APPENDIX C

WAIVER OF CONSENT AND OPT-OUT APPROACH

In certain circumstances, it might be justifiable not to obtain explicit consent from participants and to request a waiver of consent or the use of an opt-out approach. See National Statement, chapter 2.3 –Qualifying or Waiving Consent: If you are requesting a waiver of consent complete Section 1 of this form.If you are requesting the use of an opt-out approach complete Section 2 of this form.

How many participants will this waiver apply to?a

Retrospectively / Prospectively
Number of Participants
SECTION 1: WAIVER OF CONSENT

The following questions are adapted from the National Statement, section 2.3.10 (

1.1.Does the research carry no more than low-risk to participants (see paragraphs 2.1.6 and 2.1.7, page 18)?

Yes / No

If ‘Yes’, please explain your response below.

If ‘No’ you cannot request a waiver of consent and you must obtain consent from all participants in your research.

1.2.Describe how the benefits from the research justify any risks of harm associated with not seeking consent.

1.3.Is it impractical to obtain consent (for example, due to the quantity, age or accessibility of records)?

Yes / No

If ‘Yes’, please explain your response below.

1.4.Is it known or likely that participants would have consented if they had been asked? Explain your response below.

1.5.Describe how individuals’ privacy will be protected.

1.6.Describe the plan to protect the confidentiality of data.

1.7.If the results have significance for the participants’ health or welfare, describe the plan for making this information available to participants, (for example, via a disease-specific website or regional news media).

If it is not practical to provide this information to participants, please provide reasons.

1.8.Do the derivatives of the data or tissue have commercial value? If so, will participants benefit in any way? Explain your response.

1.9.Is the waiver prohibited by State, federal, or international law? Explain your response. (Refer to the information box below to assist you in responding to this question)

For health related information refer to the Statutory Guidelines made under the Health Records and Information Privacy (HRIP) Act 2002 (NSW) Statutory Guidelines on Research via Privacy NSW HRIP Act and NHMRC The Regulation of Health Information Privacy in Australia

For non-health related information refer to section 27B of the Privacy and Personal Information Act 1998 (NSW):

SECTION 2: OPT-OUT APPROACH

The following questions are adapted from the National Statement, section 2.3.9 (

2.1.Does the research carry no more than low risk to participants (see paragraphs 2.1.6 and 2.1.7, page 18)?

Yes / No

If your response is ‘Yes’, please explain your response below.

If your response is ‘No’ you cannot request the use of an opt-out approach and you must obtain consent from all participants in your research.

2.2.Describe how the public interest in this research outweighs the public interest in the protection of privacy.

2.3.Explain why this research will be compromised without using the opt-out approach, (e.g. the research requires full participation rate, explicit consent would compromise the necessary level of participation, etc.)

2.4.Describe how you will provide all prospective participants with appropriate plain language information explaining the nature of the information to be collected, the purpose of collecting it, and the procedure to decline participation or withdraw from the research.

2.5.(a)Describe what information participants will be provided with to explain the nature of the research. The example participant information and consent form is available at: (N.B. The consent section should be removed.)

(b)Describe the mechanism for prospective participants to obtain further information and decline to participate.

2.6.(a) Describe how the research will be managed and maintained in accordance with relevant security standards.

(b) Who will be responsible for managing the data Please provide details.

2.7.Is the opt-out approach prohibited by State, federal, or international law?

Yes / No

Please explain your response.

For health related information refer to the Statutory Guidelines made under the Health Records and Information Privacy (HRIP) Act 2002 (NSW) Statutory Guidelines on Research via Privacy NSW HRIP Actand NHMRC The Regulation of Health Information Privacy in Australia
For non-health related information refer to section 27B of the Privacy and Personal Information Act 1998 (NSW):

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