development and pilot testing of an online module for ethics

Ogunrin et al BMC Medical Ethics 2013 141httpwwwbiomedcentralcom1472-6939141

RESEARCH ARTICLE Open Access

Development and pilot testing of an onlinemodule for ethics education based on theNigerian National Code for Health Research EthicsOlubunmi A Ogunrin13 Temidayo O Ogundiran23 and Clement Adebamowo345

Abstract

Background The formulation and implementation of national ethical regulations to protect research participants isfundamental to ethical conduct of research Ethics education and capacity are inadequate in developing Africancountries This study was designed to develop a module for online training in research ethics based on theNigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedicalresearchers in Nigeria

Methodology This was a three-phased evaluation study Phase one involved development of an online trainingmodule based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the CollaborativeInstitutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module forcomprehensibility readability and ease of use by 45 Nigerian biomedical researchers The third phase involvedmodification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination oftest-retest reliability of the module using Cronbachrsquos alpha

Results The online module was easily accessible and comprehensible to 95 of study participants There weresignificant differences in the pretest and posttest scores of study participants during the evaluation of the onlinemodule (p = 0001) with correlation coefficients of 09 and 08 for the pretest and posttest scores respectively Themodule also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbachrsquos alphacoefficients of 092 and 084 for the pretest and posttest respectively

Conclusion The module based on the Nigerian Code was developed tested and made available online as avaluable tool for training in cultural and societal relevant ethical principles to orient national and internationalbiomedical researchers working in Nigeria It would complement other general research ethics and Good ClinicalPractice modules Participants suggested that awareness of the online module should be increased throughseminars advertisement on government websites and portals used by Nigerian biomedical researchers andincorporation of the Code into the undergraduate medical training curriculum

Keywords Ethics education Nigerian Code Online ethics module Research ethics

Correspondence bunmifunmihotmailcom1Department of Medicine Neurology Unit University of Benin Benin CityPMB 1154 Nigeria3West African Bioethics Training Program University of Ibadan IbadanNigeriaFull list of author information is available at the end of the article

copy 2013 Ogunrin et al licensee BioMed Central Ltd This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (httpcreativecommonsorglicensesby20) which permits unrestricted use distribution andreproduction in any medium provided the original work is properly cited

Ogunrin et al BMC Medical Ethics 2013 141 Page 2 of 17httpwwwbiomedcentralcom1472-6939141

BackgroundThe potentials of research to contribute to improvement inhealth may be surpassed by the magnitude of risk to partici-pants communities and local researchers Consequentlysystematic ethical regulation of research is put in place toensure that research is conducted in a manner that maxi-mizes benefits while minimizing harms to research partici-pants The National Bioethics Advisory Council in USAthe Council of International Organization of MedicalSciences (CIOMS) and the Nuffield Council of Bioethicssuggested that this situation needs initial and continuingeducation in the ethics and science of biomedical and be-havioral research for investigators members of theResearch Ethics Committees (RECs) and sponsors ofresearch [1-3] Several studies have shown that researchethics training improves ethical conduct of research andcapacity for dealing with ethical dilemmas [4-6] Hithertoresearchers in low and middle income countries (LMIC)including Nigeria have had limited access to training inresearch ethics due to weak educational social economicand health resources however there has been significantinvestment in ethics education in the last two decades withresulting improvements in ethics capacity building [78]The design and implementation of ethically and scienti-

fically valid research in any country should be guided by aset of rules and regulations based on global ethical princi-ples but domesticated within local laws regulations andculture It is against this background that the NationalHealth Research Ethics Committee in Nigeria (NHREC)developed and formulated National Code for HealthResearch Ethics (NCHRE) in August 2007 to guide allresearchers involved in human subjectsrsquo researches inNigeria [9] This Code reflects the collective concern of thegovernment and the people of Nigeria to ensure the pro-tection of human participants in scientific research to thehighest ethical standard that is possible It serves as thebasis for the operations of all institutional research ethicscommittees in the country thus allowing for uniformityand consistency The Code is based on universal ethicalprinciples historical ethical guidelines existing regulationsfrom different countries results of modern bioethicsresearch Nigerian constitution laws regulations and go-vernment guidelines as well as Nigerian custom andpracticesExamples of peculiarities of the Code include conduct of

clinical trials in the country which requires approval fromthe National Agency for Food and Drug Administration(NAFDAC) and the emphasis on community engagementin research in view of the countryrsquos traditional communi-tarian ethos Every scientist involved in human subjectresearch in Nigeria their sponsors and other stakeholdersmust function within the scope of the National HealthResearch Ethics Code This demands that researchers beaware and educated on the code with the anticipation that

the knowledge of the guidelines would translate to itspractice in conduct of health-related researchIt is therefore appropriate to develop an educational tool

that will facilitate the understanding and implementationof the Nigerian Code among stakeholders An importantavenue for the facilitation of training in research ethics isthe provision of online courses [1011] Such online coursescan be accessed at different institutions in the country andcan be effective training tool in research ethics It will alsobe of immense benefit to all research ethics committees inthe country as it will facilitate education of their membersthus empowering them to effectively perform their roles inthe protection of human subjects guided by the NCHREFurthermore international researchers and foreign spon-sors would have easy access to the code which willenlighten them on the ethical requirements for conductingresearch in Nigeria There are few studies that haveassessed the utility of online modules as ethics trainingtools in improving knowledge and skills in health researchespecially in resource poor settingsIt is against this background that this project was con-

ceived and designed with the objectives of developing anonline educational module based on the Nigerian Codeto enlighten biomedical researchers on the requirementsof conduct of ethically acceptable research in Nigeriaand evaluate its reliability in achieving this objective

MethodologyThis was a prospective quantitative three phased studyDuring phase one we developed an online training mo-dule based on the contents of the NCHRE and upload itto the Collaborative Institutional Training Initiative(CITI) websiteThe Nigerian Code is a 68 page document with fifteen

main sections (Sections A to O) and one Appendix (withsub-sections 32 to 34) [9] Because the emphasis of theonline module is on ethical requirements for research inNigeria while avoiding repetition of general ethical guide-lines which are already available on the CITI IRB modulewe compared the Nigerian Code with thirteen majorethical guidelines namely Nuremberg Code [12] BelmontPrinciple [13] Helsinki Declaration [14] CIOMS [2]United States National Bioethics Advisory Council [1]World Health Organization-Good Clinical Practice [15]World Health Organization- operational guidelines forethics committees [16] Common Rule ndash 46 Code ofFederal Regulations (CFR) [17] Nuffield Council on Bio-ethics [3] United Nations AIDS guidance on HIV preven-tive vaccine research [18] Europeans Medicine Agency ndashInternational Committee on Harmonization [19] Opinionof European Group on ethics in science [20] and Directive2001 [21] and isolated unique elements of the NigerianCode These extracted contents formed the material


content used to develop our training module (see AppendixA Annex 1)The module consisted of 2 parts an introductory part

which enumerated the genesis of the Code and its signifi-cance to Nigeria and the core educational part The corepart contained information on registration of ethics com-mittees conducting research in institutions without ethicscommittees functions and operations of the health re-search ethics committees the informed consent processthe health research ethics committee records continuingethics training disciplinary actions against those who vio-late the Code the national HREC oversight functionsclinical trials agreement materials transfer agreement andother regulatory agencies in Nigeria including NationalAgency for Food and Drug Administration and Control(NAFDAC) institutional bio-safety committees data andsafety monitoring board and community advisory boardThese elements from the Nigerian Code were thereafterre-written and arranged carefully while ensuring that theydid not lose their meanings and interpretations in theCITI format to make the uploading unto the CITI web siteeasier The module was reviewed by two experiencedbioethicists who made recommendations on how toimprove its presentation without losing the originality ofthe Code and the revised module was sent to the Directorof the CITI for uploading unto the CITI website as apreliminary training module

Selection of participantsForty five research participants were identified purpos-ively and selected by convenience sampling from amongsenior residents and consultants at the University ofBenin Teaching Hospital Benin Nigeria as well as re-search assistants and medical officers involved in thePresidential Emergency Plan For AIDS Relief (PEPFAR)program at the Institute for Human Virology Nigeria(IHVN) University of Benin Teaching Hospital andMasters of Public Health (MPH) program trainees of theCenter for Disease Control Department of CommunityHealth University of Benin All participants had beeninvolved in human subjectsrsquo research These participantsvoluntarily consented to participate in the research hav-ing received detailed information on what the researchwas about what was expected of the participants thecost to the participant (in terms of time spent tocomplete the study) expected duration of the task to beperformed by the participant any possible risk (ie con-fidentiality) and anticipated benefits (ie knowledge ofthe Nigerian Code and the award of a certificate oncompletion of module) incentive to participants (ierefreshments during the study) the fact that any of theparticipants could withdraw from the research at anystage and the addressphone contact of the researcher

Evaluation of moduleThe study participants were allowed to choose a conveni-ent day in the week when they had sufficient time to com-mence and complete the study They were divided intothree groups based on the day chosen for the pilot testingof the online module and gathered in a relatively spaciousquiet and comfortable room They were instructed onhow to register on the CITI home page complete thepretest study the online module and complete the post-test For new users access to the module was facilitated bylogging onto wwwcitiprogramorg and clicking lsquoNew Usersndash Register Herersquo on the home page The West AfricanBioethics Program was selected as training institution instep 1 of the registration procedure and adminwestafri-canbioethicsnet was entered as the institutional electronicmail address in step 2 On submission of the registrationpage a new webpage appeared with the question lsquoAre youconducting human subjectsrsquo research in Nigeria If youare conducting research in Nigeria you are required tocomplete the NIGERIAN NATIONAL CODE FORHEALTH RESEARCH ETHICS Modulersquo Access to themodule page was granted by indicating lsquoYESrsquo Once regis-tration was completed subsequent access to the moduleon CITI home page was obtained by entering usernameand passwordEach participant thereafter completed the module as

instructed The time taken to study the online modulewas noted They were given refreshments during theperiod of undertaking the study as compensationThe online module was tested and evaluated for read-

ability and comprehensibility by the 45 study partici-pants during the second phase The pre-test was ageneral quiz of multiple choice truefalse 9 questions totest the knowledge of the Code and was administered onpaper The post-test was completed online by the parti-cipants and the scores were automatically generated Asurvey with the aid of a questionnaire was then con-ducted after the post-test to assess the comprehensibilityand the ease of use of the online module and any othercomments on how to improve it were obtained from thestudy participants The participants were requested tochoose from three options namely a) easily accessibleor comprehensible b) difficult to access or comprehendand c) not accessible or comprehensible Thereafter theonline module was revised based on the suggestionsobtained from the surveyThe third phase involved the evaluation of the revised

online module Another set of study participants com-prising fifteen participants from the first group and fif-teen who did not participate in the initial evaluationassessed the revised module using the same procedureutilized in Phase Two by completing the pretest andposttest on the revised version of the online moduleThe test performances of the participants in this phase


were compared with the performances of the partici-pants in phase two to determine the test-retest reliabilityof the module

Ethical approvalThis study protocol was approved by the ethics reviewcommittee of the University of Benin Teaching HospitalBenin City Nigeria Informed consents were obtainedfrom all research participants Identifiers were omittedto ensure confidentiality and right of privacy of respon-dents in line with the ethical principle of autonomy andrespect of persons

Data management and analysisThe data was recorded in a password protected data-base and analysis was done with Stata version SE 100(Stata Corp USA) The scores from the pre and posttests were analyzed for difference in performance usingappropriate statistics for hypothesis testing namelypaired t test (to assess if there was significant differencein means of performances) and correlation coefficients(Pearson product moment) The level of confidence wastaken as p values lt 005 The effects of the demographicvariables ie sex age and specialty on pretest and postt-est scores were assessed for statistical significance usingthe likelihood-ratio chi-square analysis The test-retestreliability of the module was estimated using the Cron-bachrsquos alpha as a measure of internal consistency whichranges from 0 to 100 The acceptable level of reliabilitywas 080 or higher [22]

ResultsDemographic details of phase two study participantsForty five biomedical researchers participated in the ini-tial evaluation of the online module The participantscomprised eighteen females and twenty seven males witha mean age of 3572 years (SD 336) and a range of 255to 455 years The demographic details are as shown inTable 1 Fifteen of the participants were senior residentdoctors seventeen were MPH trainees from diversebackgrounds of health-related practices nine consul-tants two research fellows and two research assistantsTwenty of the study participants (444) had attendedany seminar or course on ethics in the past while ten(222) had received training specifically on researchethics The training were however for short periods ndash sixof the ten who received training in research ethicsattended a one day training two attended a one weektraining and the remaining two attended a six monthtraining course

Demographic details of phase three study participantsThirty biomedical researchers participated in the finalevaluation and this group included fifteen participants

from the first 45 The group comprised eighteen femalesand twelve males with a mean age of 3464 years (SD428) and a range of 255 to 455 years The demographicdetails are as shown in Table 2 Eighteen of them wereresident doctors while the rest consisted of five medicalofficers two consultants and five research assistants

Accessibility and comprehensibility of the online moduleon Nigerian codeAll the participants agreed that the online module wascomprehensible and accessible However 2 of the 45(44) study participants said that the module was noteasily comprehensible The same pattern was noted foraccessibility as 43 indicated that it was very accessiblewhile 2 (44) noted that it was difficult to access Themajor challenges of these 2 participants were slow inter-net speed irregular power supply and arduous registra-tion procedureTwenty three (511) of the 45 completed the online

module within 45 minutes while thirty five (778) ofthe participants completed the module within an hourMost of 45 participants (978) agreed that the moduleimproved their understanding of the conduct of researchin Nigeria Two participants (44) were not sure if theywould recommend the module to someone elseThe responses of the study participants on ways to im-

prove the comprehensibility and accessibility of themodule are outlined in Table 3 Forty-two (933) of therespondents suggested that comprehensibility can beimproved by increasing awareness of the Nigerian Codeamong Nigerian biomedical researchers through organi-zation of seminars distribution of the hardcopies of theCode and the addition of the Code to undergraduatemedical curriculum Twenty (444) of the respondentsindicated that accessibility to the module can be im-proved by introducing the module as a course in tertiaryinstitutions and providing an access link on the FederalMinistry of Health website

Test performance of participantsAll the 45 participants completed the pre-test and post-test for the initial evaluation The mean time taken tostudy the online module was 498 (SD 157) minutesThe mean pre-test score was 539 (SD 264) and meanpost-test score was 836 (SD 125) which was statisticallysignificantly different (p = 0001) ndash Figure 1 The age ofthe participants did not significantly affect the pre- andpost-test scores (p = 066) Likewise the sex of the studyparticipants did not affect their scores The mean pretestscores of the male (N = 27) and female (N = 18) partici-pants were 588 plusmn 286 and 575 plusmn 309 respectively(p = 089) while the means of the posttest scores were822 plusmn 135 and 868 plusmn 83 respectively (p = 020) Thespecialty of the study participants did not affect their

Table 1 Demographic data of study participants for phase 2 evaluation

Frequency of respondents (N = 45) Percentages

Sex

Female 18 40

Male 27 60

Age

21 ndash 30 2 44

31 ndash 40 39 867

41 ndash 50 4 89

Positions

ConsultantClinicians 9 200

Senior Resident Docs 15 333

Medical Officers 9 200

Pharmacists 2 44

Research Assistants 4 89

Others 6 134

Specialty

Dental Surgery 2 44

Family Medicine 3 67

Internal Medicine 23 511

Pharmacy 2 44

ObstetricsGynecology 3 67

Public Health 5 111

AIDS research (HIV adherence) 4 89

PMTCT 2 44

Optometry 1 22

Location of Research

UBTH 31 689

University of Benin 3 67

Irrua Specialist 1 22

NAUTH Nnewi 2 44

NNPC Medicals 1 22

IHVN 4 89

State HMB 3 67

(Internal medicine specialty includes clinical pharmacology dermatology endocrinology gastroenterology nephrology and pulmonology)UBTH University of Benin Teaching Hospital NAUTH Nnamdi Azikiwe University Teaching Hospital NNPC Nigerian National Petroleum Company IHVN Institute ofHuman Virology in Nigeria HMB Health Management Board PMTCT Perinatal Mother To Child Transmission


performances on the evaluation of the online module(p = 095) The duration of time taken to complete thepre- and post-tests (p = 047) and attendance at any re-search ethics course (p = 023) did not affect their scoresAnalysis of the scores of the 30 participants who evalu-

ated the modified version of the module showed a meanpre-test score of 493 (SD 212) and mean post-test scoreof 860 (SD 113) which was statistically significant(p = 0001) ndash Figure 2 The age of the participants did notsignificantly affect the pre- and post-test scores (p = 062)Likewise the sex of the study participants did not affectthe pretest and posttest scores The mean pretest scores ofthe male (N = 12) and female (N = 18) participants were

506 plusmn 205 and 479 plusmn 226 (p = 074) while the means ofthe posttest scores were 831 plusmn 135 and 893 plusmn 73 respec-tively (p = 012) The specialty of the study participants didnot affect their performances on the final evaluation of theonline module with p values of 033 and 058 for the preand post-test scores respectively The duration of timetaken to complete the pre- and post-tests (p = 058) andattendance at any research ethics course (p = 037) did notaffect their scores

Correlation analysis and reliability testingThe correlation analysis of the pretest scores obtainedfor the initial and final evaluation of the online module



Sex

Female 18 60

Male 12 40

Age

21 ndash 30 1 33

31 ndash 40 26 867

41 ndash 50 3 100

Positions


Senior Resident 18 6000



Specialty


Public Health 14 469

HIVAIDS research 2 66

IHVN(HIV adherence) 2 66

PMTCT 7 233


UBTH 17 567


IHVN 11 366

(Internal medicine specialty includes clinical pharmacology nephrology neurology and pulmonology)UBTH University of Benin Teaching Hospital IHVN Institute of Human Virology in Nigeria PMTCT Perinatal Mother To Child Transmission


yielded a coefficient of 09 and that of the posttest scoresyielded a coefficient of 08 These coefficients signifiedexcellent correlation between the scores obtained forboth the initial and final evaluations of the online mo-dule The test-retest reliability of the test performanceon the online module of the Nigerian Code was esti-mated using the Cronbachrsquos alpha a measure of internalconsistency of an instrument by comparing the pretestscores of the initial and final evaluation and the posttestscores for both evaluations Values above 08 signifyacceptable reliability index The Pretest reliability indexwas 09 while the posttest reliability index was 08 Theinternal consistency of the module as instrument to as-sess the knowledge of the participants is highly indica-tive of excellent test-retest reliability index

DiscussionThis study showed the utility of an online module basedon Nigerian Code of Health Research Ethics in improv-ing the knowledge of ethical conduct of research amongthe study participants as demonstrated by significantlyimproved scores satisfactory accessibility and compre-hensibility and excellent internal consistency The reli-ability of test instruments is paramount to its utility Aninstrument that lacks internal consistency and test-retest

reliability is less likely to be effective The ability of thepretests and posttests on the online module of theNigerian Code to measure the knowledge obtained fromstudying the module in a consistent manner is remark-able and compared favorably well with a previous studythat validated a new tool for assessment of research eth-ics knowledge and obtained Cronbachrsquos alpha of 08 [23]This suggests that the module can be effectively used asa tool for ethics training on Nigerian Code for allresearchers conducting biomedical research in NigeriaThis is important for a developing country like Nigeriawhere ethics capacity is inadequate and the teaching ofresearch ethics is still in its infancy It is pertinent tostress that the module emphasized the peculiarities ofethical regulations that administrate human subjectsrsquoresearch in Nigeria hence its focus was not on bioethicsas a whole Therefore it should be used in conjunctionwith other bioethics and GCP modules This was theadvantage of uploading it onto the CITI website as CITIprovides other modules that cover general bioethicstrainingA recent randomized study that compared the impact

and acceptability of online and onsite methods of train-ing in research ethics and statistics showed that bothmethods led to marked and similar improvements of

Table 3 Suggestions on how to improve accessibility and comprehensibility of the online module based on Nigeriancode for health research ethics

Item Suggestions to improve comprehensibility Frequency of respondents

1 Design programs and training to create awareness about the Code 26

2 Provide hardcopies of Nigerian Code for researchers 16

3 Add to the curriculum for undergraduate education in Nigeria and make bioethics a core undergraduate course 10

4 Module is voluminous and so should be shortened 6

5 Highlight key issues and definitive statements of interest 4

6 Add more examples and illustrations including pictorial presentations 4

7 Add more information on roles of PIs 4

8 Make webpage more friendly 2

9 Include case scenarios in the module 2

Item Suggestions to improve accessibility Frequency of respondents

1 Adequate internet connectivity 12

2 Recommend the module for tertiary institutions in Nigeria 10

3 Provides link for the module on Federal Ministry of Health website 6

4 Make the log in procedure easier for researchers 5

5 Develop a separate website for training on the Nigerian Code 4

6 Encourage computer literacy 2


knowledge and that the advantages of less logisticaldemands and cost-effectiveness made the online methodmore useful for expanding health research capacity inresource-limited settings [24]For online trainings a basic requirement is the avail-

ability of internet services Internet usage has beengrowing in sub-Saharan Africa in the past decade espe-cially for educational purposes In Nigeria all majorcities have internet services however quality bandwidthand consistency is low Online trainings therefore haveto take this into account by avoiding use of media-heavyweb pages that require high bandwidth It is also neces-sary to ensure web pages resume from previous locationin event of service disruption all of which were factoredinto the design of this online courseFurthermore its access is not limited by subscription

as registration on the CITI website is free The modulecan be accessed through the West African Bioethics Pro-gram institutional portal on the CITI website (wwwbioethicscenternet) This portal is freely accessible to allWest African researchers and students Access to themodule would be further enhanced with its inclusion onthe website of the Federal Ministry of Health of Nigeriaas suggested by some of the research participants Themodule has been endorsed by the National HealthResearch Ethics Committee and its timely update is theresponsibility of the NHREC An endorsed certificate ofcompletion is issued by the Director of the West AfricanBioethics Training Program on successful completion ofthe online module The certificate is sent via electronicmail to the researcher or student

The most effective way of delivery of ethics educationhas not yet being clearly identified [2526] but ethicsworkshops and conferences have been held in differentparts of Africa [8] and there are clinical fellowships onethics training available in Canada and the United States[27] One of the suggestions obtained in this study is theinclusion of ethics training in the undergraduate medicalcurriculum This is important because ethics educationprepares students to address ethical challenges [28] andthis multi-faceted formal ethics teaching equip studentswith a common framework on which to reconcilepatientsrsquo medical needs with their values perceptionssituations and beliefs It has been noted that the univer-sity setting provides an excellent environment for dis-cussions of the principles behind moral reasoning [29]This is a plausible idea but the shortage of trainedbioethicists [8] in sub-Saharan developing nations mili-tates against thisNow is the time to bridge the lsquoethics education gaprsquo

between the developed and developing countries andresolve the lsquoknowledge gaprsquo in bioethics among research-ers in developing countries especially with the increasingtrend of multi-national scientific collaborations and con-duct of clinical trials in developing countries This onlinetraining tool would therefore serve to orient nationaland international biomedical researchers working inNigeria on cultural and societal relevant ethical princi-ples It is hoped that the knowledge of ethical require-ments obtained by studying this module would translateinto conduct of ethically acceptable biomedical researchin Nigeria In the nearest future (ie 12 months from this

02

04

06

08

01

00

Box graph showing relationship between pre and post test scores

pretest score posttest score

Figure 1 Box Plot showing pretest and posttest scores oninitial evaluation of the Module


evaluation) we planned to conduct assessment of theknowledge and practice of ethical guidelines learnt fromthe online module among the participants to determinemedium and long-term benefits

ConclusionsThis study has shown that the online module based onthe Nigerian Code of Health Research Ethics can be uti-lized effectively for online ethics education The perfor-mances of the study participants improved significantly

2040

6080

100

Pretest and Posttest scores on final evaluation of module

pretest2 postest2

Figure 2 Box Plot showing the Pretest and Posttest scores onfinal evaluation of online module

on testing after studying the module and the test instru-ment demonstrated a high internal consistency As bio-ethics is being integrated into healthcare settings morewidely and systematically training in bioethics becomesequally important Online ethics training has gainedwide acceptability and many biomedical researchers allover the world had received training in research ethicswith the CITI The addition of this online module to theCITI would ensure accessibility of the Nigerian Code tobiomedical researchers interested in doing multi-national research in Nigeria as they study other generalbioethics modules on the CITI website and this in turnwill facilitate understanding of particularities of ethicalrequirements in Nigeria The final version is online forethics training at wwwcitiprogramorg

Appendix A Annex 1IntroductionAll institutions in Nigeria involved in conduct of healthresearch must have a registered health research ethicscommittee (See Section C pp 16 of the National Codefor Health Research Ethics of Nigeria 2007 and Appen-dix 1 Section 34 (1) pp 59 of the National Health Billpassed by the Nigerian National Assembly (Senate) on15th May 2008)

Functions of HRECsApart from the functions of an ethics review committeewhich have been covered in other parts of this trainingprogram when a researcher in an institution is conductingresearch at a location very far from his primary place ofemployment heshe will need to find a co-investigator inan institution near the research site and obtain ethical ap-proval from the institution there For example a Nigerianresearcher who is conducting research in Ghana orCameroun needs to find a local collaborator and obtainethical approval from the local institution The rationalefor this is that ethical review of research must be sensitiveto local conditions culture and traditions which only aproperly constituted ethics committee in that locality isbest positioned to understand and bring to bear on the re-search process Furthermore local authorities must haveeasy access to a member of the research team in case con-cerns arise with the conduct of the researchIn Nigeria an institution may propose to have more

than one research ethics committee but the jurisdictionof each must be clearly defined so that there is no over-lap For example an institution may have one ethicscommittee for biomedical research another for socialand behavioral sciences research and yet another for ani-mal research Transparent and open channels of com-munication between these multiple ethics committeesmust be put in place so that there is no ldquoethics commit-tee shoppingrdquo by members of staff Researchers in


institutions with more than one ethics committee maynot submit the same protocol to more than one ethicscommittee within the same institution either simultan-eously or sequentially Of course this does not includesituations where a particular committee decides that theprotocol is best reviewed by another committee andrefers the researchers appropriately (See Section C sub-sections c amp d pp 19 of the National Code for HealthResearch Ethics in Nigeria)

Registration of Ethics CommitteesIn contrast to the practice in many other parts of theworld the regulation in Nigeria requires that ethicscommittees be registered with the National Health Re-search Ethics Committee (See Section C pp16 of theNational Code for health Research Ethics in Nigeria)The objective of this registration is to ensure that allethics committees in Nigeria adhere to a minimumstandard of composition management and function andthat they adhere to the tenets of the National Code Alist of all currently approved ethics committees is on thewebsite of NHREC (available at httpwwwnhrecnet)The list contains the names of the institutions the prin-cipal officers of the committees their contact informa-tion category that the ethics committee falls into andwhen the registration will expire Ethics committees areregistered for two years only after which the insti-tution shall apply for re-registration The re-registra-tion application must be submitted to the NHRECwithin the last six months of the expiry of the currentregistration

Requirements for initial registrationAn ethics committee shall be eligible for registration af-ter fulfilling the following requirements

Submission of an application package which includes

A letter from the authorized head of the institutionor his designee stressing that the line of reporting ofthe Chairman of the institutional ethics committee isdirectly to the Chief Executive of the institution Thisconfers sufficient power on the ethics committeechairman and averts or forestalls undue pressure onthe committee in event of disapproval of researchprotocols

Provision of a list of members of the proposed ethicscommittee indicating names qualifications whatprofession or status (scientist non-scientist layperson community representative religiousaffiliation gender etc) they are representingresearch review experience of the committeeevidence of completion of NHREC approvedresearch ethics training and any other information

that may be construed as conflict of interest on thepart of members of the committee

Submission of a statement of agreement to complywith the National Code and

Commitment to provide office and storage space forthe committee

The guidelines for membership selection are similarto those enumerated in international guidelines anddocuments Note however that in common with manydeveloping countries Nigeria is a multi-ethnic multi-religious society where attention to cultural andreligious sensibilities is critically important (SectionC pp 16 of the National Code for Health ResearchEthics)

Requirements for re-registrationAn institution seeking re-registration for its ethics com-mittee must provide

A current list of members Report of fulfillment ofpreviously stated commitment to provideinfrastructure and logistics support for thecommittee Complete record of the activities of thecommittee (including financial records statutorymeetings complaints and litigations details ofprotocols received and their outcomes and the meantime from protocol submission to approval) for theoutgoing year

What happens if an institution fails to re-registerThe ethics committee is de-registered by the NHRECand the institution has to apply anew During this periodno research may be conducted in the institutionConducting research in institutions without ethics com-

mittee (See Section C sub-section f pp 10ndash11 of the Na-tional Code for Health Research Ethics in Nigeria)In a situation where it is necessary to conduct research

in a Nigerian institution or center without ethics com-mittee there are several options that the researchersmay pursue These include

The institution without ethics committee mayestablish a cooperative agreement with aregistered ethics committee located within thesame state as the institution or in the event ofnone in the state within the same geo-politicalzone of the country to review the research Thisagreement must be submitted to NHREC forapproval and its duration shall not be longer thanthe registration period of the reviewing ethicscommittee

The researcher may also submit the proposal toNHREC for review NHREC may review the

Ogunrin et al BMC Medical Ethics 2013 141 0 of 17httpwwwbiomedcentralcom1472-6939141

research using any of several mechanisms that weshall learn about later in this module

Functions and operations of HRECThe main objective of institutional ethics committees isthe protection of research participants in Nigeria fromegregious harm by enforcing compliance with the ethicalguidelines in the Code the clinical trial agreement andmaterial transfer agreement (see below under CTA andMTA) The ethic committees also protect the right ofresearchers to publish their findings and ensure that theyare not exploited or put under undue pressure by spon-sors institutions participants or communities takingpart in research The committee may demand an agree-ment before ethical approval is given indicating owner-ship and rights of access to data resources intellectualproperty and infrastructure generated in the course ofthe research at the pre-research stage to protect theright of researchers to publish their findings and avertfuture exploitation of the researchers (See Section Esub-section r pp 36ndash37 of the National Code for HealthResearch Ethics in Nigeria)

The review process of research protocolsThe review process of research protocols entails the fol-lowing (the details of which is available at Section E pp24 of the National Code for Health Research Ethics inNigeria)

Shall be conducted at regularly convened ordinarymeetings of the institutional ethics committeewith simple majority of members presentincluding at least a member whose primaryconcerns are in non-scientific areas except ofprotocols that require expedited review In otherwords there is no indication for emergencyreview of protocols with the risk of abuseMembers can participate by phone videoconference or VOIP

The ethics committee is expected to completereview of any protocol sent to it within 3 monthsof receipt otherwise the applicant may complainto the national ethics committee of delay Thisprovision serves to prevent undue delay ingranting approval and commencement ofresearch Ethics committee that repeatedly delayprocessing of protocols may find their categorydowngraded with resultant loss in the types ofprotocols and research that can be conducted intheir institutions

A researcher may be requested by the ethicscommittee to pay fees commensurate with therequirements for adequate oversight of research(depending on the size complexity duration status

of researcher and sponsor of research)and for any other of its activities at the discretionof the Ethics Committee Fees can be set only afterdue consultation with the principal officers of theinstitution where the ethics committee is located

The committee also performs oversight functionsfor the studies that it has approved to ensurethat all stakeholders in research perform theirresponsibilities

Requirements for conduct of researchResearch submitted to the ethics committee can only beregistered as being properly submitted and accepted forreview by the Ethics committee if a complete set of allrequired documentation has been provided The mini-mum requirements are

A copy of the research protocol and all materialsneeded for the consent process This may includeconsent form ndash with translations if necessaryinformation sheets radio jingles and video foradvertisements etc

Evidence of completion of recognized informedconsent training and that of key co-investigatorsundertaken within two years of the date ofsubmission of application for ethical review ofprotocol to HREC

Brief curriculum vitae (2-3pages) of the principalinvestigator so that the committee can ascertain hisher qualification to carry out the proposed research

Where relevant copies of letters from co-investigators laboratories and sources of resourcesthat may be required for the implementation of theproject

Evidence of sponsorship where the research is beingsponsored by organizations etc

A one page plain language summary of the proposedresearch

Copies of all questionnaires case report forms andinstruments to be used in the research

Samples of drugs placebos medical devices etcsuch as may be necessary for the ethics committeeto make a decision

Decisions of other ethic committees where this isavailable for example in multi-centered research

Copies of all agreements for example MaterialsTransfer Agreement (see Section E sub-section npp 33ndash34 of the National Code for Health ResearchEthics in Nigeria) Clinical Trials Agreement (seesection E of the National Code for Health ResearchEthics in Nigeria) Insurance certificates etc(Further details are available in the National Codefor Health Research Ethics in Nigeria Section Ksub-section f pp51-52)


After approval of research protocol researchers arerequired to submit an annual report containing a briefsummary statistics of the research (number of researchparticipants number of adverse events complaints andtheir resolutions) to the supervising HREC within threemonths of expiry of the current research approval

Informed consentInformed consent is an integral part of the ethical con-duct of research in Nigeria All researchers are expectedto design a consent process appropriate for the type andcontext of their research the expected participants andrisks anticipated (See Appendix 1 Section 32 pp 57 ofthe National Code for Health Research Ethics)Whereconsent forms are used such consent forms must not belonger than 8 pages typed in double spacing with TimesNew Roman size 12 font This is to enhance legibilityand prevent researchers from squeezing information intoforms The contents of the consent form should not bebeyond the reading ability of a Nigerian Junior Secon-dary graduate (that is 9 years of formal education) sothat participants can understand and recall the contentsThe consent form shall contain the following essentiallyin this order (See Section F subsection f pp 41of theNational Code for Health Research Ethics in Nigeria)

Title of research Names and addresses of theresearchers and sponsors (including telephone faxe-mail etc) The reason for doing the research

Estimated number of participants in the institutionWhere this is a multi-institutional research the totalnumber of participants should also be statedResearch participants tend to feel more confident ifthey are part of a larger group than a small one

What research participants are expected to do Theexpected total duration of research ndash in months oryears The duration of participantsrsquo involvement Forexample participants may be interviewed for 30minutes and their blood samples taken orparticipants may be interviewed repeatedly overseveral months for some years

The costs to the participants of participating n theresearch generally research should not costparticipants anything since those participating aredoing so out of sense of altruism

The risk of participating in the research This mustbe presented early in the consent process beforeintroducing information about benefits orcompensation so that potential participants are stillfresh and engaged when they are given theopportunity to think about the risks that may beinvolved consequent on their participation

The health benefits of participating in research arementioned next In many epidemiological studies

particularly of the casendashcontrol variety the casesalready have the condition of interest They aretherefore not likely to derive any direct healthbenefit from participating in the research Howeverthese information generating researches mayimprove knowledge about the disease that willbenefit others including the controls familymembers of cases and even the cases if the diseasemay recur in some other parts of their body Wherethere is no direct health benefit to participants thisshould be clearly stated in the consent formCompensation for lost wages transport andopportunity costs as determined by the researchersin consultation with local experts or the ethicscommittee should then be stated

It is sometimes appropriate to give participantsinducement in order to encourage their participationin research What is frowned upon is undueinducement where the amount offered is so large thatparticipants are tempted to carry out actions that arenot in their best interest Usually what constitutes dueinducement can be derived from local knowledge andconsultation with the ethics committee With regardsto compensation and inducement the specificamount (or their equivalent in kind) involved shouldbe stated in the consent form

The consent form should state the measure that willbe used to protect the confidentiality of researchparticipants This will vary with the sensitivity of theinformation collected and the complexity of theresearch

The consent form should state clearly andunequivocally that participation in the research isvoluntary and include information about what willhappen to any individual who chooses not toparticipate in the research This usually requires astatement of commitment to the individual thatthe decision they make will not in any way affecttheir care in the institution where the research isbeing conducted In some situations theparticipant may want to withdraw from theresearch after participating in part or all of itThe mode of dealing with requests for withdrawalin such circumstances varies with the type ofresearch and the individualrsquos participation In anyevent a clear statement of the modality fororderly withdrawal from the research needs to beincluded in the consent form

Some research participants may suffer injury duringparticipation in research Because of this the action(s)to be taken in case of injury or adverse events shouldbe stated In our environment this usually requiresthat the research team takes full responsibility for thecare of the research participant once it is established


that the injury is a result of participation in theresearch

Increasingly what happens to individuals orcommunities when research is over is engaging theattention of ethics committees This is a complexmatter that requires extensive dialogue betweenresearchers ethics committees and representativesof the community the institution and other interestgroups There is no single approach that works in allsituations that may arise in research howevercareful forethought and planning will avoid futureethical dilemma

The consent process should also include adequatedisclosure of any apparent or potential conflicts ofinterest as determined by the ethics committeebased on the prevailing norms

Where written informed consent is not possible (SeeSection F sub-section f p 43 of the National Code forHealth Research Ethics in Nigeria)In some circumstances it is not possible to obtain a

written consent form This includes situation whereresearch participants cannot read or are unable orunwilling to read the consent form In such situationsacceptable options include translating the consent formto local languages where the problem is inability to readEnglish language In other situations the participantsmay be unable or unwilling to read even local languagesin such situations a witnessed thumb printing or wit-nessed audio recording of the consent may be done

Re-consentingIn some research situations it may be necessary totake consent more than once This may be requiredin situations where participants are being involved inincrementally risky elements of research or in re-search studies that are taking place over a long dur-ation of time or where information comes to light inthe course of a research that changes the risk-benefitanalysis of the research project

HREC recordsAdequate documentation is expected from all registeredHRECs in Nigeria This is particularly needful for thepurpose of inspection by the NHREC and if necessary byother agencies through the NHREC and also in case offuture litigation Documentation of all its activities andmaterials pertinent to research review which must bekept include

Minutes of all meetings which shall containsufficient information on attendance of members atmeetings actions taken by the ethics committee atthe various meetings and how decisions were

reached including the vote on decisions the numberof votes for and against and abstentions

Letters of complaints from applicants whosubmitted protocol to the committee And in eventof any change of decision in a proposal status thereasons for such a change including the informationandor data used to arrive at the new decision mustbe included in the minutes of the meeting at whichthe decision was taken

A written summary of the discussion and how theissues were resolved for issues that are controversialand demanded extensive debates among members

All copies of research proposals received andreviewed by the committee including the reviewsfrom scientific andor non-scientific experts Thesemust include the dates proposals were submitted tothe committee and when the approvals were givenThis provides proof of non-delay in taking decisionson proposals by the committee as it is expected totake decisions within 3 months of receipt ofproposal

Copies of consent materials approved by thecommittee (see details above - under lsquoInformedconsentrsquo)

All progress reports submitted to the committee bythe researchers institutions and sponsors and thesemust include details of injuries and adverse events toparticipants accrue to their participation during andafter the research

All correspondences between the HREC andresearchers sponsors institutions and all otheragents consulted by the committee in the dischargeof its duties

Details of financial records showing income directexpenditure and other related expenses

Complete records of continuing oversight activitiesof the HREC for all research protocols approved byit during the period of report (See Section K pp50ndash52 of the National Code of Health ResearchEthics)

Continuing ethics training and clinicsThe Code emphasizes the importance of ethics trainingand education a function that may be performed by theinstitutional HREC or by independent suitably qualifiedindividuals and organizations Such training programsare acceptable for membership of the HREC and consid-ered adequate training in research ethics for protectionof human subjects if they

1 Contain modules on Nigerian National Code ofhealth research ethics principles of research ethicsHREC functions research integrity and misconductresearch methodology and administration and


2 Are certified by the NHREC to enforce compliancewith ethical principles and guidelines and avert non-inclusion of NHREC-certified modules in the trainingcurriculum

For the purpose of aiding researchers in the devel-opment of their protocols and providing advisory sup-port during the conduct of research the HREC mayconduct ethics clinics and consultations for a fee atits discretion and as it may determine This functionshould however be strictly separated from the HRECoversight responsibility In addition suitably qualifiedindividuals or organizations may also offer ethics con-sultancy services provided they are certified by theNHREC to ensure that there is no departure from theminimum standard expected from all stakeholders in re-search (See Sections G H I and J of the National Codefor Health Research Ethics)

Disciplinary action (see National Code for Health ResearchEthics Section M pp 54)Disciplinary actions would be taken against any re-searcher institution or sponsor who is guilty of researchmisconduct or violates the national code or institutionalguidelines The HREC may recommend such party tothe NHREC for disciplinary action after

All steps for resolutions of problems in researchhave been exhausted by the HREC and

The actions of the involved party have been fullyinvestigated and discussed at a regularly convenedmeeting of the committee

Such recommendation from the institutional ethicscommittee must reach the NHREC within two weeksfollowing the HREC meeting where the decision wastaken The recommendation must be accompanied bydetailed records of the misconduct It is important tonote that if such misconducts are either clear violationsof civil and criminal law such as fraud or assault or ofinstitutional rules the HREC may report to the appro-priate legal authorities or the researcherrsquos institution asthe case may be The affected researcher institution orsponsor shall also be duly notified of the HREC decisionNHREC may in addition take the following actions

against any researcher institution or sponsor foundculpable

Advertises such cases of research misconductsand report to other appropriate regulatory bodiesand if such breach of ethical conduct involvesinternational collaborative research then thematter is reported to the national regulatoryagency of the country of origin of the researcher

This action does not preclude the use of legalaction against such researcher or hishercollaborators in Nigeria in accordance with thelaw For instance cases of fraud deceptionfabrication or plagiarism may be reported to thepolice or other relevant authorities

The researcher may be barred from conductingresearch in Nigeria for a specified period of timebased on the severity of hisher offence

NHREC may also recommend to institutions andother relevant regulatory bodies penalties that wouldbe faced by researchers who are guilty ofmisconduct

Depending on the case under consideration theresearcher(s) may be required to make restitution toresearch participants institutions sponsorscommunities or any other person as directed by theNHREC For instance if a researcher is found guiltyof deception and fraud heshe may have to makepublic apology to the research participants orcommunity involved in research andor pay back (incash) the amount involved to either the participantsor institution as the case may be and as determinedby the HREC or NHREC In addition heshe maybe barred from conducting research in Nigeria for aperiod of time

In the event that an HREC is the offender then theHREC may be suspended for a variable period oftime based on the severity of offence

NHREC oversight functionsThe National Health Research Ethics Committee mayreview research protocols

If it involves nationwide trial (more than 3 researchsites) For example the protocol of a trial todetermine the clinical efficacy of a drug that is beingintroduced into the Nigerian market which is to betested among patients attending four tertiary healthfacilities in different parts of the country requiresNHREC review or

If it is referred by an institutional ethics committeeeither because the HREC is not qualified to reviewor otherwise or

In cases of institutions where no ethics committeeexists and such institution has no cooperativeagreement with another HREC (as stated aboveunder Conducting research in institutions withoutethics committee) or

If the NHREC so desires based on the complexityof the protocol the magnitude of risks andexistence of controversies like issues of standardof care The NHREC may achieve this by eithermandating an institutional ethics committee (thus


acting as an HREC of record) to review implyingthat such committee takes over the oversightfunction or the NHREC may constitute itself intoa committee for the purpose thus retaining theoversight function (See Section L pp 53 of theNational Code for Health Research Ethics fordetails)

The NHREC also reviews the annual report and regis-tration status of the HRECs and institutionsrsquo commit-ment to ensure proper functioning of the HRECs It alsosettles disputes arising from appropriate interpretationof the Code as it is the NHREC that is responsible forthe update revision and modification of the Code in ac-cordance with new developments in international re-search ethicsIn addition the NHREC establishes the categories of

HRECs in the country on the basis of the following cri-teria (See Section C subsection g pp 20 and Appendix1 Section 34 pp 59ndash60 of the National Code of healthResearch Ethics)

Size of the committee and the qualificationstraining and experience of its members in researchethics and science The more qualified andexperienced the members of a committee are thehigher the rating accorded the HREC by theNHREC This criterion is not taken in isolation butwith others stated below

History of the committee vis-agrave-vis its past reviewactivities from records submitted by the HREC tothe NHREC the period that the committee hasbeen in existence how good its record keeping hasbeen and the level of its compliance with theNational Code

The amount of resources at the disposal of thecommittee and the affiliated institution iesupporting personnel infrastructure and finances

These criteria are clearly outlined from time to timeso that all HRECs are aware of the pre-requisites forrating them by the NHREC at the latterrsquos regularlyscheduled meetings Each category of HREC inNigeria shall be assigned the types of research it canreview This implies that some HRECs may not bequalified to review some research protocols based ontheir categorization by the NHREC Such protocolsmay be reviewed by qualified HREC within the sameinstitution or same geo-political zone or by theNHRECThere are two important agreements that ensure ade-

quate protection of research participants and the re-search staff in Nigeria These are clinical trial andmaterial transfer agreements

What is the clinical trial agreement (CTA)

It is a contract and agreement between a researchsponsor and the principal investigator (PI) of aclinical trial enforcing compliance with all ethicalregulations governing conduct of research in NigeriaThis agreement is signed by the PI the researchsponsor and head of institution (ie where the ethicscommittee reviewing the protocol is sited)

It is a statement of commitment made by theprincipal investigator to conduct trial in compliancewith the National Code and the ICH-GCP(Available at httpwwwichorg ) andor ISO14155 for trials of medical devices and also incompliance with guidelines from relevant oversightand regulatory agencies institutional guidelines andFederal Ministry of Health requirements

This agreement also demands that the principalinvestigator and hisher institution where theethical approval is obtained will cooperate fairlyand appropriately in the event of legal claimrelating to the conduct of trial This implies thatthere shall be amicable resolution of issues arisingfrom the research for instance the institutionmay assist in the care of research participantswho suffer some form of injury or adverse eventin the course of experimentation or in the eventof litigation from community participants andnot leave the researcher alone to carry theresponsibility

In the event that the research sponsor is the PIthen heshe must include in the agreement theestimated cost of and sources of funds for the trialthe number of participants and a complete budgetof the trial and the dates of payments

What is the material transfer agreement (MTA)

It is a mandatory agreement that is required if aresearch involves the transfer of samples andbiological materials such as animals herbs andplants out of Nigeria and it must be signed by allparties involved in the research including the localand international investigators heads of localinstitutions and research sponsors The rationale forthis agreement is to protect the (a) local researchersand Nigeriarsquos human and natural resources in all itsbiodiversity (b) community participants in researchand (c) the nation from exploitation and harm

The agreement must contain the details andconditions for the transfer of the samples such as

(a) The type of materials that is to be transferred andits anticipated use (b) The locations and duration of


storage of the material outside Nigeria and (c) The li-mitations to the use of such materials and when its usewill be terminated

The MTA must be reviewed by the HREC toensure that it conforms to the objectives of theresearch and contents of the informed consentThe institutional REC may grant provisionalapproval for transfer of samples pending thesubmission of both the MTA and provisionalapproval of the HREC to the NHREC who willacknowledge its receipt for record purposes onlyIt is the responsibility of the researcher to informthe institutional HREC of the NHRECrsquosacknowledgement of receipt of the MTA Thisprevents undue delay in the commencement ofresearch but this does not preclude withdrawal ofapproval by the HREC or the right of participantsor communities from whom samples are obtainedto withdraw them according to terms of theinformed consent process Thus ensuring thepreservation of their autonomy and demonstrationof respect for persons in research

The institutional HREC has the responsibilityto grant final approval to research involving thetransfer of research samples out of NigeriaBut such approval can only be given if all theother criteria as stated in the National Codeor institutional guidelines have been met andthe NHREC has acknowledged receipt of theMTA

In the event that the NHREC fails to acknowledgereceipt of the MTA in 2 weeks and there is averifiable proof that the applicant has sent same tothe NHREC then the institutional REC can issuethe final approval for the research

If the researcher or PI makes any amendment to theMTA heshe is expected to submit a request foramendment of protocol to the institutional HRECand the HREC shall review it in the usual manner asfor protocol amendment at its regularly convenedmeeting

(See details at Section E subsection n pp 33ndash34 ofthe National Code for Health Research Ethics)

Other Nigerian regulatory agencies in researchThe conduct of clinical trials in Nigeria requires theapproval of other regulatory agencies apart from theinstitutional ethics committee There are four regula-tory agencies specified in the National Code that con-tribute to protection of research participants fromharm and ensure conduct of trials at the highest eth-ical standard

National Agency for Food and Drug Administration andControl (NAFDAC)

This agency gives permission for the conduct ofclinical trials to test the efficacy and safety of newfinished products for sale or use as food or drugs inNigeria

Such clinical trials that would be conducted inNigeria must however conform to the guidelinesissued by National Health Ethics ResearchCommittee and other regulatory bodies

Institutional Bio-safety committees (IBC)

The IBC provides bio-safety review of researchinvolving the use of classified hazardous substancesof physical or biological nature (like pathogensradioactive materials application of recombinantDNA techniques and processes etc) with the overallobjective of minimizing potential human andenvironmental risks

It is made up of a bio-safety officer and at leastthree other officers with appropriate expertise andis established by the institution where research isconducted and registered with the NHREC (seeNHREC oversight functions above)

The IBC ensures that the researcher provides safeand suitable storage for materials used for researchand also ensures that research staff has adequatetraining in bio-safety

Data and Safety Monitoring Boards (DSMB)Data and Safety Monitoring Boards (DSMB) ndash is an in-dependent group of experts (comprising individuals withappropriate training and scientific knowledge in allaspects of research with adequate medical pharmaceu-tical scientific bio-statistical and clinical trial experienceas well as ethics qualifications) assembled before thecommencement of research by the study sponsors toreview safety data during the clinical trialAt least three of the members must be independent of

the clinical trial and sponsor This is to avert or preventconflicts of interests and allow for unbiased assessmentof safety dataAll drug efficacy trials and clinical trials in Nigeria are

expected to have a safety monitoring plan implementedthrough the DSMB to ensure safety of study participantsand preserve the integrity and credibility of the research

Community Advisory Board (CAB)This committee is established by the study investigatorson the recommendation of the institution or the ethicscommittee supervising the trial depending on the natureand site of research The role of community lsquogatekeepersrsquo


in the successful implementation of research in Nigeriaunderscores the importance of the CAB The multi-ethniccultural and religious diversities of the Nigerian nationand its influence on ethical issues in research demandcommunity participation from the pre-research stage toavoid conflicts and frictions during and after the researchThe CAB consists of members from the communities

where trials are to be conducted who are selectedthrough the usual consultative process with the commu-nity (for example religious leaders persons who under-stand local laws and cultural values including genderissues representative of study population and commu-nity leaders) and some members of the research team(usually not more than 20 of the total membership)The CAB plays crucial roles in assisting researchers

conducting trials in Nigeria to understand and incorpo-rate community concerns into their research plans andactivities It provides information on traditional beliefsadvises on effective methods of information dissemin-ation recruitment and retention of study participantsand may assist in the resolution of ethical problemsthat arise during and after research (See Section Esubsection r pp 37ndash38 of the National Code of HealthResearch Ethics)Furthermore the CAB offers the com-munity members to air their views on ethical issuesrelating to the proposed research as they affect indi-vidual members the community as a whole and pos-sibly neighboring communities and the nation TheBoard also serves as s forum for disseminating preintra and post research information to members of thecommunity

(details of the Nigerian Code of Health Research Ethicscan be accessed at wwwnhrecnet)

Competing interestsThe authors have no conflicting interests to declare

Authorsrsquo contributionsCA conceived of the study OAO TOO and CA participated in the design andcoordination of the study OAO collected data performed the statisticalanalysis and helped to draft the manuscript All authors read and approvedthe final manuscript

AcknowledgementsThe contributions of Director of CITI Professor Paul Braunschweiger andmembers of the Collaborative Institutional Training Initiative (CITI) teamespecially Viviane Francis for the assistance in web-designing and spaceprovision for the online module on the CITI website are deeply appreciated

FundingThis work was made possible by Grant Number D43 TW007091 from theUnited Statesrsquo National Institutes of Healthrsquos Fogarty International Center andthe National Human Genome Research Institute Its contents are solely theresponsibility of the authors and do not necessarily represent the officialviews of the awarding office of the NIHFogarty International Center

Author details1Department of Medicine Neurology Unit University of Benin Benin CityPMB 1154 Nigeria 2Department of Surgery University of Ibadan Ibadan

Nigeria 3West African Bioethics Training Program University of IbadanIbadan Nigeria 4Department of Epidemiology and Public Health Institute ofHuman Virology and Greenbaum Cancer Center University of MarylandSchool of Medicine Baltimore MD 21201 USA 5Office of Research andTraining Institute of Human Virology 252 Herbert Macaulay Way AbujaNigeria

Received 14 June 2012 Accepted 27 December 2012Published 2 January 2013

References1 US National Bioethics Advisory Commission Ethical and policy issues

in international research Clinical trials in developing countries httpbioethicsgeorgetownedunbacpubshtml

2 Council for International Organizations of Medical Sciences (CIOMS)in Collaboration with World Health Organization InternationalEthical Guidelines for Biomedical Research Involving Human SubjectsGeneva Switzerland 2002 httpwwwciomschframe_guidelines_nov_2002htm

3 Nuffield Council on Bioethics The ethics of research related tohealthcare in developing countries 2004 httpwwwnuffieldbioethicsorgdevelopingcountriespp_0000001137asp April 2004

4 Ajuwon AJ Kass N Outcome of a research ethics training workshopamong clinicians and scientists in a Nigerian university BMC MedEthics 2008 91 httpwwwbiomedcentralcom1472-693991

5 Grady C Danis M Soeken KL OrsquoDonnell P Taylor C Farrar A UlrichCM Does ethics education influence the moral action of practicingnurses and social workers Am J Bioeth 2008 8(4)4ndash11

6 Goldie J Schwartz L McConnachie A Morrison J The impact ofthree yearsrsquo ethics teaching in an integrated medical curriculumon studentsrsquo proposed behavior on meeting ethical dilemmasMedical Education 2002 36(5)489ndash497

7 Collaborative Institutional Training Initiative West African BioethicsProgram Activities and Additional Outreach Activities ndash Africa CITINewsletter 2008 2(1)3 httpwwwcitiprogramorg

8 Ogundiran TO Enhancing the African bioethics initiative BMC MedEduc 2004 421

9 National Code of Health Research Ethics Federal Ministry of HealthNigeria 2007 httpwwwnhrecnet

10 Braunschweiger P Collaborative institutional training initiative (CITI)J Clin Res Best Pract 2010 61ndash6

11 Kalichman M Use and abuse of the internet for teaching researchethics Sci Eng Ethics 2005 11341ndash345

12 Katz J The Nuremberg code and the Nuremberg trial Areappraisal JAMA 1996 276(20)1662ndash1666

13 Belmont Report of the National Commission for the Protection ofHuman Subjects of Biomedical and Behavioral Research EthicalPrinciples and Guidelines 1979 httpwwwhhsgovohrphumansubjectsguidancebelmonthtm

14 World Medical Association (WMA) Declaration of Helsinki EthicalPrinciples for medical research involving human subjects Seoul 2008wwwwmaneten30publications10policiesb3

15 World Health Organization Handbook for Good Clinical ResearchPractice (GCP) Guidance for Implementation 2002 httpwhqlibdocwhointpublications2005924159392X_engpdf

16 World Health Organization Operational Guidelines for EthicsCommittees that review biomedical research TDRPRDETHICS20111wwwwhqlibdocwhointpublications20119789241502948_engpdf

17 Department of Health and Human Services National Institute ofHealth Office for Protection from Research Risks Title 45 PublicWelfare Part 46 Protection of Human Subjects ndash the Common Rule2001 httpwwwhhsgovohrphumansubjectsguidance45cfr46htm

18 Joint United Nations Programme on HIVAIDS Ethical considerationsin biomedical HIV prevention trials UNAIDSWHO guidance document2007 httpdataunaidsorgpubManual2007jc1349_ethics_2_11_07_enpdf

19 European Medicines Agency ndash ICH Note for Guidance on Good ClinicalPractice-ICH Good Clinical Practice CPMPICH13595 httpwwwemeaeuropaeupdfshumanich013595enpdf

20 Opinion of European Group on Ethics in Science and New Technologiesto the European Commission on Ethical Aspects of Clinical Research in


Developing Countries 2003 httpeceuropaeueuropean_group_ethicsdocsavis17_enpdf

21 Directive 200120EC of the European Parliament and of theCouncil of 4 April 2001 on the approximation of the lawsregulations and administrative provisions of the Member Statesrelating to the implementation of good clinical practice in theconduct of clinical trials on medicinal products for human useOfficial Journal of the European Communities L121 34ndash44 httpeceuropaeuenterprisepharmaceuticalseudralexvol-1dir_2001_20dir_2001_20_enpdf

22 Dawson B Trapp RG Basic and Clinical Biostatistics 3rd edition NewYork McGraw-Hill 2001

23 Taylor HA Kass NE Ali J Sisson S Bertram A Bhan A Developmentof a research ethics knowledge and analytical skills assessmenttool J Med Ethics 2012 38(4)236ndash242

24 Aggarwal R Gupte N Kass N Taylor H Ali J Bhan A Aggarwal ASisson SD et al A comparison of Online versus On-site training inhealth research methodology a randomized study BMC Med Educ2011 1137 doi1011861472-6920-11-37

25 Aulisio MP Arnold RM Younger SJ Healthcare ethics consultationnature goals and competence Ann Intern Med 2000 13359ndash69

26 Turner L A career in clinical ethics BMJ 2002 325S10527 Chidwick P Faith K Godkin D Hardingham L Clinical education of

ethicists the role of a clinical ethics fellowship BMC Med Ethics2004 56 doi1011861472-6939-5-6

28 Turrens JF Teaching research integrity and bioethics to scienceundergraduates Cell Biol Educ 2005 4(4)330ndash334

29 Taft SH White J Ethics education using inductive learning to developindividual group organizational and global perspectives J ManagementEducation 2007 31614ndash648

doi1011861472-6939-14-1Cite this article as Ogunrin et al Development and pilot testing of anonline module for ethics education based on the Nigerian NationalCode for Health Research Ethics BMC Medical Ethics 2013 141

Submit your next manuscript to BioMed Centraland take full advantage of

bull Convenient online submission

bull Thorough peer review

bull No space constraints or color figure charges

bull Immediate publication on acceptance

bull Inclusion in PubMed CAS Scopus and Google Scholar

bull Research which is freely available for redistribution

Submit your manuscript at wwwbiomedcentralcomsubmit

Abstract

Background

Methodology

Results

Conclusion

Background

Methodology

Selection of participants

Evaluation of module

Ethical approval

Data management and analysis

Results

Demographic details of phase two study participants

Demographic details of phase three study participants

Accessibility and comprehensibility of the online module on Nigerian code

Test performance of participants

Correlation analysis and reliability testing

Discussion

Conclusions

Appendix A Annex 1

Introduction

Functions of HRECs

Registration of Ethics Committees

Requirements for initial registration

Requirements for re-registration

What happens if an institution fails to re-register

Functions and operations of HREC

The review process of research protocols

Requirements for conduct of research

Informed consent

Re-consenting

HREC records

Continuing ethics training and clinics

Disciplinary action (see National Code for Health Research Ethics Section M pp 54)

NHREC oversight functions



Other Nigerian regulatory agencies in research

National Agency for Food and Drug Administration and Control (NAFDAC)


Data and Safety Monitoring Boards (DSMB)

Community Advisory Board (CAB)

Competing interests

Authorsrsquo contributions

Acknowledgements

Author details

References

Ogunrin et al BMC Medical Ethics 2013 141 of 17httpwwwbiomedcentralcom1472-6939141

BackgroundThe potentials of research to contribute to improvement inhealth may be surpassed by the magnitude of risk to partici-pants communities and local researchers Consequentlysystematic ethical regulation of research is put in place toensure that research is conducted in a manner that maxi-mizes benefits while minimizing harms to research partici-pants The National Bioethics Advisory Council in USAthe Council of International Organization of MedicalSciences (CIOMS) and the Nuffield Council of Bioethicssuggested that this situation needs initial and continuingeducation in the ethics and science of biomedical and be-havioral research for investigators members of theResearch Ethics Committees (RECs) and sponsors ofresearch [1-3] Several studies have shown that researchethics training improves ethical conduct of research andcapacity for dealing with ethical dilemmas [4-6] Hithertoresearchers in low and middle income countries (LMIC)including Nigeria have had limited access to training inresearch ethics due to weak educational social economicand health resources however there has been significantinvestment in ethics education in the last two decades withresulting improvements in ethics capacity building [78]The design and implementation of ethically and scienti-

fically valid research in any country should be guided by aset of rules and regulations based on global ethical princi-ples but domesticated within local laws regulations andculture It is against this background that the NationalHealth Research Ethics Committee in Nigeria (NHREC)developed and formulated National Code for HealthResearch Ethics (NCHRE) in August 2007 to guide allresearchers involved in human subjectsrsquo researches inNigeria [9] This Code reflects the collective concern of thegovernment and the people of Nigeria to ensure the pro-tection of human participants in scientific research to thehighest ethical standard that is possible It serves as thebasis for the operations of all institutional research ethicscommittees in the country thus allowing for uniformityand consistency The Code is based on universal ethicalprinciples historical ethical guidelines existing regulationsfrom different countries results of modern bioethicsresearch Nigerian constitution laws regulations and go-vernment guidelines as well as Nigerian custom andpracticesExamples of peculiarities of the Code include conduct of

clinical trials in the country which requires approval fromthe National Agency for Food and Drug Administration(NAFDAC) and the emphasis on community engagementin research in view of the countryrsquos traditional communi-tarian ethos Every scientist involved in human subjectresearch in Nigeria their sponsors and other stakeholdersmust function within the scope of the National HealthResearch Ethics Code This demands that researchers beaware and educated on the code with the anticipation that

the knowledge of the guidelines would translate to itspractice in conduct of health-related researchIt is therefore appropriate to develop an educational tool

that will facilitate the understanding and implementationof the Nigerian Code among stakeholders An importantavenue for the facilitation of training in research ethics isthe provision of online courses [1011] Such online coursescan be accessed at different institutions in the country andcan be effective training tool in research ethics It will alsobe of immense benefit to all research ethics committees inthe country as it will facilitate education of their membersthus empowering them to effectively perform their roles inthe protection of human subjects guided by the NCHREFurthermore international researchers and foreign spon-sors would have easy access to the code which willenlighten them on the ethical requirements for conductingresearch in Nigeria There are few studies that haveassessed the utility of online modules as ethics trainingtools in improving knowledge and skills in health researchespecially in resource poor settingsIt is against this background that this project was con-

ceived and designed with the objectives of developing anonline educational module based on the Nigerian Codeto enlighten biomedical researchers on the requirementsof conduct of ethically acceptable research in Nigeriaand evaluate its reliability in achieving this objective

MethodologyThis was a prospective quantitative three phased studyDuring phase one we developed an online training mo-dule based on the contents of the NCHRE and upload itto the Collaborative Institutional Training Initiative(CITI) websiteThe Nigerian Code is a 68 page document with fifteen

main sections (Sections A to O) and one Appendix (withsub-sections 32 to 34) [9] Because the emphasis of theonline module is on ethical requirements for research inNigeria while avoiding repetition of general ethical guide-lines which are already available on the CITI IRB modulewe compared the Nigerian Code with thirteen majorethical guidelines namely Nuremberg Code [12] BelmontPrinciple [13] Helsinki Declaration [14] CIOMS [2]United States National Bioethics Advisory Council [1]World Health Organization-Good Clinical Practice [15]World Health Organization- operational guidelines forethics committees [16] Common Rule ndash 46 Code ofFederal Regulations (CFR) [17] Nuffield Council on Bio-ethics [3] United Nations AIDS guidance on HIV preven-tive vaccine research [18] Europeans Medicine Agency ndashInternational Committee on Harmonization [19] Opinionof European Group on ethics in science [20] and Directive2001 [21] and isolated unique elements of the NigerianCode These extracted contents formed the material






















Sex

Female 18 40

Male 27 60

Age

21 ndash 30 2 44

31 ndash 40 39 867

41 ndash 50 4 89

Positions




Pharmacists 2 44


Others 6 134

Specialty

Dental Surgery 2 44



Pharmacy 2 44


Public Health 5 111


PMTCT 2 44

Optometry 1 22


UBTH 31 689



NAUTH Nnewi 2 44

NNPC Medicals 1 22

IHVN 4 89

State HMB 3 67









Sex

Female 18 60

Male 12 40

Age

21 ndash 30 1 33

31 ndash 40 26 867

41 ndash 50 3 100

Positions





Specialty





PMTCT 7 233


UBTH 17 567


IHVN 11 366































02

04

06

08

01

00







2040

6080

100


pretest2 postest2



























































































































































































Abstract

Background

Methodology

Results

Conclusion

Background

Methodology



Ethical approval


Results






Discussion

Conclusions

Appendix A Annex 1

Introduction

Functions of HRECs








Informed consent

Re-consenting

HREC records











Competing interests


Acknowledgements

Author details

References






















Sex

Female 18 40

Male 27 60

Age

21 ndash 30 2 44

31 ndash 40 39 867

41 ndash 50 4 89

Positions




Pharmacists 2 44


Others 6 134

Specialty

Dental Surgery 2 44



Pharmacy 2 44


Public Health 5 111


PMTCT 2 44

Optometry 1 22


UBTH 31 689



NAUTH Nnewi 2 44

NNPC Medicals 1 22

IHVN 4 89

State HMB 3 67









Sex

Female 18 60

Male 12 40

Age

21 ndash 30 1 33

31 ndash 40 26 867

41 ndash 50 3 100

Positions





Specialty





PMTCT 7 233


UBTH 17 567


IHVN 11 366































02

04

06

08

01

00







2040

6080

100


pretest2 postest2



























































































































































































Abstract

Background

Methodology

Results

Conclusion

Background

Methodology



Ethical approval


Results






Discussion

Conclusions

Appendix A Annex 1

Introduction

Functions of HRECs








Informed consent

Re-consenting

HREC records











Competing interests


Acknowledgements

Author details

References



Sex

Female 18 60

Male 12 40

Age

21 ndash 30 1 33

31 ndash 40 26 867

41 ndash 50 3 100

Positions





Specialty





PMTCT 7 233


UBTH 17 567


IHVN 11 366































02

04

06

08

01

00







2040

6080

100


pretest2 postest2



























































































































































































Abstract

Background

Methodology

Results

Conclusion

Background

Methodology



Ethical approval


Results






Discussion

Conclusions

Appendix A Annex 1

Introduction

Functions of HRECs








Informed consent

Re-consenting

HREC records











Competing interests


Acknowledgements

Author details

References

























02

04

06

08

01

00







2040

6080

100


pretest2 postest2



























































































































































































Abstract

Background

Methodology

Results

Conclusion

Background

Methodology



Ethical approval


Results






Discussion

Conclusions

Appendix A Annex 1

Introduction

Functions of HRECs








Informed consent

Re-consenting

HREC records











Competing interests


Acknowledgements

Author details

References






















































































































































































Abstract

Background

Methodology

Results

Conclusion

Background

Methodology



Ethical approval


Results






Discussion

Conclusions

Appendix A Annex 1

Introduction

Functions of HRECs








Informed consent

Re-consenting

HREC records











Competing interests


Acknowledgements

Author details

References

development and pilot testing of an online module for ethics

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