Obtaining Human Ethics Approval

Pipitea Human Ethics Committee

Guide to Completing the Application Form

Revised

January 2005

Introduction

University Guidelines

Why is ethical approval needed?

Risk management

Health Research

Requirement for Approvals

Other Definitions

General principles

Pipitea HEC Applications

Application fundamentals

Completing the Application Form

Information sheets and Consent forms

Information Sheets

Consent Forms

Good Research Practice

Turnaround

Introduction

At VUW the human ethics approval process is governed by the University’s Central Human Ethics Committee. The Pipitea Human Ethics Committee is a subcommittee of the University Committee. It is the University Committee that sets the guidelines by which University HEC approvals are obtained and dictates the forms required to be used for that approval.

The University Human Ethics Committee is accredited by Health Research Council Ethics Committee and as a result both it and the Faculty Committees are, in practice, constrained by HRC requirements on ethical approvals. However under the Health Research Act, there is no statutory requirement for non-health research to receive ethical approval.

University Guidelines

The University HEC issues a set of PolicyandGuidelines available in hard form and on the web at These should be read and complied with by all researchers seeking HEC approval. Paragraph references hereunder are to the Policy and Guidelines.

This information is not a substitute for the Policy and Guidelines and the Committee expects full familiarity with the Policy and Guidelines.

Why is ethical approval needed?

In the absence of a specific statutory requirement the question must be asked as to why non-health research requires ethical approval. The answer is that University has an obligation to ensure that research conducted under its auspices conforms to various statutory requirements. These include:

Privacy Act 1993
Education Act 1989
Human Rights Act 1993
New Zealand Bill of Rights Act 1990

Section 161(3) of the Education Act 1989 deals with academic freedom. The section requires that the University exercises that freedom consistently with the highest ethical standards.

Section 161 Academic Freedom

(1)It is declared to be the intention of Parliament in enacting the provisions of this Act relating to institutions that academic freedom and the autonomy of institutions are to be preserved and enhanced.

(2)For the purposes of this section, academic freedom, in relation to an institution, means

(a)The freedom of academic staff and students, within the law, to question and test received wisdom, to put forward new ideas and to state controversial or unpopular opinions:

(b)The freedom of academic staff and students to engage in research

(c)The freedom of the institution and its staff to regulate the subject-matter of courses taught at the institution:

(d)The freedom of the institution and its staff to teach and assess students in the manner they consider best promotes learning:

(e)The freedom of the institution through its chief executive to appoint its own staff.

(3)In exercising their academic freedom and autonomy, institutions shall act in a manner that is consistent with—

(a)The need for the maintenance by institutions of the highest ethical standards and the need to permit public scrutiny to ensure the maintenance of those standards; and

(b)The need for accountability by institutions and the proper use by institutions of resources allocated to them.

Risk management

The requirements for ethical approval are a legitimate part of the risk management strategy of the University. Failure to ensure that research conducted under University auspices complies with New Zealand law, including specific statutory requirements, could open the University to legal liability as well as damage the University’s academic and research reputation with long term consequences for the future of research activities. In the case of Pipitea HEC the major legal risk includes:

Complaints by individuals in respect of a breach of the Privacy Act in relation to personal information;
Civil liability for breach of contract, breach of confidence, defamation, negligence and the like if commercially sensitive information was disclosed.

Such actions, even if successfully defended, would be very costly.

The University as an academic institution has a responsibility to ensure all research is carried out in an ethically acceptable manner both for its own protection and for the protection of its employees and students.

Health Research

Health research is defined by the Health Research Act as follows;

“Health research means research that has or may have relevance to human health; and includes biomedical research and public health research:

Public health research means research into factors that influence the health of a population; and includes-

(a) Research into health systems and health services; and

(b) Research into the environmental, socio-economic, cultural, and behavioural factors that determine health status.”

It is unlikely that health research will be carried out thru Pipitea HEC unless it involves questions of health sector management or the like which involve research in a health organisation. In such cases it is almost certain that approval will be required from the relevant hospital ethics committees and this should be checked by researchers.

Requirement for Approvals

The University has decided that all research involving human subjects requires ethical approval: "Human subject" and "subject" mean any human participant, client, or informant, or any person or group subjected to experimental procedures, whether those individuals or that group is involved knowingly or otherwise.”

No research or teaching activity involving human subjects, or otherwise affecting people's privacy, rights and freedoms may proceed without human ethics approval. Failure to seek approval or to proceed without approval may result in disciplinary sanctions under the policies on staff and student misconduct.

It is the responsibility of course organisers and principal researchers or research supervisors to gain HEC approval and to ensure that required ethical standards are maintained.

Students are expected to make their own applications for ethical approval after consultation with their academic supervisors.

Approval is not needed in the following situations:

For preliminary interactions or discussions
For interviews seeking factual non-sensitive information
For research involving publicly available information

“Publicly available information” includes information that is public or is available to the public, if not actually released, or is discoverable under the Official Information Act or other statute by persons other than the subject themselves or their guardians”

Additionally the Policy [see para 4.7 for the full requirements] allow some questionnaires to be approved by a Head of School. Such questionnaires must be:

Totally anonymous
Deal with non-sensitive questions

Other Definitions

In preparing a Pipitea HEC application you should take particular note of the following definitions as they will be of particular importance in the Committee’s assessment.

"Personal information" means information about an identifiable individual

Rights under the Privacy Act relate to identifiable individuals (ie is human persons) and the Committee is particularly concerned to ensure that research (including data storage) fully conforms to the requirements of that Act.

“Sensitive information” includes private personal information that is not publicly available (e.g. personal income, sexual practices, drug taking, illegal activities), and commercial information supplied in confidence.

In the Pipitea HEC context a major concern will be that commercial and legal information supplied in confidence remains confidential. The failure to ensure this could open both the University and researchers to significant legal liability. Generally the Committee would expect standards similar to those required by the Privacy Act to be applied.

General principles

The following should be carefully noted as the general statement of principles applying to human research: taken from the Guidelines [para 2]

(a)informed consent free of coercion;

(b)respect for rights of privacy and confidentiality, in conformity with the Privacy Act 1993

(c)minimisation of risk of harm to the subject;

(d)limitation of deception;

(e)social and cultural sensitivity, including acceptance of the principles of the Treaty of Waitangi;

(f)research and teaching merit;

(g)avoidance of conflict of interest;

(h)respect for property rights;

(i)no discrimination which breaches the Human Rights Act 1993 or the New Zealand Bill of Rights Act 1990;

(j)special care taken of vulnerable participants (eg children).

The Committee will be particularly vigilant in ensuring the application of these principles. It should be noted that the Committee’s brief includes the “research and teaching” merit of the application.

Pipitea HEC Applications

In practice the main concerns with most applications dealt with by the Pipitea Human Ethics Committee are:
Are the requirements of the Privacy Act being observed?
Are issues relating to sensitive information - which includes commercial or legal information received in confidence - adequately dealt with?
Role definition in cases of student research (usually where student is doing research in their own workplace).

In such cases the application needs to explain how the employee/student roles are separated and in relation to data the application needs to be clear on whether it is collected for employment purposes or student purposes (often only the analysis may be the student component)

potential conflicts of interest/role

Application fundamentals

Applications are likely to be approved more quickly if:

both the Guidelines and the Privacy Principles (in the Privacy Act) have been read and understood
technical and discipline jargon is avoided as far as possible – the committee are effectively lay persons, not subject experts – this includes the use of acronyms, abbreviations and initials that must be completed in full
the application focuses on the elements of the research that relate to HEC approval
the application form, the information sheet and the consent are consistent – eg: the same information should appear in the application and on the information sheet
ensure all questions are clearly answered

Completing the Application Form

The following is a guide to completing the questions on the application form.

Question 2: In the case of student research there must be a VUW employee as one of the supervisors (even if pro forma)

Question 3: The start date for that aspect of the research that requires HEC approval should be at least 3 weeks after the date of the Pipitea HEC Member / School representative accepting the application for submission to the Pipitea HEC.

Question 4: While points (b) and (c) are rarely relevant you should note the comments above on health research which includes management etc in health bodies or Health Research Council funded research. Some other organisations may have internal approval processes and these must be disclosed (eg Government Departments). All approvals must be obtained before the HEC aspect of the research commences

Question 5: Problems that are common include lack of clarity regarding:

(1)item (b); method of data collection;

(2)item (d) characteristics of participants

(3)item (e): method of recruitment

These should be clearly and explicitly spelt out so that a lay 3rd party can clearly understand what is intended. Thus, for example, the sample number and method of achieving that sample should be made clear including how you will ensure that it is random (if relevant)

(4)item (i): be careful to ensure that all intended uses are specified and that answers do not conflict with answers to later questions

For example use for a conference paper is often mentioned under item (n) but not in answer to this question.

(5)item (j):

(a)One major problem here is a failure to distinguish confidentiality and anonymity. Anything that allows discovery of a participant’s identity negates anonymity – this includes face-to-face contact, requests for feedback incorporated in the questionnaire. It should be noted that the question relates to the collection of information and not to its reporting (if collection is not anonymous terms such as “confidential” or “non-identifiable” should be used in relation to reporting and publication.

(b)It should also be noted that fully informed consent becomes critical where data/opinions are to be attributable and for this reason the information/consent forms will be closely scrutinised in all such cases.

(c)In the case of anonymous research return of the questionnaire can usually be taken to be consent if the manner of return is anonymous. This is not the case if questionnaires are handed to either the researcher or a third party individually. They should usually go to some common receptacle. In some cases consent to confidential research can be taken from the return of a questionnaire or the like if the return is carried out as for anonymous research. For example you know the identities of the participants but are unable to identify any individual response. In all cases the questionnaire should state that return of the questionnaire is consent to participation. You might note that there can be no question of withdrawal from the research in the case of anonymous research or responses.

(d)For email or web-based questionnaires you should carefully explain how anonymity will be guaranteed.

(e)Answers to item (j) must be fully consistent with statements on the information sheet/consent form.

(f)In relation to consent note the following:

if access is required to an institution such as a school, university class, workplace or the like consent from the person controlling that place may be required
if access is sought to sensitive information including commercial or legal information the consent of the “owner” of that information may be required (or conformation that the informant has authority to allow access)
consent of an employer is not normally needed unless the consent relates to such things as commercial or legal information, business processes, access to the premises etc. This issue should however be considered and addressed.
Employer consent may be an issue in the case of a student/employee and the issue should be addressed.
In the case of minors consent would be expected (as appropriate) from the parent/guardian, the school or other institution and the minor. The Committee will be particularly vigilant to all applications involving children or other vulnerable groups.

(6)items (k) and (l)

It should be noted that data held by staff may be disclosable under the Official Information Act – but not that held by students

(a)These two questions are central to Privacy Act requirements that require secure storage of individual information and the destruction of that information once the purpose of collection is complete. Individuals also have rights in relation to access to their own personal information. The following should be noted:

The Privacy Act requirements relate to personal information so secure storage/destruction is not necessary for the aggregated information so long as personal information cannot be derived from that. Note that the Committee will generally equate sensitive information with personal information and expect the same standards to be applied

(b)For staff research and advanced student research it is good practice that all data is retained for an appropriate time to allow for academic verification of results. The Committee regards this as a serious issue of research ethics and will seek a justification if this is not done.

(c)In the case of any student research item (k)(ii) is an expected answer

(d)Answers to item (k) and (l) must be fully consistent with statements on the information sheet/consent form.

(7)item (m): it should be noted that feedback refers to the final results of the research (not the individual’s contribution). Feedback/verification as to the accuracy of an individuals comments or contribution is not covered under this question. For student research some schools may allow for an abstract to be posted on the Schools website.

(8)item (n):

(a)In the case of staff research and advanced student research the Committee would normally expect some form of publication to be at least anticipated – that after all is the point of the research and the justification for approaching the public. This must be specified at this stage. Anticipating publication is not a commitment to actually publishing.

(b)Answers to item (n) must be fully consistent with statements on the information sheet/consent form.

Information sheets and Consent forms

Note the following points:

The consent/information sheet must conform to and be fully consistent in all respects with the information provided in the application (ie the same wording and the same information must be in both – you cannot say “confidential” in the application and “anonymous” in the consent).
The Committee will be particularly vigilant in any case where information/data is attributable to named individuals
Insurance cover should not be mentioned
If you intend to allow withdrawal from the research (usually expected where individuals remain identifiable) you should specify a specific date. Terms such as “until data input is complete” or the like are not particularly useful.

Information Sheets

The information below is from the Guidelines [para 4] and is expected in all cases as relevant.

Information sheets should usually contain at least the following information:

An introduction explaining who the researcher is and a brief description of the project, procedures to be followed and the academic or scientific benefits/objectives.
A statement to the effect that Victoria University requires ethical approval to be obtained for research.
An explanation of the role and expectations of the participants, including an indication of how long participation is expected to take.
A statement that indicates if the responses will be anonymous or whether an undertaking is given to keep personal details of participants confidential, how information will be secured and the form in which the data will be reported. [Where there is attributable reporting (i.e. by quoting the name of the person who has provided the information or the person is otherwise identifiable), this should be clearly specified on the consent form].
It may be necessary to state that a participant will have the right to check interview notes.
What will be done with the data. Whether (and where) it will be kept for a specified period. Whether it will be deposited in an archive (such as the Turnbull Library) or whether it will be destroyed within (say) two years of the completion of the thesis or project (see section 7).
An indication of where the results will be published.
Whether feedback will be provided and, if so, how and approximately when.
The name and contact details of the researcher. In the case of student research, the name and contact details of the supervisor should also be supplied.

Consent Forms