Ethical Issues and Treatment Policies

This document is part of the  Active Parasite Detection toolkit, developed by the RBM-MERG, with contributions from the following partners: Center for Disease Control-CDC, Swiss Tropical Institute, Johns Hopkins University, The World Bank, The Global Fund against AIDS, Tuberculosis and Malaria, Liverpool School of Tropical Medicine, MACRO International, Malaria Consortium, Malaria Control and Evaluation Partnership in Africa (MACEPA) – PATH, Malaria in Pregnancy Consortium Secretariat, MEASURE Evaluation, WHO,WHO-AFRO, RBM-PS, Tulane University, UNICEF and USAID/PMI. This toolkit also largely benefited from national programmes from countries having conducted MISs.

Ethical Issues Overview

• Principles• Consent

– Who cannot give consent?– Children– Waiver of consent

• Informed consent– Information– Comprehension

• Benefits• Risks• Confidentiality• Providing useful information on malaria

Ethical Principles

• Respect for Persons– Autonomy to make decisions– Protection of vulnerable persons

• Beneficience– Do not harm– Maximise benefit and limit harms

• Justice– Fair selection of subjects

Principle of Respect for Persons: Consent

• Who cannot give consent?– Unconscious– Mentally incapable of understanding– Children under age 18

• Children: – Age 6 to 18 can give assent. If child refuses

assent, parent cannot force participation– Under 6 years: parent gives consent for child

Principles of Respect for Persons and Justice

Informed consent• Participant must know:

– The purpose of the study– How they were selected to participate– How many other people are involved– What is expected of them (procedures, time)– Who to contact if they have questions

• Written or verbal consent?

Principle of Beneficience:

Benefits• If a person is positive for malaria or anaemia,

they get immediate treatment• Survey will give information on:

– Malaria and anaemia distribution – Malaria intensity– Coverage of control measures

e.g. spraying and net use– Use of health services for malaria treatment

• The aim is to improve the malaria control program, clinical services and health knowledge

• In general, benefits to individuals are quite low in this study

Principle of Beneficience

Risks (possible harms)

• Emotional upset from talking about illness and death of children

• Side effects of treatment drugs

• In general, risks are also low in this study

Principles of Respect for Persons and Beneficience:

Confidentiality

• Try to conduct interview in private

• Never discuss someone’s answers with another person

• Potential for harm if information released

• Data will be stored without names

Principle of Beneficience:

Providing useful information on malaria prevention

• People may ask during survey about – what causes malaria, malaria symptoms, getting

treatment, how to prevent malaria, how to use net etc.• You must answer the questions• However, if asked during interview, say:

– “Those are good questions. I will answer them to the best of my ability at the end of the interview.”

• Then remember to spend a few minutes responding

• Answer briefly and refer to further sources such as health workers

Treatment Overview

• Who will be treated?

• Decision rules

• Treatment schedules

• What about other sick people?

Who will be treated?

• People will be treated based only on the results of diagnostic tests performed, not on any other clinical assessment

• Who will be treated?– Anyone with positive RDT for malaria

Decision rules

• Things to consider– Is the RDT positive ?– Is the woman pregnant?– What is the person’s age?– Is child 2 years or older?

Malaria

• Is RDT positive?– If positive for Pf plus PAN:

• Check if person is pregnant woman. – If not pregnant woman: treat with CoArtem– If pregnant: treat with Quinine

– If positive for PAN only:• Treat with chloroquine.

– If negative:• Do not treat for malaria

unless Hb<8g in child under 6

• Also refer or take to health facility based on clinical judgment

Malaria Treatment

Number of tablets per dose Weight (kg)

Age (Years)

Twice daily for 3 days

Day 1 Day 2 Day 3

Morning

Evening

Morning Evening

Morning Evening

5 – 14 3 m – 2 yrs 1 1 1 1 1 1

15 – 24 3 – 7 yrs 2 2 2 2 2 2

25 – 34 8 – 10 yrs 3 3 3 3 3 3

35+ >10 yrs 4 4 4 4 4 4

1.CoArtem: (For RDT Pan/Pf positive or for children<6 with Hb<8g)Tablets with 20 mg Artemether plus 120 mg Lumefantrine

What about other sick people?

• You will be approached by others in the village.• Do not use RDT for non-participants in other

households• Explain that you are there mainly for the survey

and your supplies have been calculated accordingly

• Give presumptive treatment according to clinical judgment

• Refer or transport to health facility if necessary