Research Compliance Committees

Transcription

1 Research Compliance Committees Ephy Khaemba, International Livestock Research Institute ILRI. Laboratory Management & Equipment Opera5ons Workshop. 1

2 Course Outline Structure of Regulatory Environment Defini5on of Research Compliance What are Research Compliance commieees (RCCs)? Func5ons of a Research Compliance commieees Composi5on of Research Compliance CommiEees Laboratory Management & Equipment Opera5ons Workshop. 2

3 Course Outline How do Research compliance commieees operate Research Compliance commieee Registra5on What do Research Compliance CommiEees Review Laboratory Management & Equipment Opera5ons Workshop. 3

4 Course Outline Rela5onships among the Research Compliance CommiEees Training and developing RCCs CommiEee mee5ngs good prac5ce Resource mobiliza5on Laboratory Management & Equipment Opera5ons Workshop. 4

5 1.1 Structure of Regulatory Environment Ins$tu$onal framework Na$onal Framework This usually is cross cusng among various government Ministries. Laboratory Management & Equipment Opera5ons Workshop. 5

6 In Kenya you have the below scenario: Technical CommiEee of the Bureau of standards to develop Na$onal and Interna$onal Standards and guidelines. A Food Safety Co- ordina$on Commi<ee was launched on the 19 th of June A Na$onal Policy on Biotechnology approved by Cabinet in 2006 The Bio- safety Act was gazeeed in February 2009 Na5onal Bio- safety Authority: RA for approval for introduc5on of GMO. Na5onal Focal Point for the Bio- safety Clearing House. Laboratory Management & Equipment Opera5ons Workshop. 6

7 Department of Public Health. RA in maeers of human health and food. Department of Veterinary Services. RA in veterinary maeers including animal feeds, research in animals and animal products. Pest Control Products Board. RA in regula5ng organisms and products intended for pest control Laboratory Management & Equipment Opera5ons Workshop. 7

8 Na5onal Environment Management Authority. RA in environmental management including release to the environment of GMO Kenya Industrial proper5es Ins5tute (KIPI) Kenya Wild Life service (KWS ) Kenya Plant Health Inspectorate service (KEPHIS) Laboratory Management & Equipment Opera5ons Workshop. 8

9 1.2 WHAT IS RESEARCH COMPLIANCE Research Compliance aim is to advance a culture of ethics, integrity and compliance with applicable laws, regula5ons and policies which govern ins5tu5ons of higher educa5on through awareness programs, monitoring and responding to non- compliance. The key ac5vity being review of proposal and research ac5vi5es / programs for compliance to Ins5tu5onal policies, na5onal policies, Interna5onal trea5es and donor requirements Laboratory Management & Equipment Opera5ons Workshop. 9

10 1.3 WHAT ARE RC COMMITTEES The cornerstone of ins5tu5onal Research Compliance oversight. Who should have a RC commieees? Do we have this commieees in our Ins5tu5on and what do we call the commieees? Laboratory Management & Equipment Opera5ons Workshop. 10

11 1.3 WHAT ARE RC COMMITTEES There re generally 3 RC commieees. These are: Bio- safety CommiEee. Animal care and Use CommiEee. Ethics CommiEee. Laboratory Management & Equipment Opera5ons Workshop. 11

12 1.4 FUNCTIONS OF RC COMMITTEES To undertake assessment and review of all research ac5vi5es in the Ins5tu5on using Ins5tu5onal guidelines. These ac5vi5es include, but are not limited to, research proposals, to iden5fy any poten5al hazard which may arise in the course of research as a consequence of any type of experiment or manipula5on that involve: v Work with hazardous materials. v Work with animals v Work with human subjects. Laboratory Management & Equipment Opera5ons Workshop. 12

13 To assess the actual and poten5al risks involved in the light of the intrinsic nature of the experiments, the competence of the personnel and the security of the work environment. To ensure appropriate inspec5on, cer5fica5on and licensing of various research programs / ac5vi5es. To advise researchers of any perceived dangers and to prescribe condi5ons under which the research may proceed or to forbid it altogether unless or un5l the commieee is sa5sfied that the work should begin or con5nue. Laboratory Management & Equipment Opera5ons Workshop. 13

14 To ensure compliance with requirements of Na5onal regulatory agencies and research gran5ng agencies in supplying informa5on and enforcing all condi5ons they may lay down for the execu5on of research conducted under their authority. To collect and disseminate informa5on on research projects to relevant authori5es. Aker ini5al review, approval and commencement of the research, annually review research conducted at the ins5tute Adopt emergency plans covering accidents and personnel contamina5on resul5ng from research ac5vi5es. Laboratory Management & Equipment Opera5ons Workshop. 14

15 In a nutshell, what must RCCs review? Ins5tu5onal research programs and projects for conformity with Ins5tu5onal & Na5onal Guidelines. Poten5al risk to environment and public health Laboratory Management & Equipment Opera5ons Workshop. 15

16 Consists:- 2.1 COMPOSITION OF RC COMMITTEES i. Bio- safety officer(s); ii. Security Officer(s) iii. Facility Manager (Engineering Manager) iv. Scien5st(s) in the relevant field; v. (iii) Representa5ve(s) of technical staff; vi. (iv) Representa5ve(s) of laboratory management; vii. Representa5ve(s) of the community where the premises are situated; viii. Representa5ve(s) of the relevant regulatory agency. Laboratory Management & Equipment Opera5ons Workshop. 16

17 2.2 HOW DO RC COMMITTEES OPERATE Opera5on of the RC commieees must be clearly documented in the TORs or in an SOP then is approved by management and the Ins5tu5onal Board. The SOP should clearly outline: v CommiEee Membership. v Establishment of a quorum. v Frequency of mee5ngs v Give guidance to research program review. v Give guidelines on procedure to be followed when reviewing a project. Laboratory Management & Equipment Opera5ons Workshop. 17

18 v How vo5ng will be done. v Requirements for project approval at Ins5tu5onal level and at the Government regula5on level. v Document flow which includes: Who should the documents for BRC be send to? Receipt of the documents by the BRC Members. CommiEee review. Approval procedure. Communica5on of commieee verdict. v Documenta5on Laboratory Management & Equipment Opera5ons Workshop. 18

19 2.3 REGISTRATION OF RC COMMITTEE Registra5on of RCC helps the ins5tu5on to comply with na5onal regulatory requirements as per various applicable Na5onal Policies and Interna5onal guidelines and best prac5ces. Register the RCC with relevant Government regulatory Authority. To Register you require: v A roster of RC members q Clearly indicate chair, contact person, and special exper5se as appropriate (BSO, animal, plant, human gene transfer) v Biographical sketches of all members Laboratory Management & Equipment Opera5ons Workshop. 19

20 Purpose of registra5on and annual membership updates: v Provides assurance of local review of RCC v Allows Government regulatory body to see that RCC exper5se consistent with the Various na+onal ACTS and policies also interna+onal guidelines and best prac+ces applicable. v Indicates ins5tu5onal point of contact v Provides Ins5tu5onal scope of research. Laboratory Management & Equipment Opera5ons Workshop. 20

21 3.1 What do RCC assess What do BRC assess in reviewing research proposal / projects? Compliance to regulatory guideline. Containment levels as per regulatory Guidelines Adequacy of facili5es, SOPs, PI and project personnel training Ins5tu5onal and inves5gator compliance; e.g., adverse event reports Laboratory Management & Equipment Opera5ons Workshop. 21

22 3.1 What do RCC assess Number par5cipant enrolled in the research. Issues raised by TCR in public review are considered Final RCC approval occurs only aker TCR Compliance with surveillance, data repor5ng, and adverse event repor5ng Laboratory Management & Equipment Opera5ons Workshop. 22

23 3.1 What do RCC assess In basic and preclinical research, RCCs have authority to: Lower containment levels for certain experiments in which DNA from Risk Group 2-4 is cloned in non- pathogenic organisms Set containment levels for experiments involving whole plants and animals Review periodically ins5tu5onal compliance with Na+onal Guidelines Adopt emergency plans covering spills, contamina5on, other accidents Laboratory Management & Equipment Opera5ons Workshop. 23

24 3.1 What do RCC assess The RRC may not: Authorize ini5a5on of rdna experiments un5l approval has been given by Na5onal regulatory departments concerned This would also apply to other experiments requiring the same approval. Laboratory Management & Equipment Opera5ons Workshop. 24

25 3.2 RCC COMMITTEES & EXEMPT RESEARCH Do RCCs determine what research is exempt? Does the PI? A maeer of ins5tu5onal policy RCCs should designate member, chair, or Compliance Officer as first line of review to make determina5ons about what is exempt and what requires full review Regulatory guidelines should act as reference to make determina5ons Laboratory Management & Equipment Opera5ons Workshop. 25

26 3.3Research Compliance Committees IBC IEC IACUC Laboratory Management & Equipment Opera5ons Workshop. 26

27 RRCs Relationships: Ethics Rela5onship not prescribed in the regulatory Guidelines Ins5tu5ons should determine best way for these commieees to interact and share informa5on IEC approval necessary before enrollment can begin in human gene transfer trials or where human subjects will be part of the research. IEC approval can come before or aker other RRCs review RRC final approval must come aker comple5on of RA review and IEC approval where human subjects are used and IACUC where animals are used. Laboratory Management & Equipment Opera5ons Workshop. 27

28 3.4 TRAINING & DEVELOPING RRCs The Regulatory Guidelines emphasize the importance of training and place responsibility on: Ins5tu5ons to train RCC members, CO, PI, and Project staff, however the training guidelines not specified. For RRCs to perform adequately, members must be trained and developed. Training should: Provide informa5on on Government legal requirements include informa5on on ins5tu5onal policies, procedures, and requirements Laboratory Management & Equipment Opera5ons Workshop. 28

29 Be tailored to the audience PhDs vs. administrators vs. Project staff staff Development can be aeained by: sponsoring RRC members for conferences. Training in specific areas e.g. risk assessment, Ethics review, Animal research review, Biotechnology etc. AEachment to other organiza5ons with developed RRC. Laboratory Management & Equipment Opera5ons Workshop. 29

30 3.5 Committee meetings Good practice a) Plan mee5ngs in advance - Where possible, plan a series of commieee mee5ngs in advance but remain flexible to address important maeers as they come up; b) Communicate - All commieee members should have a personal copy of the planned mee5ng dates, and they should be available where all employees can see them, for instance on no5ceboards or intranet pages. The commieee members should agree on standing items for the agenda and allow for other items to be added as necessary; c) Keep the date - Do not postpone or cancel commieee mee5ngs unless there are excep5onal circumstances, or members have agreed to it. If you cancel a mee5ng, agree another date arranged as soon as you can. If you don't, important issues will not be addressed and the work of the commieee, and the value of biorisk commieee, is undermined. Laboratory Management & Equipment Opera5ons Workshop. 30

31 3.6 Resource Mobilisation / RRC BUDGET As other ins5tu5onal organs RRCs need money to operate. What is the money for? v Mee5ngs tea, snacks, mee5ng rooms etc. v RCC members training. v Honorarium payments. v Consultancy for RRC work. v Legal compliance etc. Laboratory Management & Equipment Opera5ons Workshop. 31

32 Resource Mobilisation / RRC BUDGET RRC commi<ees members need to have: v CommiEee mee5ng 5me to be included as part of work plan for ins5tu5onal commieee members prepare for mee5ngs. v access to relevant informa5on, policies and programs for the purposes of the discussion at the mee5ngs; v training that is reasonable in the circumstances to allow them to perform their role, which includes aeending RRC commieee mee5ngs; v Assurance that they will not suffer a loss of pay or vic5miza5on when they aeend mee5ngs or carry out other ac5vi5es on behalf of the commieee. Laboratory Management & Equipment Opera5ons Workshop. 32

33 v prompt approval of RRC CommiEee s recommenda5ons by the employer so that such recommenda5ons are ac5oned and incorporated into the employer s Research compliance management system; v necessary support such as human and financial resources so that RRC issues and/or recommenda5ons raised in RRC CommiEees mee5ngs are responded to within a reasonable 5me. v Ins5tu5on shall cover for all liability resul5ng from decisions made by RRC commieee and not individual members. v Avail money for payment of honorarium and transport cost reimbursements. Laboratory Management & Equipment Opera5ons Workshop. 33

34 Thank you. Ques$ons & Discussion Laboratory Management & Equipment Opera5ons Workshop. 34