upcoming events - December
PRIM&R Virtual Conference: Facilitating Informed Consent in Light of the Revised Common Rule
Join the HRPP team for a viewing of this presentation from the 2017 annual conference of Public Responsibility in Medicine & Research (PRIM&R). The revised Common Rule includes new requirements for informed consent to better ensure potential human subjects are receiving the information they need to make informed decisions about their participation in research. In addition, an array of tools and technologies are now available to help human subjects better understand the nature and complexities of research. This session will review how the revised Common Rule strengthens informed consent.
Friday, December 1, 2017
9:45am - 11:00am
South Street Landing, 4th Floor, Room 445
No registration required
PRIM&R Virtual Conference: Panel Discussion - Race Matters: Ethical Challenges for the Use of Racial Categories in Research
Join the HRPP team for a viewing of this panel discussion from the 2017 annual conference of Public Responsibility in Medicine & Research (PRIM&R). IRBs are often asked to approve research that focuses on, ignores, or proposes comparative designs to study racial/ethnic group health disparities. In many instances, investigators’ racial groupings do not reflect the complexity or socio-political dimensions of such definitions that, in turn, can limit the validity of conclusions drawn from such studies and its potential impact on alleviating or sustaining systemic influences underlying health inequities. The increasing integration of genomic science into biomedical and social and behavioral research raises additional issues regarding group representation and generalization of findings. This panel will introduce attendees to the growing influence of Critical Race Theory in empirical science, the promise and challenge of racial classifications in studies of personalized medicine and studies on behavioral risk, and the importance of participant perspectives for the promotion of socially just science.
Monday, December 4, 2017
10:00am - 11:15am
South Street Landing, 4th Floor, Room 452
No registration required
Webinar: 2017 in Review - How Legal and Regulatory Changes Impact Your Research
Hosted by ORI/HRPP, presented by Kinetiq, the consulting and technology division of Quorum Review IRB
This year brimmed with significant events in the legal and regulatory realm of clinical research. It presented major changes that will serve to reshape the research landscape in 2018 and beyond. Register for this complimentary webinar to learn how recent legal and regulatory changes are affecting clinical research and how research is impacted by:
- The 21st Century Cures Act
- FDA regulatory changes
- The new Common Rule
- NIH policy
- State laws
Tuesday, December 5 or Thursday, December 7
South Street Landing 4th Floor, Room 428
1:00pm - 2:00pm
no registration required
Webinar: Social Media for Research Recruitment: Ethical and Practical Aspects
Hosted by ORI/HRPP, presented by Schulman IRB
In this free webinar, attendees will:
• Briefly review the empirical literature on social media’s effectiveness as a research recruitment tool
• Learn how to utilize sound methodology for designing and reviewing social media recruitment techniques
• Understand how the ethical principles of respect for privacy and investigator transparency apply in the social media context
12:30pm - 1:45pm
South Street Landing, 4th Floor, Room 445
No registration required
What the HRPP Can do for You
The Human Research Protection Program has dedicated resources to assist you with:
Human subject-related questions you may have as you prepare a proposal for submission to a sponsor
Writing a human subject protocol that meets regulatory requirements
FDA regulatory compliance
Template language for your protocol, consent forms, and grant proposals
Ensuring you are adhering to your protocol and regulatory requirements, via provision 0f voluntary ‘audits’ via the Quality Assurance / Quality Improvement program.
Offering general training about “IRB Basics” and related policies and procedures via Learning Point
Professional development via the Advance-CTR Human Subject Research Workshop series
Contact us to request any of the above!
The HRPP offers Open Hours for faculty, students and support staff who need assistance with preparing an IRB protocol/amendment, determining if a proposed project requires IRB review, any human research related issues or IRB-related policies or procedures. Our “Open Hours on the Road” service, during which HRPP staff can come to your department or meet with an individual or research team is also available upon request.
Open Hours at the HRPP held at the times noted below:
Tuesdays 12-1 pm
Fridays 2-3 pm
We are located on the 3rd floor of 2 Stimson Avenue, on the corner of Hope Street and Stimson Ave, next to the Aquatics and Fitness Center. The Building is card-access only; please ring the button labeled “RPO” and someone will buzz you in.
Best Practices Sessions
This is a one hour session which focuses on providing guidance and recommendations related to IRB file organization and maintenance. Topics covered include best practices related to the maintenance of IRB approved study procedures and protocols and consistency with Brown University policies and procedures concerning human research participants. Investigators and any research staff involved in field work, data collection and/or study record keeping may find this session particularly helpful.
Best Practices sessions may be scheduled to take place at the research study office or research lab at the convenience of the study, or you may choose to attend a pre-scheduled session located at the Office of Research Integrity location. Please check Learning Point for dates and times and to register for a session held at Office of Research Integrity.
"Are all your ducks in a row?"
Best Practices Checklist
Investigators and study staff can easily confirm if they are incorporating best practices into their research projects by using this helpful checklist. This is a good way to quickly, easily and independently confirm the use of basic best practices and consistency between IRB approved research procedures and actual research activities. This checklist can also serve to remind investigators of some of the important details related to human research participant protections as well as identify issues that need attention, helping to minimize the chance of an impact on study progress.
Voluntary, Best Practices Individualized Review:
Another helpful resource for investigators is a one-on-one Best Practice review. This is in person, review of study procedures and IRB documentation related to human research participants. It offers individualized assistance and guidance from HRPP staff. The completion of this review can help with streamlining IRB submissions and reviews which may reduce the time between submission and approval. It is also useful and proactive in the context of assisting the investigator with identifying any inconsistencies with IRB approved procedures. Voluntary, Best Practices Individualized Review form.
For additional information about best practices sessions and checklists, please contact Christiana Provencal at 401-863-5729 or 401-863-3050.
HRPP Policy and Procedures
The HRPP Policy and Procedures Manual is also a resource for questions about how Brown implements regulatory requirements and structures its program.
The Advance-CTR Human Subject Research Workshop Series
**The workshop series will kick off in September 2017.**
The Human Subject Research workshop series has been tailored to meet the needs of clinical and translational research trainees.
Workshops are designed to be engaging and interactive, and cover broad topic areas such as how to determine if your research requires IRB review and how to conduct post-approval monitoring of your study; to more targeted instruction, such as meeting the regulatory requirements of the FDA and ethical considerations in working with vulnerable populations.
Workshop 1: “When does research require IRB review and approval?”
Did you know that not all activities that involve interactions with or collecting information from people constitutes human subject research in accordance with the federal definition? Join the Human Research Protection Program leadership team in this interactive, one-hour workshop and walk away with an understanding of:
The purview of the Institutional Review Board (IRB)
The regulatory definition of human subject research, including a clear understanding of the terms “systematic investigation” and “generalizable knowledge”
Why research design – not just intent -- is important
What is a “human subject” and what is “identifiable private information”
The workshop will walk through common scenarios and tackle some of the gray areas of making this important determination to ensure that participants leave with the confidence to know when their research will require IRB approval (and where to seek help when they’re unsure!).