220 week 4 (Codes + Directives + Guidelines)

4.5/4.6/4.7

Code #1 of the Nuremberg Code

The voluntary consent of the human subject is absolutely essential. 

Code #2 of the Nuremberg Code

The experiment should be such as to yield fruitful results for the good of society. 

Code #3 of the Nuremberg Code

The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease.

Code #4 of the Nuremberg Code

The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

Code #5 of the Nuremberg Code

No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur.

Code #6 of the Nuremberg Code

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Code #7 of the Nuremberg Code

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

Code #8 of the Nuremberg Code

The experiment should be conducted only by scientifically qualified persons.

Code #9 of the Nuremberg Code

During the course of the experiment the human subject should be at liberty to bring the experiment to an end.

Code #10 of the Nuremberg Code

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of thegood faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

whats the Nuremberg Code used for?

Directives for Human Experimentation

• protection of human subjects

How were the 7 Directives developed?

• Since 2008

• BC First Nations involved in extensive community engagement

• Developed through hundreds of regional/sub-regional caucus meetings

• Also developed through Health Partnership Workbooks

• Guide First Nations health governance

What are the 7 Directives?

• Fundamental standards and instructions for the new health governance relationship

• Shared by FNHA, FNHC, and FNHDA

What does FNHA stand for?

First Nations Health Authority

What does FNHC stand for?

First Nations Health Council

What does FNHDA stand for?

First Nations Health Directors Association

What is Directive #1?

Community-Driven, Nation-Based

main idea of Directive #1: Community-Driven, Nation-Based?

• Overarching/foundational principle

• Programs, services, policies driven by grassroots/community level

• Protect/enhance community health agreements and programs

• Protect First Nations autonomy and authority

What is Directive #2?

Increase First Nations Decision-Making and Control

main idea of Directive #2: Increase First Nations Decision-Making and Control?

• Increase First Nations influence over health programs/services

• Increase local control

• Increase involvement in government decision-making

• Give communities flexibility to meet their own priorities

• Recognize authority of individual BC First Nations

At what levels should First Nations have increased influence over health programs/services?

• Local

• Regional

• Provincial

• National

• International

What approach to health is emphasized in Directive #2?

• Wellness approach

• Health promotion

• Disease prevention

• Injury prevention

What does OCAP stand for?

• Ownership

• Control

• Access

• Possession

How does Directive #2 apply OCAP?

• First Nations control their health data

• First Nations lead health reporting

What is Directive #3?

Improve Services

main idea of Directive #3: Improve Services?

• Improve health services accessed by First Nations

• Incorporate First Nations knowledge and healing practices

• Increase access to health care

• Support local/regional health planning

What First Nations perspectives should be incorporated into health services under Directive #3?

• Knowledge

• Beliefs

• Values

• Practices

• Medicines

• Models of health and healing

What health care access should be increased under Directive #3?

• Primary care

• Physicians

• Nurses

• Dental care

• Other allied health care

What program should be improved and revitalized under Directive #3?

Non-Insured Benefits program

What is Directive #4?

Foster Meaningful Collaboration and Partnership

main idea of Directive #4: Foster Meaningful Collaboration and Partnership?

• Work collaboratively with First Nations and non-First Nations organizations/governments

• Address social/environmental determinants of health

• Build partnerships

• Collaborate in research/reporting

• Support community engagement

What are examples of determinants of First Nations health addressed in Directive #4?

• Poverty

• Water quality

• Housing

• Other social/environmental determinants

Who should First Nations collaborate with under Directive #4?

• Other First Nations

• Federal partners

• Provincial partners

• Regional partners

• Non-First Nations organizations/governments

What is a goal of relationship-building under Directive #4?

• Align health care with First Nations priorities

• Align care with community health plans where applicable

What is Directive #5?

Develop Human and Economic Capacity

main idea of Directive #5: Develop Human and Economic Capacity?

• Develop current/future health professionals

• Provide education/training opportunities

• Gain additional funding/investment/services

• Create economic opportunities for First Nations health programs

What is Directive #6?

Be Without Prejudice to First Nations Interests

main idea of Directive #6: Be Without Prejudice to First Nations Interests?

• Health governance changes must not harm existing First Nations rights/interests

• Protect Aboriginal Title and Rights

• Protect treaty rights

• Protect self-government agreements

• Protect court proceedings

• Protect Crown fiduciary duty

How does Directive #6 affect existing federal funding agreements?

• Must not affect existing agreements with individual First Nations

• Unless First Nations want the agreements changed

What is Directive #7?

Function at a High Operational Standard

main idea of Directive #7: Function at a High Operational Standard?

• Accountability

• Clear, regular, transparent reporting

• Prudent use of resources

• Appropriate competencies

• Clear governance policies/procedures

What governance areas should have clear policies under Directive #7?

• Governance documents

• Policies/procedures

• Conflict of interest

• Dispute resolution

What are the 7 Directives in order?

1. Community-Driven, Nation-Based

2. Increase First Nations Decision-Making and Control

3. Improve Services

4. Foster Meaningful Collaboration and Partnership

5. Develop Human and Economic Capacity

6. Be Without Prejudice to First Nations Interests

7. Function at a High Operational Standard

What are the CIHR Guidelines for Health Research Involving Aboriginal People?

• Ethical guidelines for research involving Aboriginal people

• Promote culturally competent and ethical research

• Respect Aboriginal values and traditions

• Encourage mutually beneficial research partnerships

What currently governs research involving First Nations, Inuit and Métis Peoples in Canada?

• TCPS Chapter 9

• Research must also respect community-specific research codes/practices

What was the main purpose of the CIHR Guidelines?

• Promote health through ethical research

• Ensure research respects Aboriginal values/traditions

• Encourage culturally competent research

• Develop mutually beneficial partnerships

Who developed the CIHR Guidelines?

• CIHR Ethics Office

• CIHR Institute of Aboriginal Peoples' Health

• Developed collaboratively with Aboriginal partners

What group did CIHR establish in 2004?

• Aboriginal Ethics Working Group (AEWG)

• Helped develop research ethics guidelines for Aboriginal people

How do the CIHR Guidelines understand health?

• Broader than physical/mental/social well-being

• Includes spiritual well-being

• Cultural well-being

• Community well-being

• Environmental well-being

Why were special ethical guidelines needed for Aboriginal health research?

• Historical research sometimes harmed Aboriginal peoples/cultures

• Research often failed to respect Aboriginal knowledge and values

• Need to prevent further harm

• Need to recognize Aboriginal ways of knowing

• Need for community control and participation

Why is community consent important?

• Aboriginal knowledge/decision-making can be collective

• Community has right to decide whether research is in its best interest

• Community consent may be required before seeking individual consent

Does community consent replace individual consent?

• No

• Community consent may be required first

• Individual participants must still give free, prior and informed consent

What is meant by protecting Aboriginal ethical space?

• Respect Aboriginal and researcher perspectives/values

• Maintain ongoing dialogue throughout research

• Continually consider whether research practices are ethical

• Begins before research design and continues through dissemination

What is Article 1?

• Understand and respect Aboriginal world views

• Respect responsibilities connected to traditional/sacred knowledge

• Include these responsibilities in research agreements when possible

What is Article 2?

• Respect community jurisdiction over research

• Communities may control/manage research involving them

• Researchers should follow community rules, policies and procedures

What is Article 3?

• Communities should have the option of participatory research

• Community members should be active research partners

• Not simply passive research subjects

What does participatory research involve?

• Community involvement throughout research

• Formulating research projects

• Developing methods

• Determining outcomes

• Interpreting results

• Disseminating results

What should genuine research collaboration be based on?

• Partnership

• Mutual trust

• Cooperation

• Meaningful community participation

What is Article 4?

• Consult community leaders when research involves traditional/sacred knowledge or community members as Aboriginal people

• Obtain community consent before approaching individuals

• Still obtain free, prior and informed individual consent

What should researchers do before beginning research with an Aboriginal community?

• Consult appropriate community authorities

• Negotiate a research agreement

• Obtain necessary community approval

• Respect community ethics guidelines/processes

Why are research agreements important?

• Clarify researcher and community responsibilities

• Protect community interests

• Address use of knowledge/data

• Establish expectations before research begins

What should happen if research involves traditional or sacred knowledge?

• Respect Aboriginal world views

• Recognize responsibilities attached to the knowledge

• Discuss how knowledge will be protected

• Address protection in the research agreement

Why should researchers consider intellectual property rights?

• Indigenous knowledge could be commercialized or misappropriated

• Research agreements should address how traditional/sacred knowledge will be protected

What is Article 9?

Research should benefit the community as well as the researcher

What is benefit sharing?

• Research outcomes should benefit participating communities and/or community members

• Benefits should not go only to researchers

What is Article 10?

• Support education and training of Aboriginal people

• Includes research methods

• Includes research ethics

• Build community research capacity

What is Article 11.1?

• Learn about Aboriginal cultural protocols

• Apply protocols relevant to the participating community

What is Article 11.2?

• When reasonably possible, translate research materials into the community's language

• Includes publications, reports and other relevant documents

What is Article 11.3?

• Maintain ongoing communication with the community

• Communication should be accessible

• Communication should be understandable

What is Article 12.1?

• Respect individual/community rights over research data

• Respect rights over biological samples

• Recognize community and individual proprietary interests

What is Article 12.2?

• Data/biological samples cannot be transferred to a third party without consent

• Consent required from the other original party/parties

What role should Aboriginal communities have in research?

• Active participants/partners

• Input throughout research process

• Control over research affecting their communities when appropriate

• Not merely passive research subjects

What should researchers respect when conducting research in Aboriginal communities?

• World views

• Cultural protocols

• Traditional/sacred knowledge

• Community authority

• Community consent

• Individual consent

• Rights over data/samples

• Community needs and benefits

What are the major ethical themes of the CIHR Guidelines?

• Respect Aboriginal world views

• Community control

• Participatory research

• Community + individual consent

• Privacy/confidentiality

• Protection of cultural knowledge

• Intellectual property rights

• Benefit sharing

• Education/capacity building

• Ongoing communication

What is the key difference between the old CIHR Guidelines and current policy?

• CIHR Guidelines = used from 2007–2010

• No longer CIHR funding policy

• TCPS Chapter 9 now governs this research

• CIHR Guidelines helped form the foundation for Chapter 9

What is the overall takeaway from the CIHR Guidelines?

• Research should be done with Aboriginal communities, not simply on them

• Respect community authority, culture and knowledge

• Ensure meaningful participation

• Obtain appropriate consent

• Research should provide mutual/community benefit

What is Article 5 about?

• Anonymity

• Privacy

• Confidentiality

• Individual and community concerns must be respected

• Address in research agreement

What if anonymity or confidentiality cannot be guaranteed?

Clearly explain limitations to participants

Can an Aboriginal community choose whether it is identified in research?

• Yes

• May remain anonymous

• Or request recognition for participation

What is Article 6 about?

• Research agreement should address use of cultural/sacred knowledge

• Community knowledge holders should provide guidance

Who should guide decisions about cultural/sacred knowledge?

Community knowledge holders

What is Article 7 about?

Aboriginal people/communities retain inherent rights to:

• Cultural/sacred knowledge

• Cultural practices

• Traditions

What must researchers disclose if research has commercial connections?

• Explicit commercial objectives

• Direct/indirect commercial links

• Disclose during free, prior and informed consent

Why can publication create risks for Indigenous knowledge?

• Knowledge may later be commercialized

• Knowledge may be misappropriated

What is Article 8 about?

• Protect Aboriginal cultural/sacred knowledge

• Appropriate use/protection should be addressed in research agreements

What are examples of benefits under Article 9?

• Benefits should be understood from community perspective

• Can be tangible

• Can be intangible

What should researchers do when reasonably possible under Article 10?

• Train community members

• Build research capacity

• Employ community members where possible

What is an example of a cultural protocol under Article 11.1?

• Culturally appropriate gift when seeking knowledge/advice from an Elder

• Protocols vary between communities

Why must researchers learn local cultural protocols?

• Protocols differ between communities

• Do not assume all communities have the same customs

What is Article 12 mainly about?

• Data and biological samples

• Ownership/proprietary interests

• Transfer

• Secondary use

• Privacy/confidentiality

What approach to ownership of data/samples is recommended?

• Co-ownership between researchers and communities

• Depends on community views/research agreement

What if a third party wants to use transferred data/samples for another purpose?

• Further consent required

• Privacy/confidentiality must be addressed

What is the key rule for secondary use of data/biological samples?

• New consent generally required

• Unless secondary use was already agreed to

Do individuals retain access to data about themselves?

• Yes

• Individuals retain right to access their own data

Can individuals request withdrawal/disposal of their biological samples?

• Generally, yes

• If samples have not been destroyed/anonymized

• Subject to research agreement/law

What should happen with existing tissue banks?

• Consult community and individuals

• Determine conditions for future research use

What is Article 12.5?

Secondary use requires Research Ethics Board (REB) review

What is Article 13?

• Biological samples considered “on loan” to researcher

• Unless research agreement states otherwise

What does “on loan” mean for biological samples?

• Researcher does not automatically own samples

• Terms should be stated in research agreement

What is Article 14?

• Community should participate in data interpretation

• Community should review research conclusions