standard operating procedures for moi ......i. members may resign from their post by giving a letter...
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MTRH/MU IREC Page 1 of 23 | Version 8 | May 2017
Moi University College of Health Sciences
P.O. Box 4606-30100 Eldoret, Kenya.
Email: [email protected]
Moi Teaching and Referral Hospital P.O. Box 3-30100
Eldoret, Kenya. Email: [email protected]
STANDARD OPERATING PROCEDURES
FOR
MOI INSTITUTIONAL RESEARCH
&
ETHICS COMMITTEE
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Foreword
Biomedical research involving human beings has the potential for great good as well as
great harm to potential study participants. They are at risk of physical and emotional
exploitation. This is largely due to the high esteem in which health professionals and
researchers are held by the lay public, which can easily be abused. In addition, there
are, special groups including but not limited to minors, refugees and mentally unsound
who are even more prone to exploitation in research.
With increasing collaborative research involving external institutions/organizations of
diverse societal backgrounds, and different interpretations of ethical issues there is need
to regulate research activities and protection of research participants. Through the
Science, Technology and Innovation Act 2013, the National Commission for Science
Technology and Innovation (NACOSTI) was establishment to regulate research in the
country. To achieve this mandate NACOSTI facilitated the establishment of review
boards of which Moi University College of Health Sciences (CHS) and Moi Teaching and
Referral Hospital (MTRH) Institutional Research and Ethics Committee (IREC) is one of
them.
The activities of IREC especially in review of research proposals may be prone to various
forms of abuse that can inhibit rather than foster a research culture. It is therefore
important that the systems and procedure for receiving, reviewing, approving research
proposals and post-approval compliance monitoring are put in place. These systems
should be standardized so as to allow expeditious, objective and reproducible review of
proposals. The development and dissemination of the Standard Operating Procedures
(SOPs) of IREC must therefore be viewed as an important step in fostering an ethical and
humane research culture in our institutions. It is understood that, new ethical issues in
health related research will keep emerging and hence there will be need for regular
revisions of these SOPs to maintain their relevance to contemporary trends.
Chief Executive Officer, Principal,
Moi Teaching and Referral Moi University, College of Health
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Hospital Sciences
List of Abbreviations
AOB – Any other Business
CD Rom – Compact Disc Read-Only Memory
C.E.O – Chief Executive Officer
CHS – College of Health Sciences
COBES – Community Based Education and Service
CV – Curriculum Vitae
IRB – Institutional Review Board
IREC – Institutional Research and Ethics Committee
MUCHS – Moi University, College of Health Sciences
MTRH – Moi Teaching & Referral Hospital
NACOSTI – National Commission for Science, Technology and Innovation
PI – Principal Investigator
SOPs – Standard Operating Procedures
TOR – Terms of Reference
USA – United States of America
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Table of Contents
Foreword .......................................................................................................................................... 2
List of Abbreviations ....................................................................................................................... 3
1.0 ROLE OF IREC .................................................................................................................... 6
2.0 TERMS OF REFERENCE .................................................................................................. 6
3.0 MEMBERSHIP ..................................................................................................................... 6
3.1 Co-option ............................................................................................................................... 7
3.2 Appointments ........................................................................................................................ 7
3.3 Tenure and conditions of appointment ............................................................................. 7
3.4 Resignation, disqualification, replacement of members ................................................ 8
3.5 Honoraria ............................................................................................................................... 8
3.6 Review Fee ........................................................................................................................... 8
3.7 Contact Information for IREC ............................................................................................. 9
4.0 THE SECRETARIAT ........................................................................................................... 9
5.0 FUNCTIONS AND RESPONSIBILITIES ......................................................................... 9
5.1 Chair: ...................................................................................................................................... 9
5.2 Vice Chair .............................................................................................................................. 9
5.3 Secretary ............................................................................................................................. 10
5.4 Deputy Secretary ............................................................................................................... 10
5.5 Human Subject’s Administrator ....................................................................................... 10
5.6 Committee Members ......................................................................................................... 11
6.0 REGULAR IREC MEETINGS ...................................................................................... 12
6.1 Frequency ........................................................................................................................... 12
6.2 Quorum ................................................................................................................................ 12
7.0 CONDUCT OF IREC MEETINGS ............................................................................... 12
7.1 IREC Meeting Schedule and Distribution of Agenda ................................................... 12
7.2 Meeting Procedure ............................................................................................................ 12
7.3 Minutes of meetings .......................................................................................................... 13
8.0 SPECIAL MEETINGS ....................................................................................................... 13
9.0 SUBMISSION OF A NEW RESEARCH PROPOSAL ................................................. 13
Application Procedure .............................................................................................................. 13
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10.0 TYPES OF REVIEW ...................................................................................................... 16
10.1 Expedited Review ............................................................................................................ 16
10.2 Full Review ....................................................................................................................... 16
10.3 Exempt review .................................................................................................................. 17
10.4 Continuing Review ........................................................................................................... 19
10.5 Review of Study Amendments ...................................................................................... 19
11.0 COMMUNICATION OF REVIEW DECISIONS ......................................................... 20
12.0 FOLLOW UP ................................................................................................................... 20
13.0 APPEAL AGAINST COMMITTEE DECISION .......................................................... 21
14.0 RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR IN THE REVIEW
PROCESS ..................................................................................................................................... 22
15.0 HANDILING RESEARCH MISCONDUCT ................................................................. 22
16.0 DOCUMENTATION AND ARCHIVING ...................................................................... 22
17.0 REFERENCES ............................................................................................................... 23
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1.0 ROLE OF IREC
The Institutional Research and Ethics Committee (IREC), hereinafter called ‘The
Committee’, was constituted jointly by Moi University College of Health Sciences
(MUCHS) and Moi Teaching & Referral Hospital (MTRH). The Committee shall serve as
the regulatory entity for research at the MU and MT&RH and satellite areas and as an
independent representative and competent body to review, evaluate and decide on the
scientific and ethical merits of research proposals. It is committed to ensuring and
guaranteeing the rights, dignity, safety and protection of actual or potential individuals
and communities who participate in research. The Committee governs health research
as guided by applicable laws and regulations of the Kenyan and other relevant
international bodies. The Committee reviews and approves research proposals for and
on behalf of the National Commission for Science, Technology and Innovation which is
the legal entity authorized to review and approve research in Kenya under Cap 250 of the
Laws of Kenya.
2.0 TERMS OF REFERENCE
IREC shall work under the following terms of reference:
1. Review proposals and provide independent ethics and scientific review.
2. Have authority to approve (with or without modification) and disapprove research
proposals.
3. Conduct post approval compliance monitoring.
4. Make an annual report to the National Bioethics Committee.
5. Keep abreast with international developments in relation to health research and
associated ethical issues and liaise with relevant local and international
organizations
3.0 MEMBERSHIP
The Committee shall be composed of 7- 21 members, with 1/3 of the total being of either
gender, having core members from various disciplines including Biomedical, Clinical and
Social Sciences, Biostatistics, Law and a lay person(s).
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3.1 Co-option
The Committee may co-opt member(s) at any one time for independent expertise
as and when required. The Committee shall determine the duration of the co-
option.
3.2 Appointments
The Committee members shall be appointed by the C.E.O, MTRH, and the
Principal CHS hereinafter referred to as the Appointing Authority. Appointment will
not take more than 90 days following the request letter done by the chair to the
C.E.O.
3.3 Tenure and conditions of appointment
1. IREC shall have a Chair, Vice Chair, and Secretary, Deputy Secretary, and
members and will be assisted by a secretariat consisting of the human subject
administrator, records personnel, IT, secretary, data entry personnel and
housekeeping staff.
2. Members shall be selected in their personal capacities, based on their interest,
ethical and/or scientific knowledge, and expertise, as well as on their
commitment and willingness to volunteer the necessary time and effort for the
Committee’s work.
3. Members shall be appointed initially for a period of three (3) years, renewable
once.
4. To maintain continuity in the operations of the Committee, at least a third of the
membership shall be retained.
5. The outgoing Chairperson shall be an ex-officio member in the incoming
Committee for one term.
At appointment;
i. Members shall sign a confidentiality agreement at the start of the term and
abide by the confidential agreement regarding meeting deliberations,
applications, protocol submissions, information on research participants and
related matters; which they have had privilege to as a result of being members
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of the Committee. The confidentiality protects all the privacy and confidentiality
of all parties whose information may be disclosed to the Committee in the
course of its work.
ii. Members shall provide their updated bio-sketches annually and be willing to
publicize their identity; name, profession and affiliation to the Committee
iii. Members shall disclose in writing any interest or involvement - financial,
professional or otherwise - in a project or proposal under consideration.
iv. Any member who has vested interest in a proposal submitted to the
Committee- shall not participate in the deliberations of the protocol.
3.4 Resignation, disqualification, replacement of members
i. Members may resign from their post by giving a letter of resignation, at least
one month in advance, to the appointing authorities through the Chairperson.
ii. Members may also be disqualified from continuance following advice from the
committee.
iii. The Committee shall request for removal and replacement of any members
under the following circumstances
a. Persistent absenteeism of a member for more than three consecutive
meetings.
b. Voluntary withdrawal of a member.
c. Ethical/professional misconduct.
3.5 Honoraria
i. Honoraria shall be paid to the IREC members after every meeting.
ii. The community representative or any other temporarily co-opted non-
institutional member shall be paid a subsistence allowance which shall be
determined by the Committee from time to time.
3.6 Review Fee
The Committee shall charge a fee to cover administrative costs of research
proposal review. These fees shall vary from time to time as determined by the
Committee.
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3.7 Contact Information for IREC
IREC shall have a designated physical address, telephone contact, website and e-
mail address. The Human Subject Administrator shall be the contact person.
4.0 THE SECRETARIAT
The Secretariat shall consist of the Secretary, Deputy Secretary, Human Participants
Administrator and support staff.
5.0 FUNCTIONS AND RESPONSIBILITIES
5.1 Chair:
The Chair shall:
i. Conduct meetings in accordance with the regulations
ii. Facilitate induction and training of new Committee members
iii. Facilitate continuing education for members
iv. Oversee the functions and activities of the Secretariat
v. Assign responsibilities and duties to any member of the Committee
vi. Sign the minutes of the Committee meetings
vii. Sign approval letters for research proposals on
viii. Upon the recommendation of the Committee, sign approval letters for
research proposals.
ix. Shall facilitate logistical support to the Secretariat to ensure prompt
execution of IREC mandate
x. Liaise with the National Commission for Science, Technology and
Innovation and other IRBs.
5.2 Vice Chair
xi. Perform all the functions and duties of the chair whenever the chair is
absent.
xii. Perform any other duties as assigned by the Committee or the chair
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5.3 Secretary
The Secretary shall:
i. Be responsible for the safety and maintenance of Committee documents,
website and records
ii. Call meetings in consultation with the Chair
iii. Identify suitable reviewers in collaboration with the Committee
iv.Dispatch proposals to reviewers for scientific and ethical review
v.Receive reviewed proposals and monitor the review process of proposals to
ascertain comments from reviewers within the stipulated period.
vi. Prepare proposal review documents for discussion at regular Committee
meetings
vii. Design and disseminate templates for Committee submission documents,
including research protocols, informed consent materials, agreements and
periodic and final reports
viii. Oversee the functions and activities of the Administrator and the support
staff
ix. Record, process and circulate the minutes of the IREC meetings
x. Shall archive the official minutes of the meeting’s agenda and all relevant
attachments
xi. Disseminate SOPs and IREC guidelines
xii. Receive final reports from the PI (s)
xiii. Perform any other duties as assigned by the Committee or the Chair
5.4 Deputy Secretary
i. To officially deputize the Secretary
ii. Perform any other duties assigned by the Secretary
5.5 Human Participants Administrator
The Human Participants Administrator shall:
i. Perform day to day running of the IREC secretariat including financial
management with approval of the Committee
ii. Perform a pre-review of each protocol and categorize the proposals based
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on risk levels and appropriate review for consideration to ensure
compliance with administrative submission requirements
iii. Liaise with the Secretary/Deputy Secretary ratify any ‘borderline protocol’ as
necessary
iv. Manage and maintain copies of all correspondences
v. Attend Committee meetings and assist in taking of minutes
vi. Assist the Secretary in drawing the agenda
vii. Circulate research proposals and minutes to Committee members
viii. Assist in preparation and submission of annual operating budget in
consultation with the Chair
ix. Design and maintain a system for collecting and filing all Committee
documents, including meeting minutes, member qualifications, protocol
submission versions, deviations from approved protocols, and periodic and
final reports
x. Maintain inventory of all office equipment
xi. Undertake all other administrative duties as assigned by the secretary.
5.6 Committee Members
Committee members shall:
i. Review, discuss and consider all proposals submitted for review.
ii. Consider decisions taken by the Chair on behalf of the Committee for
ratification
iii. Maintain confidentiality of documents and deliberations of the Committee
meetings.
iv. Declare conflict of interest whenever applicable
v. Participate in continuing education activities in biomedical ethics and
research
vi. Attend Committee meetings regularly and contribute constructively to the
deliberations
vii. Provide technical support to uphold the integrity of IREC
viii. Perform any other duties assigned by the chair
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6.0 REGULAR IREC MEETINGS
6.1 Frequency
The Committee shall convene a meeting once a month, held every last Thursday
of the month at 9.00 am.
6.2 Quorum
Quorum shall be half (1/2) of IREC membership (including apologies) and at least a
third of the members physically present.
7.0 CONDUCT OF IREC MEETINGS
7.1 IREC Meeting Schedule and Distribution of Agenda
i. The Secretary shall notify and circulate the agenda, time, venue, and date
for the next meeting to all Committee members at least one week in
advance.
ii. The Secretary shall notify all Committee members of any changes of the
meeting time, venue, date or agenda within 24 hours.
7.2 Meeting Procedure
i. The Chair shall call the meeting to order
ii. The Chair shall request for adoption of the agenda
iii. The Standard agenda shall be as follows;
a. Prayers
b. Apologies
c. Communication from the chair
d. Declaration of Conflict of Interest.
e. Confirmation of minutes
f. Matters arising
g. Consideration of actions taken by the Chair on behalf of the
Committee
h. Receive and Consider Research Proposals
i. Receive and Adopt Reports
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j. Any Other Business (A.O.B)
iv. Committee members with interests in any research proposal shall declare
the same and shall leave the meeting for the duration of the deliberations
on the proposal.
v. IREC may where necessary invite the Principal Investigator to the meeting
to clarify certain issues relating to their proposal.
vi. Decision making of the Committee shall be by consensus.
7.3 Minutes of meetings
i. The Chair shall review the minutes for accuracy and completeness then
sign/approve for circulation
ii. The minutes of each meeting shall be distributed to members within a
period of not more than two weeks after every meeting
iii. The minutes shall be confirmed at the next meeting
iv. The confirmed minutes shall be distributed to, the CEO, MTRH and the
Principal College of Health Sciences within two weeks after confirmation.
8.0 SPECIAL MEETINGS
i. Special meetings shall be called as deemed necessary
ii. Specific agenda shall be circulated in the meeting notice. Only specified agenda
items shall be discussed.
iii. There shall be no A.O.B.
9.0 SUBMISSION OF A NEW RESEARCH PROPOSAL
Application Procedure
The requirements for submission of a research project for ethical review are clearly
described in the application procedures available on the IREC Webpage www.irec.or.ke.
The required application forms and a checklist are available on the IREC webpage
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Application procedure chart
WHAT IS MY LEVEL OF
SUBMISSION?
Exempt review less than
“minimal risk” to human
subjects example: anonymous
response survey, focus group or
questionnaire, case reports
working with a completely
deidentified (anonymous)
secondary data set
WHAT FORMS DO I NEED?
Reviewer guideline &
abstract forms required
during submission to IREC
Vulnerable population form required when dealing with
vulnerable populations
Continuing review forms to
be filled when the study
periods is approaching an end
(at least 1 month before end
of study period)
Amendment forms when
making changes to a protocol
could be a minor or major
amendment.
Other Requirements to
accompany the forms include:
4 hard copies of research
proposal
Informed consent;
Assent form for
participation of minors (if
applicable)
Budget
Evidence of ethics
training
Biosketch/ CVs
Copy of grant application
or approval letter if
applicable Expedited Review “minimal risk” to
human subject’s examples
prospective or retrospective chart
review, surveys/questionnaires
collecting limited personal identifiers
or health information, any
intervention or interaction with the
subject.
Full review more than minimal risk to
participants any research project
involving human subjects not covered
under other review categories contact
with vulnerable populations working
with data that can be traced or linked to
individual participants’ interventions
involving physical or emotional. IMPORTANT review all paperwork
carefully before submitting to IREC.
“Minimal risk” means that the risk of harm anticipated in the proposed research are not greater, considering probability
and magnitude than those ordinarily encountered in daily life or during the performance of routine physical and
physiological examinations or tests (noninvasive examples, physical, blood pressure, EKG ).
“Vulnerable populations” include those whose interests require special protection, e.g. pregnant women/fetus, prisoners,
minors, subjects with psychiatric/mental disorders, etc.
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A valid application is one which at the time of submission, is complete, with all the
necessary documents attached and is signed and dated.
The application should include the following information and materials:
i. The protocol in the required format (see annex 1) and other
accompanying/supporting materials
Four(4) hard copies of the proposal
A soft copy of the proposal (written on a CD or digital copy sent to
Four(4) copies of the reviewer guideline form
Four copies(4) of the abstract form
Vulnerable population form (4) copies in case the research involves a
vulnerable population.
Consent forms
Data collection instruments
Recruitment materials (e.g. fliers)
Detailed CV/Bio-sketch
Trans National Bank receipt produced on submission (externally funded
studies will be invoiced) payments expected once funds are availed.
ii. All applications will receive notification in writing of the decision of the IREC
Committee.
iii. Where IREC Committee requires supplementary information or changes to
documents from the applicant, the timeframe for this will be outlined in the letter of
notification.
iv. No revisions may be made, prior to the IREC Committee meeting, to an
application that has been accepted for review and assigned a reference number.
Where an applicant considers it necessary to revise the protocol or supporting
documents prior to review, the application should be withdrawn.
v. Studies are given approval for one-year
vi. Investigators wishing to continue research beyond their one-year approval time
period must submit a continuing review.
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vii. IREC must approve any changes or amendments to an approved study before the
researcher implements such changes.
10.0 TYPES OF REVIEW
There shall be five (5) types of review, namely;
1. Expedited Review
2. Full Review
3. Exempt Review
4. Continuing Review
5. Review of Amendments to a previously approved Proposal.
10.1 Expedited Review
An expedited review shall be conducted by the IREC Secretary, Deputy Secretary
or Human Participant Administrator.
The above mentioned may assign the protocols if expert review is required.
The following categories of research proposal shall qualify for an expedited review
and approval:
i. Research investigation that present no more than minimal risk to the study
participants.
ii. Minor amendment in previously approved research during the period for
which approval was granted.
Definitions of “minimal risk” and “minor amendment” will be based upon accepted
guidelines/categories as defined in national and international guidelines.
10.2 Full Review
All other research proposals submitted for review, and which do not meet the
criteria for expedited and exempt review shall undergo of a full review process as
follows;
i. The Secretary of IREC shall identify at least two suitable experts within
and/or outside the committee to review the proposal.
ii. The administrator shall provide each reviewer a copy of the proposal and a
reviewer’s standard form to assist them in reporting their review findings.
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iii. Simultaneously, the administrator shall circulate copies of the proposal
abstracts to the designated reviewer.
iv. The reviewer shall return the reviewer form, the proposal and any other
comments to the administrator within 2 weeks.
v. If after 2 weeks there shall be no response from the reviewer the proposal
shall be withdrawn and re-assigned to another reviewer.
vi. The Human Participant Administrator shall pool all the reviewers’
comments, edit and process, remove any reviewer identifiers, and hand
them over to the PI.
vii. The PI is required to address the concerns within a period of 2 weeks from
receipt date. Once the PI addresses all the reviewers’ comments, a revised
copy of the proposal shall be returned for re-review.
viii. The reviewer shall communicate their recommendations in writing to the
Secretary, who shall then advice the Committee to consider granting
approval to the PI to begin the research work.
10.3 Exempt review
Unless otherwise defined by the Committee and other relevant regulations,
research activities in which the only involvement of human subjects will be in one
or more of the following categories are exempt from these SOPs:
i. Research conducted in established or commonly accepted educational
settings, involving normal educational practices, such as
a. Research on regular and special education instructional strategies, or
b. Research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management
methods.
ii. Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or
observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human
participants can be identified, directly or through identifiers linked to
the subjects; and
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b. Any disclosure of the human participants responses outside the
research could reasonably place the subjects at risk of criminal or civil
liability or be damaging to the subjects' financial standing,
employability, or reputation.
iii. Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior that is not exempt under paragraph 10.4 (ii)
of this section, if:
a. The human subjects are elected or appointed public officials or
candidates for public office; or
b. Any laws / regulations require(s) without exception that the
confidentiality of the personally identifiable information will be
maintained throughout the research and thereafter.
iv. Research involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if these sources
are publicly available or if the information is recorded by the investigator in
such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.
v. Research and demonstration projects which are conducted by or subject to
the approval of department or agency heads, and which are designed to
study, evaluate, or otherwise examine;
a. Public benefit or service programs;
b. Procedures for obtaining benefits or services under those programs;
c. Possible changes in or alternatives to those programs or procedures;
or
d. Possible changes in methods or levels of payment for benefits or
services under those programs.
vi. Taste and food quality evaluation and consumer acceptance studies;
a. If wholesome foods without additives are consumed or
b. If a food is consumed that contains a food ingredient at or below the
level and for a use found to be safe, or agricultural chemical or
environmental contaminant at or below the level found to be safe, by
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the any local or international regulatory body.
10.4 Continuing Review
Continuing Review submissions must include all current IREC approved study
documents, even if they have not changed since the last review:
The application for review of continuation of study should include the
following information and materials:
2 hard copies of the continuing review form
2 hard copies of the study proposal document
2hard copies of the consent forms
Recruitment materials
Data collection instruments (surveys, interview questions, stimuli, etc.)
Other forms or documents utilized with human subjects
DSMB/DSMP Report (if applicable)
Research personnel list for Continuing Review
All approvals shall be valid for a period of One (1) year. Studies that last for more
than 1 year shall apply for a continuing approval annually.
For all research studies that are likely to run for more than a year, the Principal
Investigators shall apply for continuing review two months before the expiry of the
IREC approval for their study.
10.5 Review of Study Amendments
Amendments are defined as any changes to an approved research protocol. All
amendments to the study proposal shall be communicated to IREC.
The application for review of amendment should include the following
information and materials:
A cover letter detailing the amendments.
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2 hard copies of the amendment form
2hard copies of the revised proposal or other documents impacted by the
proposed research modification
2 hard copies of the newly developed documents that support the proposed
research modification
11.0 COMMUNICATION OF REVIEW DECISIONS
i. The Chair shall communicate within 2 weeks of the date of the decision to the
Principal Investigator on the review decisions.
ii. Communications shall be in writing through standard IREC documents bearing the
signature of the IREC Chair, or a designated officer appointed by the Chair.
iii. The final review decision shall be in the following format;
Formal Approval
Not Approved.
iv. When the decision is Not Approved, the reasons shall be given to the Principal
Investigator in writing.
v. The approvals shall be for one year period, renewable on application for
Continuing Review Approval.
12.0 FOLLOW UP
The Committee shall constitute a monitoring and evaluation sub Committee to monitor
post approval compliance and progress of approved research.
i. The monitoring and evaluation Sub Committee may follow up studies seeking
amendments that are likely to affect the rights, safety, and or well-being of the
participants or the conduct of the study
ii. The Sub Committee shall be expected to make a follow-up on serious and
unexpected adverse events related to the conduct of the study or study product
and the response taken by the investigators, sponsors and regulatory agencies.
iii. The Sub Committee shall be further expected to follow up any event or new
information that may affect the benefit/risk-ratio of the study
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Follow up decisions will be communicated in writing to the investigator indicating either of
the following decisions
i. Approval of amendment
ii. Suspension of study processes
iii. Termination of study
The secretariat shall require the investigators to submit
i. Progress reports upon seeking renewal of their studies
ii. Final report and notification on study completion should also follow at the
conclusion of a project.
iii. Any publications of results emanating from the study.
13.0 APPEAL AGAINST COMMITTEE DECISION
An investigator who feels dissatisfied with a review decision has a right of appeal.
i. The aggrieved investigator shall be expected to lodge their appeal with IREC Chair
within 14 days of receiving the review decision.
ii. The IREC Chair shall then constitute an Appeals Sub-Committee of five,
consisting of the IREC Secretary, the Human Subjects Administrator, a member of
IREC with expertise in the subject matter or is content expert in the area of the
research proposal under review and two non–IREC content experts and one non-
IREC ethics expert in the subject matter of the proposal under review but who
MUST not have reviewed the proposal before the appeal.
iii. The IREC Secretary shall be the convenor and the chair of the Appeals Sub-
Committee shall be the non-IREC member.
iv. The IREC members will participate in the discussion BUT will not take part in the
decision making.
v. The IREC Chair shall ensure the Appeals Sub-Committee has access to the
proposal in dispute and request them to meet once to consider the appeals merits
and present their report at the next regular IREC meeting usually within one month
of the appeal being lodged with the IREC chair.
vi. The Committee shall consider the recommendations of the Appeals Sub-
Committee and IRECs decision at this point shall be final.
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vii. If the appellant is dissatisfied with the decision of Committee, they have a right to
appeal to NACOSTI.
14.0 RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR IN THE REVIEW
PROCESS
i. The Principal Investigator shall be responsible for prompt response to reviewers’
comments, usually within one month of receiving the comments.
ii. The administrator shall remind the PI to respond to the reviewer comments after
the month grace period elapses.
iii. If after being reminded, the PI does not respond to the reviewer comments within a
further period of one month, the review shall be considered to have lapsed and the
PI shall be required to make a fresh submission for IREC review.
iv. The Principal Investigator shall submit a final report resulting from the study; in
hard and soft copies.
15.0 HANDILING RESEARCH MISCONDUCT
The Committee will conduct investigations into allegations of research misconduct and
make recommendations for determination of appropriate action to be taken by the
Appointing Authority.
16.0 DOCUMENTATION AND ARCHIVING
IREC shall document and archive the following documents:
IREC standard operating procedures
Duly signed confidentiality agreement forms
Bio-sketch/Curriculum vitae of members
One copy of all materials submitted by applicants
Correspondence by IREC members with investigators in regard to application
decisions and follow up
All correspondence and other materials received during follow-up
A list of IREC members
Records of income and expenditure
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Agenda of meetings
Minutes of IREC meetings
All written documentation received during follow-up
Notification of completion, premature suspension or premature termination of a
study
Final report of a study
Documents shall be archived for minimum period of 3 years following the completion of a
study. After the expiry of storage period, the Kenya National Archives and Documentation
Services will be notified to carry out the disposal of the hard copies. The soft copies of
the documents shall continue to be archived.
17.0 REFERENCES
1. International Ethical Guidelines for Biomedical Research involving Human subjects. Council of
International Organization of Medical Sciences (CIOMS), 1993.
2. Standard Operating Procedures. Navrongo Health Research Center Institutional Review Board, 2001.
3. Operational Guidelines for Ethics Committees That Review Biomedical Research. (WHO), 2000.
4. The ENGAGE Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing in
Conforming to the Note for Guidance on Good Clinical Practice.
5. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving
Human Subjects. World Medical Association, Inc., 2000.
6. Code of Federal Regulations (Title 45, part 46). Department of Health and Human Services, National
Institutes of Health, Office for Protection from Research Risks, 2001.
7. The Republic of Kenya, National Council for science and Technology, 2004. Guidelines for ethical
conduct of Biomedical Research involving Human Subjects in Kenya. NCST NO. 45