DRAFT
UNIVERSITY OF MALAWI
COLLEGE OF MEDICINE
COLLEGE OF MEDICINE RESEARCH AND ETHICS COMMITTEE
GUIDELINES AND OPERATION PROCEDURES
1.0
THE NEED FOR RESEARCH GUIDELINES
[a]
Research may be designed and conducted by University Academic Staff
with the following goals:i]
Academic
- advancement of scientific knowledge teaching of
students
ii]
Operational - to improve service provision
- to improve the care of patients
The college will encourage research that incorporates both [i] and [ii]. The
College Research and Ethics Committee would like to encourage a
combination of the two for obvious reasons.
[b]
Regardless of the goals for conducting the research study, the
welfare/interest of the study population [patients] comes first [refer to the
Declaration of Helsinki (1964) with its subsequent amendments] (Annex 1).
[c]
As a training/teaching institution, the College would encourage that any
research conducted by a staff member, either within or outside our teaching
hospital, should have a training component [i.e. should aim at exposing
junior members of staff of the COM to research proposals development and
conduct as well as writing of the final report and articles to be published in
peer review journals.
2.0
[d]
All research conducted by members of staff of the College of Medicine
should be of the highest possible standards, to attract funding from donors;
be relevant and take into consideration the national requirements or policies.
[e]
To ensure all the above, and facilitate the work of the College of Medicine
Research and Ethics Committee, standard guidelines for proposal writing
and submission by the members of staff, will be available.
[f]
The College Research and Ethics Committee will advise any investigator(s)
on the best present their research proposal(s), either overall or particular
aspect(s), depending on the needs of the investigator(s).
GENERAL CONSIDERATIONS:
Before writing a research proposal, the researcher should consider the following:i]
What is the problem the study intends to address.
ii]
What are the possible reasons/determinants of the problem[s] and possible
solutions[s].
iii]
What method is being proposed to either study/resolve or identify
causes/determinants of the problem(s) and/or the solution[s].
iv]
How does one propose to do that?
v]
How is the study and its results/findings going to benefit the study
population, the institution or the country?
vi]
Is there any work similar to what one is proposing to do which has been
done here or elsewhere? If so, where, when, by whom, and what did it/they
show (literature review).
vii]
Is there a need to repeat the study if a similar one has already been done?
If so, why? Is the proposed study likely to show anything new! (i.e The
rationale for the study).
viii]
What are the required or available resources to conduct the study (e.g.
manpower, laboratory, human subjects, financial, transport, computer and
time, etc). How does one hope to get these.
ix]
Is the investigator (s) qualified to undertake the research project.
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3.0
x]
What institutional facilities are available and are at the disposal of or can be
utilised by the researchers. If so, what is needed to do that. If not how does
one propose to accomplish the project.
xi]
Is the funding available or what are the possible funding.
RESEARCH PROPOSAL FORMAT
N.B. The College of Medicine Research and Ethics Committee is aware of the
fact that different funding agencies may have different guidelines/format
requirements. Where this is the case, the Principal Investigator should
prepare the proposal in the required format, provided that the format used
gives all or most of the details as contained in the College Research and
Ethics Committee Guidelines. The Principal Investigator must provide
supportive evidence for the format used to the Secretariat. Otherwise the
proposed guidelines and format should be followed.
The following is the recommended format for research proposals in which members
of staff of the College of Medicine, University of Malawi, are involved.
[a]
Title
This should be specific and precise. It should not be more than 2 to 3 lines
long, and should indicate what one intends to do/find out.
e.g.
[b]
"Validation of an algorithm on the management of urethral discharge
in Malawi".
Investigators
-
Full names, qualifications, academic titles of all the investigators,
including trainees (Assistant lecturers or postgraduate students) and
their institutional/departmental affiliation(s).
The principal/main investigator (responsible for the work) should be
the first one. If there are co-investigators these should be indicated
as appropriate with their qualifications, academic titles and
institutional affiliations.
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[c]
-
A brief up to date C.V. of each of the investigators and coinvestigators should be provided. (if it has not been submitted within
the past one year).
N.B
Most journals have restrictions on the number of authors for a paper
to be published. This may be an important consideration when
preparing a research proposal.
Institution[s] under whose umbrella the research project will be
conducted:
e.g.
[i]
[ii]
The World Health Organisation.
The College of Medicine - University of Malawi.
[i]
[ii]
The Welcome Trust Centre.
The College of Medicine, University of Malawi, etc
or
[d]
Executive Summary
-
This should include:The type of research study
The problem [to be studied]
The objectives
Methodology
Expected findings and their dissemination.
All in summary. This should not exceed one and half pages.
[e]
Background information and introduction:
-
[f]
This should include:A review of the relevant literature. It should be most current.
(Majority being in the past five to ten years at most).
Locally available information - either published or not. It may
include clinical or laboratory observations (e.g. increasing
number of adult males presenting with head injuries at the
QECH during national holidays).
Rationale/justification for the research project:
4
-
[g]
There should be a statement explaining why the researcher[s] feel
the research project is important and therefore should be carried out,
(i.e. the potential significance to health care delivery, or otherwise).
It should not be more than a paragraph or two.
Objectives of the study
[i]
Broad
The main issues that are being looked at/for, (e.g. to survey the
socio-demographic and reproductive profiles of patients with acute
gonococcal urethritis at the QECH).
[ii]
Specific
The specific issues that are being looked at/for. These must be
measurable, either qualitatively or quantitatively and form a guide to
the research methodology, data analysis and presentation of results.
-
[h]
Examples:1.
To survey the age distribution of patients presenting
with acute gonococcal urethritis at the QECH.
2.
To survey the sexual behaviour of such patients,
Methodology
This should be very detailed as it is your guide on how the study will be
done as well as the data analysis. It should provide relevant information
on:i]
The type of research study, e.g
-
case - control
prospective, descriptive
randomised clinical trial
double - blind clinical trial,
cross sectional
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This should reflect exactly what the researchers intend to do.
ii]
Study Place
-
Where the study is going to be conducted (e.g. ten secondary
schools in Mangochi District or The Queen Elizabeth Central
Hospital, Chiradzulu District Hospital and South Lunzu Health
Centre).
All the areas in/at which the survey/study will be carried out
must be indicated.
iii]
Study Population
-
Who are to be included in the study or from which group[s] of
people is the study group going to draw, e.g.
-
iv]
v]
Patients presenting with multiple pregnancy at the
QECH, in Blanytre, Malawi.
Study Period
-
The entire period of the study including preparation of the
proposal, submission and approval, training (where
necessary), pretesting (of the questionnaire), data collection,
data analysis, report preparation, and dissemination of the
findings.
-
If the study is in phases, each must be specified and the time
for each given.
Sample Size
-
Details on the sample size and how it has been arrived
at/worked out.
-
It's justification.
-
The selection/inclusion/exclusion criteria (e.g
10th client
- every
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- randomised (and how random)
- every patient who consents.
-
vi]
Data Collection:
-
vii]
The need for and type of consent must be specified, and how
it will be obtained, e.g.
- written consent
- verbal consent
Details on:-
What information is going to be looked for/collected.
-
How that is going to be done (e.g. laboratory test, with
provision of appropriate details).
-
Requirements for that, (e.g. reagents, culture media,
blood samples and their relevant tests etc). It should
include - who is going to do each of the aspects of
data collection (e.g. who will draw blood, perform the
tests, do the physical examination, interview the study
group, etc).
Data Management and Analysis
-
Details should be provided on how the collected data is going
to be managed, (e.g. coding)
-
Details on data analysis
- the computer package to be used in
data entry and analysis e.g.
- SPSS
- EPI - INFO 6.0, etc
-
The type of statistical tests to be used
e.g. - regression analysis
- student 't' test of significance,
viii] Results Presentation
A brief explanation of the format of the results as they will be
presented, e.g.
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- Pie charts
- Histograms
- Line graphs,
- Tables
ix] Dissemination of the Results
-
Indicate the person or institution to whom the report is going
to be submitted and why.
-
How does/do the investigator[s] propose to disseminate their
research findings, such as;
- attendance at local, regional or international
conferences/seminars, workshops.
- holding of a dissemination seminar/workshop.
- publications in peer-reviewed journals etc.
N.B. A copy of the final report and any published paper(s) or
abstracts of papers read at conferences out of the
research findings should be submitted to each of the
following:-
i]
The College of Medicine Research and Ethics
Committee (COMREC)
College of Medicine Library
The Health Sciences Research Committee
(through the COMREC Secretariat)
The University Research and Publication
Committee (URPC) (through the COMREC
Secretariat)
Ethical Considerations
-
What ethical issues need to be addressed.
-
How are they going to be addressed.
-
This should include protection of human subjects [clients rights]
[Declaration of Helsinki - 1964]. (Annex 1)
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j]
-
If animals will be used there is need to consider the International
Guiding Principles for Biomedical Research Involving Animals [WHO,
1985]. (Annex 2)
-
If using human tissues or other biological materials, refer to
[Guidelines for the Opportunistic Procurement and Use of Human
Tissue and other Biological Materials in Research, WHO 1991].
(Annex 3)
Possible Constraints:
-
k]
Any envisaged problems in undertaking the study.
How these will be addressed, by whom and when.
Requirements:
Details should be provided on what the research project will require.
e.g.
- personnel - and their individual roles
- training (of whom, why, when, where, by who)
- paper - for the questionnaires, reports, etc.
- transport - what form and for what.
- reagents - which/how much of each and for what.
- drugs - which, how much of each, for what, their source(s).
- space - how that will be obtained, where, when.
l]
Budgetary Estimates
-
Each line item should be quantified in monetary terms.
-
The investigator should indicate the amount to be asked for and what the
institution(s) under which the research project will be conducted, will
contribute.
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For example:-
Institutional
Contribution
Being
asked for
X
Y
(i) Personnel
- Principal
Investigator's salary
-
Each item should be quantified if possible. If it is not possible (e.g. premises
or space), it should just be mentioned as an institutional contribution.
However small the institutional contribution is, it should be indicated.
-
Sub-totals for each group should be indicated and then the grand total.
-
A 10% [of the total] administrative contribution to the College of Medicine,
should be included
- of this - 3% will go to the individuals' department(s)
- 2% will go to the College Administration
- 3% will go to the College Research Committee [to assist it in its
various activities, e.g. secretarial, holding of research
dissemination
meetings, sponsorship of research projects by students, etc).
- 2% will go to the College Library.
If there are two or more donor agencies supporting the study, each
organisation's contribution should be shown and possibly what it is meant to
support; e.g. The WHO - supply of all the reagents total cost = US dollars
20,000.00; IDRC = salary of the Principal Investigator; COM = space, etc).
m]
Justification of the Budget
The investigators must indicate how they arrived at the amount of money being
asked for, and how it is going to be disbursed.
e.g.
n]
2 principal investigators - for overall supervision of the project, data analysis,
report production and dissemination. 10% of their time for 24 months at US
dollars 300.00 = 2 x 300 x 24 = US dollars 14,400.00.
References
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-
The cited literature, it should be as current as possible and include locally
available information.
These should be in the internationally accepted format (e.g. E. Afr. Med. J.
1995; Vol. 71. 55-60).
4.0
SUBMISSION AND REVIEW OF THE PROPOSAL:
i]
The Principal investigator shall prepare (4) copies of the proposal together
with $100 processing fee or its equivalent.
ii]
The copies shall reach the Secretary - COMREC 30 days before the date of
the meeting.
iii]
A letter from the respective head[s] of department(s) indicating that the
research has the blessing of the department(s) shall be sent to the
Secretariat together with the proposal. Research affiliations like Wellcome
Trust, John Hopkins Project etc need a supporting letter from Head of
Department.
iv]
Every thing should go through the head of department including
resubmissions.
v]
A copy of a brief CV of each of the investigators shall be sent to the
Secretariat [1 copy of each]. (Except those which have been submitted
within the same academic year).
vi]
Within two weeks receipt of the proposal will be acknowledged in writing.
vii]
Following the review the results together with comments from the Research
Committee will be sent to the Principal investigator within two week. This
response will include - how to proceed e.g. resubmission or response for
specific issues.
viii]
Resubmission shall also be at least two weeks before the following meeting.
ix]
Research affiliations needs a supporting letter from the head of department.
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5.0
OPERATING PROCEDURES
The mission and policies of the COMREC are contained in the Research Policy
document. In this document standard operating procedures are outlined.
COMREC is among the many committees in the College of Medicine responsible
to the Heads of Department Committee and Management. Its main functions'
include the following:
Develop and promote Research activities within the College of Medicine.
Ethical review and approval of research protocols
Scientific Review and approval all research protocols involving Investigators
within COM.
Support dissemination of research results from approved research studies in the
country.
Monitoring of conduct of all approved research studies.
COMREC as properly constituted Ethics Committees and Scientific review body
is subject to all international conventions and codes involving protection of human
subjects participating in medical research.
5.1 MEETINGS
COMREC will meet every month, on the last Wednesday of each month
unless it is a public holiday.
The year's calendar of meeting is released by January 31 of each year and
made available to all departments in the college.
At its first meeting in January the members will discuss;
the annual report,
annual expenses,
the annual plan,
annual budget estimate
renewal of ongoing studies
The last review meeting is to be held no later than the second week after the
dissemination conference.
If the quorum cannot be achieved the meeting must be rescheduled to
following Wednesday. If the Chairman is not present the Vice Chairman will
Chair the meeting. If both are not present members will elect an acting
chairman to chair the meeting.
COMREC shall co-opt external reviewers on specific areas from college.
5.2 RESEARCH PROTOCOLS
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Submission
The submission must be accompanied by the approved amount of $100
processing fee and the appropriate number of complete copies. (4)
The format of the protocol must comply with guidelines (see guideline).
COMREC will consider review of a protocol in different format upon a formal
request by investigators in writing (i.e. Sponsor specification, multi-center
clinical trials, Students dissertation)
Application documents must be received in COMREC's office by the close of
business day of the indicated deadline for submission 30 days before the
meeting.
All applications received on time will be acknowledged indicating date received
and date to be reviewed within two weeks.
The complete submission must include original protocol, consent forms (English
and Chichewa),
investigators CV’s, forms/questionnaires both English and Chichewa.
o submissions must have a supporting letter from the host department.
o Covering letter from the Principal Investigator.
o Where direct clinical care of patients by the investigator is involved a copy of
registration from Medical Council must be included.
o Where other local institutions are involved in the research a letter of
collaboration or permission must included.
The secretariat will make copies and distribute to all members at least 14 days
before the meeting.
The package will include the agenda, minutes of previous meeting, and protocols.
Apologise must be communicated to the secretary 3 days before the meeting.
5.3 REVIEW OF PROPOSALS
If the application is missing relevant documents the secretariat will inform the
Principal Investigator within one week.
Members review all protocols on the agenda prior to the meeting. All questions
and queries by members must be written.
The COMREC may decide to limit the number of protocols to be reviewed per
session.
13
Members will discuss each protocol according to the guidelines (ethics/
science/relevance) etc.
Inclusion on of the protocols on the agenda will be done on a first come first serve
basis.
Clarifications requiring the investigators response will be in written form only.
To facilitate review process we shall introduce the practice of having primary and
secondary reviewers for selected proposals and resubmissions. Primary
reviewers for specific areas could be co-opted however they do not have powers
to vote. They would be available only for open sessions of the meeting and not
the closed sessions of the meeting which includes voting.
5.4. DISCUSSION
The primary and secondary review will present a brief summary (guidelines) of
each proposal. The discussions will be open to all members. All queries or
questions during discussion must be written. Based on the discussion the
committee will make a decision for approval or rejection. The primary/secondary
review must submit their written comments to the secretary.
5.5. APPROVAL
All queries and questions raised during the discussion of a protocol will be
recorded in the minutes by the secretary.
Options
Consensus:
The decision on approval will not depend consensus but on majority vote
however dissenting voice will be minuted.
Majority Vote:
At the end of the discussion each member will be requested to give their
comment and their decision to approve on NOT to approve. The decision will be
made through the majority vote.
5.6 CONFLICT OF INTEREST
At the beginning of the Any COMREC meeting, the Chairman will ask members
to declare if they have conflict of interest and if there are they will be requested to
step out of the room at the time of voting (Member is: is PI or Co-PI, member
from the same department, any relationship likely to compromise objective
judgement)
5.7 EXPIDITED APPROVAL:
14
During the review the committee will decide to assign specific protocols for
expedited review process.
An expedited approval refers to approval of a protocol in such special
circumstances: After a full committee review recommends and appoints selected
members to review the response to the queries and comments by the Principal
Investigator.
If in the judgment of the appointed members an approval be granted, the
appointed members will recommend for approval in writing to the committee.
The secretary will issue a letter of approval as soon as a recommendation is
'received from the appointed members in writing.
The secretary will report of the decision to the full review at the following meeting
for ratification by the full committee
6.0 GENERAL COMMUNICATION ON APPROVED AND UNAPPROVED RESEARCH
PROPOSALS
All communication from the COMREC will be addressed through the head of
department to the Principal investigator through the head of department. In cases
where the PI is in another country the communication will be addressed to the local
Co-Investigator. This is to ensure that head of departments are responsible in
making sure that correction of the research fee is being enforced.
COMREC will acknowledge receipt of protocol within two weeks working days
informing investigators of any problems with submission or date of review.
COMREC will communicate with investigators through the Secretary in writing about
its decision within two week of the review.
The letter must be signed by the Research Coordinator or Chairman or an approved
COMREC designee, and a copy ought to be sent to the Registrar, Finance officer,
Head of Department, Post graduate dean and the Principal Investigator.
The Approval letter must state the date of review or approval. The letter must also
indicate the title, COMREC ref number duration of approval.
If a protocol is not approved the letter to the investigator will clearly state all the
reasons for the rejection.
All communications by investigators must be directed to the secretary. Failure to do
so may result in significant delays.
15
The COMREC will not take responsibility of erroneous information on review of
protocol obtained through other than the secretary in writing.
Two copies of the approved protocol will be appropriately stamped. One copy will be
maintained in COMREC office and the other copy returned to the investigators.
6.1 RESUBMISSIONS
A protocol may be resubmitted for review under the following conditions:
A previous review rejected the protocol with comments or concerns
A previous approved protocol but implementation did not start until expiry of the
approval.
Up to 2 resubmissions will be permitted
No processing fee is required on the first resubmission.
6.2 MONITORING
All research studies approved by COMREC must adhere with ICH guidelines for
human subjects protection
The COMREC is responsible for ensuring that approved research studies are
implemented in accordance with ethical/scientific guidelines. COMREC will
therefore monitor the conduct every one of its approved studies through:
1. The COMREC has established a Monitoring Subcommittee with the
responsibility to ensure that research studies approved by COMREC are
monitored.
2. Progress reports: Every approved research study will submit quarterly reports
according to COMREC guidelines (see appendix for format)
Data safety: All studies involving experimental medications or diagnostic product
(registered or new products) must constitute a credible Data and Safety
Monitoring Board. The COMREC may require that a DSMB include one
appointee by the committee.
The Principal Investigator is responsible for submitting a written DSMB report to
the COMREC within 1 month of its scheduled meeting.
If the DSMB is unable to meet, the investigator must inform the COMREC in
writing within 2 weeks.
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Adverse Experiences: Investigators conducting experimental studied will be
required to report cases of adverse experiences considered to be related to the
use of the experimental medical treatment or device to COMREC.
Serious adverse events such as death of a participant must be report within 7
days of being identified unless otherwise specified in the approved protocol.
Special Monitoring: The monitoring committee can at anytime conduct a special
monitoring of any of its approved research studies. Monitoring may be conducted
by an independent team as appointed by the subcommittee.
Special monitoring on any particular study will be decided upon by COMREC and
will involve the following:
 Visiting the study site
 Review study progress
 Review consent forms for participants Review charts of participants
Interview with Principal Investigator interviews with study staff Review study
procedures
Review documentation of approved modifications.
The Principal Investigator will be informed at least 4 weeks in advance of the
monitoring visit.
7.0. COMREC MONITORING TOOL OF APPROVED RESEARCH STUDIES
A. DOCUMENTATION
Date Reviewed ____________________________________________________
Name of Principal Investigator ________________________________________
Names of co-investigators
____________________________________________
Proposal No. _____________________________
Title of study
_______________________________________________________
_________________________________________________________________
_
17
Copy of approved protocol including forms, questionnaires, consent forms and
CV for investigators
_____________________________________________________________
Approved amendments or subprotocol
___________________________________
Any correspondence with COMREC concerning the study
___________________
COMREC approval letter of the
protocol__________________________________
Date started _______________________________
Numbers recruited __________________________
Participant file _____________________________
Interview with participant
______________________________________________
Consent
form_______________________________________________________
Complete data/questions forms
________________________________________
_________________________________________________________________
_
Participants file – interview with participants, consent forms completed data
questionnaire
_________________________________________________________________
_
Likely date of completion
______________________________________________
Randomisation correctly carried out?
____________________________________
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Data collection and storage
____________________________________________
10% administration
fees_______________________________________________
Processing fees
_____________________________________________________
Date completed
_____________________________________________________
Comments of monitor
B.
MONITORING PROCEDURE
1. Meeting with Principal Investigator or Co-investigator and study staff.
2. Meeting, if applicable study coordinator.
3. If applicable, visit recruitment site, ward, clinic and meet with some study staff
and participants.
4. Random check of patient study forms and consent forms.
5. If available manual of operation or written study procedures.
6. Type of specimens being collected, if applicable.
7. Test results of specimens collected if applicable.
8. If applicable specimens shipped outside the country.
C.
IMPLEMENTATION PROGRESS
1. Review Annual reports. Manuscripts, publication reports, presentation.
2. If applicable, annual review approval letters.
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D.
CAPACITY BUILDING
1. Training type, who is attending and how many
2. Type of Equipment
GENERAL COMMUNICATION
Members:
Management
Ministry of Health
Other IRBs
Sponsors
Investigators
Participants
REVIEW GUIDELINES
Format: refers to the presentationRelevant documents: Complete protocol, CVs of all investigators, data collection
tools (forms, questionnaires), complete budget, Consent forms, safety
information, letters from relevant authorities if applicable, advertising or study
specific education materials
7.0.
CHECK LIST OF INFORMED CONSENT PROCESS
Informed consent shall include the following elements:1. Statement that the study involves research.
2. Explanation of the purposes of the research.
3. Expected duration of the subject's participation in the research.
4. Description of the procedures to be followed.
5. Identification of any procedures that are experimental.
6. Description any reasonably foreseeable risks or discomfort to the subject.
7. Description of any benefits to the subject or to others that may reasonably be
expected from the research.
8. Disclosure of appropriate alternate procedures or courses of treatment, if any,
20
that might be advantageous to the subject.
9. Statement describing the extent, if any, to which confidentiality of records
identifying the subjects will be maintained, and if applicable, a statement of
the
possibility that the food and drug administration may inspect the records.
10. For research involving more that minimal risk, an explanation as to whether
any compensation is available if injury occurs, and if so, what they consist of,
or where further information can be obtained.
11. Explanation of whom to contact for answers to pertinent questions about the
research, research subject's rights, and whom to contact in the event of a
research- related injury to the subject.
12. Statement that participation is voluntary, thatrefusa1 to participate involves no
penalty or loss of benefits to which the subject is otherwise entitled, and that
the subject may discontinue participation at any time without penalty or loss
of
benefits to which the subject is otherwise entitled.
13. Statement that significant new findings developed during the course of the
research, which may relate to the subject's willingness to continue, will be
provided to the subject.
14. The last sentence should explicitly read "I voluntary agree".
15. The consent form should be translated into the local language.
BUDGET CONTRIBUTION
Processing fee:
The processing fees are intended to contribute to meeting the costs of reviewing
of the protocol i.e. photocopying, meeting and communication. Submissions
without the fee will not be reviewed.
Ten percent budget contribution: Is a requirement by the college of Medicine. It is
intended to contribute to the costs administrative costs of hosting a research
study, space, utilities, staff time etc.
Why charge 10% budget contribution
1. We need 10% for institutional capacity building, e.g. MMJ research support for
students, research dissemination, managing of research office and buying
21
equipments for that office, paying allowance and accommodation for non
College of Medicine COMREC members.
2. We charge 10% for COM institutional things which can not be budgeted for
e.g. the use of College of Medicine building, the use of the name and also the
value of processing and granting of approvals which costs time, money,
papers and room.
3. We are in the situation where we are developing therefore we need support in
order to achieve self sufficiency in lab and computer equipment so that
eventually researchers may not need to import some equipment.
4. Because of this there is no exemption on 10%, but the COMREC has got the
mandate to waiver when the need for exemption is properly justified.
The students need to present a full budget of their proposals as part of their
training. All proposals funded by locally and not foreign sources will pay 10% that
can be waivered upon proper justification
DISSEMINATION OF RESEARCH RESULTS
Investigators will be required to disseminate their results through the journals
both in international and local or through the dissemination conference organized
by COMREC. Researchers are encouraged to use the local MMJ to disseminate
their results.
8.0 RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR
The Principal Investigator is the individual with responsibility for the technical,
administrative, and fiscal management of a project, including any applicable
subcontracts. As a practical matter, it is often necessary and appropriate to rely on
staff members for assistance in carrying out much of this responsibility. The
Principal Investigator and/or staff must:1. Be knowledgeable, at the proposal stage, about appropriate agency and
University guidelines and restrictions relative to the conduct of research, training,
and service programs, and be willing to adhere to such guidelines and
restrictions;
2. Conduct the work supported by the grant or contract in a timely and professional
manner;
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3. Comply with the specific terms and conditions of each award as stated in the
contract or grant documents and with all administrative requirements, as set forth
in various sponsoring agency and campus policy statements, concerning issues
such as publication, intellectual property, equipment screening, proprietary data,
consultants, human subjects, animal subjects, recombinant DNA, or regulated
substances;
4. Assure that expenditures made prior to the receipt of a fully executed contract or
grant award are incurred only after obtaining specific authorized approval, that
expenditures do not exceed the total amount of funds awarded, and that specific
budget category expenditure limits are adhered to;
5. Maintain budgetary control through the use of departmental bookkeeping and
cost control systems and monthly reconciliation (e.g. detail general ledger and the
distribution of payroll expense);
6. Certify that all costs charged to each contract or grant specifically benefit the
project being charged by reviewing and approving certifications of effort
expended by employees, staff employee time reports, payments of vendor
invoices for goods and services, check requests (non payroll), travel expenses
vouchers, requisitions to and acceptance of charges from campus service units,
and similar charges to the project. If it becomes necessary to make after the fact
adjustments in the knowledgeable academic official, must provide full justification
and documentation of the costs being transferred;
7. Comply with the reporting requirements of each contract and grant which may
include periodic progress reports, annual reports of project accomplishments,
reports of inventions, reports of publications generated, reports of major items of
equipment acquired, and financial reports;
8. Ensure that subcontractors are performing the work agreed upon in the scope of
work, before authorizing any payment to the subcontractors.
9.0 REMINDER TO ALL RESEARCHERS
1. You are required to pay US $100.00 as a processing fee with your proposal.
2. Pay the 10% administration fee payable to College of Medicine Research
Committee when the proposal is approved.
3. You should note that the follow-up committee will monitor the conduct of the
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approved protocol and any deviation from the approved protocol may result in
your
study being stopped.
4. You will provide an interim report in the course of the study and end of study
report.
5. Where the study project is longer than 12 months, you will be required to obtain an
approval for continuation.
6. All investigators must be fully registered with the Medical Council of Malawi, and
please send copies of registration to us.
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