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Table 1 African National Requirements for Assent, Parental Consent and Reconsent at Adulthood

From: Assent, parental consent and reconsent for health research in Africa: thematic analysis of national guidelines and lessons from the SickleInAfrica registry

Country

Year

Age of assent

Assent condition

Emancipated minors

Parental consent

Waivers for assent and parental consent

Algeria

2018

Not specified

Consent should be adopted for minors. Not stated if written or verbal assent is required

Not specified

Authorization from a single for no more than minimal risk studies. For studies that pose more than minimal risk, authorsiation is required from the familiy council

Not specified

Botswana

2012

7–17

Not stated if written or verbal but an assent template is provided

14–17 years and married or pregnant. If an emancipated minor consent to their child’s participation, a court order should be copied and included in the research records with the consent document

Both parents must provide consent unless one parent is deceased, unknown, incompetent, or not reasonably available: or a legal guardian

For less than minimal risk studies, the REC may approve consent from one parent

For greater than minimal risk studies, the REC may approve consent from one parent

Requirements for assent may be waived:

•If the research offers the child, the possibility of a direct benefit and available only in the context of the research

•When consent may be waived

Cameroon

2012

14–20

Written assent

Language and syntax of the assent form should be similar to that in the parental consent form

Less than 21 and married, pregnant, mother, head of household etc

For no more than minimal risk studies, consent may be obtained from at least one parent/guardian

For greater than minimal risk studies, consent should be obtained from both parents except where only one parent has legal responsibility or custody of the child

Assent may be waived:

•If the intervention is of direct health benefit to child and only available in the research setting

•If the study meets conditions for a waiver of consent

Democratic Republic of Congo

2011

13–17

Written assent. Researchers can decide on a higher age group for obtaining assent based on the complexity of study

Not specified

Consent from both parents or guardian

Not specified

Ethiopia

2014

12–17

Not specified if written or verbal. However, template assent form is provided

Persons less than 18 working or earning their living, married, parenting

Consent of at least one parent, next-of-kin, or guardian

Not specified

Gambia

 

12–17

Not specified

Not specified

Not specified

Not specified

Ghana

2015

8–17 Years

Written assent

Not specified

Not specified

Not specified

Liberia

2019

15–17

Written assent

Not specified

Not specified

Not specified

Malawi

2003

7–17 Years

Assent tailored to the level of comprehension

Legally married and Students under a defined Malawian law

Not specified

Not specified

Mozambique

2014

Above 16

Not specified

Not specified

A legal parent or guardian

Not specified

Nigeria

2016

12–17 years

Not specified

Researchers to justify in their research protocols when a child may be declared as ‘emancipated’

Emancipated minors can give consent in their cognizance

Less than 12: Consent of both parents or the parent/legal guardian that has primary responsibility for the child at the time of research

Above 12- A relevant parent/legal guardian

Waiver of parental consent may be granted for:

•No more than minimal risk studies

•Study holds out potential to benefit the children being involved in the study

•Study objectives could not otherwise be achieved if parents have to be consented

Rwanda

2009

9–20 Years

Written assent

Not specified

A parent or legal guardian

Not specified

South Africa

2015

Less than 18

For minors less than 7 years assent form should be read to them

Written assent for minors 7 years and above. The older the minor, the more the assent form should mirror the parental consent

An unmarried minor parent may not consent to their child’s participation in research as pregnancy and childbirth do not change the legal status of a minor mother

A parent or legal guardian

Parental consent may be waived

•For minimal risk research in particular circumstances:

•For reasons of sensitivity, like discussions about sexual activities, substance abuse in minors 16 years and older

•Where recruiting enough minors may be a challenge because they may be unwilling to participate if parental permission is required

Tanzania

2009

Not specified

Not specified

Not specified

The permission of one parent or guardian is sufficient if consistent with the laws of the country

RECs may waive the assent requirement if:

•The study involves no more than minimal risk

•The study cannot be carried out without the waiver

Sierra Leone

NA

Less than 18 to the extent of the child`s capabilities

Assent form should be similar to the informed consent form

Assent form should be signed and dated by a minor who is capable of understanding

Not specified

A parent or legal representative

Not specified

Uganda

2014

8–17 years

Not specified

Mature minors are persons 14–17 years who have drug or alcohol dependency, or a sexually transmitted infection, individuals below the age of majority who are pregnant, married, have a child or cater for their own livelihood

Mature and emancipated minors may independently provide informed consent as deemed necessary by REC

Parent or guardian

Not specified

Zambia

2013

Not Specified

Written assent required when the minor can understand the nature and potential risks and benefits of the study

Not specified

A parent or legal guardian

Not specified

Zimbabwe (JREC)*

2011

5–18 Years *

Less than 5 (oral)

5–12 years (written tailored to child’s cognitive level)

13–18 years (same as parental consent)

Not specified

Not specified

Not specified

  1. *Joint Research Ethics Committee for University of Zimbabwe College of Health Sciences and Parirenyatwa Group Hospitals (JREC)