FDA Proposes Revisions to Rules on the Protection of Human Subjects and Cooperative Research
28 September 2022 by Raymond Longaray, CITI Program

The U.S. Food and Drug Administration (FDA) proposed two new rules that would update regulations 21 CFR 50 (Protection of Human Subjects) and 21 CFR…

Plain Language Checklist for Lay Brief Summaries Added to ClinicalTrials.gov
28 September 2022 by CITI Program

As part of ongoing updates to the their Support Materials Page, the ClinicalTrials.gov site has updated its resources to include a Plain Language Checklist for…

On Campus Podcast – Doctoral and Graduate Student Advising
28 September 2022 by Raymond Longaray, CITI Program

Season 1 – Episode 19: Doctoral and Graduate Student Advising Navigating the doctoral and graduate student advising process can be beneficial and challenging for both…

What Does Diversity Mean in Clinical Trials?
27 September 2022 by CITI Program

The lack of diversity in clinical trials is a major issue that scientific research is battling today. The ethical inclusion of diverse participants in clinical…

What CITI Program is Reading – September 27th, 2022
25 September 2022 by CITI Program

“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,…

New FDA Guidance Provides Standards for Medical Device 510(k) Submissions
26 September 2022 by CITI Program

The U.S. Food and Drug Administration (FDA) issued a new guidance, entitled Electronic Submission Template for Medical Device 510(k) Submissions. 510(k) electronic submission requirements will…

New FDA Draft Guidance on Ethical Considerations for Including and Protecting Children in Clinical Trials
26 September 2022 by CITI Program

The U.S. Food and Drug Administration (FDA) issued a new draft guidance, entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. As a…

On Campus Podcast – Accommodations in Online Learning
23 September 2022 by CITI Program

Season 1 – Episode 18: Accommodations in Online Learning The Americans with Disabilities Act (ADA) aims to make education more accessible for individuals with disabilities…

Additional NIH Policy for Data Management and Sharing Resources
22 September 2022 by CITI Program

The National Institutes of Health (NIH) has released two new documents providing supplemental information to the NIH Policy for Data Management and Sharing (DMS). They…

HIPAA Regulations and Implications for Your Institution
21 September 2022 by CITI Program

Since the Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996, federal and state agencies have developed and refined privacy rules…

Compare Federal Laws, Regulations, and Policies in Science and Security
21 September 2022 by CITI Program

The Council on Governmental Relations (COGR) has released version two of their research security comparison chart, summarizing and comparing federal laws, regulations, and policies. The…

Presidential Order on Advancing Biotech and Biomanufacturing Innovation
21 September 2022 by CITI Program

The President of United States of America has issued an executive order to promote a sustainable, safe, and secure bioeconomy. Thirteen sections detail a wide-range…