Please click on the bars below to view the session descriptors.
Please note that the topic for the June 9th webinar has been changed! As we are up for AAHRPP re-accreditation, we feel that this topic is more beneficial at this time.
Brown Bag Lunch Series 2015
March 10, 2015 - IRB Process: Determination of HSR, Waivers of Consent, Expedited vs. Full Board Review
This session is designed to help you understand some of the inter-workings of the MHC IRB:
(1) How the IRB determines if a research project is human subject research vs. non-human subject research
(2) When is informed consent required for participation in a study or when can it be waived.
(3) How the IRB determines if a new research projects qualifies for expedited or full board review
June 9, 2015 - Understanding Clinical Trial Agreements
In this brown bag session we will Review the AAHRPP standards and required elements for Clinical Trials Agreements. We will also explore the responsibilities of MHC HRPP,-MCRI Contract and Budget Specialist, and the researcher with regards to the executed CTA.
September 29, 2015 - Privacy and Confidentiality
A breach of privacy or confidentiality violates an individual’s rights and poses a risk of dignitary harm to the research participant, ranging from social embarrassment and shame, to stigmatization, and even damage to social and economic status. This session will discuss concepts of privacy vs. confidentiality, HIPAA privacy rule as it relates to research and how to protect the research subject’s privacy and confidentiality.
December 8, 2015- HUDs and Emergency research
Humanitarian Use Devices (HUD) and emergency use of investigational drugs prior to IRB approval are intended for a distinct population of subjects under specified circumstances. This session will help you to understand and know:
(1) How a medical device qualifies for HUD designation.
(2) What are the criteria for using a HUD?
(3) MHC IRB notification requirements for initial and continuing approval
(4) HRPP policy on emergency use of investigational drugs and devices
***Registration and / or access information will be sent out prior to each session. Please call the HRPP office at (810) 342-1003 if you have any questions.
IRB Education Sessions
August 21, 2015 - What is a Quality Review of a Convened IRB Protocol?
The human subject regulations provide the authority to review, approve, require modifications in (to secure approval) or disapprove all research covered by those regulations [45 CFR 46.109(a); 21 CFR 56.109(a)]. While there are criteria for the approval of research (45 CFR 46.111; 21 CFR 56.111), the regulations do not provide direction on the quality of the review. This session will discuss key items that are related to the quality of the review of a protocol by the convened IRB.
September 18, 2015 - EQuIP - A Year in Review
October 16, 2015 - Approving Research with Conditions
One of the most problematic areas for IRBs, and a common finding in ORHP Compliance Letters, is that IRBs approve research with conditions that are not minor. The regulations do not explicitly address IRB approval with conditions, the Office of Human Research Protections allows for such IRB decisions. This session will help establish the difference between what is a minor condition from what is a substantive condition.
November 20, 2015 - Don’t Forget the Consent Process!
IRBs are known to spend a lot of time dissecting, revising and rewording consent forms, and making sure that the required elements of consent are all adequately covered in the document. The required and additional elements of consent appear in 45 CFR 46.116(a) and (b). This session will discuss the preface to those requirements, which sometimes takes a back seat, but is just as important as the consent requirements.
December 18, 2015 - Assessing Scientific Validity
This session will discuss the IRB’s responsibility to assess the scientific validity of proposed research. This charge is related to the regulatory determinations required for approval of research and to the IRB’s ethical responsibilities to protect subjects.