TAG ARCHIVES FOR HHS

14
Feb2019

The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) recently put out a "Request for Information on Modifying HIPAA Rules to Improve Coordinated Care." PRIM&R submitted comments encouraging HHS to take this opportunity to harmonize the HIPAA Rules with the Common Rule to improve it's use in the research context. The research community has long argued that HIPAA is confusing, awkward, inconsistent, and unnecessarily burdensome as applied to human subjects research. Read more

20
Dec2018

The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2019. I arrived in sunny San Diego early morning Wednesday, November 14, for the 2018 Advancing Ethical Research Conference (AER18) on a mission to learn everything I could about these federal policy changes. Read more

17
Nov2017

This week’s Research Ethics Roundup looks at the ethical implications of inserting human brain organoids into laboratory animals, the need for deep brain stimulation researchers to think about the potential long-term ethical dilemmas involved in their work, the argument for classifying certain kinds of organ recipients as research subjects, and President Trump’s new pick to be the secretary of the Department of Health and Human Services (HHS). Read more

25
Oct2017

Last month, the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released final guidance on meeting minutes for IRBs who oversee human subjects research under FDA and/or HHS regulations. The final guidance includes a few small changes from the draft released in November 2015. This is the first time the two agencies have jointly issued guidance in this area; the guidance summarizes how the agencies believe IRBs and institutions should apply the federal regulations as they pertain to the creation of IRB meeting minutes. Read more

30
Jan2017

On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them. Read more