-2011). Our faculty includes Nobel Laureates, Pulitzer Prize winners, multiple MacArthur fellows and scores of national academy members. Interdisciplinary teaching and research is a particular strength, with initiatives in the arts, stem cells and other biosciences, nanoscience, international studies and the environment. There are almost 40,000 students at UCLA, roughly 29,000 undergraduates and 13,000 graduate and professional students. U.S. undergraduate ethnicity includes 4% African American, 19% Hispanic, 27% White and 34% Asian/Pacific Islander.

UCLA's research portfolio includes a wide range of biomedical research projects as well as research in other sciences, humanities, and social sciences. UCLA ranks among the top institutions in research funding with $1.03 billion awarded for FY 2014-15 with $412,442,275 of the total being awarded for research involving human subjects; The Neuropsychiatric Institute received the most number of awards and the most amount of award dollars.

Founded in 1919, UCLA is one of ten campuses of the public University of California (UC) system, and one of the five campuses with a medical center. The major academic units are the College of Letters and Sciences and the 11 professional schools of Medicine, Nursing, Dentistry, Public Health, Arts and Architecture, Education and Information Studies, Engineering and Applied Science, Law, Management, Public Affairs and Theater, Film and Television.

UCLA includes the UCLA Medical Center and the Santa Monica UCLA Medical Center and Orthopaedic Hospital. The UCLA hospital encompasses the operations of Ronald Reagan UCLA Medical Center, Stewart and Lynda Resnick Neuropsychiatric Hospital at UCLA and Mattel Children's Hospital.

UCLA houses a number of Centers of Excellence including the Brain Injury Research Center, Center for Academic and Research Excellence, Center for Excellence in Pancreatic Diseases. Dental Research Centers of Excellence, Engineering and Diversity, Immunogenetics Center, Jonsson Comprehensive Cancer Center, Livestrong Survivorship Center of Excellence, Longevity Center, Male Urology, National Center of Excellence in Women's Health, Ronald Reagan UCLA Medical Center Heart Failure Program, and the SPORE in Prostate Cancer.

Researchers in the College of Letters and Sciences and the Professional Schools engage in the University of California's tripartite mission of teaching, research, and public service, incorporating best practices and integrating theory, research, professional practice, as they develop models and strategies for learning; analyze societal challenges and problems; and address national and regional issues including immigration, drug policy, prison reform, health care financing, transportation and the environment, national security, economic development, and an aging U.S. and world population.

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Mission and Purpose of the Human Research Protection Program

 

To safeguard the rights and welfare of human research subjects, UCLA adheres unequivocally to the principles of The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. UCLA has established policies, including UCLA Policy 991, to assure full compliance with all federal regulations, state laws, and University of California policies governing the participation of Human Subjects in Research.

The Human Research Protection Program (HRPP) is the global UCLA program which oversees the safety and welfare of participants in Human Subjects Research projects in accordance with all applicable federal regulations, state law and institutional policy. At the institutional level, the HRPP includes five areas: UCLA as an academic institution; the Office of the Human Research Protection Program (OHRPP) which includes the Institutional Review Boards; the investigators; the study sponsors; and the Research participants themselves. The UCLA HRPP received initial full accreditation from the Association for the Protection of Human Research Programs (AAHRPP) on June 11, 2009 and was re-accredited in 2012.

The UCLA OHRPP in partnership with the research community is responsible for:

  • Providing the highest level of research participant protection standards
  • Ensuring the ethical and equitable treatment of all human research participants in studies being conducted at UCLA and its affiliates and partners and/or being conducted by UCLA faculty regardless of site of activity;
  • Ensuring compliance with federal regulations, state laws and University polices as well as national standards for research involving human participants.

 

The Mission of the OHRPP is:

To provide a full circle of protection for research participants and researchers by:

  • Promoting and facilitating the protection of rights and welfare of human research participants.
  • Helping ensure compliance with federal regulations, state laws and University policies as well as national standards for research involving human research participants, and
  • Providing timely high quality education, review and monitoring for human research projects.  

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Organization 

 

The academic and administrative units of the University are organized under the Office of the Chancellor. The Vice Chancellor for Research oversees the administrative units of Human Research Protection Program and is the Institutional Official for the University. The Office of the Human Research Protection Program (OHRPP) is the administrative unit for the support of the UCLA HRPP and serves as the focal point for knowledge of regulations and standards for conducting human research.

UCLA Research and Administrative Units

  • The Clinical Trials Administration Office (CTAO), a part of the David Geffen School of Medicine, negotiates agreements with pharmaceutical, biotechnology and medical device companies to test new drugs, devices, diagnostics and treatments (test article) or comparisons of approved test articles to assess their safety, efficacy, benefits, costs, adverse reactions and/or outcomes in human subjects. CTAO also provides coverage analysis, study initiation services, and support for the ResearchConnect project.
  • The Human Research Policy Board (HRPB) is an administrative board charged with reviewing and recommending policies that affect the protection of human research subjects and is advisory to and appointed by the Executive Vice Chancellor. The HRPB is not authorized to accept or consider appeals of Institutional Review Board decisions. It is a standing committee composed of the Chairs of each of the five IRB panels, the Institutional Official/Vice Chancellor for Research, the Associate Vice Chancellor for Research, the Assistant Vice Chancellor for Research Policy and Compliance, the Vice Chancellor for Legal Affairs, six distinguished faculty, an Academic Senate Observer and the OHRPP Director. One of the six distinguished faculty is a representative of the Jonsson Comprehensive Cancer Center. Others may be invited to or request to attend the meeting to provide additional expertise or perspectives. The HRPB typically meets two to three times a year. At least yearly it reviews an annual report of the OHRPP that describes its performance measures, accomplishments the previous year and planned improvements for the coming year.
  • The Office of Research Administration (ORA) provides the campus with professional guidance and administrative support for all sponsored research activities. Along with the OHRPP, the following are some of the offices under the umbrella of the ORA:
    • Office of Contracts and Grants (OCGA) assists the campus research enterprise in applying for, receiving and administering contracts and grants.
    • Extramural Funds Management (EFM) manages and oversees all extramural funds.
    • Office of Intellectual Property and Industry Sponsored Research (OIP-ISR) protects, licenses and transfers all campus inventions and intellectual property rights that have commercial and research value.
    • Research Policy and Compliance (RPC) interprets and develops research policy, coordinates issues that bridge compliance boundaries, and provides the UCLA research community with advice and assistance on matters related to research policy, ethics and compliance. This office includes the Conflict of Interest Committee.
    • Office of Research Information Systems (ORIS) provides IT and business analysis services to the departments within UCLA's Office for Research Administration. In addition to its role within central administration, ORIS builds and maintains critical research enterprise systems utilized campus-wide
  • The UCLA Office of the Campus Counsel (OCC) serves as the in-house legal office for the UCLA campus, including the OHRPP as needed.
  • Office of Information Technology (OIT) The OIT manages institutional IT planning, policy setting, security practice and compliance, prioritization and decision-making processes, and with the Office of Finance of Budget is responsible for campus IT investment planning and decisions. The OIT provides program office and project oversight and consultation services.


UCLA Health System

  • The UCLA IRBs review human research for the following four hospitals and the UCLA Medical Group with its wide-reaching system of primary-care and specialty-care offices throughout the region:
  • Office of Investigator Services (OIS) of the Clinical Translational Science Institute (CTSI) provides across-the-board assistance and guidance in research project/grant proposal development. It provides a single point-of-service to CTSI scientists for navigating and accessing the complex array of research support resources and services at the CTSI. Its mission is expert consultation to investigators on all aspects of their projects, from study concept through regulatory approval and oversight, working closely with a broad range of domain experts. The CTSI includes Cedars Sinai Medical Center, Charles Drew University of Medicine and Science, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and UCLA.
  • The UCLA Investigational Drug Pharmacy provides services and support to researchers to ensure that the handling of investigational or unlicensed drugs conforms to legal and regulatory requirements.
  • UCLA Health Sciences Office of Compliance provides guidance and education for compliance matters related to the health sciences, particularly HIPAA and other privacy and security matters.
  • The UCLA Health System Office of Legal Affairs provides legal advice and counsel for the faculty and staff of the UCLA health system, including the OHRPP as needed.

 

Office of the Human Research Protection Program
The Office of the Human Research Protection Program (OHRPP) is a focal point of services and knowledge for the protection of human research at UCLA. The Director of the OHRPP reports to the Associate Vice Chancellor for Research and is responsible for the daily functioning and overall planning and development of the OHRPP.

 

This site is comprehensive and frequently updated. It contains quick links to webIRB which is the web-based IRB submission and review system, policies and guidance, consent templates, a clinical research toolkit, participant information, member information and updates, among other topics.

The OHRPP staff are very knowledgeable and available to provide consultation and assistance to the researchers. Over a third of the OHRPP staff are Certified IRB Professionals, and the majority are college educated, several with advanced degrees.

University of California

The University of California IRB Directors Group serves as a working group to review proposed regulations and policies, develop new policies and procedures, share best practices and ideas, and improve collaborations among the campuses. The group is composed of UC Office of the President (UCOP) General Counsel and legal experts in various areas related to research, the Directors and Assistant Directors of the HRPPs, and additional experts as needed. The group holds a monthly 2-hour conference call and one or two in-person meetings per year.

The five UC Academic Medical Centers each have been awarded a Clinical and Translational Science Institute (CTSI) supported by NCATS (National Center for Advancing Translational Sciences). UCLA is part of the various and robust collaborative efforts to coordinate and harmonize the IRB activities and processes, contracting and bioinformatics among its local CTSI partners and as part of the UC BRAID (UC Biomedical Research Acceleration, Innovation & Development).

The UC Office of the General Counsel provides legal services to the University, including representation, advice, research, training and opinions to the Board of Regents, administration, faculty and staff, and others acting on the University’s behalf, including the OHRPP and researchers.

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Types of Research Reviewed

 

The UCLA IRBs review a broad range of research with each IRB focusing on the following specific areas:

  • North General Campus IRB (NGIRB) reviews research from the College of Letters & Science and the Professional Schools.
  • South General Campus IRB (SGIRB) reviews social-behavioral research from South campus researchers who conduct health services research in areas such as public health, quality of care, quality of life, health prevention and health education research.
  • Medical IRB1 (MIRB1) reviews general and internal medicine, infectious diseases, and dental and ophthalmologic research.
  • Medical IRB2 (MIRB2) reviews oncology and hematology research.
  • Medical IRB3 (MIRB3) reviews neuroscience, neurology, psychiatric, drug abuse, and related behavioral science research and dental research.

 

As of June 2016, UCLA has over 6000 active approved human research protocols:

  • About 50% of the research is nonmedical, including social science, education, and behavioral, as well as health services research conducted by researchers in public health, nursing, and medicine.
  • About 50% of the research is biomedical or clinical, including clinical trials as well as studies of human biological specimens.

 

The human research participants in these studies include a wide range of individuals from all walks of life and from all over the world. Many of the participants are healthy individuals. Others are patients in clinics and hospitals throughout the Los Angeles Area with a wide range of health concerns.

Adults of all ages, including the very elderly, children, pregnant women, veterans, people from a wide variety of ethnic backgrounds, international populations, people whose decision-making capacity is impaired, and prisoners are among the many types of research participants in research being conducted by UCLA researchers. The OHRPP attempts to ensure that special protections are provided for participants who are vulnerable for any reason or economically disadvantaged.

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Concerns or Suggestions

 
Everyone involved in the human research enterprise—including faculty, researchers, research staff, residents, students, administrators and study participants—is encouraged to communicate concerns, suggestions, and allegations of coercion or undue influence to the OHRPP office or higher officials, including the Vice Chancellor of Research or the Executive Vice Chancellor. Web pages facilitating communication include For Researchers and Staff: Concerns, Complaints, Suggestions, and Compliments and For Research Volunteers: Reporting Research-Related Concerns and Complaints. People may report their concerns anonymously if they so desire.

The OHRPP welcomes suggestions for improvement and has and continues to actively seek faculty and participant feedback. A faculty committee provided direct input and direction into the development of webIRB. Until just recently the Academic Senate charged an OHRPP Oversight Committee was overseeing the efforts of the OHRPP to improve activities. As the activities of the CTSI increase the OHRPP expects likewise to increase its outreach activities to the community.

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Improving Human Research Protections at UCLA

 

In addition to the feedback mechanisms described in the links above (including Survey Monkey questionnaires for both participants and researchers), the OHRPP also frequently discusses and coordinates program improvements with its primary constituents and collaborators at UCLA, including the Neuropsychiatric Institute, the Jonsson Comprehensive Cancer Center, the Clinical and Translational Sciences Institute, the HIPAA Privacy Office, the Office of Contracts and Grants, the Clinical Trials Contract Unit, the Medical Radiation Safety Committee, and the Graduate School of Education and Information Studies.

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Sufficient Resources

 

As a reflection of its commitment to the protection of the rights and welfare of research participants for the research activities that it conducts or oversees, UCLA ensures that the OHRPP has sufficient resources. The OHRPP evaluates its efficiency by establishing and measuring performance standards, such as IRB review and approval turnaround times, and customer satisfaction and feedback. The Quality Improvement Unit conducts various activities to evaluate and measure the effectiveness of the educational outreach activities and the IRB reviews by conducting on-site reviews of clinical studies and auditing IRB files to measure compliance.

The Office of Research Information Systems (ORIS) within the Office of Research Administration generates regular as well as non-routine reports that allow the OHRPP Director and Assistant Directors to review and evaluate to determine if changes are needed in the composition of the IRBs and/or to determine if the workload for the five IRBs and for the associated staff is reasonable and equitable. ORIS also populates the ORA Online Resource Center which includes statistics for the ORA, including the IRB, and posts on the ORA website IRB statistics for the research community to evaluate for itself the performance of the IRBs.

 

  • If additional resources are needed, a request is put forward during the annual budgeting process.
  • The Associate Vice Chancellor for Research negotiates the budget on behalf of the OHRPP.
  • If resources are needed on an emergent basis funds can be made available.

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Page Last Updated: August 22, 2016