Blog

WHO Seeks Comments for New Draft GMP Guidelines

20 August 2021 by CITI Program

The World Health Organization (WHO) has released a draft working document for comments on good manufacturing practices (GMP) for investigational products. They also issued a new draft guideline for comments on pharmaceutical products that covers GMP principles of pharmaceutical products for research and development facilities. These draft revisions were inspired by the COVID-19 pandemic. Comments […]

Enforcement for FDA’s ClinicalTrials.gov Requirements

19 August 2021 by CITI Program

To comply with the ClinicalTrials.gov requirements, responsible parties should submit registration and summary results information for certain applicable clinical trials, as per regulations at 42 CFR 11. Until this year, the U.S. Food and Drug Administration (FDA) had not enforced this regulation. Timeline The following is a brief timeline of FDA enforcement actions, statements, and […]

What CITI Program is Reading – August 18, 2021

18 August 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Joint Letter on Scientific Integrity to the White House OSTP

10 August 2021 by CITI Program

In response to a request for information to improve federal scientific integrity policies, the American Association for the Advancement of Science (AAAS), Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR) have issued a joint letter to the White House […]

What CITI Program is Reading – August 10, 2021

10 August 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

NIH Studies Its Processes to Ensure Diversity in Clinical Trials

9 August 2021 by CITI Program

The NIH supports over $31 billion of biomedical and public health research and has long been concerned with the underrepresentation of minority groups in clinical trials and its effect of on these populations. The NIH’s Office of Evaluation and Inspections has recently announced a study to review how the NIH monitors and responds to clinical […]

Recent Guidance on Semiannual Inspections of Animal Facilities

9 August 2021 by CITI Program

In response to a recent NIH Request for Information (RFI), the public suggested having inspections occur annually instead of semiannually as way to reduce the administrative burden on investigators. However, it was determined that the potential risks to animal welfare outweighed the burden on the IACUC and the principal investigator. On August 2, 2021, the […]

What CITI Program is Reading – August 3, 2021

3 August 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

New OHRP Incident Reporting Form and Instructions

29 July 2021 by CITI Program

The regulations at 45 CFR 46 for nonexempt research conducted or supported by the U.S. Department of Health and Human Services (HHS) require prompt reporting of incidents to OHRP. These incidents include the following:   Unanticipated problems involving risk to subject or others Serious or continuing noncompliance Suspension or termination of IRB approval   On […]

What CITI Program is Reading – 27 July 2021

27 July 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

What CITI Program is Reading – 20 July 2021

20 July 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Integrating Sex as a Biological Variable (SABV) in Biomedical Research

16 July 2021 by CITI Program

The National Institutes of Health (NIH) Office of Research on Women’s Health (ORWH) now offers the course Sex as a Biological Variable: A Primer. Intended for researchers, NIH grant applicants, and peer reviewers, the course examines how SABV can be accounted for and properly integrated within research design, analyses, and other aspects of biomedical sciences. […]

What CITI Program is Reading – 13 July 2021

13 July 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Information Security in the Time of COVID-19

9 July 2021 by CITI Program

Many of us have been working from home, at least part-time, for quite a while. It is important to remember that recommended information security best practices are applicable now more than ever as COVID-19 has spurred an outbreak of malware and phishing. Recently, these types of scams have become more of a problem. It remains […]

What CITI Program is Reading – 7 July 2021

7 July 2021 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

WHO Guidance on Ethics and Governance of AI for Health

2 July 2021 by CITI Program

After a year and a half of deliberation among experts in various fields, including ethics, digital technology, law, and human rights as well as experts from Ministries of Health, the World Health Organization (WHO) has released a new guidance entitled “Ethics & Governance of Artificial Intelligence for Health.” The guidance document includes:   Applications of […]

New Draft Guidance for Investigational New Drug Application and Bioavailability/Bioequivalence Studies

2 July 2021 by CITI Program

The FDA has released a new draft guidance for sponsors and sponsor investigators entitled “Safety Reporting Requirements and Safety Assessment for Investigational New Drug (IND) Application and Bioavailability/Bioequivalence Studies.” The draft guidance document includes: Definitions of adverse event, adverse reaction, suspected adverse reaction, unexpected, serious, and life-threatening. An overview of IND application safety reporting requirements. […]

Details and Public Comments on Proposed Modifications to the HIPAA Privacy Rule

1 July 2021 by CITI Program

Earlier this year, the United States Department of Health and Human Services (HHS) posted “Proposed Modifications to the HIPAA Privacy Rule To Support, and Remove Barriers to, Coordinated Care and Individual Engagement.” These changes address standards that may impede the transition to value-based health care while continuing to protect the privacy and security of individuals’ […]