Trial Staff Forum Agenda,

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• Trial Staff Forum Agenda,
• 18th Jan 2006, 9.30-10.30am
• A summary of the new COREC guidance on
  PIS/consent forms - Johanna Piper
• Presentation from the mens cancer unit at St
  Barts - Rebecca Jenkin.
• Registering your study with RD (a reminder) -
  Helene Provstgaard.

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COREC guidance on PIS consent forms

• Johanna Piper, Research Governance Good
  Clinical Practice Manager
• 18th January 2006

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COREC guidance on PIS/consent forms

• Draft guidance Nov 2005 comments welcome.
• Meets ICH GCP Clinical Trials Regs, 2004.
  Guidance for all types of research, exact content
  should be amended according to the type of study.
• Proposal for a two part PIS.
• Template consent form - should be amended with
  necessary info e.g. Data being sent outside EEA.
• http//www.corec.org.uk/applicants/help/docs/Guida
  nce_on_Information_Sheets_and_Consent_Forms.doc

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Guidance on writing PIS

• Part 1 brief info about essential elements of
  study, treatment, risks/benefits. If participant
  is interested, then reads part 2 of the PIS.
• Part 2 additional info e.g. confidentiality,
  data protection, indemnity, compensation etc.
• PIS should be written in simple, non technical
  terms easily understood by a lay person.
• Use short words, sentences, font size. Use
  bullets, avoid large sections of unbroken text.

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Guidance on writing PIS

• Tone invitational but not coercive.
• Use headed paper, relevant local contact details.
• Consent form/PIS version/date header /footer.
  Pages numbered e.g. p2 of 5.
• Awareness of cultural and language needs of
  potential participants. Possible translation
  required, use of witness / interpreter if
  necessary.

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Research involving children

• PIS template produced for following age ranges
• - Children 5 years and under
• - Children 6-12 years
• - Children 13-15 years parents/guardians form
• PIS should be shorter for children adjusted to
  approximate level of cognitive development.
• Consider childs attention span, fear of
  hospitals, mental capacity due to illness,
  disease severity, previous experience illness etc.

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Consent of children for research

• European Directive trials trials of medicines
• Written consent from parents/guardians. Children
• should give assent.
• Other research
• - Law is untested currently no legal age of
  consent to take part in research, apply principle
  of Fraser (formerly Gillick competence).
• Children who are felt to be competent to
  understand the research proposal and thus able to
  make decisions can give consent on their own
  behalf

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Design content of the PIS Part 1

• Document headed patient / participant IS. The
  study title should be put on all documents.
• Invitation paragraph explain they are being
  invited to take part in a research study.
• What is the purpose of this study? Brief, simple
  background and aim of study given.
• Why have I been chosen? Explain briefly why and
  how participant was chosen, no of patients.

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Design content of the PIS Part 1

• Do I have to take part? Explain participation is
  voluntary, able to withdraw with no implications.
• What will happen to me if I take part? Length of
  study, no. of visits, intervention, procedures
  (e.g. blood tests, scans), invasive procedures,
  length of follow up. Explain research methodology
  e.g. blinding, randomisation, placebo etc.
• Expenses payments e.g. travel expenses.
• Contact details made available to participant.

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Design content of the PIS Part 1

• What do I have to do? Outline participants
  responsibilities, explain medication
  requirements.
• What is the drug, device or procedure being
  tested? Short description of intervention, method
  of administration, details of contraindicated
  drugs.
• What are the alternatives for treatment? Info
  given on alternative treatments if applicable.
• What are the side effects of the treatment?
  Describe (if known) in lay language, depends on
  phase of study, prioritise seriousness/frequency.

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Design content of the PIS Part 1

• What are the possible disadvantages/risks of
  taking part? Outline possible risks discomfort.
  Separate section genetic research (implications).
• Ionising radiation information given on the
  additional amounts of radiation involved.
• Harm to the unborn child risks to women if
  pregnant (use of tests, contraception etc). Risks
  to men if treatment could damage sperm.
  Sensitivity depending on possible patient group
  (e.g. age).

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Design content of the PIS Part 1

• What are the possible benefits of taking part? If
  no intended clinical benefit, this should be
  stated. Important not to exaggerate the benefits.
• What happens when the research study stops?
  Arrangements at the trial end explained.
• What if there is a problem? Contact number for
  complaints usual NHS complaints system.
• Will my participation in the study be kept
  confidential? Short statement of reassurance.

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Design content of the PIS Part 2

• What if relevant new information becomes
  available? State that if new safety information
  arises, will be informed. Possible could stop
  study.
• What will happen if I want to stop the study?
  Reassure can withdraw and arrangements if do so
  depending on intervention, disease group etc.
• Indemnity/harm yet to be finalised with DH.
• Involvement of GP explain GP may be notified of
  their participation (depends on type of study).

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Design content of the PIS Part 2

• More info on confidentiality Consent to allow
  access records/files. Compliance with Data
  Protection Act. Participant told how their data
  will be collected, stored securely, whether
  retained for future studies, how long retained,
  disposal. Explicit consent for transfer of data
  outside EEA.
• What will happen to my samples? Storage info,
  future research, level of identifiability,
  destruction.
• Will any genetic tests be done? MRC recommend
  separate consent, Human Tissue Act.

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Design content of the PIS Part 2

• What will happen to the results of the research?
  Plans for publication/dissemination.
• Who is organising funding the research? Details
  should be given about funder and sponsor.
• Who has reviewed the study? Name of REC which
  reviewed the study.
• Notes PIS should state that the patient will be
  given a copy of the PIS/consent form to keep.

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Template consent form

• Example given is the minimum requirement,
  alterations will be needed depending on study.
• The participant is consenting to everything
  described in the PIS.
• For some studies a fuller itemised consent form
  may be needed such as-
• Additional invasive tests/samples reqd for
  study.
• Transfer of data/samples outside EEA
• Agreement to receive feedback from testing

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Template consent form

• Signatories from patient researcher.
• An independent witness is not required unless
  deemed necessary e.g. patient is blind,
  illiterate.
• Guidance on content of PIS and consent forms to
  give to children.Template assent form.
• Wording available for text for PIS-
• Harm to the unborn child
• Genetic testing
• Questionnaires/focus groups/interviews

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Need more information?

• Joint RD Office
• http//www.bartsandthelondon.nhs.uk/research/seeki
  ng_consent.asp
• COREC
• http//www.corec.org.uk/applicants/help/guidance.h
  tmconsent
• MRC
• http//www.mrc.ac.uk/index/publications/publicatio
  ns-ethics_and_best_practice.htm