Research Ethics Committee Administration in Uganda: The Research Ethics Committee (REC) Administrators’

Perspective

Aida Nakawunde, MSc. CEB , REC Administrator School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda

MAKEREREMAKERERE UNIVERSITYUNIVERSITY

Focus of the Presentation• Definition and Roles of RECs• Establishment of Research Ethics Committees (RECs) • Overview of RECs in Uganda• The Research Approval Process in Uganda• Role of REC Administrators in Uganda • Strengths of the REC Administration system• The gaps within the REC Administration system• MakCHS case study • Conclusion

2

Definition and Role of RECsAccording to UNCST, RECs are independent committees established inor by an institution:

• To conduct initial and continuing review of research projects with agoal of protecting rights and welfare of research participants.

• Responsible for safeguarding the dignity, safety, and wellbeing of allpotential research participants.

• Maintain ethical standards of practice in research

• Protect participants and researchers from exploitation

3

Establishment of Research Ethics Committees (RECs) in Uganda

• 1960s-70s---ethical issues were guided by Helsinki Declaration 1964 & Nuremburg Code 1947;

• RECs operate under the supervision of Uganda National Council for Science and Technology (UNCST)

– In charge of research coordination and oversight

• Ethical review in Uganda was mainly triggered by pressure of conducting clinical trials.

• First REC was established in 1986 (NARC).

4

Overview of RECs in Uganda (1)

Year of existence:

Most RECs have existed for more than 5 years

Accreditation: 24 RECs accredited by UNCSThttps://uncst.go.ug/research‐ethics‐committee‐accreditation/

Source of funding:

Mainly review fees

Host institution: Hospital(s) Academic institution 

Research institution 

National agency 

6 8 6 4

5

Overview of RECs in Uganda (2)

• Number of REC Administrators: One fulltime administrator per REC

• Number of REC members: Mainly 11-15 members with 50% quorum

• Meeting schedule: Majority hold meetings once a month

• Number of protocols reviewed annually: 90-120 proposals

• Protocol submission, review, tracking and archiving: Mainly manual

6

The Research Approval Process in Uganda

7

UNCSTNDA

Office of the President

Foreign REC Local REC

Community Advisory Board

Scientific Committee

Data Safety Monitoring Board

Nat

ion

alIn

stit

uti

onal

Inve

stig

ator

L2

L3

Independent Monitor

UNHRO

L1

Role of REC Administrators in Uganda

General office administration• Check submitted proposals for completeness • Communicate feedback to investigators • Assign reviewers • Organize trainings and REC workshops • Write annual REC reports • File REC documents and other material for approved studies • Procure office supplies • Respond to queries raised by investigators• Develop site monitoring plans• Write site monitoring reports

REC meetings • Schedule REC meetings • Draft REC meeting agenda • Take REC review minutes

8

Strengths of the REC Administration System

1. National guidelines for Research involving human participants

2. Research registration and clearance policy and guidelines

3. Accreditation system of RECs4. Network of REC chairpersons (FRECU)5. Network of REC Administrators 6. The Credit point system7. Annual Research Ethics Conference (ANREC)8. Research oversight

9

National guidelines for Research involving human participants

• Provide mechanisms for protecting research participants

• Provide ethical standards and procedures for conduct of research

• Ensure that researchers take into account social and cultural values

10

Evolution of research ethics guidelines in Uganda

11

<1997May 1997

March 2007

July 2014

Ethical review largely based on Helsinki Declaration & Nuremburg code

Research registration and clearance policy and guidelines

• Guard against research misconduct

• Assist researchers access data for research

• Prevent unnecessary duplication of research

• Avoid unauthorized collection and transfer of research material or information

12

Regulation by National Drug Authority

Clinical Trials have additional regulation by NDA;NDA Act Cap (206):

• S. 40a. “The authority (NDA) may issue a certificateto any person for the purpose of carrying out clinicaltrials in respect of a drug that may be specified in thecertificate.”

• S.40b. “No person may carry out any clinical trial in respect of any drug unless he or she is in possession of a certificate issued under subsection (1)”

13

Accreditation system of RECsObjective:

• To improve efficiency and effectiveness of REC operation

• Ensure that RECs provide the highest possible ethical standards and protection to research participants

• Build public trust and confidence in national ethical review system

Benefits• Well constituted RECs • Refresher trainings for REC members and staff• Operational REC offices

14

Network of REC chairpersons (FRECU)

• Updates of REC performance

• Knowledge sharing

• Share experiences and scenarios

• Settle grievances between RECs

• Ground for advocacy in amendments of

guidelines, REC operations

15

Network of REC Administrators

• Knowledge acquisition towards office administration

• Share training opportunities

• Share experiences in office management

• Seek advise on how to handle critical situations

• Conduct exchange visits

• Develop guidelines for REC Administrators

16

The Credit point systemObjective:

• Continuously improve the quality of REC review and research oversight

• Improve the skill and competence of REC members

17

Annual Research Ethics Conference (ANREC)

Held since 2009 in JulyObjectives:

• Improve the efficiency in research protocol review• Build research ethics capacities of investigators and ethics

committees• Discuss topical and emerging bioethical issues.

Benefits • Share experiences • Sensitize the public about issues related to research ethics• Identify options to address ethical dilemmas encountered in

research• Opportunity to network

18

Research oversightMain Objective:To ensure that research projects approved by the REC conform to the research guidelines right from their implementation throughout their completion.

19

Benefits: • Opportunity to interact with research

participants• Interact with the study team

The gaps within REC Administration system (1)

1. Financial constraints• Entirely depend on review fees• Few grants fund REC activities• Structural issues i.e. most RECs are not institutionalized

Result into:• Turnover of REC Administrative staff due to inadequate

remuneration• Under staffing• Few site monitoring visits are conducted• Poor remuneration of REC members

20

The gaps within REC Administration system (2)

2. Lack of formal training of REC Administrative staff and members in research ethics

• Affects the quality of review and administrative work

3. Failure to meet deadlines• Lack of commitment by REC members due to other

responsibilities• Quorum issues• Heavy workload

4. Inadequate filing systems• Limited office space• Under staffing• Huge volume of paper work

21

The gaps within REC Administration system (3)

5. Perception towards research ethics committees• REC are looked at as a stumbling block for

researchers

6. Lack of a clear strategy to protect researchers against exploitation

• Data sharing• “Local researchers are used as data collectors”• Follow up on exported samples• Capacity building

22

Case Study of MakCHS

23

RECs at MakCHSHosts 4 RECs

• School of Medicine Higher Degrees Research Ethics Committee

• School of Public Health Higher Degrees Research Ethics Committee

• School of Biomedical Sciences Higher Degrees Research Ethics Committee

• School of Health Sciences Higher Degrees Research Ethics Committee

24

Research Support CentreCentre for all research related activities at the College

Host:• 4 RECs

• Grants office

• Finance office

• IT department

25

Research Support Centre

26

MakCHS eIRB System

27http://chs.mak.ac.ug/eirb/

Research policy & guidelines• University research policy

• Research misconduct and misbehavior– Anti plagiarism detection software

• Conflict of interest

• National guidelines for Research involving human participants

28

Bioethics activities

Bioethics centreIHRET program

Masters of Health Sciences in Bioethics (MHSc. Bioethics)

Short courses• Research Ethics• Responsible Conduct of Research • Clinical Ethics

Bioethics working group

29

Clinical Trials Unit• Trainings

– Good Clinical Practice– Study designs– Data collection techniques – Data management – Data analysis – Informed consent process

• Seminars

• Monitor clinical trials30

Conclusion• UNCST has played a significant role towards establishment and

operationalization of RECs in Uganda in abide to protect all stakeholders involved in research

• Research should be done for the benefit of society

• Research integrity is essential

• The safety, rights, values, interests and welfare of the human research participants is essential

• A good research ethics system ensures beneficial research is done without harming or inconveniencing the research participant.

31

Conclusion However:• Secure a reliable and sufficient source of funding for

REC activities

• Establish an eIRB system

• Formal training in research ethics of Administrative staff and REC members

32

Aida NakawundeMSc. CEB

REC Administrator School of Medicine Makerere University College of Health

Sciences,Uganda Kampala

aidan.kiseka@gmail.com+256704369754

33