Programme |
OVERVIEW|PRE-CONFERENCE WORKSHOPS|CONFERENCE PROGRAMME |
Pre-Conference Workshops (7 March 2012)
* Participants can register for either PRIM&R Institutional Review Board (IRB) 201 or 250 |
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| Institutional Review Board (IRB) 201 is designed to provide the knowledge needed to become experienced Institutional Review Board (IRB) / ethics committee (EC) chairs, members, and staff. This educational program will include information directly relevant to IRB / EC chairs, members, and staff who conduct reviews as part of a convened IRB / EC or through the expedited procedure. This course has been designed for IRB / EC members and staff who understand the fundamentals of IRB / EC operations and who are now interested in obtaining the next level of training. By attending Institutional Review Board (IRB) 201, participants will gain the knowledge and skills needed both to serve as effective IRB / EC reviewers and to teach others to become effective IRB / EC reviewers. Note that this course will not cover administrative issues of IRB / EC operations. The highly regarded faculty members leading this course will highlight key criteria for the review of research, including: Risks to participants are minimized; Risks are reasonable in relation to anticipated benefits; Selection is equitable; Informed consent will be sought and waivers of informed consent; Informed consent will be documented including waivers of documentation; Research plan makes adequate provisions for monitoring safety; Adequate provisions to protect privacy and maintain confidentiality; and Additional safeguards for participants likely to be vulnerable to coercion or undue influence. |
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| Institutional Review Board (IRB) 250 is specially crafted for experienced IRB Chairs / members or participants who have completed IRB201. The workshop comprises of five modules: Criteria for the Review of Research This module reviews regulation and how it relates to the Belmont principles. More specifically, this module covers risk/benefit, subject selection and recruitment, informed consent, data safety monitoring, privacy and confidentiality, and vulnerable populations. Informed Consent The module on informed consent will review the historical and ethical underpinnings of informed consent, the process and regulatory requirements, documentation of informed consent, waivers and alterations, and informed consent in special circumstances. International Research This module will begin by reviewing international research trends, and will then discuss assessing host country performance sites, including their unique culture and ethics. In addition, the module will identify applicable international policies, regulations, and law, and will discuss how communication flows within international sites. Finally, the curriculum will review education and training for research investigators, staff, and IRB/REC members. Internet Research The curriculum for this module will review recruiting subjects over the Internet, observation of Internet activity, and collecting data over the Internet. In addition, the module will consider IRB review issues, including risk/benefit, consent, participation by minors, and privacy and confidentiality. Finally, this module will discuss electronic data security and IRB review requirements. Conflicts of Interest Using several well-known examples, this module begins with a brief introduction on the definition of conflicts of interest. The module then goes into detail on the following topics: the federal agencies and regulations governing conflicts of interest and disclosures by researchers, the laws and regulations governing IRB members, and the governmental and non-governmental guidance documents, and best practices relating to conflicts of interest in research. |