. 2023 Mar 8;79(4):575–578. doi: 10.1007/s00228-023-03472-w

Table 1.

Modifications and waivers of informed consent in Australia, Canada, and USA regulations and in CIOMS guidelines^a

Australia [3]	Canada [4]	USA [5]	CIOMS (WHO) guidelines [2]
2.3.9.- Only an HREC^b may grant waiver of consent for research using personal information in medical research, or personal health information. (…) 2.3.10.-Before deciding to waive the requirement for consent (…), an HREC (…) must be satisfied that: a. involvement in the research carries no more than low risk^c to participants b. the benefits from the research justify any risks of harm associated with not seeking consent c. it is impracticable^d to obtain consent d. there is no known or likely reason for thinking that participants would not have consented if they had been asked e.there is sufficient protection of their privacy f.there is an adequate plan to protect the confidentiality of data g. in case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them (…) h. the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled i. the waiver is not prohibited by state, federal, or international law	Article 3.7A.- The REB^b may approve research that involves an alteration to the requirements for consent set out in (…) if the REB is satisfied, and documents, that all of the following apply: a. the research involves no more than minimal risk^e to the participants; b. the alteration to consent requirements is unlikely to adversely affect the welfare of participants; c. it is impossible or impracticable^f to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required; d. in the case of a proposed alteration, the precise nature and extent of any proposed alteration is defined; and e. the plan to provide a debriefing (if any) that may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials, shall be in accordance with (…)	45CFR 46.116.f.3.- In order for an IRB^b to waive or alter consent as described in this subsection, the IRB must find and document that i. The research involves no more than minimal risk^g to the subjects; ii. The research could not practicably be carried out without the requested waiver or alteration; iii. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; iv. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and v. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation	Guideline 10.- (…) A REC may approve a modification or waiver of informed consent to research if: 1. the research would not be feasible or practicable to carry out without the waiver or modification; 2. the research has important social value; and 3. the research poses no more than minimal risks^h to participants

Australia [3]

Canada [4]

USA [5]

CIOMS (WHO) guidelines [2]

2.3.9.- Only an HREC^b may grant waiver of consent for research using personal information in medical research, or personal health information. (…)

2.3.10.-Before deciding to waive the requirement for consent (…), an HREC (…) must be satisfied that:

a. involvement in the research carries no more than low risk^c to participants

b. the benefits from the research justify any risks of harm associated with not seeking consent

c. it is impracticable^d to obtain consent

d. there is no known or likely reason for thinking that participants would not have consented if they had been asked

e.there is sufficient protection of their privacy

f.there is an adequate plan to protect the confidentiality of data

g. in case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them (…)

h. the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled

i. the waiver is not prohibited by state, federal, or international law

Article 3.7A.- The REB^b may approve research that involves an alteration to the requirements for consent set out in (…) if the REB is satisfied, and documents, that all of the following apply:

a. the research involves no more than minimal risk^e to the participants;

b. the alteration to consent requirements is unlikely to adversely affect the welfare of participants;

c. it is impossible or impracticable^f to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required;

d. in the case of a proposed alteration, the precise nature and extent of any proposed alteration is defined; and

e. the plan to provide a debriefing (if any) that may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials, shall be in accordance with (…)

45CFR 46.116.f.3.- In order for an IRB^b to waive or alter consent as described in this subsection, the IRB must find and document that

i. The research involves no more than minimal risk^g to the subjects;

ii. The research could not practicably be carried out without the requested waiver or alteration;

iii. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

iv. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

v. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation

Guideline 10.- (…) A REC may approve a modification or waiver of informed consent

to research if:

1. the research would not be feasible or practicable to carry out without the waiver or modification;

2. the research has important social value; and

3. the research poses no more than minimal risks^h to participants

HREC human research ethics committee, IRB institutional review board, REB research ethics board, REC research ethics committee

^aCIOMS guidelines were prepared in collaboration with the World Health Organization, Geneva, Switzerland

^bNames received by research ethics committees in different jurisdictions

^cResearch is ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk. Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk³

^dFor example, due to the quantity, age or accessibility of records³

^eMinimal risk: Research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research⁴

^fIncapable of being put into practice due to a degree of hardship or onerousness that jeopardizes the conduct of the research; it does not mean mere inconvenience⁴

^gMinimal risk (45CFR 46.102.j): the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

^hMinimal risk standard: is often defined by comparing the probability and magnitude of anticipated harms with the probability and magnitude of harms ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests²