Australian Health Ethics Committee

Ethics Committee Assessment Form for IECs and HDECs: 1 January 2010 - 31 December 2010

Health research council

of new zealand

2010 Ethics committee assesment form (ecaf) for committees accredited by the health research council ethics committee (hrcec)

Reporting period: 1 January 2010 – 31 December 2011

submission date:1 APRIL 2011

IEC/HDECname:

The HRC Ethics Committee (HRCEC) is established under the Health Research Council Act (1990) as a committee of the Health Research Council. Section 25 covers the Committee’s functions. Set out below are the functions relevant to the accreditation of ethics committees:

To ensure that, in respect of each application submitted to the Council for a grant for the purposes of health research, an independent ethical assessment of the proposed research is made either by the Ethics Committee itself or by a committee approved by the Ethics Committee (section 25(1)(c))
To give, in relation to ethics committees established by other bodies, advice on –

(i) the membership of those committees; and (ii) the procedures to be adopted and the standards to be observed, by those committees (section 25(1)(f))
Accredited ethics committees are able to undertake independent assessment on behalf of the HRCEC
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Regional and Multi-Regional Health and Disability Ethics Committees (HDECs) are established as Ministerial committees under section 11 of the New Zealand Public Health and Disability Act 2000. The Operational Standard for Ethics Committees (Operational Standard) applies to ethics committees that review the ethics of research and innovative practice, and provide advice on issues relating to the delivery of health and disability services. The Operational Standard derives its public authority from the terms of reference of ethics committees established by the Minister of Health under section 11 of the New Zealand Public Health and Disability Act 2000. Those terms of reference have precedence over the Operational Standard on any point of conflict.
Institutional Ethics Committees (IECs) are established by organisations, such as universities or private companies and review research applications directly related to the organisation or their agent. While the principles of the Operational Standard for Ethics Committees (Operational Standard) apply to IECs, often the research that they review is not health related and they have policies and procedures that reflect the nature of the research that they review.

ELECTRONIC SUBMISSION

Please complete the form electronically and send to the Secretary of the HRCEC by e-mail at the following address:

Relevantdeclaration page with signatures may also be submitted electronically via email or fax

(64 9 377 9988) or sent by post. If sent by post, it must be submitted to the following address:

HRC Ethics Committee

Health Research Council of New Zealand

PO Box 5541, Wellesley Street, Auckland

INQUIRIES

If you have any queries, please contact the Secretary of the HRCEC by e-mail at the above e-mail address.

OPTIONAL CHAIRPERSON’S REPORT
This is a good opportunity for the Chair to summarise the main progress, changes and any issues from the year and present these to the HRCEC. These identified issues may be used to provide a summary across ethics committees for analysis by the HRCEC.
Topics often mentioned are: workload, resource, changes to committee policies, changes to structure of review (i.e. introduction of low risk expedited review), institutional climate (i.e. undergoing restructure), scenarios of difficult review, or requests for advice on how to review particular topics. Any other substantive changes which the committee or its Chair feels should be noted can be included.

Please include the Chairperson’s Report in the box below

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ORGANISATION OF THIS REPORT

Section 1 contains 9 Questions on approval information and identification questions about the ethics committee (EC) and the primary organisation responsible for it, including contact information

Section 2 contains 18 Questions on the EC’s policies and procedures
Section 3 contains 19 Questions onmembership of the EC
Section 4 contains 5 Questions on training of committee members during the reporting period.
Section 5 contains 6 Questions on Cultural responsiveness
Section 6 contains 7 Questions on the applications considered by the EC
Section 7 contains 1 Question regarding the complaints received by the EC
Section 8 contains 1 Question about the issues faced by the EC
Section 9 contains 1 Question regarding the guidelines for chairpersons delegation
Section 10 - Appendix 1 contains the table to describe the details of the protocolsconsidered by the EC
Section 11 - Appendix 2 contains the membership table and membership summary tableto complete
Section 12 - Appendix 3 contains the Reporting lines diagram
Section 13 – Appendix 4 contains Copies and Attachments of the relevant documents attached by the EC

The questions in this report contain both Annual Reporting Questions and Questions important for the continuing accreditation of the EC. The former questions inform the HRCEC about the work of the committee and enable the HRCEC to provide feedback to the committees regarding issues that arise. The latter, accreditation questions refer to information required by the HRCEC to ensure that the EC continues to meet the requirements of accreditation. Accreditation questions regarding the procedures and policies of the EC are clearly marked throughout this form.

Ethics Committee Assessment Form for IECs and HDECs: 1 January 2010 - 31 December 2010

SECTION 1:
HRCEC Approval and IDENTIFICATION INFORMATION
Section 1 asks you to provide approval information and identification information about your ethics committee (EC) and the organisation that holds primary responsibility for your EC.
NOTE:
If this is your first time completing the Ethics Committee Assessment Form (ECAF) please complete all of the questions below (1.1-1.9). In subsequent Annual Reports only answer these questions if the details have changed during the last Annual Reporting period.

A: Approval by the Health Research council

1.1Date of last HRCEC Accreditation (dd/mm/yyyy)

B: Details of EC

1.2 Name of EC

1.3 EC contact details

Mailing address

All EC Chair and Administrator correspondence will be sent to this address.

(Provide address exactly as it should appear on a mailing label.)

Address line 1

Address line 2

Address line 3

Address line 4

Suburb/City Postcode

E-mail

Please use a dedicated business e-mail address.

Website

Specific URL for EC information.

1.4 EC Administrator

Name

TitleFirst NameLast Name

Position

Phone()

Fax()

E-mail

(If differentfrom email listed in question 1.3)

1.5EC Chairperson

All correspondence to the chairperson will be sentto the ‘EC Mailing Address’

Name

TitleFirst NameLast Name

Position

Phone()

Fax()

E-mail

B: Details of organisation with primary responsibility for the EC

1.6Name of organisation

1.7Head of this organisation

Name

TitleFirst NameLast Name

Position

Mailing address

(Provide address for the head of organisation exactly as it should appear on a mailing label. You do not need to repeat the name and position details already provided above.)

Address line 1

Address line 2

Address line 3

Address line 4

Suburb/City Postcode

E-mail

1.8Has a reporting mechanism been established between the EC and the organisation(s) responsible for it?

YesNo (If NO, provide reasons below.)

1.9Describe the reporting mechanism(s):

Minutes of EC meetings are provided to management level of organisation(s),
e.g. to DVC or Board

Regular reports are provided by EC to management level of organisation(s),
e.g. to DVC or Board, at least annually

Other:(Provide details.)

SECTION 2:

Policies and procedures

Please indicate where in your policies you cover the following material:
NOTE:

When filling these answer boxes below, briefly state the response to the questions about your committee. Should the information be covered in your attached material (Appendix 4), a ‘cut-and-paste’ method can be used in the answer boxes and/or a reference to the specific page number provided
Questions 2.4, 2.5, 2.10 and 2.18 are specific to either IECs or HDECs and will only need to be completed by the relevant committee, as indicated in blue writing font below the questions
Questions 2.1 – 2.18 are ‘accreditation questions’ opposed to standard ‘Annual Reporting’ questions and are marked with an ‘*’

If this is your first time completing the ECAF please complete all of the questions below. In subsequent Annual Reports only answer the questions marked with an‘*’ and identify where THE DETAILS OF THE POLICIES AND PROCEDURES HAVE CHANGED during the last Annual Reporting period.

2.1 Please describe the function of the Committee*

E.g. The function of the committee is ______, a reference is enclosed under ______at ______pp ______

2.2 Please attach the EC’s Terms of Reference*

2.3 Please describe the Method of Application to the EC*

If appropriate, a flow chart diagram can also be included with your description

2.4 Please describe the normal procedure for review*

(Question for IECs only. HDECs please go to Question 2.6)

Describe or give reference to the relevant policies and procedures describing the normal procedures for review

2.5 Please describe any variations to normal procedures*

(Question for IECs only. HDECs leave please go to Question 2.6)

Describe any variations to the normal procedures, or give reference to the appropriate section(s) of your policies and procudures

2.6 Please describe the decision making process*

Outline the decision making process. E.g. consensus, majority vote

2.7 Please describe the applications that require ethics approval*

Describe the kind of applications which require ethics approval, or give reference to appropriate parts of the EC’s policy and procedures

2.8 Please describe the applications that do not require ethics approval*

Describe the kind of applications which do not require ethics approval, or give reference to the appropriate part of the EC’s policy and procedures

2.9 Please describe any fast track procedures*

Explain any fast track procedures, including the types of research activities that can be approved by expedited review

2.10 Please describe the EC’s research activities*

(for IECs only. HDECs please go to question 2.11)

Describe in detail any research activities approved by delegated committees of the IEC or other means (e.g. departmental level) and the lines of reporting to the IEC. Alternatively the lines of reporting can be illustrated in Appendix 3: Reporting Lines Diagram

2.11 Please describe the EC’s complaints procedure*

(A description summary of complaints is requested in Section 7)

2.12 Please describe the EC’s policy on confidentiality and privacy*

IECs should outline the Institution’s procedures relating to confidentiality and privacy. HDECs may refer to the relevant section of the Operational Standard.

2.13 Please describe the EC’s consent procedures*

Outline the way in which your informed consent procedures meet the requirements of the Code of Health and Disability Services Consumers’ Rights, 1996

2.14 Please describe the EC’s policy for remuneration of participants *

2.15 Please describe the EC’s policy and procedures on injury or harm*

2.16Please describe the EC’s process for researchers whose application for ethical review is deferred or approved subject to conditions (or equivalent) by the EC*

2.17Does the EC have a process for expedited review? *

YesNo

2.17.1 If YES, please describe the types of research that can be approved by expedited

review

2.18 Does the EC have any committee specific policies and guidelines? *

(Question for HDECs only. IECs please go to Section 3)

YesNo

2.18.1If YES, describe these in detail below or give reference to the relevant sections of your policies and procedures.

SECTION 3:

Membership

Section 3 relates to the membership of ethics committees in compliance with the requirements of the HRC Guidelines for Ethics Committee Accreditation, 2008.

Composition of your EC

NOTE:

Please also complete the ‘current membership list’ in Appendix 2
Questions 3.7– 3.16 are specific to either IECs or HDECs and will only need to be completed by the relevant committee, as indicated in the blue writing font.

GENERAL MEMBERSHIP QUESTIONS

FOR IECS AND HDECS (questions 3.1-3.6)

3.1Are there at least 10 members on the IEC or 12 members on the HDEC?

YesNo (If NO, provide reasons below.)

3.2What was the male/female ratio throughout the reporting period?

3.2.1If the male/female ratio was less than the recommended 50% please provide the reasons below and indicate how long this deviation persisted.

3.3Were there at least twoMāori members on the committee throughout the reporting period?

YesNo (If NO, provide reasons below.)

3.4Was there a member on the committee with formal training in ethics throughout the reporting period?

(Please ensure that the member’s appropriate affiliation and/or qualification is outlined in the ‘list of current members’ in Appendix 2.)

YesNo (If NO, provide reasons below.)

3.5Was there a lawyer on the committee throughout the reporting period?

YesNo (If NO, provide reasons below.)

3.6 Did membership include adequate expertise to review qualitative and quantitative

research throughout the reporting period?

For HDECS this must include: expertise in the main kinds of health and disability research (e.g. interventional, observational, kaupapa Māori, and social research in both quantitative and qualitative research methods.)

YesNo (If NO, provide reasons below.)

B. IEC SPECIFIC MEMBERSHIP QUESTIONS (questions 3.7 – 3.10)

(HDECs please go to Question 3.11)

3.7Was there at least one student member on the committee throughout the reporting period?

YesNo (If NO, provide reasons below.)

3.8Is the Chairperson an external member?

YesNo (If NO, provide reasons below.)

3.9Were there at least two external members on the committee throughout the reporting period?

(The definition of “external members” can be found in the HRC Guidelines for Ethics Committee Accreditation. June 2008, in Appendix 2)

YesNo (If NO, provide reasons below.)

3.10Does the committee review low risk health research?

YesNo (If NO, go to question 3.11)

3.10.1If YES, are there two appropriately qualified health professionals, one clinical and one in active practice?

YesNo

(If YES, identify these committee members and note their professional affiliations below.)

Name: Affiliation:

3.10.1.1If NO to Question 3.10.1, provide reasons below

C. HDEC SPECIFIC MEMBERSHIP QUESTIONS(question 3.11 – 3.16)

(IECs please go question 3.17)

3.11Is the Chairperson a Lay person?

(The definition of “Lay person” can be found in the HRC Guidelines for Ethics Committee Accreditation. June 2008, in Appendix 1)

YesNo (If NO, provide reasons below.)

3.12Is the deputy Chairperson a Non-lay person?

YesNo (If NO, provide reasons below.)

3.13Did membership include a consumer representative and community representative throughout the reporting period?

YesNo (If NO, provide reasons below.)

3.14Did membership include a pharmacist/ pharmacologist and a biostatistician at all times?

YesNo (If NO, provide reasons below.)

3.15Were there two health researchers on the committee at all times?

YesNo (If NO, provide reasons below.)

3.16Were there two health practitioners, one currently in active practice, on the committee at all times?

YesNo (If NO, provide reasons below.)

D. MEMBERSHIP OVER THE ANNUAL REPORTING PERIOD

FOR IECS AND HDECS (questions 3.17 – 3.19)

3.17Were there any committee membership changes in 2009?

YesNo (If NO, go to question 3.18)

(If YES, please complete the resignation and appointment tables below)

A: RESIGNATIONS:

Please indicate all member resignations within the Reporting period.

Note: Expertise of these and all other members attending any meeting in the last reporting year needs to be entered in the ‘current membership list’ in Appendix 2.

Member John Smith Resignation date 31/07/2009

Member Resignation date

B: APPOINTMENTS:

Please ‘copy and paste’ the following box, and complete, for each new member on the committee

Note: Expertise of these and all other members attending any meeting in the last reporting year needs to be entered in the ‘current membership list’ in Appendix 2.

Name

Representation (internal/ external member or Lay/Non Lay for HDECS)

Member category (expertise)

Gender (m/f)

Date of Appointment (dd/mm/yyyy)

Term of Appointment

Retirement Date from the Committee (dd/mm/yyyy)

Professional Affiliations

3.18Please complete this membership attendance grid

Note: Please refer to the legend below

Members / Internal/external (I/E) / Lay/non-lay (L/N) / Gender M/F / Jan / Feb / Mar / Apr / May / Jun / Jul / Aug / Sep / Oct / Nov / Dec / Total
John Smith * / I / L / M / X / Y / Y / Y / Y / A / Y / Y / Y / / / / / / / 07/08
Total No. members present
No. applications considered

LEGEND:

* After name indicates Māori member
Y = Present
A = Apology
X = Meeting cancelled / No meeting scheduled
/ = Not member of committee during this time

3.18.1Please include any additional comments specific to the membership attendance

grid in the box below:

e.g. “no meeting was scheduled for May 2009 because the committee did not meet quorum”

3.19Was there at least one member from each core membership category present at all meetings where research proposals were considered?

YesNo

3.19.1If NO, was the Chair satisfied, prior to a decision being reached, that the absent core member(s) were informed, had an opportunity to contribute their views, and these views were recorded and considered?

YesNo(If NO, provide reasons below.)

SECTION 4:

Training

These questions relate to training of any sort undertaken during the reporting period by EC members, to enhance their capacity to undertake their work as a member of the EC

NOTE:

Question 4.1 is an ‘accreditation question’ opposed to a standard ‘Annual Reporting’ question and is marked with an ‘*’

When filling this answer box below, briefly state the response to the questions about your committee. Should the information be covered in your attached material (in Appendix 4), a ‘cut-and-paste’ method can be used in the answer box and/or a reference to the specific page number provided.
If this is your first time completing the ECAF please completethe questions below marked with an ‘*’. In subsequent Annual Reports, only answer the questions marked with a ‘*’ if the details have changed during the last Annual Reporting period

A: Training for New Members