Ethics and Regulatory Approvals

Alison RobertsonCMDHB Research Officer

Ethics committee membership

• The committee is a mixture of both specialists and lay people that have no vested interest in the trial but ensures the safety of the participants

Each clinical trial, study, audit or observational project in which

results will be published or may change clinical practice requires

ethical approval.

http://www.ethicscommittees.health.govt.nz

ETHICS REQUIREMENTS

PREPARATION

• All trials require a protocol

• Once the protocol is written it makes filling out the forms easier

The Principal Investigator is totally responsible for all

aspects of any trial despite delegating tasks and authority.

A REMINDER

Good Clinical Practice - GCP• What is GCP?

– International ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects

• Why is it needed?– To ensure that the RIGHTS, SAFETY and

WELLBEING of the trial subjects are protected– Ensure the CREDIBILITY of clinical trial data

• Why has it developed into formal guidelines?– Public disasters, serious fraud and abuse of human

rights

I don’t know what process I need to go through for my particular trial

I don’t know what forms I need to fill in.

HELP!

RESEARCH OFFICER

Alison Robertson

Ethical Review Categories

• Audit / observational studies which require expedited review

• Full application for all other projects

Expedited Review

Audit / Observational studies

Non-interventional

Full ethical approval

Involving human participants or volunteers in which• Compares an established procedure with other

procedures that are not regarded as established • involves access to personal information for

purposes other than direct consumer care or clinical audit

• seeks to further scientific or professional knowledge by means of questionnaires, interviews or other techniques of information gathering, or by means of laboratory analysis of human blood or tissue from living people, cadavers, or discarded body tissue

• is conducted by a government department, except where a statutory exclusion applies (e.g. Statistics New Zealand)

• is observational research or a physiological study • is a clinical trial • involves the use of radiation, organ imaging or surgical

technique • involves innovative practice • is a new treatment or intervention which uses pain or

deprivation of basic food or drink as a means to change behaviours.

MAAORI RESEARCH REVIEW COMMITTEE (MRRC)

• All studies requiring full ethical review also need approval from the CMDHB Maaori Research Review Committee

• The final approval letter is included in the ethics application

• 1st Wednesday each month, sent in by midday of the prior Thursday

Other forms not included but maybe required for full approval

• Locality assessment

• Part 5 if taking tissue (blood,saliva,skin)

• Part 6 if genetic studies

• Part 7 if xenotransplantation

• Part 8 participants unable to consent for themselves

REGISTRATION PROCESS

All projects must be registered with the Research Officer prior to sign off of any documentation.

This is a simple

procedure.

On South Net press the button labelled Research (left). This links to the Research approval site where there is access to the portal for registration.

• Enter the simple details required and a number will be issued that is unique to the project. Attach this to your Locality Assessment (required for ethical approval) when requesting the GM to sign it

• The Research Officer is then emailed with your details and can contact the Investigator when necessary

REMEMBER

• Have all your forms, signed documents and letters of MRRC approval ready

• Find out the meeting times, agenda dates and each committees requirements.

AVOID• Writing in the first person, e.g.

instead of “we think” write “the expectation is”.

• Documenting how you received a top grade in a qualification for this project idea.

CMDHB RESEARCH APPROVAL

DOCUMENTS REQUIRED

Copy of the signed Locality Copy of signed Part IV Ethics letter of approval Budget attached MRRC letter of approval Copy of the national ethics application or a two page summary about the research project

RESEARCH OFFICE

Once you have all your documents completed, send them to the Research Office to arrange final sign off and issuing of the CMDHB Research Committee approval letter:

Research Office

Support Building – Room 132

ANY QUESTIONS?

CMDHB Research Officer

Alison RobertsonEXT 9124

(021) 943 784