Essential research ethics and the approval process

Dr Xiaoming Zheng

Chair, School of Dentistry and Health Sciences

Research Ethics Committee

17 March 2011

Objectives

By the conclusion of this lecture, students should be able to:

• identify ethical matters in research proposals

• identify and clearly describe

(a) any information needed from researchers and

(b) the reasons for that information

• be confident in submitting Minimal Risk projects to the School ethics committee or more than minimal risk to full CSU EHRC review.

Points for Discussion

• Why ethics approval is required for research involving humans?

• What are the guidelines on the human research ethics?

• What is the ethics approval process at CSU?

• Case studies• What I should do if I am going to submit

an ethics application?

Historical Context

• From 1870’s, medical research ethics: researcher - subject

• Since 1946 Nuremberg, international & national codes

• 1964 Helsinki, 1974 USA, 1976 Australia, 1982 CIOMS

• 1992 NHMRC: Research Guidelines• Unethical research examples continue

National Statement

• 1999 NS; AHEC• revision 2004• ToR for Working Party December 2003• Working party of NHMRC (AHEC), ARC and AV-CC June 2004• First consultation draft December 2004• 178 submissions - about 1000 pages• Second consultation draft – January 2006• 186 submissions - 1120 pages• Endorsed and released March 2007• Training sessions rolled out latter half 2007

National Statement

• With approval of ARC, AV-CC & AHEC, approved by NHMRC Council March 2007

• Final version tabled in both houses of Federal Parliament 28 March 2007

• Institutions to report against it from 1 January 2008

• Transition period for information, promotion and preparation for institutional compliance

• National “road show” August 2007

National Statement

User guidePreamblePurpose, Scope and LimitsSections:1 Values and principles of ethical conduct2 Themes in research ethics: risk and consent3 Ethical considerations specific to research

methods or fields4 Ethical considerations specific to participants5 Processes of research governance and ethical

review

National Statement - preamble

Ethical background

Historical context of ethics & of research ethics

Ethical justification for national guidelines

Research governance

National Statement - purpose

To promote ethically good research, i.e.research

• in which participants are accorded the respect and protection that is due to them, and

• that is of benefit to the community

National Statement – scope

• Broad definition of research

• Drawn from the UK Research Assessment

Exercise (2005)

• Same as used in the Australian Code for

Responsible Conduct of Research, (NHMRC,

ARC, UA, 2007)

Human research

Human research = research that involves humans through:

• Surveys, interviews etc• Psychological, physiological or medical testing• Being observed• Use of personal documents• Collection or use of tissue samples• Access to their information

Limits: ethics and law

• Australian law governs research through statutes, common law and contracts

• Advice about compliance with legal obligations not in scope of NS

• Some Commonwealth legislation specific to research is identified – not State/Territory laws

• Responsibilities in NS intended to be consistent with international human rights instruments Australia has ratified

• Responsibility of institutions and researchers to be aware of relevant legal obligations

National Statement - legal status

• Issue of NS fulfils NHMRC statutory obligation to issue ethical guidelines on medical research involving humans

• Also provides guidelines for other human research

• No intrinsic force from Parliament tabling

• Given statutory force by legislative reference, e.g Therapeutics Goods Act & regulations

• Given contractual force by public research funding grants

• Conformity may be part of institutional policy

• Probable source of standard of reasonable care in ethical conduct & review of human research

Principal Values

Four principle values: • Research merit and integrity• Justice• Beneficence• Respect for human beings

Apply to all human research

Types of Research

Qualitative methods• Databanks• Interventions and therapies, including clinical

and non-clinical trials and innovations• Human tissue samples• Human genetics• Human stem cells

Types of Participants

• Women who are pregnant and the human foetus• Children and young people• People in dependent or unequal relationships• People highly dependent on medical care who may be

unable to give consent• People with a cognitive impairment, an intellectual

disability, or a mental illness• People who may be involved in illegal activities• Aboriginal and Torres Strait Islander peoples• People in other countries

Specific guideline

3.3.3 Researchers should show that:(a) the research is directed to answering a specific

question or questions

reflects general principle that:1.1 research that has merit is(a) justifiable by its potential benefit . .

and expresses value that . .“Unless proposed research has merit and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable.”

Specific guideline

4.3.4 People in (dependent relationships) are vulnerable to being over-researched because of the relative ease of access to them as research populations. Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as research participants

reflects the general principle that1.4 In research that is just:

(c) there is no unfair burden of participation in research on particular groups

and expresses the value thatJustice involves a regard for the human sameness that

each person shares with every other.

Specific Guidelines

Value that . . “Researchers exercise beneficence in several ways: in assessing and taking account of the risks of harm and the potential benefits of research to participants and to the wider community;”

is expressed in general principle that . .1.7 Researchers are responsible for:

(a) designing research to minimise the risks of harm or discomfort to participants

and a specific guideline that:3.1.11 Where possible, participants should be informed

about any potential to be identified in results of research even if identifiers, such as name and address, are removed.

Specific Guidelines

Value that“recognising that each human being has value in himself or herself, and that this value must inform all interaction between people.”

is expressed in general principle that:1.10 respect for human beings involves giving due scope,

throughout the research process, to the capacity of human beings to make their own decisions

and the specific guideline that:4.2.6 researchers should be attentive to the developmental

level of children and young people when engaging them in understand the nature and likely outcomes of research

Institutional responsibilities

Research governanceProcesses for ethical reviewLegal protection of those involved in ethical review of researchOversight and review of ethical review proceduresResearch involving no more than low riskResearch that can be exempted from review

Institutional Ethics Committee

HRECs: research involving more than low riskestablishmentcompositionappointment of membersHREC procedures

CSU: Minimal Risk Review Process

Low Risk Review

CHARLES STURT UNIVERSITY ETHICS IN HUMAN RESEARCH COMMITTEE Minimal Risk Review Checklist

• Please complete the checklist below to ascertain whether your research project would be eligible to be submitted to your School’s Ethics in Human Research Committee (SEHRC) for ethical review as a minimal risk research. Student researchers must review the completed checklist with their supervisors. If you answer “YES” to any items in the checklist your project would normally not be eligible for submission to the appropriate School Ethics Committee for review (unless you can make a special case – refer section 6) and you should complete an ethics application form (Form 1) and email it to ethics@csu.edu.au for review by the Ethics in Human Research Committee.

• Timing constraints are not an acceptable reason for seeking expedited review through this process where projects are of more than everyday risk.

• PROJECT TITLE• CHIEF INVESTIGATOR• Name (Title/ given name / family name)• Student No (if applicable)• School/Research Centre/ External Organisation (of Chief Investigator or

supervisor)• Level of Study (eg Undergraduate practicum/clinical research project, Honours

research project, postgraduate Masters or PhD) CourseSubject Title and Code

Common mistakes

• Research students submit their application without consulting their supervisor. Students need to be informed of the need for ethics applications to be reviewed by more senior researchers prior to their submission. Supervisors DO have the responsibility to help the student complete the EHRC Application Form

• Acronyms are used without suitable explanation.

Common mistakes

• All sections of the application form are not addressed. All sections require responses. In some instances the answer is a simple ‘NO’. The question requires a response, however. Often the questions left unanswered DO reveal to the committee a lack of understanding or lack of awareness on behalf of the researcher, of ethical issues raised by the researcher’s project

• The section relating to the involvement of indigenous persons and persons whose first language is not English requires a written explanation. Although such persons may not be targeted in the research, it is possible that some may be included in the sample. If there is no issue within the research that targets these populations, a simple statement relating to this fact should be provided.

Common mistakes

• Sections of the EHRC application form are pasted from other documents relating to the research (eg. Proposal documents, applications from funding). While this activity is tempting, it is important that the EHRC receives information that is directed at its decision-making processes. [In a number of instances there is too much detail on research design and literature background. In some cases there is no reference to literature to support the project and/or methodology. Information provided needs to be minimum but sufficient.]

• Consent forms and information forms need to be ‘project personalised’

Case Studies

• Survey questionaries• Use music to reduce stress• Clinical trials (medical devices, tooth brush)• Research vs teaching• Consent ages

Any Questions?