Research Ethics

Session 15: Research Ethics

Total Session Time: 60 minutes +240 minutes assignment

Prerequisites

 None

Learning Tasks

By the end of this session students are expected to be able to:

 Define research ethics

 Identify areas of research requiring ethical clearance

 Describe procedure for research ethical clearance

Resources Needed

 Flip charts, marker pens, and masking tape

 Black/white board and chalk/whiteboard markers

 Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

2 10 minutes Presentation Definition of Research Ethics

10 minutes Presentation Areas of research requiring ethical clearance

3

Buzzing

20 minutes Presentation Procedure for Research Ethical Clearance

4

Brainstorming

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

7 05 Presentation Assignment

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SESSION CONTENTS

STEP1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definition of Research Ethics (10 Minutes)

 Research ethics

o Research Ethics is defined here to be the ethics of the planning, conducting, and

reporting of research

o It is clear that research ethics should include: Protections of human and animal

subjects.

o ―"ethics": is defined as norms for conduct that distinguish between acceptable and

unacceptable behavior‖.

 STEP 3: Identification of areas of research requiring ethical clearance

(10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

 ‘Which areas of research require ethical clearance?

ALLOW few students to respond

WRITE their responses on flipchart or board

CLARIFY and SUMMARIZE by using the content below

procedures are likely to cause any physical or emotional harm.

o Violating informants‘ right to privacy, by posing sensitive questions or by gaining

access to records which may contain personal data.

o Observing the behavior of informants without them being aware

o Allowing personal information (which informants would want to be kept private) to

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be made public.

o Failing to observe/respect certain cultural values, traditions or taboos valued by your

informants. Using human biological tissue, using human in trial of drugs.

o Obtaining informed consent before the study or the interview begins.

o Do not explore sensitive issues before a good relationship has been established with

the informant.

o Ensure the confidentiality of the data obtained.

Learning enough about the culture of informants to ensure it is respected during the

o data collection process.

If sensitive questions are asked, for example, about family planning or sexual

practices, or about opinions of patients on the health services provided, it is advisable

to omit names and addresses from the questionnaires.

o Inform participants that they are free to withdraw from the study at any point

STEP 4: Procedure for Research Ethical Clearance (20 Minutes)

Activity: Brainstorming (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

ALLOW few students to respond

WRITE their responses on flipchart or board

CLARIFY and SUMMARIZE by using the content below

 Health research coordination in Tanzania is under the Medical Research Coordinating

Committee (MRCC). MRCC is the national health research coordinating body that

ensures all health research follows the national health ethics requirements.

 Procedure for research ethical clearance

o The whole process of receiving, reviewing and approving the protocols takes a

maximum of 6 weeks

o National Health Research Ethics Committee (NatHREC) carries research monitoring

by on-site visits in collaboration with district and regional medical authorities.

In this regard, copies of certificates of cleared research proposals are sent to

respective District and Regional Medical Officers where research is to be carried out.

o Research certificate approval is renewed annually, and PIs are required to submit

progress reports biannually.

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o To publish the findings, the principal investigator will have to seek permission from

the National Institute for Medical Research.

o All proposed health research in Tanzania must get an Institutional Ethical approval at

the host institution where the research will be based.

o In case there is no any Institutional Ethics Committee, the approval will be sought

from the NatHREC.

o For all health research involving external collaborators (non-Tanzanians), the

researchers must apply for the Institutional Ethical Clearance as well as the National

Ethics Clearance.

o Non-Tanzanian researchers are required by law to get Research Clearance and

Research Permit from the Tanzania Commission for Science and Technology

(COSTECH) (www.costech.or.tz).

o Protocols for Clinical trials to be conducted in Tanzania are reviewed by another

specialized sub-committee, Clinical Trials Sub-Committee.

 This sub-committee has nine members and meets monthly and reports to the

NatHREC.

o Clinical trials are required to also obtain a Clinical Trials Certificate from Tanzania

Food and Drug Authority (www.tfda.or.tz) before the commencement of the study.

 Application procedures

o Applicants for research clearance are required to submit application form, Curriculum

vitae, Research proposal and three passport size photographs preferably two months

before commencement of research.

o Permits are given for a period of one year and can be renewed for similar period

provided satisfactory progress reports for the previous periods are received by

COSTECH.

o If and when these formalities have been satisfactorily completed (which may take

several months) applicant will receive a formal written offer of a research clearance.

o Applicant should not make any irreversible preparations to leave for Tanzania unless

and until he/she receives this offer letter.

o Soon after obtaining a research permit, the researcher will be required to proceed to

the Immigration Department and apply for class C residence permit.

STEP 5: Key Points (5 minutes)

 Research Ethics is defined here to be the ethics of the planning, conduct, and reporting of

research

 As we develop our data collection techniques and implement research, we need to

consider whether our research procedures are likely to cause any physical or emotional

harm

 Applicants for research clearance are required to submit application form, Curriculum

vitae, Research proposal and three passport size photographs preferably two months

before commencement of research

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STEP 6: Evaluation (5 minutes)

 What is research ethics?

 What ethical issues are involved in the implementation of research?

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STEP 7: Assignment (5 minutes)

Activity: Take Home Assignment (5 minutes)

DIVIDE students in groups or individuals

 ASK the students to work on the following Assignment

Identify ethical issues you will follow when conducting the research, you are developing

ALLOCATE time for students to do the assignments and submit

REFER students to recommended reference

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References

National Institute of Medical Research (2014) 2ND Edition. Standard Operating Procedures

for the National Health Research Ethics Committee, Dar es Salaam, Tanzania

http://www.nimr.or.tz/wp-content/uploads/2018/11/SOPS-2014-KEY-NatHREAC-SOPs-

Final-17th-June-2014.pdf

Mashalla, Y.J.S., Shija, J.K., Kitua, A.Y., Mwaikambo, E., Kohi, Y.M., Ndossi, G.D.,

Health Research in Tanzania, Tanzania National Health Research Forum, Dar es

Salaam, Tanzania

Hardon A, Boonmongkon P, and Streefland P. et al (editors) (2001). Applied Health research,

Anthropology of health and health care, third revised edition,, Het Spinhuis

Publishers, The Netherlands

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