Document Number: SOP/01/V4

Title: Obtaining Informed Consent and Assent for Research Studies
Author: Pam Dicks/Susan MacFarlane

Effective Date:

/

20 Nov 2015

Periodic Review Date:

/

19 Nov 2018

Superseded version number and date (if applicable):

/

V3 27/2/2013

1.0 Background

1.1 Informed consent and assent should protect the child’s rights, well-being as well as their autonomy, and should be an on-going process of information exchange.

1.2 Definitions, principles and legislation pertaining to the consent and assent of a child, young person and legal guardian for research are detailed in the ScotCRN Guidance Obtaining Informed Consent for Clinical Research in Children and Young People under 16 in Scotland.

1.3 To assist with determining the study purpose and the appropriate person for assessing competency and obtaining consent please refer to the Consent & Assent Decision Tree, Appendix 4

  1. Purpose
  2. This Standard Operating Procedure (SOP) describes the correct procedure for obtaining written informed consent and assent from a child, young person and legal guardian for clinical research studies.

2.2 For this purpose of this SOP the term “child” will be used whilst recognising this may be child or young person up the age of 16 years.

  1. Scope

This SOP applies to the correct procedure to be followed when obtaining informed consent and assent for all studies.

Informed Consent is:

“The voluntary agreement of an adult or competent child, based on adequate knowledge and understanding of relevant information, to participate in research”. MRC (2004)

And as:

“A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and datedinformed consent form.” ICH GCP 1:28 (1997)

Child Assent is a child’s agreement to participate in a research study when consent is not appropriate for reasons of competence. A signed assent form (Appendix 1), where possible, should be obtained from a non-competent child when the parent has consented for their child to participate (Appendix 2).

Parental Assent is the parent’s agreement to their child participating in a study when the child or young person has been deemed competent to provide their own consent (Appendix 3). Although this is not legally required when a competent child provides their own informed consent, parental assent may also be sought as parental support is usually required for full participation in research studies. However, when sensitive areas such as sexual health, personal attitudes and behaviours are included in the proposed research, the competent child’s right to privacy must be respected and parental assent omitted.

Competency of a child or young person:

For Clinical Trials of an Investigatory Medicinal Product (CTiMP) competency must be assessed by a medical practitioner. After competence has been determined, the process of obtaining consent or assent can be delegated to a suitably qualified healthcare professional. The competent child provides their own consent accompanied by parental consent. Non-competent child provides assent with parental consent.

For a Non-CTiMP but the study involves surgical, medical or dental procedures or treatmentscompetency must be deemed bya qualified medical practitioner.

If deemed competent then child consent is obtained. Parental assent is good practice to support the child/young person’s decision. Consent from the competent child/young person can be obtained by the medical practitioner or delegated to asuitably qualified health care professional.

If deemed non-competent by the medical practitioner then responsibility for consent falls to the parent with assent taken from the child. This can be obtained by the medical practitioner or delegated to asuitably qualified health care professional.

For Non-CTiMPstudies that do not involve surgical, medical or dental procedures or treatments(eg.observational, epidemiological and follow up cohort studies) but use assessmentssuch as DNA analyses,height, weight, lung function or healthquestionnairesto characterise subjects and their disease for research purposes but do not determine an individual child'sdiagnosis or guide or influence their treatment, competency can be assessed by a qualified medical practitioner orsuitably qualified health care professional and the appropriate consent and assent obtained.

Where there is uncertainty on the purpose of the research study this should be discussed with the Scottish Children’s Research Network and Sponsor(s) of the clinical research who will advise on the assessment of competency and role of research staff members.

.

  1. Responsibilities

4.1 ICH/GCP (1997) guidelines state that:

“The investigator, or a person designated by the investigator, should fully inform the subject…”

and that:

“the written informed consent form should be signed…by the person who conducted the informed consent discussion.” ICH GCP 4.8.5

“Children and young people should not be involved in research if they object or appear to object in either words or actions, even if their parents consent.” GMC (2007)

4.2 Research nurses may obtain informed consent and assent when it is

appropriate for the type of study, they are suitably trained and are named on the delegation log.

4.3 It is the responsibility of the Principal Investigator to ensure that the appropriate organisations are informed if research nurses are taking consent and assent on their behalf. This may include the ethics committee that approved the study, the R&D office and study sponsor.

4.4 It is the responsibility of the person taking informed consent and assent to consider the following issues when obtaining consent and assent:

  • Age of the subject
  • Mental capacity of the subject and of the parents/guardians
  • Competency of the subject (child)
  • Parental guardianship*
  • The Law
  • Research Guidelines.

* The Children Act 1989 states that the following people have parental guardianship and are therefore eligible to consent on behalf of “their” child:

  • Married parents
  • An unmarried mother
  • An unmarried father if a court order is in place(or effective since 1st December 2003) if he is registered as the father on the birth certificate.The Adoption and Children Act 2002
  • The local authority if a child is in care
  • Step-parents if a court order is in place (effective since December 2005).

5.0 Procedure

5.1 Check the child’s name, date of birth and ensure that they and their parents/guardian have received all appropriate documentation (information sheet and any other relevant study information).

5.2 Enquire as to whether the child or their parents/guardian has any questions relating to the study documentation.

5.3 Give a full explanation of the study and what is involved.

5.4 Check inclusion and exclusion criteria.

5.5 Explain that the child is under no obligation to participate and that they can withdraw at any time, and that this will not affect their treatment now or in the future.

5.6 Establish if the child and their parents/guardian has had enough time or if they require more time to consider participation, or if they would like to speak to a member of the research team. Within ICP guidelines the child and their parent/guardian must have at least 24 hours to contemplate the information before consent is obtained.

There may be circumstances where the ethics committee has agreed that participants can be approached within an earlier time frame.

5.7 Ask if the child or their parents/guardian has any questions and if they are willing to participate in the study.

5.8 Competency of the child is assessed by either a medical practitioner or suitably trained healthcare professional, determined by the research study purpose, to ensure the appropriateness of consent or assent.

5.9 Ask the child or their parent/guardian to read the statements and initial boxes on the consent form or assent form, as appropriate, and sign/date the relevant sections.

5.10 Ask if the childhas read or have had read to them the study information. If the child wishes to continue and to participate in the trial ask them to write their name and the date in the appropriate sections of the consent or assent form as deemed by competency.

5.11 Signing an assentform is age dependent and the ability of the child should be assessed during the consent/assent process. If written assent is not obtained from the non-competent child the reason for this should be documented in the medical notes/CRF.

5.12The research staff member obtaining consent and assent must countersign and date theforms and file. A copy of the consent and assent forms is given to the child and their parents/guardian and a copy placed in the study file/clinical notes.

6.0 Related documents & references

  • ScotCRN Guidance Obtaining Informed Consent for Clinical Research in Children and Young People under 16 in Scotland.
  • Delegation of tasks log (if required).
  • Approval for Research Nurses to take informed consent (if required).
  • Consent and assent forms
  • ICH/GCP Directive/guidelines
  • EU Clinical Trials Directive: The Medicines for Human Use (Clinical Trials) regulations 2004
  • Medical Research Council (2004) ‘Medical Research Involving Children Ethics Guidelines
  • 0-18 Years: Guidance for all doctors, page 16, GMC 2007
  • Adoption and Children Act 2002

7.0 List of Appendices

Appendix 1: Generic Assent Form

Appendix 2: Generic Parental Consent Form

Appendix 3: Generic Participant Consent form

Appendix 4: Consent & Assent Decision Tree

8.0 Approval & sign off

Author:
Name: Susan MacFarlane
Position: Lead Paediatric Nurse, Tayside
Signature: Date: 20/11/2015
Approved by:
Name: Pam Dicks
Position: Network Manager
Signature: Date: 20/11/2015
Authorised by:
Name: Prof Stephen Greene
Position: Network Director
Signature: Date: 26/2/2013

APPENDIX 1 Printed on Headed Paper

ASSENT FORM

Study Title:

Study Doctor:

Child (or if unable, parent on their behalf)/young person to circle all they agree with:

Have you read (or had read to you) about this study?Yes / No

Has somebody else explained this study to you?Yes / No

Do you understand what this study is about?Yes / No

Have you asked all the questions you want?Yes / No

Have you had your questions answered in a way you understand?Yes / No

Do you understand it’s okay to stop taking part at any time?Yes / No

Are you happy to take part?Yes / No

If any answers are ‘no’ or you don’t want to take part, don’t sign your name!

If you dowant to take part, you can write your name below

Your Name ______

Date ______

The study doctor/person who explained this study to you needs to sign too:

Print Name ______

Sign ______

Date ______

Parental/Legal Guardian consent to be obtained with assent, where appropriate, for children and young people assessed to be non-competent to consent to a Non-CTiMP study. 1 original for participant, 1 original for medical notes and 1 copy for study file.

APPENDIX 2 Print on Headed Paper

PARENT/LEGAL GUARDIAN

INFORMED CONSENT FORM

Title of Study:

Name of PI: Please initial box

I confirm that I have read and understood the information sheet version……. dated…………..for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. /
I understand that my child’s participation is voluntary and that he/she is free to withdraw at any time without giving any reason, without any medical care or legal rights being affected. /
I understand that relevant sections of my child’s medical notes and data collected during the study may be looked at by appropriate individuals from the University of ……………. or from NHS ……………….., where it is relevant to my taking part in this research. The Sponsor may appoint a third party to access mychild’s medical records or other identifiable data. I give permission for these individuals to have access to my child’s records. /
I agree to my child’s GP being informed of their participation in the study. /
I agree for my child to take part in the above study.

______

Name of child or young person

______

Name of Parent/Legal Guardian DateSignature

______

Name of person taking consentDateSignature

Parental/Legal Guardian consent to be obtained with assent, where appropriate, for children or young people assessed to be non-competent to consent to a Non-CTiMP study.

1 original for participant, 1 original for medical notes and 1 copy for study file

APPENDIX 3Print on Headed Paper

PARTICIPANT INFORMED CONSENT FORM

Title of Study:

Name of PI:

Competency to consent assessed by ……………………………………….. Date: ……………….

Please Initial box

1 / I have read and understood the information sheet version……. dated…………..for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.
2 / I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without any medical care or legal rights being affected.
3 / I understand that relevant sections of my medical notes and data collected during the study may be looked at by appropriate individuals from the University of ……………………..or from NHS ……………………., where it is relevant to my taking part in this research. The Sponsor may appoint a third party to access my medical records or other identifiable data. I give permission for these individuals to have access to my records.
4 / I agree to my GP being informed of their participation in the study.
5 / I agree to take part in the above study.

______

Name of Participant Date Signature

______

Name of person taking consentDate Signature

As parent/legal guardian I agree to support my child’s decision to participate in this study.

______

Name of Parent/Legal Guardian Date Signature

To be used for competent children and young people when recruiting to Non-CTiMP studies

1 original for participant, 1 original for medical notes and 1 copy for study file

APPENDIX 4Consent Decision Tree

Revision History

Document number and version / Reviewer Comments and/or changes / Date of Review / Reviewers Signature
SOP1/V3 / Changes to format and content to reflect ScotCRN consent guidelines / 26/2/13 / Susan MacFarlane
SOP1/V3 / New SOP template, no changes to content / 10/4/14 / Susan MacFarlane
SOP1/V4 / No changes to content, new review dates / 20/11/15 / Susan MacFarlane

SOP 1Effective date: 20/11/2015Version 4

Review date: 19/11/2018