an introduction to the ethics review procedure lindsay unwin: research & innovation services,...

An Introduction to the Ethics Review

Procedure

Lindsay Unwin: Research & Innovation Services, UREC Secretary

Routes for ethics approval

1.1.University ethics review procedure University ethics review procedure (administered in each academic department)

2.2.Alternative ethics review procedure Alternative ethics review procedure (other HEIs/organisations)

3.3.Administrative research ethics Administrative research ethics review procedurereview procedure

4.4.NHS ethics review procedure/Social NHS ethics review procedure/Social Care Research Ethics Committee Care Research Ethics Committee (IRAS)

University ProcedureRemit:Remit:

• Research project (investigationto gain knowledge & understanding)

• Involves human participants or personal data

• Is led by this University• Takes place within the UK• Research involving NHS

staff or NHS premises

Remit:Remit:• Research conducted outside UK;

or

• Research led by another UK university/research organisation

BUT:BUT:

• The other procedure must be judged to be sufficiently robust by the UREC; if in doubt, apply if in doubt, apply University procedureUniversity procedure

Alternative Procedure

Administrative Procedure• Research undertaken in

administrative departments

• Reviewed by central UREC

• Student Services has its own procedure

NHS ProcedureRemit:Remit:

• Patients & users of the NHS(current or previous)

• Relatives or carers of NHS patients• Access to data, organs, other bodily

material of past or present NHS patients• Foetal material & IVF involving NHS patients

• Recently dead in NHS premises

NRES provide comprehensive guidance on the types of research that require NHS review

Social Care Research Ethics Committee (SCREC)

• Apply via NRES (as per NHS procedure)

Remit:

• Staff-led social care research projects in Staff-led social care research projects in which some or all of the human which some or all of the human participants are adults who lack the participants are adults who lack the capacity to consent for themselves;capacity to consent for themselves;

• Department of Health-funded staff-led Department of Health-funded staff-led social care research projects in which the social care research projects in which the human participants are adultshuman participants are adults

University ethics University ethics review procedurereview procedure

How to apply ?

Staff:

•Find relevant ethics application (dept. website/Ethics Administrator/online system)

•Fill in application

•Submit to Ethics Administrator

•Receive decision within 2 weeks

*Can also do generic applications (single application for several similar student projects)

How to apply ?

Postgraduate research students:

•Find relevant ethics application (dept. website/Ethics Administrator)

•Fill in application

•Submit to supervisor for sign-off

•Submit to Ethics Administrator

•Receive decision within 2 weeks

How to apply ?Undergraduate/postgraduate-taught students:

•Supervisor should help identify relevant ethics application

•Fill in application in consultation with supervisor

•Submit to supervisor

•Supervisor decides on risk level

•Low risk: supervisor reviews and gives decision

•High risk: supervisor submits to Ethics Administrator for review by 2 people: receive decision within 2 weeks

FOR ALL APPLICANTS:

MAY NEED TO REVISE AND RESUBMIT SO ALLOW TIME FOR THIS PROCESS!

What happens once I’ve submitted my application*?•Ethics Administrator identifies reviewers:

- Staff/PGR projects – 3 (not including supervisor for PGRs)

- Potentially high risk UG/PGT projects – 2 (usually supervisor +1)

(Potentially low risk UG/PGT projects – supervisor reviews)

•Reviewers provide comments and decision

•‘Lead reviewer’ forms a consolidated response

•Ethics Administrator confirms decision to applicant

*SPECIFIC ARRANGEMENTS VARY BY DEPARTMENT

Review process for UG/PGT

Student

Ethics administrator

2 reviewers (usu. supervisor +1)

Lead reviewer

Ethics administrator

Student

SupervisorLow risk

Supervisor review

Potentially high risk

Student

Ethics administrator

Review process for PGR/staff

Researcher

Ethics administrator

3 reviewers (not inc. supervisor)

Lead reviewer

Ethics administrator

If PGR - supervisor sign

off

Researcher

Ethics administrator

Outcomes of review procedure

• Approval = GO AHEAD!

• Approval with suggested amendments = GO AHEAD BUT CONSIDER SUGGESTIONS

• Approval with compulsory amendments = MAKE CHANGES AND RE-SUBMIT

• Approval with suggested and compulsory amendments = MAKE CHANGES AND RE-SUBMIT + CONSIDER SUGGESTIONS

• Not approved = BACK TO DRAWING BOARD

Issues for applicants to consider

Have I provided enough information (in lay language)?

What risks does the project pose & how will they be managed?

Is participant information appropriate for audience (no jargon, abbreviations etc)?

Is participant information appropriate for audience (no jargon, abbreviations etc)?

Does the project require special ethical consideration e.g. vulnerable people or sensitive topics?

Does the project require special ethical consideration e.g. vulnerable people or sensitive topics?

How will I seek informed consent?

How will I seek informed consent?

How will I protect participant’s confidentiality/ anonymity?

How will I ensure participant safety and well-being?

Principles: Safety and Well-beingPrinciples: Safety and Well-being

• Consideration must be given to potential for harm/distress

• Steps should be taken to minimise harm/distress (e.g. informing participants of possibility; providing help/support after participation)

• In some research (e.g. clinical trials), the researcher may need to knowingly cause harm BUT possible harm should be outweighed by the potential benefits

• Participants should be informed of procedures for contacting researcher if problems arise

• Safety/well-being of researcher should also be considered

Principles: Informed consentPrinciples: Informed consent

• Participants should be fully informed about reasons/method and be able to ask questions/reflect – INFORMATION SHEET?

• Participants should give free and voluntary consent, and not be coerced

• Consent should ideally be in writing or witnessed oral consent instead, although this may not always be appropriate – CONSENT FORM?

• Must have right to refuse to participate or withdraw

• Need consent for data to be used for secondary analysis;

• Special consideration should be given to projects where informed consent will not be sought

Principles: Anonymity, Principles: Anonymity, Confidentiality & Data Confidentiality & Data

ProtectionProtection• Must comply with Data Protection Act 1998

• Participants’ identities should not be disclosed without prior consent; data should be anonymised where possible

• Access to data that could identify individuals should be restricted to lead researcher(s) unless there is agreement from the research participants

• Participants should be informed of:

1. Any risk that confidentiality may not be maintained (eg disclosure of criminal activity);

2. Who will have access to data;

3. The purpose for which the data is to be used

Key points to take away • Each research project should be considered

on a case by case basis but there are key principles;

• Ethics review is about heightening risk awareness –not about preventing ‘potentially high risk’ research;

• Ethical review is about encouraging researchers tothink through potential ethical challenges;

• An ethically robust research project may stillencounter unexpected ethical challenges;

• Conducting research involving participants isnot an exact science-nor is the ethics review process

Put yourself in the participant’s shoes....

Further Guidance

Lindsay Unwin/Peggy Haughton

(Research & Innovation Services)

l.v.unwin@sheffield.ac.ukp.haughton@sheffield.ac.uk

www.sheffield.ac.uk/ethics