Research Integrity Dr. Hilary Tierney, SRESC with thanks to Dr. - - PowerPoint PPT Presentation

Research Integrity

• Dr. Hilary Tierney, SRESC

with thanks to Dr. Carol Barrett MU Research Development Office

research.ethics@mu.ie

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Trust & Credibility

The trust of the public, professional colleagues, those who commission and fund research and those being studied requires an effective system of ethical review, clear lines of responsibility and a manageable degree of independent

• verview.

(Iphofen, 2011: p.5)

Iphofen, R. (2011) Ethical Decision Making in Social Research: A Practical Guide, New York: Palgrave

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Research Ethics & Research integrity Policies

Responsibility To you To Participants

Your responsibilities Best practice Ethical approval

Human Participants The Right to…

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Maynooth University Committees

Biomedical and Life Sciences Ethics Sub Committee NUIM Ethics Committee Social Research Ethics Sub Committee

Rolling & Monthly reviews – 3 tiers

Surveys Interviews Data access Observation

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Sources & Resources

MU Research Ethics Policy (2016) MU Research Integrity Policy (2016) Research Ethics page https://www.maynoothuniversity.ie/research/research- development-office/research-ethics Social Research Ethics Sub-committee page https://www.maynoothuniversity.ie/research/research- development-office/ethics/social-research-ethics-sub-committee- sresc

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Three Tiers of Approval

All MU staff, PhD and M.Litt. students, are required to complete ethical review prior to data collection.

• Tier 1 - rapid review of routine or non-contentious

applications (2-3 weeks). Separate Form*

• Tier 2 - expedited review of proposals that may have been

approved elsewhere (as in collaborative studies) or have few contentious or non-standard aspects (3-4 weeks).

• Tier 3 - standard review for proposals that require greater

scrutiny (8+ weeks)

• Specific criteria for each Tier

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Tier 1 appropriate for Research [SRESC] …

• …conducted in an established third level educational setting,

involving a researchers own normal/routine educational practices (Staff)

• ….involving adults (with the exception of those identified as

vulnerable) where the topic is of a non-sensitive nature and data are collected in a manner that participants cannot be identified (i.e. subjects enjoy complete anonymity, no personal details taken or held). Surveys, and/or some observational studies.

• ….. involving the collection or study of existing data,

documents, and records if these sources are publicly available and participants originally consented to the use of their data for research purpose.

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Tier 2 appropriate for Research [SRESC] …

• .. involving adults (excluding vulnerable adults) in non sensitive nature where

the research subjects may be identified either directly or through a key/indicators linked to subjects. This includes surveys, interviews and/or

• bservational studies.
• … involving adults (vulnerable*) involving non-routine but standardised

educational or psychological testing, in which the anonymity of participants is guaranteed.

• In receipt of ethical approval from a recognised health-care centre or
• hospital. If no research is to be carried out at Maynooth University,

applicants need only submit the hospital ethics application and approval

• letter. If projects include research elements at Maynooth University as well

as a hospital, the Maynooth University form should be completed and submitted together with the hospital ethics application and approval letter.

• A single renewal /extension or minor amendment of applications, with non-

substantive modifications to previously approved Tier 3 applications involving non vulnerable humans.

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Tier 3 required for Research [SRESC] …..

• children (excluding proposals exempted from full review under the

specific conditions described above)

• pregnant women as subjects.
• adults who may be deemed to be vulnerable in some way. Research

addressing sensitive issues, broadly defined.

• more than one phase/wave of data collection and/or involving high

respondent burden.

• induces affective arousal, physical stress or discomfort.
• potential exposure to harm or risk greater than that encountered in

normal life.

• deception or withholding of information.
• substantial revisions/renewals to previously approved Tier 3

applications (e.g. additional study groups, major additional

• bservation strategies).

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The Biomedical and Life Sciences Research Ethics Sub-Committee [BSRESC]

BSRESC reviews research projects that involve human participants, human derived material (e.g. blood and tissue samples), vertebrate animals and higher order invertebrate animals, genetically modified organisms (GMOs) and biohazardous materials, in order to ensure that the proposed research is ethically sound and does not present any risk of harm to research participants.

• Research Ethics Criteria

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Legal obligations

Freedom of Information Data Protection

• Information technology rules (India)
• EU data protection directive
• Personal data ordinance (Hong Kong)
• The Privacy Law (Australia)

Check Laws in a Territory

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Data Protection Act, 1988. 2003

• Collect personalised data for a SPECIFIC purpose only
• Know what kind of data falls outside of the Data Protection Act?
• Inform participants of the limits to confidentiality
• Know what action to take if data is stolen
• Inform participants of how the data will be managed

https://www.maynoothuniversity.ie/data-protection/data-protection-policy

General Data Protection Regulation (GDPR) compliance by end May 2018 – review of policies in MU - changes will come

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Data Protection Advice

• Remove from

camera, laptop, phone, recorder

Mobile device

• Back up to hard

drive

• Encrypt

Desktop

• Sign and date & Lock it up
• Remove identifiers use a

‘key’

• Keep ‘key’ and data separate

Paper

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The rights of your participants

• Respect
• Dignity
• Privacy

Rights

• Welfare
• Minimise harm
• Cultural

sensitivities

Protect

• Fully briefed
• Manner of

consent

• Autonomy

Consent

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The Rights of Animals

Regulation 3R’s

Authorisation

• Replace animals
• Reduce number
• Refine practices
• Health Products

Regulatory Authority

• Animal Welfare

Body

• Individual
• Project

authorisations awb@nuim.ie

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The Best Rule of Thumb

Inform Consent

Risk Benefit

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Risk/Benefit Analysis

What are the benefits of the research?

• Are the benefits to you
• To your participants
• To the wider community/society

What are the risks associated with the research/outputs?

• Are there any risks to the participants
• To the wider community/society
• To you

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Risk/Benefit Analysis

Assessing the risks

• Are you suitably trained to manage the subject matter/participants

with whom you will be interacting

• If you are not formally trained have you relevant experience
• Have you access to suitable trained/experienced personnel for

advice

• Have you a good working knowledge of other research practices for

this piece of research

• Are you working in the right environment? Is it the safest

environment for the participants?

• How do you protect the wider community, are there cultural

sensitivities?

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Risk/Benefit Analysis

Participant Selection

• Are you working with a vulnerable group and why? Is it because

you have access?

• Conflict of interest
• What specific considerations do you have to include depending
• n the vulnerability?

Mitigation against risk

• Detail potential routes to mitigate against each risk
• If you can’t mitigate against a particular risk to suitable level –

what are the benefits, do they make it worth taking such a risk?

• If there are no benefits you have to question why?

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When do I need to get approval?

Surveys Interviews Observation Animals Sampling

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MU Ethical Approval Submission Protocol (SRESC)

• 1. Tier (2/3)
• 2. Title
• 3. Researcher Information (incl.

supervisor)

• 4. Previous Ethical Approval (if

applicable)

• 5. Research Objectives (150 words)
• 6. Methodology (4 sections)
• 7. Participants (8 sections)
• 8. Vulnerable Persons (3 sections)
• 9. Risk/Benefit Analysis (3 sections)
• 10. Informed Consent (2 sections)
• 11. Follow Up
• 12. Data Management, Storage

and Retention (7 sections)

• 13. Professional Code of Ethics
• 14. Declaration

Annexes Project Information Sheet(s) Consent Form(s) Prior/other ethical approval Questionnaires Letters of Support if needed*

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Top Tips

• Start preparing well in advance of the submission deadline- proof read
• Answer ALL the questions
• Put your self in the readers’ shoes – use plain English
• Make sure the information in protocol and information sheet/consent

form are aligned and appropriate for context

• Address the ‘nuances’ of informed consent e.g. especially in multiple

engagements

• Think through and address vulnerabilities/risks/compliance issues
• Think through and address data handling/storage/security/destruction
• Ensure you include limits on confidentiality statement
• Check your annexes – is everything there?
• Don’t stress if you get asked questions or to make revisions – it’s all

part of the process

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How do I get approval?

Staff Research Masters/PhD students Undergraduates/Taught Masters Department Level

• Sensitive subject
• High Risk category
• Vulnerable groups

Research Ethics Committee

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Choose criteria for Tier 1 or BSRESC or SRESC Tier 2/3 Applications to research.ethics@mu.ie Letter of approval issued Secretariat liaises with applicant & committees regarding further information

Applicant

Email/ Letter sent to applicant Below acceptable standard for review Eligibility check Tiers 1 & 2 Rolling Submission Secretariat compiles feedback Tier 1 Rapid review Reviewed by Secretary/ Committee Chair 2-3 weeks Notify ref

• No. &

Tier Tier 2 Expedited review Reviewed by 2 members

• f SRESC or

BSRESC 3-4 weeks Tier 3 Submission for monthly closing date Tier 3 Standard Review Reviewed by full SRESC

• r BSRESC

6-8 weeks

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https://www.maynoothuniversity.ie/research/resea rch-development-office/research-ethics

research.ethics@mu.ie