New FDA Guidance on Certificates of Confidentiality

15 December 2020 by CITI Program

Investigators can request discretionary Certificates of Confidentiality (CoCs) from the U.S. Food and Drug Administration (FDA) for non-federally funded research that is subject to FDA regulations. The FDA recently announced new guidance on Certificates of Confidentiality that explains the Agency’s implementation of discretionary CoCs. See “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and […]

New Guidance on College and University J-1 Exchange Programs

7 December 2020 by CITI Program

The Department of State’s Exchange Visitor Program (BridgeUSA) has issued Guidance Directive Exchange Visitor Program – Confucius Institutes 2020-01, which provides new guidance on the relationship of college and university J-1 exchange programs to Confucius Institutes and associated activities at K-12 schools and universities. If this regulatory update applies to you or your organization, consider CITI […]

FDA Guidance for More Inclusive Clinical Trial Enrollment Practices

11 November 2020 by CITI Program

Clinical drug and biologics trials should aim to have participants represent the likely users of the approved medication. The FDA has issued guidance for sponsors that recommends approaches to increase enrollment of underrepresented populations in clinical trials. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry […]

OHRP’S Annotated Comparison of the Revised Common Rule and the Pre-2018 Requirements

11 November 2020 by CITI Program

OHRP has added an annotated comparison of the pre-2018 Common Rule with the 2018 regulations. On this page you’ll also find additional information about whether a pre-2018 Common Rule provision has moved to another location in the 2018 Common Rule, and where to find it. While not an official version of the revised Common Rule […]

Are you thinking about participating in vaccine research?

4 November 2020 by CITI Program

As we continue to work together to fight COVID-19, we are reminded of the importance of volunteers to serve in vaccine trials. But deciding to participate in a vaccine trial can be confusing and scary. CITI Program has adapted its “Are You Thinking About Being in a Research Study?” module and has created a new […]

Public Trust in Science with Dr. Fauci

20 October 2020 by CITI Program

On November 19, 2020 and as part of the of The Hastings Center’s series, Securing Health in a Troubled Time, Dr. Anthony Fauci, Director at the National Institute of Allergy and Infectious Diseases participated in a virtual discussion about the public’s understanding and trust in science. View the Recording Now CITI Program’s Public Health Research […]

Are teachers born or made?

19 October 2020 by Carole Mottaz, EdD - University of Wisconsin – River Falls, Capella University

This was one of the first questions asked of us when I started teacher training college in England a number – possibly a great number – of years ago. For most of us in my year, the former seemed to be true. But then we had all chosen to be teachers so felt we had […]

The Importance of Cybersecurity for NIH-Supported Research

20 October 2020 by CITI Program

In recognition of National Cybersecurity Awareness Month, Dr. Michael Lauer, the NIH’s Deputy Director for Extramural Research, has published some thoughts on the importance of strong cybersecurity protocols. Data breaches can threaten the integrity of research and affect the public’s trust in scientific findings which is why the protection of sensitive and confidential data for […]

2020 Nobel Prize in Chemistry Awarded for Development of Tools to Edit DNA

19 October 2020 by CITI Program

Emmanuelle Charpentier and Jennifer Doudna have won the Nobel Prize in Chemistry for their contributions to genome editing. The pair partnered in 2011 and by 2012 had published a landmark paper detailing how they could reprogram a previously unknown molecule, tracrRNA, to cut DNA molecules at pre-determined sites allowing genetic code to be rewritten. Learn […]

Examining the Ethical and Regulatory Approaches to Artificial Intelligence (AI) in Human Subjects Research

12 October 2020 by Tamiko Eto, MS, CIP - Division of Research, Kaiser Permanente

We are excited to add two new modules to our Technology, Ethics, and Regulations course: “Artificial Intelligence (AI) and Ethics in Human Subjects Research” and “Regulatory Approaches to Artificial Intelligence (AI) in Human Subjects Research.” These in-depth modules review the ethical and regulatory challenges around AI human subjects research (AI HSR). The modules are the […]

The Most Overlooked Factor in Successful Tech Transfer

5 October 2020 by CITI Program

Research conducted at universities and academic medical centers is responsible for the development of a myriad of innovative products over the years. These innovations vary from drugs such as Remicade® to new varieties of fruits such as the Honeycrisp Apple. According to the Association of University Technology Managers (AUTM), technology transfer has contributed over $865 […]

Turn Conflict Into Cooperation

10 August 2020 by LaVena Wilkin, PhD - Sullivan University

Most people learn reading, writing, and math in school. However, few of us learn how to productively manage the inevitable conflicts that show up in our lives. As a result, many of us simply are not very good at conflict management, and we are either always ready to aggressively confront the other person, or to […]

Clinic’s HIPAA Violations Result in Hacked Database and $1.5 Million Settlement

24 September 2020 by CITI Program

Hacking is a significant threat to health care data and attacks can be very costly. Recently, an orthopedic clinic serving 138,000 patients annually, paid $1,500,000 as part of a settlement agreement with the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services. The clinic was attacked by a hacker and […]

The Path to Heritable Genome Editing

18 September 2020 by CITI Program

The U.S. National Academy of Medicine, National Academy of Sciences, and the UK’s Royal Society have formed the The International Commission on the Clinical Use of Human Germline Genome Editing to provide guidance for heritable genome editing also known as Germline editing. The committee issued a report with 11 recommendations that address specific ethical and […]

Fighting Undue Foreign Influence in Research

17 September 2020 by CITI Program

The U.S. government, as well as academic leaders, are actively trying to protect their position as a global leader in research and technology. At the same time, they are committed to ensuring transparency and openness, the ingredients that have made U.S.-based research the envy of the world. After several years of internal investigations, officials at […]

Remote Contact Tracing: Free Foundational Training to stop COVID-19 Spread From Home

15 September 2020 by Joanna Drowos, DO, MPH, MBA - Florida Atlantic University

As many organizations and communities struggle to stop the spread of COVID-19, contact tracing remains an effective public health strategy in this fight. Contact tracing is a tool where interviews with those infected with COVID-19 identify others they may have exposed before becoming ill. These contacts are then monitored and advised to change their behavior […]

GDPR Class Action Lawsuits Filed for 10 Billion Euros

15 September 2020 by CITI Program

The Privacy Collective filed wrongful use of personal data class-action lawsuits against Oracle and Salesforce (Forbes 2020). The companies are accused of violating the General Data Protection Regulation (GDPR) by not getting consent from individuals for how their data would be processed, and for not securing the personal data appropriately. The GDPR aims to protect […]

Join OHRP’s 3rd Annual Exploratory Workshop on Single IRB (sIRB) Review

15 September 2020 by CITI Program

OHRP will be hosting Practical and Ethical Considerations for Single IRB Review on Thursday 17 September 2020. No registration is required and you can view the event for free on the videocast page. This workshop will cover topics such as: Quality review Local context Oversight responsibilities Opportunities and challenges presented by the sIRB mandate Using […]