Ross Woods, 2021
The underlying principles of the US Part 46 standard and the Australian National Statement on Ethical Conduct in Human Research are remarkably similar but the two documents are very different in structures and detail.
This is a comparison of their sections on information for informed consent. The differences indicate that compliance with one is no guide to compliance with the other.
| US | Australia |
|---|---|
| Required information Ref.: 46.116(b) |
Chapter 2.2 General requirements for consent, 2.2.6 |
| The study involves research. | Nil |
| The purposes of the research. | Nil |
| How long you expect their participation. | Nil |
| Any procedures subjects should follow. | Nil |
| Any experimental procedures. | Nil |
| Foreseeable risks or discomforts. | Nil |
| Any expected benefits to subjects or others. | any expected benefits to the wider community; |
| Any alternative procedures or courses of treatment that might help subjects. | any alternatives to participation; |
| How you will keep records of subject's identities confidential. | how privacy and confidentiality will be protected; |
| If more than minimal risk, explain: • whether any compensation is available • any medical treatments available if injury occurs and what they are • where the recipient can get further information. |
any payments to participants; |
| Whom to ask about subjects' rights. | Nil |
| Whom to contact if the research causes an injury. | provision of services to participants adversely affected by the research; |
| Participation is voluntary. | Nil |
| Refusal to participate will involve no penalty or loss of benefits. | Nil |
| The subject may discontinue at any time without penalty or loss of benefits. | the participant’s right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data; |
| If collecting identities: • Identifiers might be removed and then the information could be used for future research studies, or • The information will not be used for future research studies. • Any other information required by law in that jurisdiction. Ref.: 46.116(i) |
any other relevant information, including research-specific information required under other chapters of this National Statement. |
| Nil | how the research will be monitored; |
| Nil | contact details of a person to receive complaints; |
| Nil | contact details of the researchers; |
| Nil | the amounts and sources of funding for the research; |
| Nil | financial or other relevant declarations of interests of researchers, sponsors or institutions; |
| US | Australia |
|---|---|
| Other information that might be required Ref.: 46.116(c) |
Chapter 2.2 General requirements for consent, 2.2.6 |
| Any other currently unforeseeable risks: • To subjects • To embryos/foetuses if subjects might fall pregnant | Nil |
| When can the researcher end the subject's participation without their consent? | Nil |
| Any possible extra costs to the subject. | Nil |
| The consequences if a subject decides to withdraw. | the participant’s right to withdraw from further participation at any stage, along with any implications of withdrawal, and whether it will be possible to withdraw data; |
| A procedure to withdraw. | Nil |
| Significant new findings during the research that might affect subject's willingness to continue. | Nil |
| The approximate number of subjects in the study. | Nil |
| Whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions. | the likelihood and form of dissemination of the research results, including publication; |