The purpose of the research oversight and monitoring guidelines is to ensure that research projects approved by FOMREC conform to the research guidelines right from their implementation through to their completion.
During each monitoring review, the trial conduct, procedure, and processes will be evaluated.
The monitor will also assess the study staff├ö├ç├ûs knowledge and compliance with National and International regulations as well as GCP guidelines.
The monitor will assess and recommend any training needs of the study staff. Any deficiencies with the staff and/or study will be identified and a corrective plan designed.
Types of Monitoring and Oversight Reviews:
1. For-cause monitoring review; this may arise when the IRB learns of any of the following:
a. Multiple protocol violations, deviations, and/or departures from protocol
b. Subject complaint (s)
c. Staff complaint (s)
d. Numerous reportable unanticipated problems
e. Research non-compliance such as failure to submit reports
2. Routine, not for cause review (Sites selected without bias based on specific, objective criteria)..
For more information about research at Makerere University, please download the files below or visit our website.
For any Inquries please contact
Faculty of Medicine Research and Ethics Committee
Makerere University College of Health Sciences
P. O Box 7072, Kampala- Uganda
Tel: 256 41(+256) 0414 -533541
One of the publications from the College is the African Health Sciences Journal - an internationally refereed journal publishing original articles on research, clinical practice, public health policy planning, implementation and evaluation, in the health and related sciences relevant to Africa and the tropics. African Health Sciences was launched in August 2001, as a means to public high quality medical research from Uganda and other African countries. The quality of the journal was endorsed by acceptance on Medline. From 2005 African Health Sciences was published for times a year in March, June, September and December. The African Health Sciences has a twinning partnership with the British Medical Journal. Online accessibility available at:
Please click here for a list of published research for the period 1982 - 2007
|FOMREC SOPs.zip||82.5 KB|
|REC ADMINISTRATION FORMS.zip||280.95 KB|
|FOMREC ROSTER.doc||62.5 KB|
|FOMREC MEMBERS.xls||31 KB|
|hdc members.doc||108.5 KB|
|over sigh tguidelines.pdf||77.56 KB|
|SOP 10 specimen.doc||31.5 KB|
|SOP indicators.pdf||42.11 KB|
|current tracking sop5.pdf||70.47 KB|
|current submisionssop1.pdf||184.37 KB|
|current SOP10 specimen.pdf||56.99 KB|
|current SOP9 adverse.pdf||64.77 KB|
|current sop8sops.pdf||60.44 KB|
|current patient data sop6.pdf||65.88 KB|
|current minutes sop3.pdf||56.4 KB|
|current expidited sop7.pdf||75.6 KB|
|current determining sop4.pdf||60.02 KB|
|curren tmeetings sop2.pdf||68.72 KB|
|Consent-Assent form-Sample copy.doc||26 KB|
|Brief Historical Background for FOMREC.doc||19.5 KB|
|Approved studies from 2002 to 2009.doc||367.5 KB|
|Approved 02-09.pdf||244.4 KB|
|Approvals 2010 and expiry dates.xls||367.5 KB|