Table 1 Emerging issues in paediatric research consent forms

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