Researching - MNCLHD · Researching Human Research Ethics & Governance Processes . What is Human...

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Mid North Coast Local Health District (MNC LHD) Researching Human Research Ethics & Governance Processes

Transcript of Researching - MNCLHD · Researching Human Research Ethics & Governance Processes . What is Human...

Mid North Coast Local Health District (MNC LHD)

Researching

Human Research Ethics & Governance Processes

What is Human Research? Human Research is conducted with or about people, or their data or tissue. Participation in Human research: • surveys, interviews, focus groups • testing or treatment • observed • access to personal documents / information • Collection and use of boy organs, tissues or fluids • Impact on the lives of both the participants those are not participants

What is Quality Assurance? Quality improvement / assurance activities may raise ethical issues requiring review. Individuals engaged in these activities in the NSW public health system should refer to the NSW Health Guideline:

Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW (GL2007_020)

The Overlapping Model

Research overlaps Quality Improvement

Research ‘increasing knowledge’

Quality Improvement

‘improving health care’

Apply Research Governance

Apply Clinical Governance

Steps in Research

NEAF (Ethics)

SSA (Governance)

PROJECT

Step 1: The research approval process • All research involving humans is subject to ethical review.

• All research proposals must be submitted on the National Ethics

Application Form (NEAF) for review by an Ethics Committee

• The Ethics review ensures that research applications comply with the National Statement on Ethical Conduct in Human Research (National Statement - 2007) which was recently updated in March 2014.

Values and principles of ethical conduct include:

• Research merit and integrity • Justice • Beneficence • Respect

• The Ethical review also gauges Risk

All research applications require the Research Governance Officer to consider the following:

• Ability for the site to conduct the research • The benefits for the PHO, do these outweigh Risks? • The risks to PHO. • Resource implications both human and financial. • HREC approval – appropriate committee, conditions attached? • CVs relevant to the project. • Students supervision. • Documents implemented are the latest approved version- footer

information provides future document sequencing. • Recommendation to CE or delegate

Step 2. Governance Authorisation Process

Other functions of the Governance role:

• Monitoring ongoing trial activity through progress reports, COC, SAEs, protocol violations, correspondence

• Review and authorise amendments

• Manage complaints

• Monitor SAEs and SUSARS

• Maintain AURED

• CTRA, Indemnity, CTN

Ethics – Low Risk

The National Statement of Ethical Conduct in Human Research 2007 - updated December 2013 describes research as “low risk” where the only foreseeable risk is one of discomfort. Discomforts may include minor side-effects of medication, discomforts related to measuring blood pressure or anxiety induced by an interview. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

The National Statement of Ethical Conduct in Human Research 2007 - updated December 2013 describes research as “negligible risk” where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience to the participants. Inconvenience is the least form of harm that is possible for human participants in research. The most common examples of inconvenience in human research are filling in a form, participating in a survey or giving up time to participate in a research activity. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.

Ethics – Negligible Risk

Examples of research with low and negligible risk include: • Questionnaires and general surveys on non-controversial, non-personal

issues

• The use and/or disclosure of information from existing data collections

• Human tissue where participant consent is not required because broad consent has been provided for use of the tissues in research and specific individuals cannot be identified from specimens used

• Requiring access to individual medical records or to information stored electronically

Research that is not eligible for low or negligible risk review: • Interventions and therapies, including clinical and non-clinical trials and

innovations or new treatment modalities

• Active concealment or planned deception of participants

• Exposure of illegal activities

• Research specifically targeting Aboriginal or Torres Strait Islander peoples.

Research projects that include any of the following are not eligible for low or negligible risk review, except where the research uses collections of non-identifiable data and involves only negligible risk: • Human genetics; • Human stem cells; • Women who are pregnant and the human foetus; • People who are highly dependent on medical care who may be unable to give

consent; • People with a cognitive impairment; • People with an intellectual disability or a mental illness; and • People who may be involved in illegal activities. In addition, research projects involving people with sexually transmissible infections or blood-borne virus infections are not eligible for low or negligible risk review, except where the research uses collections of non-identifiable data and involves only negligible risk.

Accessing Medical Records etc……

NSW Health Privacy Manual (Version 2) 2005: http://www.health.nsw.gov.au/policies/pd/2005/pdf/PD2005_593.pdf 3.1 Who is bound by the manual? 3.5 What health staff and service providers have a right to expect? 4.1.1 Health Administration Act 1982 11.2.4 Management, training or research 15.14.4 Access to data collections

NORTH COAST NEW SOUTH WALES HUMAN RESEARCH ETHICS COMMITTEE

(NCNSW HREC)

Covering the Northern New South Wales Local Health District (NNSW LHD)

and Mid North Coast Local Health District (MNC LHD)

The NCNSW HREC is constituted and operates in accordance with the National Health and Medical Research Council’s

National Statement on Ethical Conduct in Human Research (National Statement – 2007 – updated March 2014).

A list of all NSW Health Ethics Committees is available from: http://www.health.nsw.gov.au/ethics/Pages/hrec.aspx

Dr David Hutton

Chair – Clinical Research Knowledge / experience of professional care (Medical)

Mr Paul Corben

Chair – Non-Clinical Research Current research experience (Public Health)

Mr Greg Bell Knowledge/experience of professional care (Public Health) Mr Thomas Reynolds Layman Dr Nicola Jayne Laywoman (Knowledge of Statistics) Mr Sean Kearns Lawyer Rev Peter Richards Pastoral Role -Minister of Religion Mr John Whiteford Knowledge/experience of professional care (Pharmacist) Ms Debbie Deasey Current research experience

Knowledge / experience of professional care (Nursing & Midwifery) Dr Graeme Browne Current research experience

Knowledge / experience of professional care (Nursing & Midwifery) Dr Greg Fairbrother Current research experience

Knowledge / experience of professional care (Nursing & Midwifery) Dr Hudson Birden Current research experience

Knowledge / experience of professional care (Public Health) Ms Mandy Hubbard Current research experience

Knowledge / experience of professional care (Hospital Scientist/Public Health) Ms Nyomie Johnson Current research experience

Knowledge / experience of professional care (Nursing & Midwifery/Clinical Trials) Ms Rosa Flaherty Current research experience

Knowledge/experience of professional care (Psychology / Child Protection) Ms Susie Malady Lawyer

Knowledge/experience of professional care (Nursing & Midwifery) Ms Cassandra Rupnik Knowledge/experience of professional care (Health Information Management/Privacy Matters) Ms Janine Holston Executive Officer

NCNSW HREC - Membership

Preparing for Submission of an Ethics Application The NEAF & LNR NEAF Forms are available on the online forms website. A covering letter

Document version number and date Site Specific Information and Consent Documents - based on a Master. Data Storage and Retention

Use the Ethics Application Submission Checklist, on the NEAF, to ensure

your application is complete prior to submission

Contact the relevant Research Ethics Officer prior to submission of your application

How are the forms accessed?

The NEAF /LNR NEAF and the SSA forms are available from the Online Forms site: http://www.ethicsform.org/au/SignIn.aspx

Supporting documents (examples): • Protocol / Study Plan/Proposal

• Participant Information Sheet/s

• Consent Form/s or Assent Form (for children)

• Data Collection Tools

• Questionnaire / Survey

• Semi Structured Interview Questions

• CTN / CTX (for clinical trials only)

• Tips:

• Lay language – Australian terminology • Gender – instead of Sex • Age Bands/Groups – not DOB or ages • Version Number and date in footer – of very document

NCNSW HREC meetings are held monthly (10 meetings per calendar year – February to November) and applications must be received by the Executive Officer by the submission closing date. Submissions to NCNSW HREC require one (1) original (file copy) plus eighteen (18) copies (total 19) printed double-sided, stapled or clipped together in the top left corner and 2 hole punched. Please do not use plastic sleeves or binders. Applications should be sent to:

NCNSW Human Research Ethics Committee PO Box 821 Murwillumbah NSW 2484

Electronic copies (of all documents) should also be sent to: [email protected]

After the meeting Advice will be forwarded, in writing, to the Principal Investigator (and Contact person if different) from the NCNSW HREC in regards to the decision / outcome of your project submission as soon as possible after the meeting date. • Approval • Approval – subject to • Amendment / Clarification / further information After final approval - Reporting / Amendments • Annual progress • A completion report NO research is to be undertaken until both Ethics approval and Governance (SSA) authorisation has been granted.

Preparing a Research Governance or Site Specific Assessment (SSA) application Why?

The Site Specific Assessment (SSA) form

Complete the SSA Submit the SSA to the RGO - with all supporting documentation

SSA Application Submission Checklist

Contact the relevant Research Governance Officer if you have any

questions – prior to submission of your application

Access request – when can it be used? Access request review may be used if the project involves one or more of the following activities at the Public Health Organisation: Participant recruitment through posters, leaflets, handouts and letter of

invitation but not recruitment through direct contact with potential participants or enrolment;

Distribution of surveys and questionnaires through staff of the Public Health Organisation but not collation and analysis of responses at that Public Health Organisation; and

Access to data or tissue held at the Public Health Organisation but not processing or analysis at that Public Health Organisation.

The Research Governance Officer has the discretion to request that the application is submitted for site specific assessment if they consider that the project involves the conduct of research at a site.

Complete SSA applications only will be accepted and can be forwarded electronically ie: via email to: Mid North Coast LHD - Research Governance Officer (Mondays and Tuesdays): Ms Maureen Lawrence

C/- Administration Kempsey District Hospital River Street Kempsey NSW 2440 Phone: 042 888 2170 Email: [email protected]

All documents with original signatures should also be forwarded to the Research Governance Officers in hard copy – especially Clinical Trial documentation.

After submission of the SSA:

The Review or Assessment Process • It should be noted that NO research is to be undertaken until both

Ethics approval and Governance (SSA) authorisation has been granted. Authorisation

• Authorised / Authorised with Conditions / Not Authorised Ongoing responsibilities / monitoring

• The Principal Investigator is responsible for ensuring that all updates to the study/project are forwarded to the Research Governance Officer

After submission of the SSA:

The Review or Assessment Process • It should be noted that NO research is to be undertaken until both

Ethics approval and Governance (SSA) authorisation has been granted. Authorisation

• Authorised / Authorised with Conditions / Not Authorised Ongoing responsibilities / monitoring

• The Principal Investigator is responsible for ensuring that all updates to the study/project are forwarded to the Research Governance Officer

For researchers external to the Local Health Districts: You may also be requested to provide additional documents prior to your SSA being accepted for review ie:

Privacy Undertaking Statement – Signed and witnessed

Signed declaration of NSW MoH Code of Conduct

Provision of two (2) items of colour photo identification – (to be scanned

and forwarded in electronic format) to the relevant Governance Officer eg: Student ID, Drivers License, Passport etc

Whilst not required in NNSW and MNC LHDs - some LHDs may also request you complete a Criminal Record Check Form

Resources: NNSW and MNC LHDs Human Research Ethics and Governance: http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/ NCNSW HREC: http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/the-north-coast-nsw-human-research-ethics-committee/ Preparing an Ethics application: http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/preparing-an-ethics-application/ Preparing a Governance application: http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/preparing-a-governance-application-ssa/ Resources/Forms: http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/resources-forms/ Human Research and Governance (intranet): http://int.nnswlhd.health.nsw.gov.au/clinical-governance/human-research-ethics-and-governance/ Quality Assurance/Improvement Activities (intranet): http://int.nnswlhd.health.nsw.gov.au/clinical-governance/human-research-ethics-and-governance/quality-assurance-activities/ Publications (intranet): http://int.nnswlhd.health.nsw.gov.au/clinical-governance/human-research-ethics-and-governance/publications/

NSW Ministry of Health (MoH) Research Ethics and Governance: http://www.health.nsw.gov.au/ethics/Pages/default.aspx Ethics Committees: http://www.health.nsw.gov.au/ethics/Pages/contacts_hrecs.aspx Research Governance Officers: http://www.health.nsw.gov.au/ethics/Pages/rgo-contact-details.aspx Office for Health and Medical Research: http://www.health.nsw.gov.au/ohmr/Pages/default.aspx Research Ethics and Governance FAQ’s: http://www.health.nsw.gov.au/ethics/Pages/faqs.aspx Research Ethics and Governance Policies: http://www.health.nsw.gov.au/ethics/Pages/re-and-g-policies.aspx Quality Improvement and Ethics Review: A Practice Guide for NSW: http://www0.health.nsw.gov.au/policies/gl/2007/GL2007_020.html Privacy Manual (Version 2) 2005: http://www.health.nsw.gov.au/policies/pd/2005/pdf/PD2005_593.pdf Patient Privacy: http://www.health.nsw.gov.au/patients/privacy/Pages/default.aspx Privacy Leaflet for Patients and Poster: http://www.health.nsw.gov.au/patients/privacy/Pages/privacy-leaflet-for-patients.aspx Privacy Information for Staff: http://www.health.nsw.gov.au/patients/privacy/Pages/privacy-information-for-nsw-health-staff.aspx

Other National Health & Medical Research Council: http://www.nhmrc.gov.au/ National Statement on Ethical Conduct in Human Research (2007) – updated March 2014: http://www.nhmrc.gov.au/guidelines/publications/e72 Online Forms site: www.ethicsform.org/au/SignIn.aspx NSW - Aboriginal Health & Medical Research Council: http://www.ahmrc.org.au/index.php?option=com_content&view=article&id=13&Itemid=12 NSW - Health Records and Information Privacy Act 2002 No 71: (Current version for 1 January 2014 to date): http://www.legislation.nsw.gov.au/viewtop/inforce/act+71+2002+FIRST+0+N/ Medicines Australia: http://medicinesaustralia.com.au/issues-information/clinical-trials/clinical-trials-research-agreements/ Therapeutic Goods Administration (TGA): http://www.tga.gov.au/index.htm