Genetics Research

Webinar Bundle: Genetics Research

The Genetics Research webinar bundle is made up of a curated selection of PRIM&R's recorded webinars, hand-picked to provide in-depth instruction. Developed and presented by experts, the webinars in this bundle offer insight into some of the fundamental concepts and challenges in genetics research. Webinar topics include gene therapy, ethical considerations of sharing genomic data, and best practices for Institutional Biosafety Committees (IBCs).

Continuing Education

 Webinar viewers holding the Certified IRB Professional (CIP®) credential may apply continuing education credits from each webinar towards CIP recertification. This webinar bundle is eligible for a total of 7 continuing education credits. Learn More »

Included Webinars

Data Sharing in Genomics Research: Participant Attitudes and Ethical Issues

2012

Speakers: Laura Lyman Rodriguez, PhD and Amy McGuire, JD, PhD

Policies for genomic data sharing are likely to be relevant to anyone collecting biospecimens for future research. However, many institutions don’t know what those policies are, how to comply with them, how to address them, or how to discuss them in consent forms and consent processes. For pre-existing studies, determining whether data sharing is consistent with the original consent remains a challenge. Many older consent forms do not explicitly address data sharing, and consequently, it can be challenging to know how to assess them. In addition, genomic science is advancing rapidly and the issues relevant to data sharing are evolving along with it. During this transitional time, there is great uncertainty about how to deal with genomics and genomic data. This webinar addresses the following topics:

  • The current state and evolution of data sharing policy, including other relevant developments in federal policy
  • IRB issues, best practices, and informed consent
  • Results from a randomized study of consent for data sharing conducted at Baylor College of Medicine, including:
    • Preconceptions and evolving opinions on controlled access and open-access data release
    • Changes in preferences following changes in data sharing options

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Genetic Research: Benefits, Risks and Ethical Issues

2010

Speakers: Ingrid Holm, MD, MPH and Lisa Lehmann, MD, PhD, MSc

The webinar provides an overview of the core ethical issues currently faced by scientists engaged in all areas of genetic research. During this webinar, speakers:

  • Explore complex ethical questions related to informed consent for genetic research, including the disclosure of test results
  • Discuss what investigators should do with incidental findings/variants of unknown significance
  • Review the issues to consider when engaging family members in research studies
  • Offer strategies for subject recruitment and drafting of informed consent documents for genetics research protocol
  • Explore the appropriate use of identified, archived specimens, for current and future research

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

IRB Review of Human Gene Transfer Protocols: New Guidelines and Considerations

2016

Speakers: Charlotte Coley, MACT, CIP and Joan Robbins, PhD

Human Gene Transfer (HGT) studies present unique challenges for IRB review, as many IRBs lack the expertise to evaluate these protocols. The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, released on April 27, 2016, details a new system in which IRBs are responsible for assessing whether review by the NIH Recombinant DNA Advisory Committee (RAC) is warranted. With the IRB's role in this research increasing, how can the efficient and timely review of HGT studies be facilitated while continuing to protect human subjects?

In this intermediate-level webinar, a biosafety and gene therapy expert and a nonscientist IRB member will cover the following topics as they relate to reviewing HGT protocols:

  • Gene Therapy 101: a primer on HGT, its defining characteristics, and how to recognize it
  • Coordination between the IRB, IBC, and RAC in accordance with the new NIH guidelines
  • Informed consent elements
  • Assessing risks and benefits

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Promoting Science and Safety: NIH Oversight of Human Gene Transfer Research

2010

Speakers: Marcia C. Finucane and Allan Shipp

This webinar promotes the professional development of those associated with IBCs by providing participants an opportunity to:

  • Discover the range of responsibilities that IBCs have under the NIH Guidelines;
  • Examine the relationship between IBCs and IRBs, and how these committees may work together in the oversight of human gene transfer research;
  • Work through case studies designed to clarify federal expectations with regard to biosafety review and surveillance of recombinant DNA and related research;
  • Gain insight into the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC) as a key federal advisory committee; and
  • Understand the requirements of Appendix M, along with the process of protocol submission to the National Institutes of Health Office of Biotechnology Activities (NIH OBA)

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

The Havasupai Settlement: Implications for HRPPs, IRBs, and Researchers

2010

Speakers: William Freeman, MD, MPH, CIP and Pearl O’Rourke, MD

This webinar focuses on the history, background, and analysis of the Havasupai Indian case.

This webinar addresses some of the questions that surfaced in the aftermath of the settlement, including:

  • What are the facts that led to the litigation and settlement of the Havasupai case?
  • What are the potential implications of this case for HRPPs and IRBs?
  • What does the Havasupai case say about implementing waivers of informed consent?
  • What insight might this case provide about how to conduct informed consent in research involving future and possibly unknown uses of DNA?
  • What might be inferred from this case concerning the return to subjects of clinically-important findings in DNA research?
  • How might HRPP/IRB discussions about the Belmont Report’s principle of beneficence be affected by the Havasupai case?

Participation in this 60-minute webinar counts as 1 CE credit hour.

Access Webinar Bundles

Webinar bundles are available to individual PRIM&R members at no cost. For a fraction of the cost of this bundle, become a member to watch the included webinars and gain dozens of other member benefits. 

Nonmembers can purchase individual or group access to this webinar bundle using the order form below. Each webinar is also availalbe individually. 

Individual nonmember rate: $900

Group nonmember rate: $1,925

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