Skip to Main Content.
Human Subjects site of Office of Research Support link to UT home link to Office of Research Support

The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011 or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

HOP policy 5-2011 QUESTIONS? Contact the Provost’s Office evpp_coi@austin.utexas.edu or call Janet Dukerich, Senior Vice Provost for Faculty Affairs at (512) 232-3310.

Webinar Archive

This page contains a listing of past webinars. To view a listing of future training opportunities, visit our News page.

OLAW Webinar: Meeting Requirements for Alternatives Searches: Information for IACUCs and Investigators

Date: June 26, 2014
Time: Noon - 1 p.m.
Location: FAC 426HH

Join OLAW for a webinar, Meeting Requirements for Alternatives Searches: Information for IACUCs and Investigators. Kathleen Gregory, reference librarian at the University of Denver, will provide information for IACUCs and researchers about the alternatives search required by the USDA Animal Welfare Regulations.


BCF Webinar: What You Need to Know About Animal Law

Date: June 4, 2014
Time: 11 a.m. - Noon
Location: FAC 426HH

Moderator: Jacquie Calnan, AMP

Presenters:

Nancy Halpern, DVM, JD
Patent attorney representing animal owners, veterinarians, animal-related businesses and the pharmaceutical industry in veterinary and animal law matters at Fox Rothschild LLP

Jim Newman
Director of External Communications
The University of Texas MD Anderson Cancer Center - Houston
Former TV news producer; Also served as associate director for media relations in the Strategic Communications department at Oregon Health & Science University and directed communications for OHSU’s Oregon National Primate Research Center.


NABR Webinar: Understanding Animal Legal Personhood Issues

Date: April 16, 2014
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

Richard L. Cupp, a law professor who writes and speaks extensively about animals’ legal status, will be the guest speaker for NABR's next webinar. Professor Cupp has advised numerous organizations about law and animals, and has been quoted by many print, television, and radio news sources from around the world. He is well-known for supporting humane treatment of animals rather than an animal rights paradigm.

Professor Cupp will speak on Understanding Animal Legal Personhood Issues. The animal rights movement was originally characterized by philosophical arguments, but now it is increasingly focusing on concrete legal action. A widely publicized habeas corpus lawsuit was recently filed in New York asserting "legal personhood" for chimpanzees kept by a research facility. Although a trial court dismissed the lawsuit seeking relocation of the chimpanzees, the case is now on appeal, and numerous similar lawsuits should be expected in other states. Court battles over animal legal personhood will likely entail a long-term struggle extending over many years and many jurisdictions.

Professor Cupp's presentation will explain legal personhood arguments and counterarguments, and will analyze the legal landscape regarding personhood claims. The presentation will also address possible implications for biomedical research, including how the litigation may expand beyond chimpanzees over time to include other animals more frequently utilized in research.


OLAW Webinar: Oversight of Research Involving Wildlife

Date: March 20, 2014
Time: Noon - 1 p.m.
Location:FAC 426HH

Topic:  Wildlife Biologist Robert Sikes, PhD, presents suggestions and a sample IACUC protocol form to facilitate IACUC review of research involving wildlife.

Who should attend? The program is tailored to IACUC staff, IACUC members, IOs, veterinarians, compliance personnel, animal care staff and others involved in animal programs.

Submitting questions:  You can submit questions in advance by email to olawdpe@mail.nih.gov or submit during the Webinar.

Webinar materials:  For recordings, slides and transcripts, go to Education Resources.

PRIM&R Webinar: Best Practices for Assessing Risk in Social and Behavioral Research

Date: February 12, 2014
Time: Noon - 1 p.m.
Location: POB (Formerly ACE) 2.404B

Risk to subjects is one of the central issues in research ethics. Institutional review boards (IRBs) and investigators must not only evaluate the risks in the study, but also ensure that the risks are minimized and are reasonable in relation to the benefits of the research.

There is lingering confusion about the definition of risk; for example, it’s frequently confused with harm. Risk is not harm; it is the possibility of harm. The evaluation of risk requires evaluating both the magnitude of the possible harm and the likelihood of the harm occurring. In addition, the risks and harms inherent in social, behavioral, and educational research (SBER) frequently differ from those associated with biomedical research. This webinar will provide a framework for identifying and assessing risks in SBER.

With references to case studies, the following topics will be addressed during this webinar: 

  • Assessing risk level, including applying the definition of minimal risk
  • Identifying risks in SBER
    • Types of risk that commonly arise in this research domain
    • Unique characteristics of SBER risks
  • Best practices for ensuring that risks are minimized 
  • Framework for evaluating whether the risks are reasonable in relation to the benefits
  • Best practices for informing subjects about risks in SBER

PRIM&R Webinar: Investigator-Initiated Device Studies

Date: January 30, 2014
Time: Noon - 1:30 p.m.
Location: FAC 426HH

US Food and Drug Administration (FDA) approval of an investigational device exemption (IDE) is required for studies of significant risk devices that involve human subjects and are not approved or cleared for the indication being studied. The process of applying for an IDE can be challenging for institutional review boards (IRBs) and investigators.

In most academic centers, investigators frequently rely on IRBs for guidance with the IDE submission and approval process. The goal of this webinar is to provide the tools for determining whether an IDE is necessary, charting a timeline for the application process, and identifying the respective responsibilities of investigators and IRBs. The webinar will cover:

  • Is an IDE needed?
    In order to assist the investigator in making this determination, the IRB needs to understand the goals of the study and whether the proposed research presents significant risk.
  • Application process
    If it is determined that an IDE is needed, IRB review must focus on the unique characteristics of device studies. Presenters will highlight the distinctions between device and drug studies as they pertain to IRB and FDA review, and identify key pieces of information that investigators need to present to the IRB and/or include in an IDE submission to FDA.
  • Deciphering the FDA decision letter
    The FDA decision letter will fully approve, approve with conditions, or disapprove the IDE. Presenters will review each of these potential decisions and offer insight into their implications.
  • Role of the IRB in the subsequent steps
    If the IDE is approved with conditions or disapproved, FDA’s decision letter will ask the investigator to respond to certain questions. If the IDE is fully approved, the sponsor may begin enrollment in the study without being subject to such requirements. The presenters will discuss how IRBs can assist investigators in preparing responses to FDA as well as in successfully initiating the IDE study.

NABR Webinar: The USDA Inspection Process in 2014: What’s New, What’s Not.

Date: January 7, 2014
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

A preliminary analysis of the FY 2013 inspection data would appear to indicate some things are changing. While the Top Ten cited sections still are topped by IACUC functions and veterinary care issues, the number of citations and the nature of citations provide some interesting insights into the inspection process.

Join us on January 7, 2014 when we will:

  • Review the Top Ten categories of citations
  • Provide an overview and analysis of the nature of those citations
  • Provide advice on how to avoid those citations
  • Provide a perspective on the overall inspection process

PRIM&R Webinar: AVMA Guidelines for the Euthanasia of Animals: Key Changes in 2013

Date: November 12, 2013
Time: Noon - 1: 30 p.m.
Location: FAC 426HH

The 2013 edition of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals contains substantial revisions from the previous publication of the guidance that may require operational changes for those working in animal care and use. Presenters Samuel C. Cartner, DVM, PhD, DACLAM, and Michael J. Huerkamp, DVM, DACLAM, will discuss the history, impact, and implications of some of these key changes. Topics for discussion will include: 

  • New technical requirements and challenges regarding the flow rate of CO2
  • Euthanasia of neonates and fetuses, including application to avian species: technical and ethical considerations
  • Training, proficiency, and competency: euthanasia by cervical dislocation and decapitation, and implications of the dropped term “scientific justification”
  • Disaster preparedness considerations for mass euthanasia
  • Elimination of thoracic compression as an allowable method and associated issues with wildlife
  • Euthanasia of aquatic species including hypothermia of fish
  • Comparison between AVMA guidelines and the guidelines in Canada and Europe

NABR Webinar: Are Your IACUC Records Putting You at Risk?

Date: October 8, 2013
Time: 11:30 a.m. - 12: 30 p.m.
Location: FAC 426HH

In today’s regulatory environment, the information contained within institutional records can form the basis for USDA citations.  The same records are also frequently the subject of FOIA/state open records requests and then used by animal rights groups in press releases and requests for additional enforcement action that can lead to  fines.  Join NABR and Dr. Lisa Halliday from the University of Illinois at Chicago on Tuesday, October 8, 2013 as we discuss:

  • Strategies for ensuring that your records are “FOIA Ready,” meaning they contain the facts and only the facts.
  • Guidance on what information should be included in documents specifically required by the animal welfare regulations.
  • Approaches for writing medical records, necropsy records and other documents often used to evaluate the compliance of an Animal Care and Use Program.

NABR Webinar: Q&A with the USDA

Have a question that you are just dying to ask the leadership of the USDA? You will now have that chance.

On July 9, 2013, Drs. Betty Goldentyer and Robert Gibbens, the Eastern and Western Regional Directors, USDA/APHIS/Animal Care, have graciously agreed to join us for our July Webinar to answer questions you have submitted in advance.

The questions that you submit will be reviewed and formatted to prevent duplication and submitted to the USDA representatives in advance of the Webinar.

Questions will be answered in the order they are received, so get your questions in soon. As in the past we will schedule the session for an hour, but it will last until all your questions are addressed. Send your questions to info@nabr.org.


NABR Webinar: Defusing Crises: Why Everything You Know About Crisis Management is Wrong

Date: April 9, 2013
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

NABR is excited to announce the guest speaker for our next webinar: Eric Dezenhall. As a renowned crisis communications expert, a frequent TV commentator on CNBC, MSNBC, Fox and other network broadcasts,  author of  fiction and non-fiction books including Nail 'em!: Confronting High-Profile Attacks on Celebrities and Business and Damage Control: Why Everything You Know About Crisis Management is Wrong, and as a guest columnist in the Huffington Post and Daily Beast, Dezenhall has seen it all. On April 9, he will join us at NABR Headquarters in Washington, DC to dispel common myths about crisis management and provide time-tested advice for understanding and defusing crises.   Drawing on his wealth of experience, Dezenhall will explain what you should, and perhaps more importantly, should not do when your organization becomes the target of misleading and inaccurate claims by critics including animal rights groups, the press, or other “‘unfriendlies.”

Dezenhall has provided advice to the highest profile celebrities and Fortune 500 company CEO’s.  This webinar provides a unique opportunity to hear from one of the most effective crisis handlers in the country.  NABR encourages you to invite colleagues from other departments in your organization to attend this webinar.


PRIM&R Webinar: Online Research, Social Media, and the IRB: Assessing Ethics, Norms, and Risks 

Date: March 12, 2013
Time: 12 - 1 p.m.
Location: FAC 426HH

The emergence of online communities and research on and through social media has presented challenges to institutional review boards (IRBs) who assess novel recruitment methods, data collection techniques, and diverse forms of risk. This webinar will describe an array of online spaces, with a particular focus on appropriate IRB review.

The following topics will be covered during this webinar:

  • The specificity of social media as it relates to online research
  • Different types of social media used in human subjects research
  • Tips for evaluating what qualifies as appropriate recruitment and data collection techniques in diverse online spaces
  • Relevant issues and important considerations for IRBs  regarding social media research
  • Techniques for IRBs to address questions of social norms in online communities and social media fora
  • Strategies for how IRBs can estimate baseline risks to subjects, and specifically, what constitutes risk and what constitutes more than minimal risk in online research.

OLAW Webinar: Disaster Planning

Date: March 7, 2013
Time: 12 - 1 p.m.
Location: FAC 426HH

Participate in this Webinar to learn about OLAW's expectations of Assured institutions regarding planning for and responding to natural and other disasters that may have an impact on their animal care and use programs. Guest speaker Stephen Durkee will provide best practice insights into developing a disaster plan compliant with the Guide.


Quorum IRB Webinar: IRB Evaluation of Advertisements and Consent Forms

Date: March 5, 2013
Time: 12 - 1 p.m.
Location: FAC 426HH

Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward.

Advertising is the beginning of the informed consent and subject selection process and sets the stage for the consent process. Understanding the regulatory and ethical obligations that form IRB evaluation of advertisements and consent forms is critical during the development of the recruitment and consent plans and tools.

Quorum Review presents a special webinar with J. Claire Carbary, JD, CIP, to address some of the common issues confronted during ethics review of advertisements and consent forms from the perspective of the IRB.

Attendees will learn:

  • Specific requirements and types of information that should be included in advertisements as well as language to avoid
  • How to provide adequate discussion of procedures, risks, and alternatives in the consent form
  • Restrictions related to exculpatory language and tips for avoiding therapeutic misconception in clinical research advertisements and consent documents

 

PRIM&R Webinar: Key Decision Points: Is it Research Involving Human Subjects?  Is it Exempt? Is IRB Review Required? 

Date: February 28, 2013
Time: 12 - 1:30 p.m.
Location: FAC 426HH

This webinar will focus on identifying whether activities are human subjects research and, if so, what level of review they require. Using case studies from both biomedical and social science/behavioral research, presenters will discuss the process for determining when an activity constitutes research involving human subjects, and when such research is exempt, qualifies for expedited review, or must undergo full institutional review board (IRB) review.

  • What is considered human subjects research?
    During this part of the presentation, the speakers will identify when an activity is considered “research” and when that activity involves “human subjects” as defined in the Department of Health and Human Services (DHHS) and U.S. Food and Drug Administration (FDA) regulations. They will also briefly explore what it means to be “engaged in research” and therefore obligated to apply the regulations.
  • When is research exempt?
    This section will feature an overview of the federally mandated exemption categories and the differences between DHHS and FDA regulations with regard to exempt research.
  • When is IRB review required?
    This section of the webinar will focus on the criteria for expedited review, and the speakers will compare this type of IRB review with full board review.  

APHIS Webinar: Animal Welfare Act Contingency Plan Final Rule

Date: February 15, 2013
Time: 12 - 1 p.m.
Location: FAC 426HH

On December 31, 2012, APHIS published a final rule requiring all dealers, exhibitors, intermediate, handlers, carriers, research facilities, and other entities regulated by the Agency under the Animal Welfare Act (AWA) to take additional steps to be prepared for potential disaster situations. This is the first time APHIS will be hosting a live, interactive webinar open to the public on a new rule. Please join us for a general overview of the regulation and an opportunity to have your questions about the regulation answered. A recording of the presentation section of the webinar and answers to questions will be posted online for those who can’t make it to the webinar.


AAHRPP Webinar: IRB Review of Local Context

Date: January 31, 2013
Time: 2:30 - 4 p.m.
Location: FAC 426HH

With the increased use of single IRBs for review for multi-site studies, as well as for single site studies that are reviewed by an IRB external to the site where the research is conducted, questions about the reviewing IRB’s responsibilities in considering local context have been raised.  The Office for Human Research Protections has archived its 1998 guidance on Knowledge of Local Context, and has issued a letter dated April 30, 2010, which clarifies that OHRP fully agrees with the Food and Drug Administration’s position on the benefits of relying on a single central IRB for multicenter research. This webinar will address what information an IRB needs to obtain and review to ensure research sites protect human participants.


PRIM&R Webinar: Ethics, Scientific Merit Review, and Harm-Benefit Analysis in Animal Research

Date: January 30, 2013
Time: 12 - 1:30 p.m.
Location: ACE 2.402

Conducting research with animals is essential to the advancement of knowledge related to human health, animal health, and other areas that benefit society. The institutional animal care and use committee (IACUC) is the society’s gatekeeper charged with ensuring that research involving animals is both ethically and scientifically justified.  

This webinar will address the following topics:

  • Ethical principles applied to animal research
  • Opposing viewpoints related to animal research
  • IACUC review of scientific merit in accordance with the Public Health Service (PHS) Policy, the 8th edition of the Guide for the Care and Use of Laboratory Animals, and Animal Welfare Association (AWA) regulations
  • Harm-benefit analysis in animal research 

NABR Webinar: The USDA Inspection Process - The Top 10 Most Cited NCIs and How to Prevent Them

Date: January 08, 2013
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

During 2012, the top ten noncompliant items made up more than 40 percent of all USDA citations and almost 65 percent of these citations were related to the function of the IACUC. As the USDA continues to place increased emphasis on its enforcement process, it is more important than ever to avoid common mistakes that lead to citations.

This January 8, 2013 webinar will:

  • Review and analyze the top ten most frequently cited items of non-compliance for FY 2012;
  • Compare the citations for FY 2012 with those reported for FY 2011 and assess the differences between the two periods;
  • Discuss what these differences mean to your institution;
  • Review the appeals process, including recent developments; and
  • Provide proven tips to help you successfully manage the inspection process.

EH&E Webinar: Meeting the Challenges of BSL-2+: When to Use it and How to Adapt it to Your Facility

Date: November 13, 2012
Time: 12 - 1 p.m.
Location: FAC 426HH

Biosafety Level 2+ (BSL-2+) is the term frequently used to describe laboratories where work with microorganisms is conducted in a BSL-2 laboratory with biosafety practices and procedures typically found at BSL-3. The biosafety level is determined by a risk assessment process. In some cases the risk assessment reveals that safety practices over and above those required at BSL-2 are needed, yet a more complex BSL-3 laboratory facility is not necessary.

BSL-2+ has been used for many years, however, most research institutions still find it challenging to decide when to use this approach and which BSL-3 practices to use. This is due to the fact that it’s not a recognized containment level in biosafety guidance documents such as the Centers for Disease Control and Prevention’s (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL) or the National Institutes of Health’s (NIH) Guidelines for Recombinant DNA Research.

This webinar will help environmental health and safety and biosafety professionals by detailing a practical approach to implementing BSL-2+ practices and procedures, including how to:

  • Identify what work or projects require BSL-3 practices.
  • Conduct the risk assessment.
  • Modify BSL-3 practices and procedures for the BSL-2 environment based on your institution’s specific needs.
  • Properly train researchers in the use of BSL-3 practices in a BSL-2 laboratory.
  • Develop a project-specific Standard Operating Procedure (SOP).
  • Facilitate the collaboration between the Principal Investigator, Biosafety Officer, Institutional Biosafety Committee (IBC) and laboratory personnel.

AAHRPP Webinar: IRB Review of Research Involving Adults with Diminished Capacity to Consent

Date: October 25, 2012
Time: 2:30 - 4 p.m.
Location: FAC 426HH

Almost every IRB deals with research involving participants with diminished capacity to consent, either in projects directly studying such populations or by incidental inclusion.  This webinar will describe the AAHRPP requirements for research involving participants with diminished capacity to consent, what researchers should know and plan for, and how IRBs should review and approve such research. Presenters are:

  • Leslie Katzel, M.D., Ph.D., University of Maryland School of Medicine and the Baltimore Veterans Affairs Medical Center
  • Susan Stayn, J.D., Stanford University

NABR Webinar: Are You Being Cited Correctly? Are You Sure?

Date: October 16, 2012
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

In recent months, NABR members have reported changes in the focus of USDA's inspection process and inspections that did not follow procedures outlined in USDA’s Consolidated Inspection Guide. In the current regulatory enforcement climate, it is becoming increasingly important to ensure that your facility is not inaccurately cited.

This webinar will answer the question, “what to do if you are cited incorrectly” by:

  • Using real life scenarios from inspection reports  
  • Providing proven tips for effectively managing inspections
  • Revealing the process for correcting erroneous citations

PRIM&R Webinar: The IACUC’s Role in Environmental Enrichment Programs

Date: October 9, 2012
Time: Noon - 1:30 p.m.
Location: FAC 426HH

The goal of environmental enrichment programs is to provide research animals with housing that promotes species-specific behaviors and enhances overall well-being. This webinar will focus on the role of the IACUC in the development and operation of environmental enrichment programs. Topics for discussion will include: 

  • Ensuring that IACUC members know the behavioral repertoires of and best practice enrichments for the species that are housed at your institution
  • Developing an enrichment program and determining best practice enrichments with a focus on nonhuman primates (NHP) and rodents
  • Interpreting the regulations in the 8th edition of the Guide for the Care and Use of Laboratory Animals and European Union directive on enrichment and behavioral husbandry
  • Identifying the IACUC’s role in reviewing the environmental enrichment program and exemptions
  • Educating personnel responsible for animal care and husbandry to monitor the effects of enrichment and identify adverse or abnormal behaviors
  • Reporting requirements pertinent to environmental enrichment such as noncompliance, deviation, and activity suspension

PRIM&R Webinar: Community Engagement in International Research: Considerations for Ethics Review

Date: September 27, 2012
Time: Noon - 1:30 p.m.
Location: FAC 426HH

The U.S. Presidential Commission for the Study of Bioethical Issues has recently suggested that enhancements to engagement strategies for host communities during international research studies could improve the protection of both the individual research participants and their communities. While community engagement is increasingly recommended and mandated as part of ethical research both domestically and abroad, there is little agreement among stakeholders about what constitutes meaningful engagement, and how it reduces the risk of harm for research participants and the communities of which they are a part. 

This webinar will focus on community engagement in research conducted abroad and its relevance to the work of human research protections professionals. After defining key ideas and terminology, our esteemed faculty will examine three questions central to the design and assessment of ethical community engagement strategies.

  • Why engage communities? 
    During this part of the presentation, the speakers will explore the ethical value of community engagement by examining the kinds of research harms that arise in the international context and explaining how community engagement offers protections from these harms.
  • Who should be engaged? 
    Engaging communities in research requires deciding what constitutes the relevant “community” for any research study. In this segment, the speakers will share ideas about the meaning of "community" for research, and share strategies for identifying the relevant community for any specific research study.
  • How should the community be engaged?
    During this segment, the presenters will discuss key elements of meaningful community engagement programs, to guide institutional review boards (IRBs) in assessing research proposals and researchers in designing and implementing programs.

OLAW Webinar: Departures from the Guide

Date: September 13, 2012
Time: Noon - 1 p.m.
Location: FAC 426HH

OLAW Online Seminars program is a free webinar series to help Institutional Animal Care and Use Committees (IACUCs) and Institutional Officials (IOs) explore their responsibilities in the oversight of PHS-funded research that involves the use of live vertebrate animals. This webinar will be presented by Patricia Brown, VMD, MS, DACLAM, Director, OLAW, NIH.


PRIM&R Webinar: Research Ethics Beyond Respect, Beneficence, and Justice

Date: September 12, 2012
Time: Noon - 1 p.m.
Location: FAC 426HH

Most human research protections professionals are familiar with the ethical principles of respect, beneficence, and justice as laid out in the Belmont Report and as codified in the US federal regulations governing research with human subjects.

However, the domain of research ethics encompasses much more than these three principles, and engaging directly with the other important concepts can help research ethics professionals better understand and more thoughtfully fulfill their roles.

This webinar will look beyond the Belmont principles to explore some of the additional ethical questions and concepts that come into play during the protocol review process, but are not well delineated or defined in the regulations. More specifically, we will explore why research with human subjects raises special, though not necessarily unique, ethical questions, as well as discuss the difference between ethics and compliance and why it is useful for those who review research to engage with ethical questions and concepts directly. Additional topics for discussion will include:

  • Informed Consent: The role of voluntariness, disclosure, and comprehension in genuinely informed consent, and how the requirement for informed consent embodies respect for persons.
  • Undue influence: What constitutes undue influence, why it is a concern, and how it is distinct from coercion.
  • Vulnerability: What it means to be vulnerable, which populations are considered vulnerable and why, and the ethically important differences between types of vulnerability.

AAHRPP Webinar: Quality Metrics for Institutional Review Board Performance

Date: July 26, 2012
Time: 2:30 - 4 p.m.
Location: FAC 426HH

IRBs must both comply with regulations, as well as make ethical decisions concerning approval of research. This webinar will explore measures of quality of IRB performance in both areas.


OLAW Webinar Housing Laboratory Rodents According to the 8th Edition of the Guide

Date: July 19, 2012
Time: Noon - 2 p.m.
Location: ACE 2.402

This webinar will focus on rodent housing and breeding practices at PHS Assured institutions. Collaborators Dr. Guy Mulder of Charles River Laboratories and Dr. Joe Garner of Stanford University will present a framework for assessing rodent well-being from the perspective of a large commercial breeder and an academic researcher. Dr. Axel Wolff will present the OLAW position. 


PRIM&R Webinar: Conflicts of Interest in the Wake of NIH’s New Policy

Date: July 11, 2012
Time: Noon - 1:30 p.m.
Location: NOA 5.318 (Note location change)

Compliance with the final rule on financial conflicts of interest (COI), issued by the National Institutes of Health (NIH) in August 2011, must be achieved by August 24, 2012. Any institution applying for or receiving NIH funding from a grant, cooperative agreement, or contract will need to be in adherence with all of the revised regulatory requirements by the aforementioned date. This webinar will focus on the changes brought on by the new rule and will provide examples of possible implementation strategies and case studies.

The following topics will be discussed during this presentation:

  • Background information on COI and the current state of affairs
  • What potential research participants want to know, and how this information influences decisions to participate
  • Current literature on the implications of COI: findings about the relationship between industry sponsorship of clinical research and industry-favorable research findings; the lack of empirical data on the impact of COIs or their management on research integrity; and emerging literature on the counterproductive impacts of disclosure 
  • Operationalizing the new NIH COI policy: how the new rule will change what information is available to institutional review boards (IRBs) and COI programs and affect IRB decisions about what should be included in informed consent processes and documents
  • Difficult elements of the new policy: institutional determinations of when conflicts exist, travel disclosures, bias assessment, and mitigation plans
  • Changes to how conflicts will be formally assessed and the lack of NIH guidance on acceptable institutional COI management strategies
  • Contextualizing COI: Variability among institutional approaches to COI and case studies to demonstrate how  institutions are dealing with complex scenarios

NABR Webinar: How Will USDA’s Consolidated Inspection Guide and FOIA Impact You?

Date: July 10, 2012
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

In this webinar we will highlight key points and changes in USDA’s new Consolidated Inspection Guide to help assure your institution has a proper inspection management process in place. We will also review the latest uses and abuses of information that is available through the federal Freedom of Information Act (FOIA) and state open records laws and provide useful tips on how you can monitor and manage this information.

  • USDA’s new Consolidated Inspection Guide contains information not included in the previous Research Facility Inspection Guide, which should be incorporated into your inspection management process. Among the additions is crucial language that could be used to appeal citations that have been erroneously issued.
  • Recent FOIA requests have sought significant amounts of photographic and written information related to inspections. Such information is increasingly forming the basis of targeted campaigns against research facilities. Now more than ever, research facilities should develop strategies and policies for identifying and managing publicly-available information.

Institutional Officials, Attending Veterinarians, Communications Staff, IACUC Members and employees responsible for implementing Animal Care and Use programs are encouraged to attend. This webinar will include a live Q&A session. However, to ensure your issues and concerns are adequately addressed, please submit them in advance to info@nabr.org.


PRIM&R Webinar: Data Sharing in Genomics Research: Participant Attitudes and Ethical Issues

Date: May 24, 2012
Time: Noon - 1:30 p.m.
Location: FAC 426HH

Data sharing is a tenet of research traditionally expressed through publication and the opportunity for others to review, critique, and attempt to reproduce scientific findings. Data sharing has also increasingly become standard practice as a means to promote resource sharing across the research community.

Genomics research, in particular, is built on principles of rapid and broad data sharing through community resources. Since 2008, NIH-funded genomics studies have shared information through the database for Genotypes and Phenotypes (dbGaP), the NIH database designed to archive and distribute data from genome-wide association studies (GWAS). 

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.

During this webinar, the following topics will be discussed:

  • The current state and evolution of data sharing policy, including other relevant developments in federal policy
    • e.g. issues under discussion by the Presidential Commission for the Study of Bioethical Issues: privacy vs. access; individual vs. societal benefit
  • 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

AAHRPP Webinar: Ethical Requirements in Exempt Research (Element II.2.B.)

Date: April 26, 2012
Time: 2:30 - 4 p.m.
Location: FAC 426HH

Although exempt from the regulations, research that is determined to be exempt must still be conducted under ethical standards and respecting the rights and welfare of the participants. This webinar will discuss the ethical considerations in exempt research including obtaining consent and maintaining confidentiality of data.


OLAW Webinar: Performance Standards

Date: April 19, 2012
Time: Noon - 1 p.m.
Location: FAC 426HH

The seminar is being conducted by the Office of Laboratory Animal Welfare (OLAW). OLAW provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.


NABR Webinar: Animal Rights: What To Do When Your Institution is Targeted

Date: April 10, 2012
Time: 11:30 a.m. - 12:30 p.m.
Location: ACE 2.402

This NABR webinar will examine approaches your institution can take when it becomes the target of an animal rights campaign. Recent animal rights campaigns have included misleading and inaccurate reports, data mining of government information using FOIA, media attention, extensive use of social media, and protests. Effective responses to these types of campaigns will be examined in detail and an analysis of institutional responses will be presented. Specific topics that will be addressed include:

  • Determining if your institution is likely to be targeted
  • Communicating with the press and other stakeholders
  • Materials you should have prepared prior to becoming a target
  • Resources available from NABR and the Foundation for Biomedical Research

This webinar will include a live Q A session. However, to ensure your issues and concerns are adequately addressed, please submit them in advance to info@nabr.org.


Quorum IRB Webinar: Research and HIPAA – Recruitment, Consent, and Beyond

Date: April 10, 2012
Time: Noon - 1 p.m.
Location: FAC 426HH

A "nuts and bolts" training regarding the implications and requirements of HIPAA in the context of recruitment, the consent process, the duration of the study and even after study closure. This presentation will provide an overview of HIPAA privacy rules and guidelines. Covered topics will include the responsibilities of the researchers, sponsors, and IRBs.


PRIM&R Webinar: Ethical Internet Research: Informed Consent Regulations and Realities

Date: March 15, 2012
Time: 12 - 1:30 p.m.
Location: FAC 328

This webinar will examine existing regulations that pertain to informed consent in the context of research conducted via the internet.  

The goal of this webinar is to:

  • Identify specific Internet research settings and conditions for consent
  • Discuss how to apply Common Rule regulatory requirements for informed consent to Internet research
  • Explain regulatory flexibilities applicable to consent in Internet research
  • Address obtaining parental consent and child assent in Internet research involving minors
  • Present sample language for informed consent documents for Internet research regarding data security and confidentiality of research-related information

OLAW Webinar: Use of Non-Pharmaceutical-Grade Chemicals and Other Substances in Research with Animals

Date: March 1, 2012
Time: 12 - 1 p.m.
Location: FAC 426HH

The seminar is being conducted by the Office of Laboratory Animal Welfare (OLAW). OLAW provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.


EH&E Webinar: Best Practice Strategies for Laboratory Safety Programs

Date: February 7, 2012
Time: 12 - 1 p.m.
Location: FAC 426HH

Recent news regarding significant laboratory accidents out of UCLA and UFL has revealed several vulnerabilities in laboratory safety management in higher education and research institutions. Internally, Board and C-level inquiries and independent third-party audits can be anticipated in the coming weeks and months. Federal OSHA and state regulators are likely to be more focused on laboratory safety and facilities operations.

Institutionalizing a culture of safety among researchers, their staff, and the Safety and Facilities departments is essential for successful and sustained efforts. This webinar focuses on best practices and proven strategies for implementing, maximizing, and tracking the effectiveness of laboratory safety management programs.

This online event will focus on the following areas of the laboratory safety program:

  • Risk-based Inspection Protocols
  • Strengthening your Existing Laboratory Inspection Program with Corrective Action and Documentation Management
  • Creating a Laboratory Hazard Assessment Tool – and Using It
  • Risk Management of High Hazard Chemicals 
  • Employee Training and Documentation Management
  • Management Challenges in Laboratory Safety

AAHRPP Webinar: Community Involvement in Research - What Researchers and IRBs Need to Know

Date: January 26, 2012
Time: 2:30 - 4 p.m.
Location: FAC 426HH

Community-based participatory research is a popular methodology to study participants in hard-to-reach populations. Community involvement helps make many research projects more successful. But community-based research has its own set of ethical issues that can be challenging to IRBs that are not experienced or knowledgeable in this type of research. This webinar will describe the processes and issues involved in community-based participatory research and what IRB members and researchers need to know.


AAALAC Webinar: Module 4 - Chapter 5 of the New Guide, Physical Plant

Date: January 18, 2012
Time: 10 - 11 am.
Location: ACE 2.402

The final module in the series will cover key topics in Chapter 5 of the new Guide for the Care and Use of Laboratory Animals; Physical Plant.  Topics to be discussed include animals in laboratories, doors, windows, floors, temperature control and failsafe, HVAC minimum function, lighting and override systems, storage, vibration, rack washer safety, environmental monitoring, surgery in laboratories, barrier facilities, imaging facilities, and behavioral studies.


AAALAC Webinar: Module 3 - Chapter 4 of the New Guide, Veterinary Care

Date: January 17, 2012
Time: 10 - 11 am.
Location: ACE 2.402

This module will review important topics in Chapter 4 of the new Guide for the Care and Use of Laboratory Animals; Veterinary Care. Key elements of this chapter include the role of the Attending Veterinarian and the overall program of veterinary care, procurement, transportation, breeding colonies, surgical training, presurgical planning, aseptic technique and intraoperative monitoring.


AAALAC Webinar: Module 2 - Chapter 3 of the New Guide, Environment, Housing and Management

Date: January 12, 2012
Time: 10 - 11 am.
Location: ACE 2.402

This module will review key topics in Chapter 3 of the new Guide for the Care and Use of Laboratory Animals; Environment, Housing and Management. Topics of discussion will include relative humidity, VAV systems, recycled air, social housing, cage and pen space, environmental enrichment and aquatics.


NABR Webinar: Examining USDA’s “Age of Enforcement”

Date: January 10, 2012
Time: 11:30 a.m. - 12:30 p.m.
Location: FAC 426HH

As the USDA inspection process continues to evolve in this “Age of Enforcement,” it is important to review and analyze the most frequently cited items of non-compliance and discuss what they may mean to your institution.  In our January 10, 2012 webinar we will:

  • Review and analyze the top 10 most frequently cited items of non-compliance for FY 2011 (61% involved IACUC activities);
  • Compare the citations for FY 2011 with those reported for FY 2010 and assess the differences between the two periods;
  • Discuss what these differences may mean to your institution; and
  • Provide proven tips to help you successfully manage the inspection process

This webinar will include a live Q&A session. However, to ensure your issues and concerns are adequately addressed, please submit them in advance to info@nabr.org.


AAALAC Webinar: Module 1 - Chapter 2 of the New Guide, Animal Care and Use Program

Date: January 09, 2012
Time: 10 - 11 am.
Location: ACE 2.402

This module will review the key topics in Chapter 2 of the new Guide for the Care and Use of Laboratory Animals; Animal Care and Use Program.  The function of the IACUC will be emphasized as well as institutional collaborations, personnel training, program oversight, occupational health and safety, protocol review, harm-benefit analysis, establishing humane endpoints, and unexpected outcomes and other select topics.


Quorum Review IRB Webinar: Using Electronic Consent and Technologies to Facilitate and Improve the Research Process - Regulatory and IRB Considerations

Date: November 30, 2011
Time: Noon - 1 p.m.
Location: ACE 2.402

Implementing electronic technologies may facilitate research, improve research efficiency, and benefit research participants. However, successfully implementing these technologies requires understanding the applicable regulatory requirements and IRB considerations. This webinar will address electronic technologies for obtaining consent, facilitating consent, storing study data, and monitoring study data. For each of these four topics, the presenter will discuss the current regulatory and IRB framework to ensure compliance and a successful IRB submission.


PRIM&R Webinar: Post-Approval Monitoring: From Primer to Production

Date: November 15, 2011
Time: Noon - 1:30 p.m.
Location: ACE 2.402

This goal of this webinar is to provide a broad overview of post-approval monitoring (PAM). Topics to be addressed during this webinar will include:

  • The function, purpose, and variety of post-approval monitoring
  • Strategies and resources for success in running your PAM program
  • Tailoring PAM to the needs of your institution
  • Integrating of PAM with other animal care and use function
  • Practicing diplomacy: education, outreach, and training
  • Facilitating compliance by keeping research staff informed about new regulations

NABR Webinar: Exploring Chapter Three of the New Guide

Date: November 1, 2011
Time: 11:30 a.m. – 12:30 p.m.
Location: FAC 426HH

This webinar will review recommendations contained in Chapter 3 of the new Guide for the Care and Use of Laboratory Animals and its impact on your animal care and use program. Identifying changes to the Guide is more important than ever as AAALAC is now using the Eighth Edition of the Guide to assess and accredit animal care and use programs. OLAW has announced plans to issue position statements after it completes an in-depth analysis of the public comments it received in May.

Chapter 3 provides guidelines for the environment, housing and management of laboratory animals used or produced for research, testing, and teaching. While the increase in the total number of “musts” and the addition of 20 pages are largely attributed to a new aquatic animal section, there are 164 “shoulds” that may require changes to your animal care and use program. Topics covered by this webinar will include:

  • Environment, Housing and Management of Terrestrial Animals
  • Changes to Cage Size Recommendations for Trio Breeding
  • The Results of a NABR Survey of Predominantly Used Cage Sizes
  • Environment, Housing and Management of Aquatic Animals

To put the recommendations in Chapter 3 in perspective requires an analysis of where the “musts” and “shoulds” appear and careful consideration of what impact they will have on the management of your animal care and use program. In the preparation of this webinar, NABR is conducting a survey of its members to determine the predominant type of caging currently in use for housing mice. This webinar will include a live Q&A session. However, to ensure your issues and concerns with Chapter 3 are adequately addressed, please submit your questions to info@nabr.org by the close of business on October 28, 2011.


AAHRPP Webinar: Protecting "Other" Vulnerable Populations In Research

Date: October 25, 2011
Time: 2:30 - 4 p.m.
Location: FAC 426HH

This webinar hosted by the Association for the Accreditation of Human Research Protection Program (AAHRPP) will discuss application of the following two elements related to vulnerable populations and human subject research:

Element II.4.A The IRB or EC has and follows written policies and procedures for determining the risks to prospective participants who are vulnerable to coercion or undue influence and ensuring that additional protections are provided as required by applicable laws, regulations, codes, and guidance.

Element II.4.B The IRB or EC has and follows written policies and procedures requiring appropriate protections for prospective participants who cannot give consent or whose decision-making capacity is in question.


PRIM&R Webinar: When the Stakes are High: Managing Communication and Public Opinion in Research Settings

Date: October 18, 2011
Time: Noon - 1:30 p.m.
Location: ACE 2.402

This webinar is intended to provide those working in the research field with how-tos as they relate to managing a research crisis and communicating about animal research.

Suzanne Rivera’s portion of the presentation will cover:

  • Examples of what constitutes a research “crisis.”
  • Addressing concerns about the safety of human subjects, animals, research personnel, and the environment.
  • Analyzing root causes and identifying signs of stress in your research program, implementing a plan for prevention of repeat occurrences, and repairing the damage to institutional reputation.
  • Assembling your recovery team and selecting an executive sponsor who empowers the group to act.
  • Developing a communication strategy for both internal and external messages.

Paul McKellips’ portion of the presentation will cover:

  • The fall of public support (1948 to today) and where the public’s opinion of animal research stands today.
  • Messaging strategies that are effective in altering public opinion.
  • Targeting the demographic most opposed to animal research and the rise of the extreme animal rights movement.
  • The depiction of animal research in the media.The Humane Society of the United States (HSUS) and the ballot initiatives and state referendums.

PRIM&R Webinar: Improving Informed Consent: Innovations in Form and Process

Date: September 22, 2011
Time: Noon - 1:30 p.m.
Location: FAC 426HH (Please note the room change)

Improving Informed Consent: Innovations in Form and Process, will feature an overview of the current practices around informed consent, identify shortcomings, and offer ideas for improvement.

The topics to be discussed during this program may help answer questions such as:

  • What is missing from consent forms, and what is included that should not be?
  • What happens after institutional review board  (IRB) review, but before the implementation of the consent process?
  • How much emphasis should be placed on the consent form, and what needs to be addressed during the consent conversation?
  • Would the IRB be able to adequately review the consent process if it were primarily verbal?
  • How can and should those who create, review, and administer consent processes respond to the needs of the limited English proficiency populations?

OLAW Webinar: Occupational Health and Safety Programs

Date: September 8, 2011
Time: 1 - 2 p.m.
Location: ACE 2.402

The seminar is being conducted by the Office of Laboratory Animal Welfare (OLAW). OLAW provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.


PRIM&R Webinar: Primer on the Advance Notice of Proposed Rulemaking

Date: August 10, 2011
Time: Noon - 1 p.m.
Location: FAC 330

The Department of Health and Human Services (DHHS) has posted proposed changes to the 'Common Rule,' and will accept public comments through September 26, 2011. To help ensure that the University of Texas at Austin is aware of the intricacies of the Advance Notice of Proposed Rulemaking (ANPRM), PRIM&R is pleased to announce a webinar titled PRIM&R's Primer on the ANPRM.

This webinar will be offered on Wednesday, August 10, at noon. The webinar will be hosted by, and feature a live question-and-answer session with, P. Pearl O'Rourke, MD, PRIM&R board member and director of human research affairs at Partners HealthCare Systems.

This webinar will feature an overview of ANPRM proposals for consideration, including:

  • Creating mandatory standards for data security and information protection
  • Eliminating the requirement for annual continuing review for some research
  • Requiring informed consent for research using identifiable or de-identified biospecimens
  • Expanding the types of research that can be exempted from institutional review board (IRB) review
  • Improving informed consent forms

At the conclusion of Dr. O'Rourke's summary, there will be time allotted for points of clarification only, but she will not be able to respond to inquiries concerning the interpretation or implications of the ANPRM.


NABR Webinar: The New Guide: Diving Into the Details of Chapters 1 & 2

Date: July 12, 2011
Time: 11:30 a.m. - 12:30 p.m.
Location: ACE 6.336

As OLAW is considering comments on the new Guide and AAALAC will begin using the new edition for program evaluations beginning in September 2011, now is the time to ensure you know how changes to the Guide will impact your Animal Care and Use Program. This NABR webinar will provide a detailed review and analysis of chapters 1 and 2, primarily focusing on Chapter 2. Chapter 2 is more than twice as long as the corresponding chapter in the previous edition of the Guide and contains 70% more “musts” and 68% more “shoulds”. Chapter 2 also includes the following topics, which will be covered in our webinar:

  • Program Management (Program Management Responsibility & Personnel Management)
  • Program Oversight (Role of the IACUC, Postapproval Monitoring)
  • Disaster Planning and Emergency Preparedness

To put these changes in perspective requires an analysis of where new “musts” and “shoulds” appear within the chapter and the impact they will have on the management of your Animal Care and Use Program. While the webinar will include a live Q&A section, to best assure that your issues and concerns with Chapter 2 are addressed in detail, please submit them to info@nabr.org by the close of business on July 1, 2011.


PRIM&R Webinar: Community IRB Members: Supporting Their Involvement to Advance Research

Date: July 12, 2011
Time: Noon - 1:30 p.m.
Location: ACE 2.402

Community IRB Members: Supporting Their Involvement to Advance Research will focus on the engagement of community members in the function of Institutional Review Boards (IRBs). The presenters for this webinar will include an institutional official, a community member of an IRB, and a federal agency representative.

During this webinar, you will learn more about:

  • The role of the community IRB member: meeting the need for community representation and providing the benefit of fresh perspectives.
  • The IRB’s responsibilities: educating new community members and sensitizing other IRB members to the value of community members’ contributions to the research enterprise. 
  • The community member experience: challenges of joining an IRB, what to expect in the first year, and tips for integration.
  • The Department of Energy’s initiative for enhancing community member participation: past programs and future directions.

PRIM&R Webinar: No More Excuses: Building Trust and Capacity through the Bioethics Research Infrastructure Initiative

Date: June 14, 2011
Time: Noon - 1:30 p.m.
Location: ACE 2.402

Building Trust Between Minorities and Researchers is a federally funded initiative based at the University of Maryland’s Center for Health Equity. The goal of this initiative is to develop, implement and evaluate strategies aimed at increasing minority participation in biomedical and public health research. PRIM&R has partnered with the research team to facilitate the development and presentation of educational programs that improve research literacy for and respectful engagement with minority communities.

No More Excuses: Building Trust and Capacity through the Bioethics Research Infrastructure Initiative is the third webinar in a three-part series that will introduce two curriculum products, one aimed at minority communities for the general public and one at researchers, research staff and institutional review board members and staff.


ACUP Webinar: Post Approval Monitoring (PAM)

Date: May 16, 2011
Time: Noon - 1 p.m.
Location: ACE 2.402

This presentation is designed for institutions that do not currently have a formal PAM program, but are considering adding one.

This webinar will cover:

  • Goals of a PAM program
  • Designing a PAM program to fit your institution
  • Staffing your program with appropriate individuals
  • Choosing the PAM tasks that fit your institutional needs
  • Scheduling PAM tasks for appropriate time intervals
  • Formalizing your program; why it’s important, types of policies/SOPs to develop
  • Training your PAM staff: what to include, common compliance problems to look for, developing inspection check-off sheets
  • Implementing your program; ideas for fostering trust

CDC Webinar: Measures to Prevent Disease Associated with Animals in Public Settings

Date: April 21, 2011
Time: 1 - 2 p.m.
Location: ACE 2.402

The convergence of people, animals, and our environment has created anew dynamic in which the health of each group is inextricably interconnected. Disease outbreaks associated with animals in public settings have been increasingly reported in recent years. Our increasing interdependence with animals and animal-based products is a critical factor to our health and well-being with regard to infectious diseases. Join us for this COCA call, where subject matter experts will discuss the importance of public health reporting of clusters of illness associated with animals in public settings and review CDC and National Association of State Public Health Veterinarians recommendations to minimize associated disease and injury risks related to animal contact.

Objectives: At the conclusion of the session, the participant will be able to:

  • Describe outbreaks associated with animals in public settings
  • List common pathogens causing outbreaks associated with animals in public settings
  • Identify common animals associated with outbreaks of enteric infections involving public settings
  • Discuss recommendations to minimize disease risks associated with animals in public settings

NABR Webinar: The New Guide: How Will It Impact Your Institution?

Date: April 12, 2011
Time: 11:30 a.m. - 12:30 p.m.
Location: ACE 6.336

The 8th edition of the Guide for the Care and Use of Laboratory Animals (ILAR 2010) contains nearly twice as many "musts" as the 7th Edition. AAALAC will begin using the new edition for program evaluations beginning in September 2011 and, if OLAW adopts the new Guide (comments are due by March 25), the proposed implementation plan would require PHS-assured institutions to use it for at least one evaluation by March of 2012. Beyond mandatory requirements indicated by the word "must," the 8th edition also contains over 600 "shoulds" that may require changes in your institution's animal care and use program. Join us on Tuesday, April 12, 2011, as we review the changes in the 8th edition of the Guide and highlight the new Guide's possible impact on your Animal Care and Use Program.


PRIM&R Webinar: Lessons from Researchers: Best Practices for Respectful Engagement with Minority Communities

Date:  Wednesday, March 2, 2011
Time: 12 - 1:30 p.m.
Location: ACE 5.336 (Note: This location may change)

Building Trust between Minorities and Researchers is a federally funded initiative based at the University of Maryland’s Center for Health Equity. The goal of this initiative is to develop, implement and evaluate strategies aimed at increasing minority participation in biomedical and public health research. PRIM&R has partnered with the research team to facilitate the development and presentation of educational programs that improve research literacy for and respectful engagement with minority communities. The second webinar in a three-part series, Lessons from Researchers: Best Practices for Respectful Engagement with Minority Communities will present the findings from an in-depth and unique survey and interviews of researchers, research staff and IRB members and staff.

Topics for discussion will include:

  • Researchers’ attitudes toward community engagement
  • Challenges in building community partnerships
  • Best practices for community partnerships
  • Impact of community engagement on recruitment and retention

EH&E Webinar: Coping with Exponential Improvements in Reading and Writing DNA: Understanding the Safety and Regulatory Aspects of Genomic Research

Date: Tuesday, February 22, 2011
Time: 12 - 1:15 p.m.
Location: ACE 3.336

Genome-based research is already enabling medical researchers to develop more effective diagnostic tools, to better understand the health needs of people based on their individual genetic make-ups, and to design new treatments for disease. Genomics has the potential of offering new therapeutic methods for the treatment of some diseases, as well as potential applications in the food and agriculture sectors. This webinar will provide biosafety professionals with a very current view of genomic research techniques and unique challenges relating to potential exposure to both chemicals and synthetic DNA. 

This online event will cover: 

  • Overview of genomics, including the changing landscape of reading and writing DNA. 
  • Overview of the Personal Genome Project and related regulatory issues.
  • The manipulation and creation of DNA sequences for the creation of biological agents (i.e., synthetic DNA).
  • Biological safety and regulatory issues related to genomics/synthetic DNA.

PRIM&R Webinar: International Research: Applying Ethical Principles and Research Guidelines in Global Settings

Date:  Wednesday, February 16, 2011
Time: 12 - 1:30 p.m.
Location: ACE 2.402

International Research: Applying Ethical Principles and Research Guidelines in Global Settings, a webinar to be held on Wednesday, February 16, 2011, from 12 to 1:30 p.m., will focus on the following topics:

  • Working with IRBs: Challenges of applying the terms of your federalwide assurance (FWA) in international research settings and of teaching US IRBs about global research contexts.
  • Obtaining informed consent: Meeting the ethical goals of consent requirements in settings with oral rather than written traditions; navigating gender and power relationships in consent authority; honoring commitments to communities; and developing strategies for community engagement.
  • Evaluating risks and benefits in variable risk environments: Do researchers have a duty to minimize the non-research related risks of daily life? What are researchers’ obligations to address study participants’ non-study-related medical conditions?
  • Ensuring equitable distribution of research findings: What are researchers’ obligations to the participants?

PRIM&R Webinar: Practical Strategies for Common Challenges: What Your IACUC Needs to Know

Date:  Thursday, February 03, 2011
Time: 12 - 1:30 p.m.
Location: ACE 5.336

Practical Strategies for Common Challenges: What Your IACUC Needs to Know will provide dual perspectives on the following two topics:

  • Trend data - This webinar will present an overview and analysis of trend data compiled by Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International after conducting over 1500 site visits. Attendees will learn about deficiencies related to protocol review and program oversight, semiannual inspection/review issues, and problems related to IACUC policies (or lack thereof).
  • The “New” Guide for the Care and Use of Laboratory Animals - John Bradfield and Beth Ford will discuss some of the updates in the “new” 2010 Guide that are most relevant to the functioning of IACUCs.

EH&E Webinar: Use of Novel Viral Vectors in Neurobiological Research

Date: Tuesday, January 25, 2011
Time: 12 - 1:15 p.m.
Location: ACE 6.336

Viral vectors are commonly used as research tools for genomics efforts, protein over-expression and in complementation studies. Additionally, viral vectors are also used to trace neural circuits. This webinar will provide biosafety professionals with insights from a leading researcher on the development of new viral vectors and how they are being used in current neurobiological research.  A subsequent discussion will review potential safety risks associated with their use, and best practices for managing risk and compliance requirements.

This online event will cover: 

  • Current view of neurobiological research.
  • Development of and uses for vectors based on pseudorabies virus and lentivirus in neurobiological research.
  • Biological safety issues with the use of viral vectors in cell culture and animal models.
  • Regulatory issues related to the use of viral vectors.

NABR Webinar: Surviving the Age of Enforcement

Date:  Tuesday, January, 11, 2011
Time: 11:30 a.m. - 12:30 p.m.
Location: ACE 3.116

Is your institution prepared to survive the USDA's "Age of Enforcement?" The USDA has been taking "actions to strengthen their enforcement of the Animal Welfare Act (AWA)" as part of what APHIS officials have called, the "Age of Enforcement." To implement this increased focus on enforcement, the USDA has developed an action plan and an Inspections Requirements Handbook with attachments that it uses to train its inspectors. This webinar will review the action plan and the new handbook and discuss changes institutions should consider making to their existing programs in order to effectively manage the inspection process. Included in the discussion will be a review of the most commonly cited areas of non-compliance and suggestions about how to assure your institution is in full compliance with the regulations and standards.


PRIM&R Webinar: The Guatemalan Inoculation Study: Susan M. Reverby on Research Ethics and Lessons for HRPPs

Date:  Wednesday, October 20, 2010
Time: 12 - 1 p.m.
Location: Texas Union Sinclair Suite (UNB 3.128)

The Guatemala syphilis study, unearthed by medical historian, Susan M. Reverby, is another shocking and sadly familiar example of the abuse of human subjects in research.

Ms. Reverby will present her findings in a webinar titled The Guatemalan Inoculation Study: Susan M. Reverby on Research Ethics and Lessons for HRPPs, which will address the horrific story of US public health researchers intentionally infecting hundreds of people in Guatemala, including mental patients, with gonorrhea and syphilis without their knowledge.

A professor at Wellesley College who has published two books about the US Public Health Service Syphilis study that took place in Tuskegee, AL, Ms. Reverby will share her findings and insights on what today’s research professionals may learn from this astounding example of immoral research practices that occurred more than 60 years ago.

This webinar will cover:

  • The story of a research study involving deliberate infection of human subjects with sexually transmitted diseases without permission or consent;
  • The aspects of this study that distinguish it from other examples of human subjects abuse; and
  • The ways in which this story illustrates the importance and potential weaknesses of our current system of research protections.

PRIM&R Webinar: Conflicting Interest and Conflicting Expectations: Challenges Presented by NIH's New Rule

Date:  Wednesday, October 6, 2010
Time: Noon - 1:30 p.m.
Location: ACE 2.402

Conflicting Interest and Conflicting Expectations: Challenges Presented by NIH's New Rule, a webinar to be held on Wednesday, October 6, 2010, will provide an overview of the challenges faced by institutions when dealing with financial conflicts of interest, especially in light of the anticipated US National of Institutes of Health (NIH) rule.

Presented by two of the most respected speakers in the conflicts field, this webinar will provide an array of concrete tools to assist those who will be charged with developing strategies to manage the transitions required once the NIH rule is finalized.  More specifically, this webinar will:

  • Broaden your understanding of the laws, ethics, and recommended standard operating procedures (SOPs) for identifying and managing financial conflicts of interest;
  • Explain the expected areas of focus in the forthcoming NIH rule;
  • Discuss the procedures that will likely be necessary to comply with the new rule;
  • Offer strategies for integrating those procedures into your institutional culture;
  • Review some of the unique challenges involved in educating institutional leadership and faculty, including possible approaches for effective educational programs; and
  • Compare the roles and responsibilities of IRBs and institutional conflicts committees in identifying, responding to, and/or managing conflicts.

AAHRPP Webinar on Non-Compliance

Date:  Wednesday, September 29, 2010
Time: 1 - 2:30 p.m.
Location: ACE 2.402

Nicholas C. Slack, M.B.E., Associate Director of Accreditation, Association for the Accreditation of Human Research Protection Programs (AAHRPP), will host the Educational Webinar, “Simplifying the Complexities of Non-Compliance,” on the afternoon of September 29, 2010. The session will be from 1:00 to 2:30 p.m.

The webinar will provide a common sense approach to developing a non-compliance review model that is tailored to the unique features of your human research protection program. There will be two parts to Mr. Slack's presentation. He will first highlight the core components of a standard operating procedure for non-compliance and later discuss five models that can be employed to review non-compliance.

He will be joined by Yvonne Higgins, C.I.P., Director, Human Research Protections, University of Pennsylvania. Ms. Higgins will share her organization's procedures for reviewing non-compliance and discuss strategies for handling difficult non-compliance cases.

We welcome you and your colleagues to join Mr. Slack and Ms. Higgins in these discussions.


NSABB Webinar: Does Your Research Raise Security Concerns? Strategies For Promoting Responsible Research in the Life Sciences

Date: Wednesday, September 22, 2010
Time: 7 - 9:30 a.m.
Location: Online

Advances in the life sciences have the potential to transform our world. From the discovery of novel antimicrobial compounds to the emerging technologies of synthetic biology, life sciences research will lead to new approaches to address human health, environmental and agricultural challenges. However, the same research and technologies that hold such immense promise can, in the wrong hands, be misused to pose a threat to public health and national security. Such research is often called "dual use research." The webcast will include a discussion of dual use research within the context of antimicrobial resistance issues and synthetic biology, as well as various approaches to manage risks associated with dual use research.

Effective global dialogue on concerns and issues regarding dual use life sciences research is essential to achieving an effective balance between public health priorities and national security concerns. This international Webcast is the second in a series of internet-based meetings aimed at engaging the international community by region. To learn more about dual use life sciences research visit BiosecurityBoard.gov.

To view this webinar, visit the http://oba.od.nih.gov/biosecurity/
internationalwebcast_europe2010.html
. This page contains information about the webinar as well as instructions on how to view it from your computer.


PRIM&R Webinar: Distrust, Race, and Research: Overcoming Barriers to Recruitment and Retention of Minority Populations

Date:  July 14, 2010
Time: Noon - 1:30 p.m.
Location: ACE 2.402

Overview

Distrust, Race, and Research: Overcoming Barriers to Recruitment and Retention of Minority Populations will address historical and contemporary barriers to involvement of minorities in research. The primary goal of this session is to focus on solutions that are culturally relevant and scientifically sound.

Agenda

The webinar will present:

  • Lessons learned from selected cases of research abuse involving racial and ethnic minority populations
  • Background and context of the U.S. Public Health Service Syphilis Study at Tuskegee, the subsequent presidential apology, and NIH supported research initiatives designed to repair the damage caused by this study
  • The National Bioethics Research Infrastructure Initiative: Building Trust Between Minorities and Researchers
  • Preliminary data from a qualitative study of investigators, as well as survey data from institutional review board (IRB) members, IRB staff, and researchers
  • A new conceptual model of the research continuum that serves as a viable framework for designing, implementing, and evaluating measures that aim to overcome barriers to minority recruitment

AAHRPP Webinar: Organizational Conflict of Interest

Date:  June 17, 2010
Time: 10 - 11:30 a.m.
Location: ACE 2.402

The AAHRPP Webinar: Organizational Conflict of Interest will discuss what to
include in your conflict of interest policy and how to implement it.
Dr. Peter Vasilenko, Vice President of Accreditation for AAHRPP, will lead
the discussion and several AAHRPP clients will present their organization's
policies.


PRIM&R Webinar: Promoting Science and Safety: NIH Oversight of Human Gene Transfer Research

Date:  June 16, 2010
Time: Noon - 1:30 p.m.
Location: ACE 2.402

Overview

Promoting Science and Safety: NIH Oversight of Human Gene Transfer Research, a webinar to be held on Wednesday, June 16, 2010, from noon to 1:30 p.m., will provide an overview of the NIH Guidelines for Research Involving Recombinant DNA Molecules as they apply to human gene transfer research.

Agenda

This webinar promotes the professional development of those associated with institutional biosafety committees (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 Institutional Review Boards (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)

PRIM&R Webinar: The Havasupai Settlement: Implications for HRPPs, IRBs, and Researchers

Date:  May 20, 2010
Time: 1 - 2 p.m.
Location: ACE 2.402

Overview

The Havasupai Settlement: Implications for HRPPs, IRBs, and Researchers, a webinar to be held on Thursday, May 20, 2010, from 1 - 2 p.m., will focus on the history, background, and analysis of the recent Havasupai Indian case.

Agenda

This hour-long webinar will address some of the questions that have 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 human research protection programs (HRPPs) and institutional review boards (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?

AAHRPP Webinar: Providing Equivalent Protections to Participants When Conducting Research Outside the U.S.

Date:  March 2, 2010
Time: 2:30 - 4 p.m.
Location: NOA 5.318

Overview

Dr. Vasilenko will be hosting AAHRPP’s second in-depth webinar on Tuesday, March 2, from 2:30 p.m. to 4:00 p.m. We welcome you and your colleagues to join him in a discussion where you will learn how to apply AAHRPP's new standard on transnational research:

STANDARD 1-3: The Organization’s transnational research activities are consistent with the ethical principles set forth in its Human Research Protection Program and meet equivalent levels of participant protection as research conducted in the Organization’s principal location while complying with local laws and taking into account cultural context.


PRIM&R Webinar: Top Tips for IACUCs: Perspectives in Animal Care

Date: Tuesday, February 9, 2010
Time: Noon - 1:30  p.m.
Location: Texas Union Sinclair Suite (UNB 3.128)

Top Tips for IACUCs: Perspectives in Animal Care, will bring together representatives from the Office of Laboratory Animal Welfare (OLAW) and a university veterinary service and animal care office to address some of the current issues facing institutional care and use committee (IACUC) professionals.

Agenda

  • A review of top reportable issues to OLAW – Learn about the types of reportable issues from OLAW's analysis of case reports from 2000 to 2009. What species are involved, who at an institution is responsible for the most reportable events, what corrective actions are typically taken by the IACUC?
  • An OLAW perspective on crisis preparation and management – Learn about the IACUC's oversight role in preparing for and preventing crises that could impact the animal care and use program, e.g. natural disasters, and pandemics.
  • Selection and training of new IACUC chairs and committee members – It is imperative that IACUC members and Chairs be knowledgeable about the rules and regulations in order to fulfill roles and responsibilities towards the humane care and use of laboratory animals. Learn key strategies for selecting and educating new IACUC members and creating effective and respectful relationships with other key stakeholders (researchers, vet staff, administration, etc.).
  • The fundamentals of program review and inspections – Understand the basics for the who, what, where, when, why and how of program review and facility inspections.

PRIM&R Webinar: Who "moved" my approval? Managing suspended Research

Date: Thursday, January 28, 2010 
Time: Noon - 1:30 p.m.
Location: Texas Union Sinclair Suite (UNB 3.128)

Who "moved" my approval? Managing suspended Research will address different reasons for suspending approved research and the management of those suspensions. Research can be suspended for several reasons, including compliance problems or because new information arises that mandates a re-evaluation of the study design or the experiences of subjects. This webinar will provide valuable guidance on understanding the implications of a suspension and successfully managing the repercussions of such a development.

  • What is the meaning of IRB approval in the context of continuing review, revisions, and ongoing compliance? What conditions or the experiences of subjects may require a re-evaluation of the study design or the approval of the research?
  • Why might a protocol be suspended temporarily or permanently?
    • What does it mean when an IO suspends a study?
    • What are the IRB’s responsibilities once a study has been suspended?
  • How do you respond when research transcends the IRB's approval (research that has lapsed, continued beyond the scope of the approval, or changed based on what the IRB approved)? How do you determine whether it’s a compliance issue or something else?
  • What is the IRB’s responsibility with respect to problematic studies? Should the IRB have the authority to put a study on “clinical hold” and stop new accruals without suspending it?

PRIM&R Webinar: Unanticipated Problems Involving Risks to Participants or Others

Date: Tuesday, October 13, 2009 
Time:  2:30 - 4 p.m.
Location: ACE 2.402

Overview

Dr. Vasilenko will be hosting a repeat of AAHRPP’s first webinar this fall, on Tuesday, October 13, from 2:30 p.m. to 4:00 p.m. Topics include:

  • How to identify an unanticipated problem involving risks to participants or others, and the requirements to report it.
  • How to differentiate between an unanticipated problem involving risks to participants or others, and an adverse event.
  • About how to harmonize OHRP and FDA guidance.
  • And what should be in your policy and procedures for identifying, managing, and reporting unanticipated problems involving risks to participants or others.

PRIM&R Webinar: Genetic Research: Benefits, Risks and Ethical Issues

Date:  Tuesday, October 26, 2010
Time: 1 - 2:30 p.m.
Location: ACE 2.402

Genetic Research: Benefits, Risks and Ethical Issues, will provide an overview of the core ethical issues currently faced by scientists engaged in all areas of genetic research. This webinar will:

  • 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; and
  • Explore the appropriate use of identified, archived specimens, for current and future research.

PRIM&R Webinar: Introduction to Medical Device Research and Making the Risk Determination

Date: Wednesday, June 17, 2009 
Time:  Noon-1:30 p.m.
Location: Alec Conference Room, ECJ 1.300

Overview

This device-specific webinar, designed by the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, focuses on basic information members of Institutional Review Boards (IRBs) should know about medical device research including the sponsor and clinical investigator responsibilities.  This webinar will also cover the FDA’s recommended procedures of how an IRB should meet its regulatory requirement to make a risk determination of non-significant risk device studies.  In addition, there will be a brief demonstration of how to locate PMA and 510(k) devices labeling information.

Agenda

  • Introduction to Investigation Device Exemption (IDE)
    • Discussion about when an IDE is necessary and when it is not
    • Sponsor responsibilities and interactions with IRB
    • Clinical investigator responsibilities and interactions with IRB
    • IDE studies supporting marketing applications
    • Tools to find approved labeling of cleared 510(k)s and Premarket Approvals
    • 21CFR 812.66 the IRB responsibility to make a risk determination
  • The IRB Significant Risk vs. Non-significant Risk Determination
    • Discussion of significant risk device
    • How IRB's should go about determining the risk of a non-significant risk device study
    • The role of the sponsor, clinical investigator, IRB, and FDA

PRIM&R Webinar: New Solutions for Ongoing Problems When Reviewing Social, Behavioral, and Educational Research

Date: Wednesday, February 25, 2009
Time:  Noon-1:30 p.m.
Location: NOA 5.318*

Overview

New Solutions for Ongoing Problems When Reviewing Social, Behavioral, and Educational Research, a webinar on February 25, 2009 at Noon, will address some of the issues facing those involved in social, behavioral, and educational research. Examples of possible solutions, helpful tools, and proven strategies will be given, and participants will gain insight into areas in which enhancement of their policies and procedures may be needed.

Agenda

In this engaging offering from PRIM&R's respected faculty, participants will learn more about...

  • Determining what is exempt and what is expedited in social, behavioral, educational research
  • Ethical research, oral history, and ethnography: when the rules don’t apply
  • Ethical issues in survey research