Ethics and Research in Special Populations as Applied to Clinical Research

An understanding of the place of ethics in clinical research common ethical issues that arise and how to analyse them and find solutions. The role of ethics committees, applications to ethics committees and Good Clinical Practice. An in-depth consideration of obligations under the Treaty of Waitangi with special regard to ethics and community based research. The development of an appropriate and inclusive approach to clinical research with special populations.

Course overview

Points

15

Fees

$1338 NZD

International fees

$5402.25 NZD

Course offered in

  • Trimester 1

Duration

1 trimester

Prerequisites

Co-requisites

Restrictions

Taught by

The School of Biological Sciences

Wellington Faculty of Science

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Course content

This course is taught mostly online, but there are two important face-to face components of the course, which are compulsory:
 
1. Weekend Seminar
(See course timetable) an in-person on-campus event held on the Kelburn campus. This may be held on zoom due to COVID19.
 
 
2. Teleconferences
, often held as zoom meetings.
 

If you are an international student who is not in NZ you will need to email the Course Coordinator to seek permission to take this course.
 
This course develops an understanding of the place of ethics in clinical research, common ethical issues that arise, how to analyse these issues and find solutions. The role of ethics committees, appllications to ethics committees and Good Clinical Pracitce. An in-depth consideration of obligations under the Treaty of Waitangi with special regard to ethics and community based research. The development of an appropriate and inclusive apporach to clinical reserach with special populations.

Course learning objectives

Students who pass this course will be able to:

  1. Have a comprehensive understanding of the critical place of ethics and good ethical practice in clinical research

  2. recognise the issues associated with ethical problems and find solutions to ethical problems in clinical research

  3. Have an in-depth understanding of issues around research in the context of disadvantaged or ‘vulnerable’ populations such as Māori, Pacific peoples, people with mental health conditions and people with physical and intellectual impairments, and children

  4. describe the need and demonstrate how to undertake specific community based research inclusively

  5. address issues related to the Treaty of Waitangi for a specific research project whether or not Māori are a focus of that research

  6. explain the requirements of the Ministry of Health’s ethics application process

Academic requirements

All students must apply to be accepted by the Programme Director

Available offerings

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Offering CRN 18712

This course outline is final and archived.

Duration

28 February 2022 - 26 June 2022

Starts

Trimester 1

Campus

Inter-institutional (NZ)

People

Lecturers

External teaching staff

Dr Hilary Stace
hilary.stace@vuw.ac.nz
04 472 1575 or 021 138 0731

Schedule

28 February 2022
Course begins

28 February 2022 to 3 June 2022
Teaching
11 April 2022 to 24 April 2022
Break
6 June 2022 to 9 June 2022
Study period
10 June 2022 to 25 June 2022
Exam period
26 June 2022
Course ends

Teaching format

There are four parts of this course. The seminar on 06 March will introduce the topics which will be developed further in telephone conferences. During the course, we will post relevant material onto Blackboard, the online system which supports learning and teaching at VUW.

  • Release of course material: We will regularly release course material for you to read.  This may include links to recommended additional material. You should review this material and be ready to discuss it by the teleconference date.
  • Online interaction: You should make use of the Blackboard site to discuss readings with your fellow students.  There is a wide range of clinical experience in this programme, so asking questions or initiating online discussions is a good way of drawing on others’ experience, or offering your contribution, to better your understanding of course materials.
  • Zoom conferences: These conferences are compulsory. These are 90 minutes long, and may include visiting speakers from around New Zealand. Typically, the first part of each conference will be taught, followed by discussion and questions. Conferences do not cost you any additional fees or charges. Instructions for connecting to them are set out below in the section on Teleconferences. They are held by Zoom and recorded and posted on Blackboard.
The course will cover the following topics during the semester.
 
Why ethics
Introduction to clinical ethics history and principles
The New Zealand ethics application process
Māori consultation
Bi-cultural ethical considerations, the importance of consultation with Māori, Te Ara Tika
Ethical issues
Principles of beneficence, respect and justice, including informed consent, autonomy, security, privacy, conflicts of interest, serious adverse events, and research methodological challenges
‘Special’ populations
Including people with intellectual and other impairments, mental health issues, children and elderly people, prisoners, ethnic minorities, other potentially vulnerable groups

Workload

As a 15 point course it is expected that students undertake 150 hours of work over the course of the trimester.

Additional classes

This course is taught mostly online and there is usually an important face-to face component held in Wellington, ie. the Weekend Seminar, which is compulsory. However, to provide certainty for planning and arrangements in advance this year, the course convenors have decided to conduct the Weekend Seminar online by Zoom. Details for connecting to the Weekend Seminar will be supplied and attendance will be recorded.

 
Monthly Zoom conferences
Zoom conferences are compulsory and contribute to assessment. If for some reason you are unable to attend, you will need to let the course tutors know. Sessions will be recorded but listening to them later will not be as useful for you as being able to join in the discussion. The dates and times for CLNR 402, together with the provisional topics, are below. Any updates or changes to the dates, times or topics will be given on Blackboard as well as by general email (please ensure you also supply your email address to Richman Wee at rwoffc@gmail.com).
 
 For dates, times and topics of teleconferences please see Blackboard under "Teleconferences" heading.

Texts

Required

See separate PDF for suggested reading

There are no required texts for this offering.

Recommended

Required materials and equipment

Course materials and references will be uploaded onto the Blackboard site and will be regularly updated.  For this reason, it is important that you have ready access to a computer with reliable internet connection. There is no recommended textbook for this course but students will be given readings and websites to visit and expected to contribute to discussion in teleconferences.
 
BLACKBOARD is a very important tool for this course and for other courses in the PG Diploma, so we recommend that you take time early on to familiarise yourself with how it works.  You can use Blackboard to download course notes, access links to materials on the web, listen to recordings of teleconferences, and discuss topics with your fellow classmates. 

Assessment

Assessment will be as follows:

  • Attendance at all-day/Sunday seminar

    CLO:

    • 1,
    • 2,
    • 3,
    • 4,
    • 5,
    • 6,

    Mark: 10%

  • Attendance and participation in Zoom conferences:
    Consultation with Māori
    Ethical issues in disability research
    Overlapping ethical and legal issues in human participants research, using examples in genomics, and the handling of research data
    Revision and further ethical questions

    CLO:

    • 1,
    • 2,
    • 3,
    • 4,
    • 5,
    • 6,

    Mark: 10%

  • Deadline for report on MoH ethics committee (after having attended and observed an earlier ethics committee meeting)

    CLO:

    • 1,
    • 2,
    • 3,
    • 4,
    • 5,
    • 6,

    Mark: 20%

  • Deadline for Māori consultation essay “In not more than 1,000 words, outline the case you would make on behalf of a group of clinical researchers justifying the importance of consulting with Māori.”

    CLO:

    • 1,
    • 2,
    • 3,
    • 4,
    • 5,
    • 6,

    Mark: 30%

  • Deadline for Participant Information Sheet and Consent Form (focusing on a potential study which could still be theoretical at this stage)

    CLO:

    • 1,
    • 2,
    • 3,
    • 4,
    • 5,
    • 6,

    Mark: 30%

Mandatory requirements

In addition to achieving an overall pass mark of at least 50%, students must:

  • Attend the weekend seminar
  • Attend at least two of the teleconferences
  • Complete all written assessment

If you believe that exceptional circumstances may prevent you from meeting the mandatory course requirements, contact the Course Coordinator for advice as soon as possible.

Marking criteria

Assessment for this course has been designed to help you develop practical skills.  All work to be handed in should be emailed to gabriel.prinsich@vuw.ac.nz or rwoffc@gmail.com.
Students in this course will be evaluated on the basis of:

  1. Attendance and participation at the seminar of 06 March (10% of final evaluation)
  2. Participation in Zoom conferences (10% of final evaluation)
  3. Visit to one of the Ministry of Health’s regional ethics committees (10%) and posting a short report about your visit on Blackboard (10%) (Total of 20% of final evaluation)
  4. Māori consultation exercise (30% of final evaluation)
  5. Participant Information Sheet and Consent Form for theoretical or real research project (30% of final evaluation)

Work submission

All work to be handed in should be emailed.

Extension

N/A

Penalties

To pass CLNR 402, you must complete all of the mandatory course requirements and gain a mark of 50% or higher for the course as a whole. The mandatory requirements are attendance at weekend seminar and at least two Zoom conferences, and all written work. (The Zoom conferences will be recorded and posted on Blackboard. If you are not able to attend one, it may be acceptable to listen at a later date.)

Communication and additional information

We use Blackboard for course materials, communication of marks, online discussions, and announcements. You should ensure that you check Blackboard regularly for such information. Important messages will also be circulated by email.

Student feedback

Information on student feedback can be found on https://www.victoria.ac.nz/learning-teaching/partnership/student-feedback

You can view Student course feedback collected for the University courses from the last completed trimester for which feedback was collected

Class representative

The class representative provides a useful way to communicate feedback to the teaching staff during the course. They also work with the VUWSA Education Office on any academic issues that arise in their course. Reps are elected by students by the third week of classes every trimester. Being a rep requires a weekly commitment.

The Use of Te Reo Māori for Assessment Policy

Te Herenga Waka—Victoria University of Wellington values te reo Māori. Students who wish to submit any of their assessments in te reo Māori must refer to The Use of Te Reo Māori for Assessment Policy - PDF 134kb

He mea nui te reo Māori ki Te Herenga Waka. Ki te pīrangi koe ki te tuhituhi i ō aro matawai i roto i te reo Māori, tēnā me mātua whakapā atu ki te kaupapa here, The Use of Te Reo Māori for Assessment Policy - PDF 134kb

Course additions and withdrawals

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Important information

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