The 2018 revised Common Rule included a new requirement that consent forms begin with a presentation of the key information most likely to help potential participants understand why they might or might not want to participate in the research. This section must be short and be presented to facilitate comprehension. Unfortunately, many investigators are … Continue reading "The Key Information Section in Consent – Why, What, and How"
Learn eCORE is pleased to feature this blog on clinical research project management authored by Desiree Underwood-Williams, a well-regarded clinical research professional and a dedicated mentor to others working in this field. Learn eCORE’s library of soft skills training that are included with all subscriptions has project management courses directly related to the tips … Continue reading "The Clinical Project Manager’s Role in Ensuring Success in Clinical Trials"
Dr. Stephen Rosenfeld is an experienced researcher and IRB executive, having served in leadership positions at Western IRB and Quorum Review. Together with colleagues, he recently founded the non-profit North Star Review Board. We recently had the opportunity to talk to Stephen about the role of IRBs, including independent IRBs, and the recent GAO report … Continue reading "An Interview with Dr. Stephen Rosenfeld"
The federal regulations for the protection of human subjects in research, also known as the Common Rule, require that informed consent of potential research participants present adequate information to allow them to understand why they might or might not want to participate in the research, including details about the purpose of the research and … Continue reading "Is Deception in Research Ethical?"
Protecting the privacy of research participants and maintaining the confidentiality of their data is an important aspect of ensuring adequate protections in human subjects research. For most investigators, this means having strong physical and electronic methods to protect research information. However, for research that collects sensitive information where release to those outside of the … Continue reading "What is a Certificate of Confidentiality and Does My Research Need One?"
In Part II of this IRB submission blog series, we focus on some common errors seen during IRB review. While each study is unique, there are some errors that are commonly seen. Below are examples of these common mistakes based on the IRB experience of the Learn eCORE founders and are supported from informal … Continue reading "Successful IRB Submissions Part 2: Common Mistakes Noted During IRB Review"
All federally funded human subjects research, and at many institutions, all human subjects research, must be approved by an Institutional Review Board (IRB). The IRB is an independently functioning committee charged with reviewing human subjects research to ensure that participants are protected according to accepted ethical standards and regulatory requirements. IRBs can be based … Continue reading "Successful IRB Submissions Part 1: Three Simple Tips"
Investigators conduct human subjects research to advance scientific knowledge that will improve people’s lives. However, there may be situations in which an investigator’s professional judgment regarding their research could be negatively influenced by a secondary interest such as potential financial gain or professional advancement. These secondary interests are referred to as “investigator conflicts of … Continue reading "Understanding Investigator Conflict of Interest (ICOI)"
Learn eCORE is pleased to announce that our expert compliance courses can be placed on other Learning Management Systems (LMS’s). Learn eCORE online courses were purposefully developed to be readily transferable to other LMS’s for customers who prefer this option. This allows customers to have seamless access to Learn eCORE courses along with their … Continue reading "New Value-Added Feature"
Our most recent blog featured Dr. Reid Blackman discussing the main ethical issues associated with AI development, including its use in research, and ways to mitigate these. Because of the outstanding response we had to this blog, we are following it up with a curated list of resources on AI research ethics. Our list … Continue reading "Resources for Ethical Issues in the Use of Artificial Intelligence (AI) in Human Subjects Research"
Dr. Reid Blackman is an ethicist who specializes in ethics related to new technologies, in particular, artificial intelligence or AI. He is the founder and CEO of Virtue, an ethical risk consultancy for businesses and other organizations that use AI. He is also the author of “Ethical Machines: Your Concise Guide to Totally Unbiased, … Continue reading "Reid Blackman on AI ethics"
Data from patients and health care systems (referred to as Real World Data) are being increasingly used along with data from traditional controlled clinical research to support clinical and regulatory decision making. For our first blog of the new year, Learn eCORE turned to Dr. Valery Gordon, an expert in bioethics and federal research … Continue reading "Human Research Protections in Research with Real World Data"
As we reach the end of 2022, we are grateful for an amazing first year in which we launched Learn eCORE, a minority and woman owned small business providing expert online training on high demand compliance and research ethics topics. Thank you to our wonderful customers who love our courses, complimentary materials, and … Continue reading "Learn eCORE Year In Review"
Ann Hardy, a Learn-eCORE co-Founder, is presenting along with other certified IRB professionals Rebecca Fasano (Augusta University) and Petrice Longenecker (USUHS), at the upcoming Public Responsibility in Medicine and Research (PRIM&R) annual conference in Session B3 “Perfect” Study Submissions: Approaches to Improving IRB Submissions for a Better Review Process. This session will provide perspectives … Continue reading "Learn eCORE’s Ann Hardy to present at the 2022 PRIM&R Conference"
This blog continues Learn eCORE’s discussion with Dr. Martin Mendoza, Director of health equity for the National Institutes of Health’s All of Us Program and focuses on the data generated by the All of Us Program and efforts to encourage its use by diverse investigators. See Part I of this blog series to learn … Continue reading "Diversity and Inclusion in the All of Us Research Program Part II: How All of Us is Creating Diverse Data Sets and Encouraging Their Broad Use"
Learn eCORE recognizes the importance of improving diversity and inclusion in research. Our courses address these topics and we have discussed this issue in other blogs and on social media. We recently had the opportunity to speak with Dr. Martin Mendoza, Director of health equity for the National Institutes of Health’s All of … Continue reading "Diversity and Inclusion in the All of Us Research Program Part I: Enrolling Diverse Participants"
Learn eCORE is pleased to feature a second blog from our colleagues at Solutions IRB that provides guidance on another common issue for investigators: Determining when a study needs IRB certification. Federal guidelines dictate specific requirements that must be followed when research involves human subjects. An Institutional Review Board or IRB is the … Continue reading "Defining Research for IRB Review of SBER Studies"
Learn eCORE frequently blogs on topics related to protecting the rights and welfare of human research participants. This guest blog, from Solutions IRB, addresses a very basic but common question in research: How to determine if a study involves human subjects research. Thanks to the Solutions IRB team for letting us share this with … Continue reading "What is Human Subjects Research?"
In keeping with our goal to publish timely and useful information related to human subjects research, Learn eCORE asked Donna Lloyd-Jones to share her expertise on the importance of health literacy to the research enterprise. Designing Health Literate Clinical Research By Donna Lloyd-Jones, Ph.D October is Health Literacy Month. It’s a good time to … Continue reading "Designing Health Literate Clinical Research"
Learn eCORE is pleased to feature this blog on clinical research diversity and health equity written by Dr. Doris Browne, MD, MPH, an experienced clinician and recognized advocate for increasing minority participation in all levels of clinical research. About the Author: Doris Browne, MD, MPH is the President and CEO, Browne and Associates, LLC, a … Continue reading "Diverse Clinical Trials and Health Equity"
What Is Social, Behavioral, and Educational Research (SBER) and How Does It Differ From Biomedical Research? Many people think that human subjects research is primarily focused on studying medical conditions. However, there are many types of non-medical research that involve human participants, such as research that falls under the umbrella term “social, behavioral, and educational … Continue reading "What Is Social, Behavioral, and Educational Research (SBER) and How Does It Differ From Biomedical Research?"
Long COVID: The Pandemic Within the Pandemic? In 2020, a new acute respiratory infectious disease rapidly became the global COVID-19 pandemic, causing widespread illness and death. Early on, clinicians noted that some patients continued to have a range of symptoms long after their acute infection had resolved. This more sustained form of COVID-19 goes by … Continue reading "Long COVID: The Pandemic Within the Pandemic?"
Learn eCORE Partners with NIH Research Initiative Learn eCORE is proud to announce its partnership with the National Institutes of Health (NIH)’s All of Us Research Program through its Community Advocate Network (CAN). All of Us is a large research program working to enroll one million or more participants across the U.S., including people and … Continue reading "Learn eCORE Partners with NIH Research Initiative"
Clinical Trials: A Participant’s Perspective While our Learn eCORE blogs often focus on compliance or ethical issues for those involved in the conduct or oversight of research, we thought it would be interesting to provide the perspective of a research participant. We recently spoke with Elaine Jones who participated in the 2020 Pfizer COVID vaccine … Continue reading "Clinical Trials: A Participant’s Perspective"
The Best Tools and Resources for Productive Clinical Trial Monitoring Visits If you work in Clinical Research, you know that there are different requirements for each type of Monitoring visit. Whether you are conducting a Pre-Study Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV)/Routine Monitoring Visit (RMV), or a Close-Out Visit (COV), each … Continue reading "The Best Tools and Resources for Productive Clinical Trial Monitoring Visits"
Ethical Issues for Research Involving Participants with Diminished Capacity to Consent Alzheimer’s Disease continues to be a common disorder of aging. In the United States, it is estimated that about 6 million Americans have Alzheimer’s Disease, which underscores the need for continued research on this form of dementia. The controversial approval in 2021 of the … Continue reading "Ethical Issues for Research Involving Participants with Diminished Capacity to Consent"
Decentralized Clinical Trials: Here to Stay? The COVID-19 pandemic instigated many changes in the clinical research enterprise. Among them was the need to quickly pivot to remote and digital methods for human subjects research in order to reduce exposure to the virus for both researchers and study participants. For clinical trials, this shift to less … Continue reading "Decentralized Clinical Trials: Here to Stay?"
The Pandemic’s Silver Lining: Increasing Participant-Centered Research Approaches At the start of COVID-19 pandemic in early 2020, scientists quickly pivoted to study this new disease’s transmission, clinical course, treatments, and identify prevention strategies. At the same time, the many social changes made in response to the pandemic such as restrictions on travel, and group activities … Continue reading "The Pandemic’s Silver Lining: Increasing Participant-Centered Research Approaches"
The Belmont Report, published 42 years ago, is the seminal document credited with creating the ethical foundation for research involving human participants in the United States. But new technologies have transformed the research world since then. Does the Belmont Report remain relevant today?
Do you need to certify that you understand how to conduct ethical research? Are you responsible for ensuring compliance for your organization’s research program? If so, then Learn eCORE (electronic Compliance and Research Ethics) can help by providing accurate, engaging, and affordable online research compliance and ethics courses specifically targeted to..