Search results
Feb 8, 2024 · With this final rule, HHS is implementing the confidentiality provisions of section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (enacted March 27, 2020), which require the Department to align certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health ...
- Office For Civil Rights (OCR)
Appellate Rule 9(A)(1) requires the notice of appeal to be filed in the trial court and that copies be served on all parties of record and filed with the appellate court clerk.
The Indiana Supreme Court, the Indiana Court of Appeals, and the Indiana Tax Court (collectively “appellate courts”) apply, interpret, and update the Appellate Rules through appellate decisions and amendment orders. This Article tracks the developments in appellate procedure between October 1, 2010, and September 30, 2011.
- Revised Human Subjects Definition
- New & Revised Exempt Categories
- New Exempt Categories
- Limited IRB Review
- Broad Consent
- No More Continuing Review
- Informed Consent Considerations
- Single IRB Review
- How The Final Rule Differs from Previous "Advanced Notices"
Although the criteria for what constitutes human subjects research has not changed, the actual text has. The definition of “human subject” has been changed to include “identifiable biospecimens” as well as how data and/or biospecimens have been collected or will be used. Human subject means a living individual about whom an investigator (whether pr...
Minor revisions to existing categories
There have been some minor revisions to the following categories: Exempt 1: Now includes a statement that the research cannot “adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.”
Exempt 3: This is a new category specific to “benign interventions” involving adults that allows for deception under certain conditions. Data may also be sensitive and identifiable as long as a “limited review” is conducted by the IRB.
Limited IRB review is a new Final Rule activity that is designed to dovetail with several of the exempt categories. In essence, limited review provides a safeguard for activities that fall slightly outside the spirit of the exempt categories. By conducting a limited review, the IRB has the opportunity to weigh in on research that may include potent...
As outlined in the Final Rule, broad consent is geared toward repositories for which the primary purpose is secondary research use, with the understanding that later use is not exactly known; broad consent is permitted as an “alternative” to the standard informed consent requirements. While some of the traditional elements are still required, addit...
Annual continuing review requests are no longer required in the following circumstances: 1. Research eligible for expedited review 2. Research reviewed by the IRB in accordance with the limited IRB review 3. Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Da...
New language/Clarity
Consent forms must be clearer and more focused and many of the added changes are intended to emphasize that information must be provided to facilitate a potential subject’s understanding of why one would participate or not.
Basic and Additional Elements
The following elements have been added: 1. Informed consent must begin with a concise and focused presentation of the "key information" that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This element is unique because it cannot be waived. 2. If the research involves the collection of identifiable private information or identifiable biospecimens, a statement on whether the identifiers might be removed...
When more than one institution is involved in a research study, the regulations define this as a “cooperative research project.” In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects; however, this creates a situation where there are multiple IRBs involved, asking ...
(adapted from the OHRP press release) The Final Rule differs in important ways from the proposed rule. Some examples of proposals that, based on feedback from the public, are not being adopted include: 1. The Final Rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it d...
Introduction. This Article will briefly explain the 2007 amendments to the Indiana Rules. of Appellate Procedure (the "Rules"). This Article will also undertake a. retrospective look at remarkable cases from this past reporting period, which. specifically address intricacies of the Rules as they are applied in everyday. appellate practice.
The Indiana Law Course is now available. This course is an admission requirement for all applicants who have taken the UBE Bar Exam in Indiana or who have transferred their UBE score to Indiana. You have six months from the date of notice to complete this course.
People also ask
What is the Indiana Law Course?
When will the Final Rule be implemented?
Is the Indiana Law Course available in 2023?
Can I practice law in Indiana on a Ube score?
Does the final rule change the criteria for human subjects research?
Does the final rule include standardized privacy safeguards?
interprets the statutes that supply the rules of decision, and the courts’ only role (as we have interpreted AOPA) is to defer to all aspects of the agency’s decision-making.
