Must take six.
Responsible Conduct of Research (RCR) for Research Administrators
Content Level: All Levels
Research administrators and research staff members (i.e., coordinators, data management specialists, assistants, etc.) play an important part in promoting the integrity of the research enterprise. Frequently, those in a nonscientific, supporting role encounter ethical decisions in an environment of competing obligations and responsibilities. In order to function effectively and make appropriate ethical decisions, administrators need to be aware of the prevailing rules, regulations and guidelines. It is not enough to just know where a certain policy is posted on the web or sitting in a binder on the shelf. All of those involved in research must abide by a core of ethical principles in order to do their jobs properly and to contribute to the overarching culture of responsibility.
Learning Objectives:
- Raise awareness, in order to be able identify when situations present ethical dilemmas or conflicts.
- Reason among possible courses of action and effectively implement the best solution to the problem.
Prerequisites: None
Clinical Trials: Rules and More Rules
Content Level: Intermediate
Clinical trials must comply with the Good Clinical Practice guidelines (GCP). Unfortunately, the GCP is not well defined. This session will review Department of Health and Human Services, Food and Drug Administration, and major international regulations and guidelines, as well as other institutions governing clinical research. Participants will learn how the actions of regulatory agencies affect budget development, contract negotiations and the way studies are conducted. Topics will include the ethical origins of the GCP, historic milestones and their regulatory significance, and discussion of best practices to enhance regulatory compliance.
Learning Objectives:
- Identify three important documents that form the core ethical basis for the regulatory environment.
- Identify three best practices for improving regulatory compliance in clinical trials.
Prerequisites: None
Clinical Trials Budget Negotiations
Content Level: Intermediate
Budgets for clinical trials should be based on sound accounting principles and an accurate analysis of the protocol. Often, establishing the costs for procedures is relatively straightforward, but accurately estimating hidden costs, such as investigator time and start-up costs, can be more difficult. A systematic process for analyzing protocols, determining costs and negotiating budgets will be discussed, along with relevant aspects of contract negotiations and establishing payment schedules. Tips to optimize budgeting for clinical trials will also be presented.
Learning Objectives:
- Learn the four components of a clinical trial budget.
- Explain the differences between budgeting for clinical trials funded by industry versus federal sources.
Prerequisites: None
Research Integrity: The Institutional Perspective
Content Level: All Levels
This session can be used to fulfill the “Research Integrity General” category for the Research Integrity certificate. Academic and other research institutions are becoming more and more aware that many faculty, researchers, staff and students are not properly trained in ethics, professional standards and responsible conduct of research. This session provides a brief summary of the overall issues encountered and approaches to enhance the training and competency in research integrity and professional standards across several different types of organizations.
Learning Objectives:
- Identify the institutional and cultural-discipline-specific challenges to RCR training.
- List strategies to address the challenges in gaining "buy in" and implementing RCR training.
Prerequisites: None
Institutional Responsibilities for Monitoring Human Subjects Research
Content Level: All Levels
An institutional Human Research Protection Program (HRPP) is comprised of several integrated parts: all of which benefit from continuing self-assessment, monitoring, and quality improvement. This introductory session will describe some of the ways institutions may monitor research with human subjects after Institutional Review Board (IRB) and institutional approval and funding. The panelists will present examples of institutional policies and procedures, self-assessment of the IRBs, communication with research administration, and monitoring the conduct of the research.
Learning Objectives:
- Describe strategies for monitoring the institution's HRPP.
- Identify challenges of implementing a self-assessment and monitoring program.
Shades of Gray - Determining What is and Is Not Human Subject Research
This session will outline the difference between activities that meet the definition of research with human subjects and those that do not (e.g., Quality Assurance, Process Improvement, public health effort, etc.) and research with human subjects that might meet exemption criteria. The session will emphasize the role of the research administrator and the institution's responsibilities for policies and procedures.
Learning Objectives:
- Describe characteristics of activities that meet the definition of human subject research
- List some similarities and differences between research
- The Pack Rat Syndrome: Databases, Biobanks and Drawers of Documents and Records
Content Level: All Levels
The Pack Rat Syndrome: Databases, Biobanks and Drawers of Documents and Records
Under the umbrella of Data Integrity as a core element for the responsible conduct of research, this session will describe the current guidance on establishing "banks" of materials, including collecting, storing and sharing the "bank's vault." The session will emphasize the roles of investigators, research administrations, the IRB and the institution.
Learning Objectives:
- Identify key elements of "banking" data, documents, and specimens.
- Describe the roles of investigators and research administrator with regard to "banking."
- Challenges Facing Investigators and Institutional Review Boards when Research Studies are Conducted at Non-U.S. Sites
Challenges Facing Investigators and Institutional Review Boards when Research Studies are Conducted at Non-U.S. Sites
Content Level: All Levels
The Declaration of Helsinki states that the ethical, legal and regulatory standards for human subjects' research must be upheld in investigators' own countries as well as in international sites. Domestic institutions involved in international biomedical and behavioral research must therefore ensure that recognized ethical and procedural protections are afforded to persons participating in research conducted in countries outside the United States, and must take into consideration the laws, regulations, and standards of the countries in which the research is to be performed. This session will summarize the challenges faced by Institutional Review Boards and investigators in meeting this requirement, and the regulations and ethical guidance regarding international research. Speakers will describe the challenges of meeting both, and detail the procedures and practices developed at their institution to help researchers navigate the review process for international research studies.
Learning Objectives:
- Gain a general understanding of the regulations and ethical guidance that govern U.S. institutions engaged in research at non-U.S. sites.
- Gain an understanding of the challenges faced by investigators as well as Institutional Review Boards in meeting complex and sometimes inconsistent regulatory requirements and ethical standards with regard to international research.
- Learn the procedures developed by Seattle Children's Institutional Review Board to ensure investigators meet requirements for conducting research at international sites without facing an unduly burdensome review process.
Research Support: The Transition and Growth of Monitoring an Education Program
Content Level: Intermediate
Recent trends in Human Research Protection Programs (HRPPs) have highlighted the merit of prospective monitoring of clinical research and education programs. An innovative model for developing an innovative Office of Research Compliance and Education (ORC&E) is based upon continuous quality improvement initiatives. This session will establish the key steps in the implementation of a research compliance monitoring and education program. Trends associated with resource utilization, monitoring procedures and educational activities of the program will be presented, as well as an analysis of the impact of the program. Conclusions and future trends will address the value of building a quality improvement based research monitoring and education program to support researchers.
Learning Objectives:
- Learn how to effectively develop research support programs.
- Learn to establish the key elements of a quality improvement approach in a research compliance and education program.
- Be able to identify essential required research education "tracks" and future education trends identified through quality improvement.
- Human Research Protection Programs
Human Research Protection Programs
This session will provide an overview of the history of human research protection programs. Speakers will describe in detail what a human research protection program is, and will review organizational roles and responsibilities.