Table 1.

Emerging issues in paediatric research consent forms

Emerging issues in paediatric research discussed in consent forms	N total (43)	%
1. Consent
Scope of parental consent
Specific	13	30
Broad	18	42
Broad or Specific (option)	2	5
Not addressed	10	23
Child’s ability to dissent
Addressed	19	44
Not addressed	24	56
Possibility for child’s assent and/or future consent
Assent or future consent addressed	22	51
Neither addressed	21	49
2. Risks and benefits
Financial, social or psychological issues as potential risks	11	26
Cumulative harms considered	3	7
How ‘benefit’ characterised
Indirect	29	67
Unspecified	11	26
Direct or combination of direct/indirect	3	7
3. Extent of withdrawal
Ability for child to withdraw
Addressed	28	65
Not addressed	15	35
Extent of withdrawal
All data/samples destroyed	7	16
No further use of data/samples	1	2
Retention of data/samples collected to date	3	7
Not addressed or unspecified	32	74
Process for handling parental-child disagreement on withdrawal	0	0
4. Return of research results and incidental findings
Not addressed	17	40
Addressed	26	60
No return	6	14
General/aggregate results return	7	16
Individual results return	7	16
General/aggregate and individual results return	6	14
Any return of results that include incidental findings (with or without option)	8	19
5. Privacy and confidentiality
Scope of parental right to access information concerning their child	0	0
Nomenclature for data/sample identifiability
Unspecified	14	33
Coded	25	58
Anonymised	4	9
6. Transfer and data sharing
Retention period(s) of data/samples
Indefinite	12	28
Specified time periods	18	42
Combination of indefinite and specified time periods, depending on whether material is data or samples	4	9
Not addressed	9	21
Access to data/samples
No transfer	2	5
Disclosure that data/samples may be transferred to another location	17	40
Disclosure and discussion of procedure for external data/sample transfer	4	9
Not addressed	20	47