Introduction to Ethics, Medical Ethics

1
SCU Human Research Ethics CommitteeCoffs
Harbour Campus Sub-Committee Presentation 8
November 2006
2
Coffs Campus Sub-Committee Members

• Prof Colleen Cartwright (Chair)
• Dr Steve Provost (representative to main HREC)
• Mr Grant Cairncross
• Anna Bloemhard (Project officer, Division of
  General Practice SCU Masters student - External
  representative).
•  The sub-committee is authorised to accept ethics
  approval applications from students and staff for
  research which only requires expedited approval
  (that is, low risk and non-vulnerable subjects). 

3
Main Ethical Principles in Western Thinking

• Autonomy - Respect for Individual Rights
• Non-Maleficence - Do No Harm
• Beneficence - Do Good
• Justice - treat all equally (but may sometimes
  need to treat unequally to level the playing
  field).

4
Practical Implications of Principles for Research

• Respect for autonomy
• respect individual rights (NB privacy)
• informed consent
• confidentiality (including for interviews)
• use of data
• protect those with ? autonomy (more vulnerable is
  study population, more care/ responsibility
  accrues to researcher)

5
Respect for Autonomy

• Prospective research participants must be given
  the information they need, in an appropriate
  form, to determine whether or not to participate
  in a study.
• There should be no pressure to participate, no
  risk of negative outcome for not participating
  and there should be ample time to decide.
• Respect for persons demands that participants
  enter into the research voluntarily and with
  adequate information this is called informed
  consent.

6
Why do student dissertations need Ethics Approval?

• The University has legal liability for actions
  taken by students as part of their course
  requirement.
• Completing an ethics approval application assists
  students to understand the ethical principles
  that govern research in Australia, as well as
  their responsibilities to their research
  participants and the wider research community
• Students must not start their research until
  they have received ethics approval.

7
When May Expedited Approval be Given?

• If the research is NOT HEALTH related and would
  possibly fit into one of the following
• Social science questionnaires on
  non-controversial, non-personal issues.
• General student surveys where participation is
  anonymous.
• Observation studies in public situations which
  focus on non-sensitive issues.
• Studies of existing de-identified data,
  documents, records.
• Applications for approval of amendments to
  previously approved research protocols or studies
  that are similar to another study already
  approved.
• Review of an ethics application already approved
  by another institution.
• Please note Expedited Review is never
  justifiable solely on the grounds of a
  researchers claim to the need for urgent review
  of their project.

8
What Does Expedited Approval Entail?

• For Coffs Campus HRESC
• one hard copy of the Ethics Approval Application
  with all required signatures, plus one electronic
  copy emailed as an attachment to the HRESC
  secretariat, leanne.carpenter_at_scu.edu.au
• an Information Sheet and Consent Form that
  specifically relate to the study (or component of
  the study) that the researcher/student will be
  doing
• (If part of an already-approved study) a copy of
  the Ethics Approval given for the main study,
  showing that it covers the work the
  researcher/student will be doing

9
When Should the Proposal be Submitted to the
Ethics Sub-Committee?

• Short answer ASAP!
• Longer answer in plenty of time (and at least 3
  weeks) before the student starts the project.
  The Ethics Sub- Committee consists of staff who
  do this work as an extra their own research,
  marking and other commitments means they cannot
  always call a meeting just because you are late
  submitting your application
• If the Sub-Committee decides that the study is
  not suitable for expedited approval because of
  the degree of risk to participants and the
  application should be a full submission to the
  main University Committee, it will have to wait
  for the next full Committee meeting to receive
  approval- and the student must not begin the
  research until approval is given.

10
What should be in the Information Sheet?

• Adequate information, in non-technical language,
  so that potential participants know (at least)
• - the title/purpose of the study
• - names/positions/affiliations of investigators
• - what is required of the participant (
  where/how long,etc)
• - benefits to participants (if any) or to others
• - participation is voluntary free to withdraw
  and no adverse consequences of that
• - assurance of confidentiality
• - access to results/feedback
• - study has ethics clearance (and from where)
• - who to contact if any concerns (including
  phone number)
• (Note Participant keeps the Information Sheet)

11
What Should Be In The Consent Form?

• The title of the study
• - names/positions/affiliations of investigators
• - provision of space for full name of
  participant
• - written declaration of informed consent (e.g.
  I (name) ..confirm that I have been given an
  Information Sheet about the study named above. I
  understand that (list all that the participant
  is agreeing/consenting to, e.g.)
• - my participation is voluntary and I am free to
  withdraw at any time without any negative
  consequences
• - all information collected will be kept
  completely confidential and no identifying data
  will be published
• - I may ask for the tape recorder to be switched
  off at any time (if relevant)
• - provision for signature of participant date
• (Note Researcher Keeps Consent Form)

12
Coffs Campus HRESC Process

• Coffs Campus HRESC will meet one week before HREC
  agenda is compiled expedited ethics applications
  will be considered and approved or sent back to
  researchers for amending.
• Approved Applications will be sent to HREC
  Secretary for approval notification and number
  research may start as soon as these are received
• Applications from the HRESC that have been
  approved given an approval notification and
  number by the HREC Secretary are included in the
  Agenda for ratification by the full HREC.
• Applications ratified by the HREC - if the HREC
  has further queries about a particular
  application they may contact the HRESC or the
  researcher/supervisor.
• (Note Last HREC meeting date for 2006 is 4
  December Closing date for applications, Monday,
  20 November 2006).

13
HREC Meeting Dates 2007
14
Relevant Documents for Ethics Approval
Applications

• National Statement on Ethical Conduct in Research
  Involving Humans www.nhmrc.gov.au
• Any new FULL ethics applications to be reviewed
  by the HREC are to be submitted on the National
  Ethics Application Form (NEAF). The NEAF website
  is www.neaf.gov.au. It is self-explanatory.
• Applications for expedited approval must be on
  the Expedited Review form, available from the
  ASLaRC website http//aslarc.scu.edu.au, go to
  downloads

15
Contact details for Secretariats

• Coffs Harbour HRESC
• Leanne Carpenter
• ASLaRC
• Ph 6659 3197
• email leanne.carpenter_at_scu.edu.au
• website http//aslarc.scu.edu.au
• Lismore HREC
• Sue KellyGraduate Research CollegePh 6626
  9139email sue.kelly_at_scu.edu.au