Broad consent for biobank research in South Africa - Towards an enabling ethico-legal framework

Figures & data

Table 1. POPIA research exceptions.

Research specific exception	POPIA section related to the exception
1. Records containing personal information may be retained longer than necessary for research purposes if sufficient protections are in place.	Purpose specification: condition 3, s.14.
2. Personal information should not be processed further unless it is going to be utilised for research and will not be published in an identifiable manner.	Further processing limitation: condition 4, s. 15(3).
3. If the information is collected for research purposes, it is not necessary for openness to prevail when informing participants about the collection of their personal information as required by s. 18(1).	Openness: condition 6, s. 18(4).
4. The restriction on processing special personal information, which includes information about a person's race, ethnicity, religion, biometrics, health, and sexual life, does not apply when the processing is done for research and the goal is in the public interest, when obtaining consent seems impossible or would require an unreasonable amount of work, or when there are sufficient safeguards in place to ensure that the processing will not negatively impact a person's privacy.	Special personal information processing: s. 27(1).
5. Personal information about inherited characteristics may not be processed unless it is required for a research activity.	“Authorisation concerning the data subject’s sex or health life” (Part B, s. 32(5)).
6. Prohibition on processing personal information of children is not applicable if it is for research purposes, serves a public interest or obtaining consent seems to be difficult or would require an undue amount of work, and enough safeguards are in place to make sure that the processing will not adversely impact the child's personal privacy in an undue manner.	Processing of children's personal information is generally prohibited: Part C, s. 35 (1).

Table 2. Comparison of the DoH Ethics Guidelines, SA MTA, and the WMA Declaration of Taipei in relation to consent for storage and future use of human samples and personal data.

Key information aspects for participants	NDoH Ethics Guidelines	SA MTA	WMA Declaration of Taipei
Purpose of sample collection or biobank	✓	✓	✓
Nature of material to be collected	✓	✓	✓
Risks associated with material collection, use, and storage	✓	X	✓
Investigate the possibilities and, where applicable, explain genetic research and its implications	✓	X	X
A choice between samples remaining identifiable or for de-identification of samples, explaining risks and benefits for each option	✓	X	✓
That samples will not be sold for profit	✓	X	X
Research conducted must have been approved by a REC	✓	✓	✓
The right to refuse and withdraw from research participation	✓	X	✓
If materials are no longer identifiable, the participant may not know what their material is used for and will not be able to withdraw consent	✓	X	✓
How privacy (WMA) and confidentiality (NDoH) will be maintained	✓	✓	✓
Procedure for return of results which includes IFs	X	X	✓
Rules of biobank access	X	X	✓
When applicable, commercial use, benefit sharing, IP, material sharing with other countries	X	✓	✓
Regulating transfers of personal data/personal information	✓(limited)	✓	✓