CLNR 402

For academic year

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

$1374.75 NZD

International fees

$5618.4 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 available to take fully online and in person for the Weekend Seminar component of the course.
 
Lectures for this course will be live streamed via Zoom and recordings of these will be available for preparation for assessment.
 
The Weekend Seminar (See course timetable) is an on-campus event held on the Kelburn campus and also live streamed via Zoom with attendance in person unless compelling reasons not to be there. 
 
Attendance at scheduled times is required for all teaching lectures.
 
If you are an international student and you are not in NZ, you will need to email the Course Coordinator to request 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.
 
The course will cover the following topics during the trimester:
 
Why ethics
Introduction to clinical ethics, history and principles
The New Zealand ethics application process
 
Māori consultation and engagement
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

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 provisional and subject to change until the course commences.

Duration

27 February 2023 - 25 June 2023

Starts

Trimester 1

Campus

Inter-institutional (NZ)

Schedule

27 February 2023
Course begins

27 February 2023 to 2 June 2023
Teaching
10 April 2023 to 23 April 2023
Break
5 June 2023 to 8 June 2023
Study period
9 June 2023 to 24 June 2023
Exam period
25 June 2023
Course ends

Teaching format

Zoom classes 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 the University’s intranet system as well as by general email (please ensure that, at the start of the course, you also supply your email address to Richman Wee at rwoffc@gmail.com).
 

  • WHEN?
  • Sunday 05 March, 9:00am-2:00pm – Weekend Seminar
  • Thursday 16 March, 5:30-7:00pm – Treaty of Waitangi and Māori engagement
  • Thursday 30 March (to be confirmed, in lieu of the April class), 5:30-7:00pm – Overlapping ethical and legal issues in human participants research, using examples in genomics, and the handling of research data
  • Thursday 11 May, 5:30-7:00pm – Ethical issues relating to research involving disabled people
  • Thursday 25 May (in lieu of the June class), 5:30-7:00pm – Revision and further ethical issues
 
(Further details about Zoom conferences and additional readings will be provided closer to the time.)
 
  • HOW?
The Zoom link will be sent out beforehand. Please check well in advance of class that your computer or device can access Zoom.
 
For the monthly Zoom classes, please connect promptly by 5.30pm.
Please ensure you're in a quiet place when you connect. Background noise can disrupt classes so stay on mute unless speaking to the class.
 
Zoom conferences do not involve additional fees or charges, but only students enrolled in this diploma may attend.
 
Use the 'Class Discussions' forum on the Discussion Board to communicate with fellow students about the course materials. There is a lot of experience and knowledge represented in the group, so make use of this and contribute your own knowledge by making good use of the Discussion Board.
 
If you have questions that have not been addressed during the Zoom classes, you can ask your question by posting it online on the Discussion Board.

Workload

As a 15 point course it is expected that students undertake 150 hours of work over the course of the trimester.
 
On completion of this course students will have:

  • A comprehensive understanding of the critical place of ethics and good ethical practice in clinical research.
  • The ability to understand the issues associated with ethical problems and find solutions to ethical problems in clinical research.
  • An in-depth understanding of issues around research in the context of disadvantaged or ‘vulnerable’ populations, as well as communities of interest, for example, Māori, Pacific peoples, people with mental health conditions, people with physical and intellectual impairments, and children.
  • The ability to understand the need for, and demonstrate how to undertake, specific community-based research in inclusive manner.
  • The ability to address issues related to the Treaty of Waitangi for a specific research project whether or not Māori are a focus of that research.
  • Understanding of the requirements of the Ministry of Health’s ethics application process.
There are four parts of this course. The seminar on 05 March will introduce the topics that will be developed further in the monthly Zoom classes. During the course, we will post relevant material onto Nuku 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 Nuku 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. They are held by Zoom and recorded and posted on Nuku.

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. To provide certainty for planning and arrangements in advance this year, the course convenors have decided to conduct the Weekend Seminar in person. Students are strongly encouraged to attend ‘in person’ for the Weekend Seminar, which will be recorded. Permission from the course convenors must be sought in advance if the student can only participate for the Weekend Seminar by Zoom. Attendance will be noted for the Weekend Seminar and all other classes during the trimester.

Texts

Required

There are no required texts for this offering.

Recommended

The following New Zealand materials are strongly recommended:
 

  • http://www.statnews.com/2016/01/11/childrens-study-nih-precision-medicine/bioethics
  • https://www.bioedge.org/
  • Deer, B (2020). The man who fooled the world: Andrew Wakefield’s war on vaccines.  Scribe
  • Elliott, C. (2014) How the destitute and mentally ill are being used as human lab rats https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe
  • Emanuel EJ, Wendler D, Grady C. (2000). What makes clinical research ethical? JAMA. 2000 May 24-31; 283(20):2701-11.
  • Fisher, J.A. (2009) Medical research for hire: The political economy of pharmaceutical clinical trials Rutgers Press
  • Goldacre, B. (2012). Bad Pharma: How drug companies mislead doctors and harm patients. London: Fourth Estate. (See also his website and blog www.badscience.net)
  • McLean, S., ed. (2010) Healthcare research ethics and law: regulation, review and responsibility Routledge Cavendish, Oxford.
  • Perry, G. (2012) Behind the shock machine: the untold story of the notorious Milgram psychology experiments. Scribe.
  • Petryna, A. (2009) When experiments travel: clinical trials and the global search for human subjects Princeton University Press.
  • Skloot, Rebecca (2010) The immortal life of Henrietta Lacks New York, Crown. (Not only is this book a great read, it illustrates many aspects of clinical research ethics in a well-told medical biography)
  • Thomas, D., Hodges, I.D. (2010) Designing and Managing Your Research Project: Core Skills for Social and Health Research:  Sage.
  • A relatively recent interesting piece, with graphics, about disparities:
     
    • Morris, Toby. (2022) The Side Eye’s Two New Zealands: The 2,700 Day Gap. The Spinoff. Click here.

Required materials and equipment

Course materials and references will be uploaded onto Nuku 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.
 
Nuku 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 Nuku 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 weekend seminar

    Due: 05/03/2023

    CLO:

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

    Mark: 10%

  • Attendance and participation in Zoom conferences:
    Treaty of Waitangi and Māori engagement for Health Research
    Overlapping ethical and legal issues in human participants research, using examples in genomics, and the handling of research data
    Ethical issues relating to research involving disabled people
    Revision and further ethical issues

    Due: 16/03/2023 to 25/05/2023

    CLO:

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

    Mark: 10%

  • Written Assignment (due by 5pm on the stated date):
    Report on MoH ethics committee (after having attended and observed an earlier ethics committee meeting)

    Due: 31/05/2023

    CLO:

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

    Mark: 20%

  • Written Assignment (due by 5pm on the stated date):
    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.”

    Due: 31/05/2023

    CLO:

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

    Mark: 30%

  • Written Assignment (due by 5pm on the stated date):
    Participant Information Sheet and Consent Form (focusing on a potential study which could still be theoretical at this stage)

    Due: 08/06/2023

    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)
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 Nuku. If you are not able to attend a Zoom conference, it may be acceptable to listen at a later date and to obtain the grade for doing that.)
 
We use Nuku for course materials, communication of marks, online discussions, and announcements. You should ensure that you check Nuku regularly for such information. Important messages will also be circulated by email.

Work submission

All work to be handed in should be emailed.

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 participation at weekend seminar and at least two Zoom conferences, and all written work. (The Zoom conferences will be recorded and posted on Nuku. If you are not able to attend one, it may be acceptable to listen at a later date.)

Communication and additional information

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

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

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