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Peo Project Launch Meeting March 09, 2017

Overview of regulatory supports for project coordination, submission to HRDC, maintaining records, and capacity building. |

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Peo Project Launch Meeting March 09, 2017

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  1. Peo Project Launch MeetingMarch 09, 2017 Regulatory/IRB Aspects Ms. T Sekoto

  2. Overview • Regulatory supports for Peo project are within the Coordination core (BHP) • Support submission to HRDC for research projects related to the 3 priority NCD areas • Maintain records and documentation • Support regulatory training and certification of project related researchers (if not available through home institutions)

  3. Overview II • Partner institutions (through study PIs) responsible for: • Submitting protocols through internal review processes and to IRB committees based outside Botswana • Where relevant, initiating cede procedures • Keeping coordinating core (BHP) updated on any changes or new documentation • For the longer term, there is need to identify needs and gaps to be addressed to build regulatory capacity in GOB organ (UB or other)

  4. Why regulatory aspects matter • To protect human subjects taking part in proposed research • To safeguard public confidence and trust • To commit and comply with sponsor requirements on human subjects protection Investigator has a primary responsibility to protect the study participant

  5. Investigator responsibility • Factor in IRB review process in your timelines • Quality and clarity of research projects -scientific designs to realize the scientific objectives of the study -Scientific designs of the research realize social value -Research study is feasible within all the applicable contexts and timelines it is conducted upon Quality+ Clear Proposal=Positive IRB outcomes

  6. IRB/EC`s Role • 1 National Ethics Committee[HRDC] -Committed/mandated to protection of human subjects according to the common rule/45CFR part 46 and applicable local and other international regulations -Facilitate implementation of human subjects research projects in Botswana -timely and objective reviews of research projects crucial

  7. IRB/EC`s Role • Research projects meeting the category of “Exempt” according to CFR should be deemed as such to facilitate implementation Common understanding on projects which meet non-exempt i.e. human subjects research and those which do not meet the definition as in CFR is imperative among investigators and EC members

  8. Important issues to be addressed Informed consent -conditions for waiver of consent -consent for long-term storage and future use/testing of samples -genetic testing -shipping of samples outside the country for specialised testing -long-term storage, local vs international repository

  9. P20 trainee`s Human subjects training All recipients will be expected to undergo human subjects training -face to face if institutions are able to provide -online trainings- commonly used[Collaborative Institutional Training Initiative-CITI] Additionally, Responsible Conduct of Research[RCR] or Research Integrity-available online

  10. RCR Topics/Pillars -Data Acquisition, management, sharing & ownership -Mentor/trainee responsibilities -Peer review -Collaborative science -Human Subjects -Animal Research -Research Misconduct -Conflict of Interest & Commitment

  11. As a by the way….. Revised CFR to be in use effective January 2018 -broad consent obtained for future research -new exempt categories based on risk to participants to allow IRBs focus more on high risk studies -removal of CR for ongoing studies if the review does little to protect participants -requirements or elements of consent now give participant a better understanding to make a fully informed decision

  12. Singapore statement on Research integrity: 2010 Its principles are: • Honesty in all aspects of research • Accountability in the conduct of research • Professional courtesy and fairness in working with others • Good stewardship of research on behalf of others http://www.singaporestatement.org/

  13. Progress • Breast cancer • HRDC approved, to be submitted to Harvard IRB (with Penn cede) • Hypertension • Amendment to BCPP in process • Trauma • No IRB protocol to be submitted in initial phase, rather data sharing agreement to be developed

  14. Conclusion • Regulatory supports are available through the coordination core at BHP, including: liase and support to HRDC for the 3 NCD areas, training/certification • For the longer term, there is need to identify needs and gaps to be addressed to build regulatory capacity in GOB organ (UB) • Inputs from today’s discussion would be helpful in better understanding current capacity and gaps to be addressed

  15. ? Thank you Ke a leboga

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