Institutional Scientific and Ethics Review Committee (ISERC) Policy Document

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1.0 PURPOSE OF DOCUMENT
To define the mandate, composition and functioning of the Institutional Scientific and Ethics Review Committee (ISERC) at Primate Research – (IPR)

1.1. PREAMBLE

INSTITUTIONAL Scientific and Ethics Review Committee shall provide independent and timely review of scientific merit, ethics and animal welfare of proposed studies. In their composition, procedures and decision-making, IRC shall be independent from political, institutional, and market influences. The ISERC is responsible for carrying out review of proposed research before commencement of research projects. This includes review of all animal welfare issues in proposals to ensure comprehensive harm-benefit analyses of animal experimentation.

The committee shall also review the relevance of proposals to the society, safety of the experiment in relation to our human and physical resources and therefore give the appropriate recommendation to the Director on the measures needed to enhance our competitiveness and capacity in research.

The review committee shall also ensure that there is regular evaluation of ongoing studies, to ensure continual adherence to approved study contents and procedures.

1.2 Mandate

ISERC is a peer-review committee that reviews scientific merit, ethics and animal welfare components of proposed and oversees the set experimental protocols, prior to implementation of the projects(s) at IPR. It also ensures that a comprehensive harm-benefit analysis of animal experimentation is carried out in proposals to be reviewed. All projects proposals funded internally or externally (including collaborative projects) must be reviewed by ISERC.

ISERC shall review projects based on Replacement, Refinement and Reduction (3Rs) principles of Russels and birch (1959). In addition, the five freedoms of animals’ welfare shall also be considered. These are freedom from hunger and thirst – by ready access to fresh water and a diet to maintain full health and vigour; freedom from discomfort – by providing g an appropriate environment including shelter and a comfortable resting area; freedom from pain, disease – by preventation or rapid diagnosis and treatment; freedom to express normal behavior – by providing sufficient space, proper facilities and company of the animal’s own kind and freedom from fear and distress – by ensuring conditions and treatment which avoid mental suffering.

Where appropriate, e.g., studies involving humans, proposals must submit evidence of relevant international and national ethical approvals.

ISERC must ensure: a) proposals, are scientifically and ethically sound, b) the safety of the people involved in the experiments and c) environmental safety when reviewing proposals.

In addition to review of proposals, ISERC shall:

a) Oversee and evaluate Institutional animals resources, husbandry and management programs.
b) Ensure proper use, care and humane treatment/handling of animals used in research at IPR and field based research by IPR scientists, research associates and scientists affiliated to IPR.
c) Inspect animal facilities and activity areas (field sites) at least once every 6 months and forward finding and recommendations to the Director IPR.

1.3 Good Research Practices: GLP, QPBR, EPPE

Rules of good research practices holds the researcher to perform his/her work in compliance with his/her own pre-established plan and their standardized procedures. IPR has trained its staff in Principles of Good Laboratory Practice (GLP), Quality Practice in Basic Biomedical Research (QPBR) and Effective Project Planning in Health Research (EPPE) with the help of UNDP/World Bank/WHO Special Program for Research and training in Tropical Diseases (TDR) and ISO 9001-2008 quality management principles.

These regulations do not concern the scientific and/or technical content of the research programs. They do not aim to evaluate the scientific value of the studies. They aim to protect the right and safety of the human participants involved and to ensure that the study data are credible (reliable, reproducible, auditable, and reputable).

1.4 Membership and Tenure of ISERC

The Director shall appoint up to 8 members of ISERC including Chief of Research and for a period of three (3) years. The ISERC members will elect their Chairman and Secretary during their first meeting. The ISERC shall set up a sub-committee of three members to review Animal Care and Use issues and undertake animal facility inspections. Care shall be taken to ensure exclusion of animals Sciences Department staff members from the committee. One external member shall be nominated to represent the local society. The Director is an ex-officio member of ISERC.

1.5 Independent Consultants

ISERC will establish a standing list of, independent consultants who may provide special expertise to the committee on proposed research protocols, including proposal review. These consultants may be specialists in ethical or legal aspects, specific diseases or methodologies, or may be representatives of communities, patients, or special interest groups.
1.6 Conditions of Appointment

A member should sign a confidentiality agreement regarding meeting deliberations, applications, information on research participants, and related matters. This should include the external member and consultants.

1.7 Disqualification Procedures

A member may be disqualified from the membership of ISERC for: 1) Non-attendance of three consecutive meetings without administrative approval from Chairman. 2) Breach of ethics as outlined in “confidentiality agreement”.

1.8 Replacement Procedure

The ISERC Chairman will request the Director to appoint a replacement should there be a vacancy. The new member shall serve the remaining term of the committee and not necessarily entire 3 years.

2.0 REVIEW PROCESS

2.1 Submission of a proposal for review

A duly completed proposal review form together with the required number of copies of the complete proposal will be submitted to the ISERC secretary. The secretary will peruse the documents and forward to reviewers. A calendar of meetings for each year will be issued every January to enable researchers plan for their research projects.

2.2 Number of copies to be submitted

The applicant will submit one signed printed/hard copy and an electronic copy OR one duly signed electronic copy to the secretary ISERC. The secretary will allocate each proposal a unique identification number at the point it is submitted by the investigator for review.

2.3 Duration of Review

Four weeks from the date the application is lodged with ISERC secretary should be allowed as the period of review. Reviewers will be allowed a maximum period of two weeks for reviewing the proposals.

2.4 Format for Submitting a proposal for Review

Applicants will be required to fill in an official ISERC proposal review form in English. The form includes the following: The abstract will not be more than 200 words. A full proposal will be appended as Annex 2. A one page CV of the study collaborator(s) will be provided as Annex 3. Clearances from other relevant authorities where necessary will be attached as Annex 4. A fee of US$100.00 for internal proposals and USD 500 for external proposals will be charged on each proposal for the administrative process. These fees will be charged to every lodged proposal prior to the review process and therefore will be paid upon application to the IPR accounts office and proof of payments lodged with the secretary ISERC.

2.5 Review Process

The review will focus on scientific merit, ethical consideration and animal welfare. Each proposal will be sent to two independent reviewers. Proposals requiring animal experimentation will also be forwarded to the Animal welfare subcommittee for comments regarding comprehensive harm-benefit analysis of animal experimentation. ISERC Secretary will distribute the submitted proposal to the reviewers for review, comments and approval. In the absence of the Secretary of ISERC, the Chairman will appoint a member of ISERC (at the beginning of the calendar year) for the purposes of receiving the proposal review form and appointment of review form and appointment of reviewers. This member will also act as the ISERC Chairman during the discussion of the proposal.

The reviewers will be expected to make their comments on a standard review form provided by the Secretary ISERC alongside the proposal for review. Reviewers’ comments will be submitted to the secretary. The applicant’s proposal review form together with reviewers’ reports will be discussed at a meeting of the entire ISERC committee.

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September 2, 2012