Concurrent Session #3

The EU General Data Protection Regulation: What Researchers Need to Know 
Presented by Peter J. Guffin, Esq. a partner at Pierce Atwood LLP

This session will provide an overview of the EU’s GDPR and its impact on scientific research involving human subjects, highlighting the similarities and differences with HIPAA’s Privacy Rule and the Common Rule, as well as its interplay with national laws in the EU member states. We will focus on the issues of participant consent, the public interest (health) exception, and implementation of new procedures and practices required under the GDPR, including designation of a data protection officer, data protection impact assessments, rules regarding the reuse of personal data for research purposes, and notification and communication of personal data breach. The GDPR, which goes into effect on May 25, 2018, strengthens data protection principles applicable to personal data processing for scientific research purposes, adding requirements with respect to data integrity, confidentiality, accountability, and data protection by design and by default. It also introduces new definitions, such as “data concerning health,” “genetic data,” and “biometric data,” expands the rights of data subjects, specifically with respect to right to rectification, to erasure, to be forgotten, to restriction of processing, to data portability and to object, and creates opportunities for the development of codes of conduct and other self-regulatory approaches.

Public Health Surveillance Under the Common Rule 
Presented by Laura Youngblood of Centers from the Disease Control and Prevention

Title 45 of the US Code of Federal Regulations, Part 46 (45 CFR 46), also known as the Common Rule, defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The Common Rule requires review by an Institutional Review Board (IRB) for all non-exempt human subjects research conducted or supported by the federal government. As such, it is necessary to correctly identify research involving human subjects in order to comply with regulatory review requirements for federally-conducted or -supported research.

Recent revisions to the Rule have explicitly removed certain classes of activities from this definition, including public health surveillance. The explicit removal of public health surveillance from the definition of research in the revised Rule represents a shift in how the definition of research has historically been interpreted and applied to public health surveillance. The absence of clear guidance on how to interpret “designed to develop or contribute to generalizable knowledge” in the context of public health surveillance has contributed to observed variation in how public health surveillance activities have been classified under the pre-2018 Rule.

Although activities not meeting the definition of research are not subject to the requirements of the Common Rule, including requirements for IRB review, institutions have a duty to ensure that their scientific activities adhere to accepted ethical standards. We believe that this duty, coupled with uncertainty about whether public health surveillance activities should be considered research or non-research, has led many institutions to treat all public health surveillance activities as research.

In this presentation, we propose best practices for interpreting and applying the new public health surveillance category under the revised Rule, documenting decisions regarding the applicability of human subjects research regulations under this provision and assessing adherence to ethical standards for activities found to be outside the scope of IRB review requirements.

Developing guidance for the new requirement for informed consent: What constitutes a concise summary of key information. 
Presented by Judith Navratil, Nena Ansari & Dana DiVirgilioof University from the Pittsburgh Human Research Protection Office

The revised final rule to update the current regulations at 45 CFR 46, Subpart A include important changes to the requirements for informed consent intended to “better protect human subjects involved in research, facilitate research, remove ambiguity, and reduce regulatory burden.” To facilitate this, the revised rule requires that the informed consent process begin with a concise and focused presentation of the “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. Informed consent documents must be organized and presented in a way that does not merely provide lists of isolated facts, but in a way that facilitates comprehension. The concise and focused summary of “key information” should provide the information that a “reasonable person” would want to have in order to make a decision. This new requirement does make sense as a possible remedy to the current state of informed consent documents, but it is problematic in that clearly, the “key information” required about one type of research study may be significantly different from the “key information” required for a different type of research study. And the information that one “reasonable person” would require may be significantly different from that required by a different “reasonable person.” And then there is the question of whether research investigators or IRB members are the best judges of whether the key information requirement is satisfied for any particular research study.

  • In order to address these ambiguities, the University of Pittsburgh Human Research Protection Office formed a working group composed of IRB staff, board members including community (unaffiliated) members, research investigators and research coordinators from the University of Pittsburgh School of Medicine divisions including Oncology and Psychiatry, as well as researchers from the School of Public Health, Psychology and Education. Focus group discussions yielded a Guidance template, and a survey of potential research subjects is currently being administered to members of a CTSI based research registry. We will share the preliminary results of the survey. We are looking forward to discussions with attendees about how other Human Research Protections offices are handling this change.
Inspection Ready? Collaboration is the Key 
Presented by Kelly Barrett, Ted Myatt and Kathryn Holthaus from the Brigham and Women’s Hospital

Institutional investment in a culture of collaboration and cooperation among all stakeholders in animal research can yield significant gains in compliance, safety, and operational efficiency. By actively engaging ancillary groups—such as Maintenance and Engineering, Security, Emergency Management, Occupational Health, and Environmental Health and Safety—some of which may not traditionally work closely with the IACUC or other compliance entities, institutions can increase the overall quality of their animal research program and better prepare for external site visits and inspections (e.g., AAALAC, USDA, CDC). Additionally, encouraging a collegial relationship among more obvious stakeholders in a program of animal care and use, from the animal husbandry staff to researchers, can contribute to the overall success of the animal program.
Speakers will share their firsthand experience at employing best practices that enhance collaboration, from the intensive and time-sensitive preparation that goes into an external site visit, to more long-term initiatives that foster buy-in and encourage communication throughout the year. At the end of the session, attendees should understand the demonstrated value in developing these inter-group relationships, and will be equipped with a starter toolbox of strategies and resources to implement at their own institutions. Topics of discussion will include:

  • Developing and empowering advocates for compliance within other research support groups;
  • Coordinating joint inspections to maximize efficiency, reduce burden on labs, and prevent issues from falling through the cracks;
  • Cross training to identify areas of concern for other research support groups;
  • Developing and maintaining creative channels of communication;
  • Employing unique buy-in strategies to encourage compliance among busy researchers