Research Ethics – PST06210 Operational Research
NTA Level 6 • Semester 2 • PST06210 Research Ethics Operational Research • Source Session/Topic 15 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. 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 ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 124 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 • In developing data collection techniques, it is important to consider whether the research procedures are likely to cause any physical or emotional harm. • Harm may be caused, by: 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 ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 125 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. • Several methods for dealing with ethical issues are recommended: 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 • ‘What are procedures for research ethical clearance? 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. ___________________________________________________________________________ PST 06210 Operational Research NTA Level 6 Semester 2 Facilitator Guide 126 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