Blog

Discrepancies Between ClinicalTrials.gov and Corresponding Publications

17 August 2020 by CITI Program

A recent study finds high rates of discordance between trial reporting on ClinicalTrials.gov and corresponding publications. Findings accentuate the need to monitor for accurate reporting. See “Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA” CITI Program’s Clinicaltrials.gov Content Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov provides a video-enhanced guide […]

Managing Conflicts is a Critical Skill in the Workplace

14 August 2020 by CITI Program

Where people gather, conflict is likely to occur. Even in an age when many professionals may be working remotely, conflicts within teams can occur. Unfortunately, managers are often ill-equipped to deal with conflict effectively. Some may even exacerbate the conflict with well-intentioned, but poorly considered, interventions. Conflicts within teams are detrimental to individuals and organizations […]

OHRP’s New Subpart C Certification Form

7 August 2020 by CITI Program

OHRP now has a new Subpart C Certification Submission Form to be submitted as part of the certification request for the inclusion of prisoners in HHS conducted or supported research, in compliance with 45 CFR 46.305(c). It has been approved for use by OMB through 31 July 2023, under Control Number 0990-0473. U.S. Department of […]

FDA Issues Guidance For Clinical Research Using Cannabis

24 July 2020 by CITI Program

The FDA has issued guidance detailing the FDA’s current thinking on clinical research with cannabis and cannabis-derived compounds. It includes quality considerations, reviews key FDA regulatory concepts, and provides recommendations related to cannabis sources and THC percentage calculation. See the full guidance for more details: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research CITI […]

OHRP’s Video on Informed Consent Available in Spanish

16 July 2020 by CITI Program

OHRP’s latest video, Informed Consent for Research: What to Expect, on their Informational Videos page, is also available in Spanish. It covers the basics of informed consent and the information that potential study participants should receive to help decide if they want to volunteer. See the “Protegiendo a los voluntarios que participan en las investigaciones” […]

The Impact of the EU’s General Data Protection Regulation (GDPR) on U.S. Higher Ed Organizations

10 July 2020 by Ann Kristin Glenster, Member of the Centre for Intellectual Property and Information Law, Faculty of Law, University of Cambridge

In February 2018, the European Union (EU) adopted the General Data Protection Regulation (GDPR), which regulates the processing of personal data in the EU. The Regulation is wide in scope and applies to higher education organizations, whether they are located inside or outside the EU if they process personal data in the EU or that […]

OHRP Issues Decision Charts for Current and Pre-2018 Requirements

9 July 2020 by CITI Program

OHRP recently posted new decision charts for the revised Common Rule (2018 Requirements) on their website. These charts are intended to help decision-makers determine if research is considered human subjects research, if exemption categories apply, if continuing review is required, if documentation of consent can be waived, and if informed consent can be waived or […]

New Online Course Provides Information on Ethical Issues and Governance Approaches for Emerging Technologies

7 July 2020 by CITI Program

Since the onset and spread of COVID-19, many communities, businesses and individuals have relied on some of the latest technologies. From telemedicine to teleconferencing to online learning, technologies have eased the challenges of working from home. The World Economic Forum has identified ten technology trends to watch during the pandemic, including digital payments, telehealth and […]

CIP Exam Preparation and Recertification Using CITI Program Content

30 June 2020 by CITI Program

Study Help for the CIP Exam As the application deadline for the Fall 2020 CIP examination approaches (14 August for the exam window of 7 September through 7 October), remember that CITI Program’s Human Subjects Research and IRB Administration courses can help you prepare. Re-review our basic modules that cover key topics for human subjects […]

New HHS Fact Sheet: COVID-19’s Impact on Minorities

10 June 2020 by CITI Program

The HHS has released HHS Initiatives to Address the Disparate Impact of COVID-19 on African Americans and Other Racial and Ethnic Minorities. It covers the following topics: Improving our Understanding of COVID-19’s Impact on Minorities Making Testing More Accessible and Afordable Making Treatment More Accessible and Afordable Tailored Guidance for Individuals & Communities Most At […]

FDA Issues New COVID-19 Guidance for IRBs and Clinical Investigators

4 June 2020 by CITI Program

In order to support response efforts to this pandemic, the FDA has issued guidance to provide non-binding recommendations regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions. Learn more about these recommendations intended to assist IRBs in complying with the requirements in 21 CFR Part 56. View the […]

Technology, Ethics, and COVID-19

3 June 2020 by CITI Program

Read AI, Robots, and Ethics in the Age of COVID-19 published by MIT’s “Sloan Management Review” for an expert’s perspective on the impact of robots and artificial intelligence (AI) during this public health emergency. It covers the following topics: Attitudes towards robots and AI Adopting robots and AI as the “new normal” The importance of […]

CITI Program Contributor Kelly Willenberg Has a New Research Blog

2 June 2020 by CITI Program

Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC is one of CITI Program’s expert contributors in clinical trial billing. As a respected expert in the research community, she started the “Research Beast” blog available on the Kelly Willenberg & Associates website. View “Research Beast” Blog View CITI Program’s Clinical Trial Billing Compliance Course View CITI Program’s […]

COVID-19 Trial Shows Remdesivir is Superior to Standard Treatment

26 May 2020 by CITI Program

According to the authors of a recently published article in the New England Journal of Medicine, findings from the Adaptive COVID-19 Treatment Trial, support remdesivir as the standard treatment for patients hospitalized with COVID-19 and requiring supplemental oxygen therapy. Peer-reviewed data shows remdesivir for COVID-19 improves time to recovery

CTTI Webinar – Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials

16 June 2020 by CITI Program

At 12 PM ET on Thursday, June 18, CTTI will host Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials. The webinar will include discussion on how to recruit and enroll diverse populations of participants more effectively. Speakers will include: Christina Brennan, Northwell Health Richard Knight, American Association of Kidney Patients Fabian Sandoval, Emmerson […]

Recovery From Advanced COVID-19 Accelerated by Remdesivir in NIH Clinical Trial

30 April 2020 by CITI Program

In an NIH clinical trial involving 1063 patients with advanced COVID-19, preliminary results indicate that those who received broad-spectrum antiviral treatment Remdesivir recovered 31% faster than those who received a placebo. More detailed results will be published in a forthcoming report. View the complete news release

Researchers Race Toward a COVID-19 Vaccine at Breakneck Speed

29 April 2020 by CITI Program

In recent weeks biotech and clinical research communities have pivoted resources toward developing vaccines against SARS-CoV-2. Teams around the world are researching various methods of vaccine development, some of which have no approved precedent in the United States. As of this writing, researchers are investigating over 90 potential vaccines. Several of these vaccines are already […]

CITI Program Author Charles Hennekens Publishes Several Articles on COVID-19 and Public Health

28 April 2020 by CITI Program

Charles Hennekens, MD, DrPH is one of the expert authors of CITI Program’s Essentials of Public Health Research course. As a respected expert on public health, he has published several articles on COVID-19 focused on public health leadership. The Emerging Pandemic of Coronavirus: The Urgent Need for Public Health Leadership COVID-19 response and communications must […]

New Questions and Answers Added to the FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

23 April 2020 by CITI Program

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency was released in March for industry, investigators, and institutional review boards (IRBs). On April 16th, 2020 new questions and answers were added to the appendix section with new content on several topics including: Conducting remote clinician-reported outcome or performance outcome […]

NIH Begins Trial Evaluating COVID-19 Treatment Regimen

19 May 2020 by CITI Program

This clinical trial will test the safety and efficacy of a treatment regimen of the remdesivir plus the anti-inflammatory drug baricitinib for COVID-19. It is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT), which began on February 21, 2020 and evaluated Remdesivir. In this next trial called ACTT 2, all participants will receive […]

Webinar – COVID-19: Supporting Ethical Care and Responding to Workforce Concerns in a Public Health Emergency

22 April 2020 by CITI Program

Presented by Nancy Berlinger, PhD – The Hastings Center. This webinar discusses public health duties during a public health emergency. Webinar Highlights Clarifies public health duties in relation to the duty of care during a public health emergency. Identifies ethical challenges in resource allocation (staff, stuff, space) and managing changing work conditions. Discusses responding to […]

Webinar – COVID-19 and Human Research Protection Programs

14 April 2020 by CITI Program

Presented by Brenda L. Ruotolo, BA – Columbia University; Challace D. Pahlevan-Ibrekic, MS – Columbia University. An in-depth discussion on how one institution and its HRPP responded to the COVID-19 pandemic that may help guide other organizations. Webinar Highlights Provides a detailed exploration of how a human research protection program (HRPP) responded to and has […]

NIH Study to Quantify Undetected COVID-19 Cases

13 April 2020 by CITI Program

A new NIH study will analyze blood samples from up to 10,000 volunteers without confirmed cases of COVID-19 for the presence of antibodies to the virus. It aims to provide insight into the undetected spread of the virus as well as which communities and populations are affected most. NIH begins study to quantify undetected cases […]

OHRP issues guidance on COVID-19

13 April 2020 by CITI Program

On April 8, 2020, the Office for Human Research Protections (OHRP) issued guidance on the regulatory requirements of 45 CFR 46 and actions taken during COVID-19 for the research community. Specifically, the guidance addresses public health and clinical activities, research changes to eliminate apparent immediate hazards, proposing and reviewing study changes, and whether suspensions of […]

Scale Training to Help Staff Take on Research Roles

22 April 2020 by CITI Program

Although most research is paused during the global pandemic, there are new COVID-19 research studies starting every day. During this time, organizations may need to train individuals that have asked to take on new roles, including the conduct of clinical trials. If your organization is moving staff from non-research to research roles, we can help […]

Webinar – FERPA and Online Learning in the Time of COVID-19

7 April 2020 by CITI Program

Presented by Thomas Gold, PhD – Acceleration Group, Inc.. This webinar explores how the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR 99) applies to online learning. The presenter explores student privacy issues and discusses different approaches aimed at safe learning and protecting student information. Review the learning objective and […]

Webinar – “Nuts & Bolts” of Running a Virtual IRB Meeting

16 March 2020 by CITI Program

Presented by Angela L. Bruch, PhD – Capella University. This webinar discusses the pragmatic issues of running a convened Institutional Review Board (IRB) meeting virtually. The webinar is designed for IRB Chairs and administrators and identifies best practices to ensuring adequate review of submissions and documentation of IRB determinations in a virtual meeting. Provides strategies […]

Technology Use to Manage Patient Care in the Era of COVID-19.

10 April 2020 by CITI Program

An article this week in Wired Magazine outlined how physicians and other health care providers in hospitals are using technology to manage patient care in an era of COVID-19. Using a combination of tablets, smart phones and video conferencing, physicians are conducting virtual rounds, whereby one physician moves from one patient room to another and […]

Guidance Issued on Defending Against VTC Hijacking and Zoom-bombing

7 April 2020 by CITI Program

The Cybersecurity and Infrastructure Security Agency (CISA) has published an article detailing steps to improve cybersecurity for video-teleconferencing (VTC) platforms. It also recommends several other VTC cybersecurity resources. Read FBI Releases Guidance on Defending Against VTC Hijacking and Zoom-bombing. CITI Program’s Information Privacy & Security (IPS) Courses These courses cover the principles of data protection, […]

OCR Bulletin: Civil Rights, HIPAA, and the Coronavirus Disease 2019 (COVID-19)

31 March 2020 by CITI Program

On March 28, 2020, the Health and Human Services Office for Civil Rights in Action (OCR) issued the bulletin Civil Rights, HIPAA, and the Coronavirus Disease 2019 (COVID-19) to ensure obligations are met under laws and regulations that prohibit discrimination in HHS-funded programs during the COVID-19 emergency. Compliance with HIPAA is critical during this pandemic […]

CITI Program’s Contribution to Health Literacy in Research

31 March 2020 by CITI Program

CITI Program continues to encourage the adoption of health literacy in research. Our Associate Director of Content and Education, Margaret Rankovic, is currently participating in a Multi-Regional Clinical Trials (MRCT) Center working group to help develop tools, training, and communication strategies for the IRB community on this important topic. MRCT’s Health Literacy in Clinical Research […]

Apps Being Developed to Improve Clinical Care

19 March 2020 by CITI Program

Mobile app research is growing in both medical and social-behavioral-educational fields of research. For example, bedside apps are being studied to see how they can improve consent during childbirth. It’s important that app researchers and IRBs are aware of important research issues involving mobile apps. CITI Program’s Mobile Apps and Human Subjects Research module discusses […]

Preparing for COVID-19, Impacts on Research Organizations

18 March 2020 by CITI Program

The rapidly evolving federal, state, and local policies regarding COVID-19 are impacting every walk of life in the United States and around the world. Companies, as well as academic and government researchers, have pivoted their focus on vaccines and possible treatments for the novel coronavirus. Health and research organizations are trying to keep up with […]

COVID-19 Vaccine Phase 1 Trial Begins

17 March 2020 by CITI Program

NIH is conducting a Phase 1 clinical trial of a new vaccine for COVID-19. Phase 1 research is the first clinical trial phase conducted with humans after animal (preclinical) research. The trial is being conducted at Kaiser Permanente Washington Health Research Institute, a NIH clinical trials center since 2007. Read more from the NIH CITI […]

Time to revisit your disaster plan?

11 March 2020 by CITI Program

COVID-19 dominates daily news headlines as communities and organizations evaluate policies regarding public gatherings, quarantines, and other issues. Many states, including New York and California, have declared states of emergency in order to free up budgets to prepare for what public health officials believe will be a continuing crisis. At the University of California, San […]

Research During Global Health Emergencies

9 March 2020 by CITI Program

Complying with research ethics is notably challenging during global health emergencies such as the outbreak of coronavirus disease (COVID-19). Investigators must have an ethical framework in place to address challenges created by the accelerated research that is sometimes necessary during these emergencies. Read the report Research in Global Health Emergencies published by The Nuffield Council […]

U.S. Federal Regulatory Agencies Provide Guidance for Clinical Trials in Response to COVID-19

24 March 2020 by CITI Program

As COVID-19 continues to impact research organizations and clinical sites, federal agencies are issuing guidance for clinical trials. Organizations are closing or dramatically reducing operations and on-site staff; supply chains are disrupted; and travel restrictions have left investigators, organizations, and sponsors scrambling to respond. In response, the FDA is providing guidance for those impacted. The […]

Compliance With Posting Clinical Trials Results on ClinicalTrials.gov

6 February 2020 by CITI Program

Both the journals Science and The Lancet have recently published studies showing a lack of compliance with posting clinical trials results on ClinicalTrials.gov. Be sure your research program and investigators meet these critical requirements with CITI Program’s ClinicalTrials.gov course and webinar. Course: Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov Webinar: Building a ClinicalTrials.gov Compliance […]

Ethical Considerations for Replicating Bones with 3D Printing

24 January 2020 by CITI Program

Evolving technology now makes 3D printing an inexpensive technology for reproducing replica bones. Digital bone repositories around the world are currently working through the ethical issues involved with this technology, such as who owns the right to print which bones or if it is even possible to own the rights to part of a person. […]

Webcast of NAS Workshop, An Examination of Emerging Bioethical Issues in Biomedical Research

23 January 2020 by CITI Program

The National Academy of Sciences, Engineering, and Medicine will be hosting An Examination of Emerging Bioethical Issues in Biomedical Research on February 26, 2020 at 8:30 am Eastern time. The workshop will, “bring together stakeholders to discuss potential ethical issues that may arise from new and emerging trends in biomedical research (including behavioral and social […]

The Importance of Improving ClinicalTrials.gov Compliance

12 February 2020 by CITI Program

For two decades, the federal government has encouraged transparency in research. As a result of these efforts, it established ClinicalTrials.gov, a national registry of U.S. clinical trials. The objective was to improve public trust in research and to help potential participants find appropriate trials. Since then, researchers are also required to post summary results in […]

Improving Drugs Through Patient-Centric Design for Clinical Trials

9 January 2020 by CITI Program

Read about the approach to drug development that includes tolerability, ease of use, compliance with therapy, and quality of life as topics addressed along with traditional quantitative risk-benefit analysis. The author speaks to the need for new and creative solutions that address the broader needs of patients as individuals. Improving the next generation of drugs […]

OHRP Releases the 2020 Edition of the International Compilation of Human Research Standards

10 March 2020 by CITI Program

View OHRP’s 2020 edition of the International Compilation of Human Research Standards. This compilation of laws, regulations, and guidelines is helpful to CITI Program organizations that are involved in international research. The included laws, regulation, and guidelines have been classified into nine categories: General Drugs and Devices Clinical Trial Registries Research Injury Social-Behavioral Research Privacy/Data […]

Resource to Determine if Your Research Involves Human Subjects

8 January 2020 by CITI Program

The NIH Office of Extramural Research (OER) provides a decision tool to help determine if research is considered human subjects research and if it may be considered exempt from Federal regulations. This tool was recently updated to reflect the 2018 Revised Common Rule requirements. Decision Tool: Am I Doing Human Subjects Research? Did you know […]

Guidance Issued on the Application of FERPA and HIPAA to Student Health Records

3 January 2020 by CITI Program

The U.S. Departments of Health and Human Services and Education have released “Joint Guidance on the Application of the Family Educational Rights and Privacy Act (FERPA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to Student Health Records.” It provides guidance on each rule’s applicability and what information can be shared under […]

Revised Common Rule Now in Full Effect

22 January 2020 by CITI Program

On January 20, 2020, the sIRB requirement under the revised Common Rule went into effect. This marked the final step in the timeline for full implementation of the revised rule. sIRB Training Resources Webinar: Preparing for Single IRB (sIRB) under the Common Rule Add this webinar and have learners listen to Dr. Nichelle Cobb, the […]

9 Ways to Encourage Learners to Complete Required Courses

4 December 2019 by CITI Program

After considering feedback from our subscribing organizations, we have compiled 9 strategies that will help you streamline your account and encourage learners to complete their training more efficiently. Assess the learner group set-ups to make sure the content meets current training needs. You may be able to reduce the number of required modules to the […]

Tips to Get Ready for the Common Rule Single IRB requirement

4 December 2019 by Nichelle Cobb, PhD - University of Wisconsin-Madison

Although single IRB (sIRB) review has long existed as an option for institutions to use for the oversight of human subjects research, most institutions only used sIRB in limited situations, such as when required by a Federal agency (e.g., the National Cancer Institute for many studies supported by that agency), an industry sponsor, or to […]

Apple Watch Heart Study Results

15 November 2019 by CITI Program

Stanford Medicine has published the complete results of their study, “Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation.” The study utilized user-owned Apple smartwatches to monitor irregular heart pulses in over 400,000 study participants. The study concluded that this siteless study design, “provides a foundation for large-scale pragmatic studies in which outcomes or adherence […]

Congratulations to Susan Z. Kornetsky, MPH, 2019 ARENA Legacy Award Recipient

11 November 2019 by CITI Program

CITI Program would like to congratulate PRIM&R’s 2019 ARENA Legacy Award recipient, Susan Z. Kornetsky, MPH, Senior Director of Clinical Research Compliance at Boston Children’s Hospital. She has been honored for promoting the professional excellence and encouraging the advancement of individuals working in the research enterprise. We are proud to work with Susan as she joins […]

Considerations on “Reducing Administrative Burden for Researchers: Animal Care and Use in Research”

23 September 2019 by Cynthia S. Gillett, DVM, DACLAM, CPIA

A recently published report on “Reducing Administrative Burden for Researchers: Animal Care and Use in Research” describes the collective recommendations of a Working Group of Experts convened by the NIH, USDA, and FDA as part of the 21st Century Cures Act. Of particular note are actions recommended to: Clarify OLAW’s guidance on IACUC protocol to […]

Join the Free, Live Webcast of OHRP’s Latest Exploratory Workshop

18 September 2019 by CITI Program

OHRP will be hosting Exploratory Workshop: Privacy and Health Research in a Data-Driven World on Thursday, 19 September 2019. This is a free event, available live via webcast. The agenda includes the following sessions: Is Privacy a Casualty of Advancing Research? Approaches to Protecting Privacy & Confidentiality Protecting Privacy & Confidentiality: A Shared Responsibility Learn […]

Training Resource on Human Gene Transfer Research

16 September 2019 by CITI Program

Human gene transfer is a rapidly growing field of research that requires training on unique ethics and policy issues as well as regulatory guidance and requirements. This webinar serves as an efficient training resource and covers some of the essential issues in human gene editing. Ethics & Policy Issues in CRISPR Gene Editing This webinar […]

NIH Funds Eleven CITI Program Subscribing Organizations

4 September 2019 by CITI Program

CITI Program wishes to congratulate eleven of our subscribing organizations that will share approximately $187 million in funding by The National Institute on Minority Health and Health Disparities (NIMHD), as part of the Research Centers in Minority Institutions (RCMI) Specialized Centers program. Charles R. Drew University of Medicine and Science University of Texas at El […]

Integrating Health Literacy into Clinical Research Studies: MRCT Center announces web-based resources to support clear communications for participants

3 October 2019 by Sylvia Baedorf Kassis, MPH, CYT - Program Manager, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

Sponsors and investigators work to create clinical research materials, including educational resources and informed consent forms to optimize understanding and public and participant engagement. However, one third of the U.S. population has basic or below basic levels of health literacy and medical information is technical and complex. No longer can the burden of understanding rest […]

Prepare for Your Upcoming CIP Exam and Learn How to Recertify with CITI Program Content

29 July 2019 by CITI Program

As the application deadline for the 2019 CIP examination approaches (August 16th for the exam window of September 9th-21st), remember that CITI Program’s Human Subjects Research and IRB Administration courses can help you prepare. View Human Subjects Research Courses | View IRB Administration course Recertify with CITI Program’s CIP Courses Approved by CCIP Advanced-level CITI […]

Learn About the NIH Mission and Review its Latest Call for Proposals

25 July 2019 by CITI Program

The NIH recently released the video, NIH Story, to inform the public on the NIH mission and what drives them to improve health and fight disease. View the video and learn about the NIH community and the incredible work they do at over 2,500 organizations around the world to enhance health, lengthen life, and reduce […]

Hurricane Season is Here. Make Sure Your Organization is Prepared for a Disaster.

15 July 2019 by CITI Program

History should serve as a reminder that all research organizations need to implement an effective disaster preparedness and business continuity plan. Disaster Planning for the Research Enterprise (DPRE) educates IACUCs, IBCs, IRBs, PIs, and others responsible for research oversight on disaster preparedness and business continuity with respect to: Responsibilities of the Principal Investigator in Human […]

June 2019 Newsletter

20 June 2019 by CITI Program

We invite you to review our June 2019 newsletter which includes a letter from our Managing Director and discusses new/updated content, implementation of PHS policy, and CIP continuing education credits. You will also find tips to help get the most out of your organization’s CITI Program subscription and a link to events we will be attending […]

Final Rule on Transfers Made by or for a Department or Agency of the U.S. Government

19 April 2019 by Wendy Epley, MSc-RTC, ECoP®-EAR & ITAR

On April 19, 2019, the U.S. Department of State issued the final rule on Transfers Made by or for a Department or Agency of the U.S. Government. This final rule revises section 126.4 to clarify when exports, reexports, retransfers, temporary imports, and performance of a defense service may be made by or for an agency […]