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Review of Chapter 2.3 of the National Statement: Qualifying or waiving conditions for consent submission

ID: 
3
Personal Details
First Name: 
Brian
Last Name: 
Stafford
Specific Questions
1. Please comment on the following definition of ‘opt-out’:: 
As a lay member of a HREC I agree with the fundamental principle that research on a person can only take place with the prior informed consent of that individual in a free and confidential situation to the participant. In that way the consent is rightly considered to have been actively sought by the researcher. The foundation is NOT that if they did not want to participate they would ‘opt-out’. My position is that the same has to apply for situations where the research will/ has commenced without prior participants agreement. I acknowledge there will be situations when research will, and I believe should, commence without prior participant informed consent. However, that occasions should be in the minority and have as a foundation the inability of the participant to give informed consent at the time. That is they were unconscious or lacked capacity at the time. Under such conditions as a general principle I support such research. It would be under those events that I support the participant on recovery to consciousness or intellectual capacity that the person must be immediately informed and informed consent given. If that is declined that such a person’s details must be considered to have been withdrawn from that time one. For the greater good there may be a need to retain information around the state of people unable to give informed consent and as such we should be able to use that information. A similar situation exists around a person who dies that the family be informed but that the information recoded should not be lost to research for the greater good regardless of family opposition, if any. On issues of religion, I support the right of every individual to withhold consent. However, as best medical treatment is not determined on religion that should not prevent the collection and use of data, suitably de-identified, from being used from a case where due to inability on the part of the person to inform researchers the information was collected.
2. Please comment on the rationale provided for an opt-out approach (i.e. Section 3).: 
As a lay member of a HREC I support the opt-out approach to the collection and use of data collected from the public when the research is probably closely linked to issues of public health. No more that we as a society could allow a carried of a transmissible and deadly disease to exercise their person right to freedom of movement can we allow the society to collect, record and maintain information on the spread of a disease. This has to be clear that this cannot be ever applied to a political or religious dimension. The current criminal trials around the knowing transmission of AIDS is an example where the private and consensual acts of intimacy is later moved to the public domain for the greater good in public health. Never to be confused as an exercise of morality policing
3. Please comment on the proposed limited application of an opt-out approach (i.e. Section 4).: 
As a lay member of a HREC I object to the inclusion of explicit consent. Its use and inclusion is abhorrent to me as it introduces ambiguity. Explicit, implicit, implied, what every the researceher thought was in the mind of the other person is unacceptable. Informed consent is given or not given is a fact that can be relied upon. Euphemisms have no place in science or the law and most definitely should not be built into its standard, or statute.
4: Please comment on the flow chart (i.e. Section 4).: 
As a lay member of a HREC I am concerned with sections 3b and 6d of the flow chart. My concerns are that it sounds as though some, any, members of the public can/ will be bypassed in the requirement of respect expressed in part by that person’s informed consent. Further, by the 3b and 6d that not all people will be afforded the respect of obtaining prior informed consent. That is not acceptable. As a lay person this currently reads as though if the person was not provided with full information of the research it was the participants fault. They didn’t ask. The person in the research without their full knowledge came under ‘opt-out’ because they have not declined [to be part of the research]. That is disingenuous and as such unethical from a lay perspective. There are situations when I agree there has to be capacity for research to take place on an opt-out situation. However, in those cases it should never be attributed to they didn’t ask. That is offensive. The opt-out is because of …., or under this subsection it is implemented.
5. Please comment on the appropriate mechanism for providing information to participants for the opt-out approach represented at box 6d of the flow chart.: 
As a lay member of a HREC I am concerned with sections 3b and 6d of the flow chart. My concerns are that it sounds as though some, any, members of the public can/ will be bypassed in the requirement of respect expressed in part by that person’s informed consent. Further, by the 3b and 6d that not all people will be afforded the respect of obtaining prior informed consent. That is not acceptable. As a lay person this currently reads as though if the person was not provided with full information of the research it was the participants fault. They didn’t ask. The person in the research without their full knowledge came under ‘opt-out’ because they have not declined [to be part of the research]. That is disingenuous and as such unethical from a lay perspective. There are situations when I agree there has to be capacity for research to take place on an opt-out situation. However, in those cases it should never be attributed to they didn’t ask. That is offensive. The opt-out is because of …., or under this subsection it is implemented.
6. Please comment on the proposed amendments to the National Statement (see Attachment A underlined and in red text).: 
Depending upon the circumstances of an individual project it may be justifiable to employ an optout approach to consent. This is where a potential participant is provided with information approved by an ethical review body and, unless the participant communicates a choice not to participate in the research or related activity, their willingness to participate is presumed. As a lay member of a HREC I accept that in the event a HREC have approved research that includes an opt-out disclosure that should be considered as accepted. However, I maintain that in the way this is framed it implies that there was a choice on the part of the participant and that participant made a choice after full disclosure not to opt-out. By the language used this suggests to me, as a lay HRCE member that did not happen. That conclusion is based on ‘unless the participant communicates a choice not to participate.’ At best it relies on a negative event and not the assumed standard of an affirmative action to participate. For documentation and clarity of process what will be the evidence required that the participant was given a choice? The turn ‘choice’ is used in the above. A single research project may involve discrete elements where different approaches to informed consent could justifiably be used. For example, a project may involve some elements where explicit consent must be sought and other elements where an opt-out approach may be considered or where a waiver of the consent requirement may be applied. As a lay member of a HREC I want to see the protection of the community maintained by all human research having prior approval action by a HREC. As above, I remain very concerned around opt-out and the amorphous nature of this cover. I recommend that there is informed consent or a HREC waiver only. If opt-out then it must always be predicated upon full disclosure to the participant
7. Are there situations where an opt-out approach might be appropriate that have not been considered in the proposed amendments?: 
As a lay member of a HREC I have an open mind to the issue. From my above expressions I believe I have made my position clear. However, I do believe that there may be unforseen events where an opt-out approach may be appropriate. In that event the matter must always have HREC approval where the exceptional circumstances can the explained and properly considered in order that approval is given. Never should those engaged, directly or indirectly, be given the power to make the decision of what an opt-out can be used as it always is a burden that the participant has to tolerate.
8. Are there any situations you can think of where the draft amendments would allow an opt-out approach that may be inappropriate?: 
As a lay member of a HREC I believe that there are. One example, but not limited to just one, would be were the integrity of the individual may unnecessarily compromised for the benefit of the researcher. I am reminded of the reason why we have HREC and the inclusion of certain lay people. Because with the best intend, at the time, research into science pre and during WWII was later consider to be an abomination to any civilised society. Although only one side of that war were held to public odium many other human research was continued until long after WWII that are now considered unacceptable. That is why researchers are never to be given self management of what is ethical in the wider society. The opt-out idea should never to left to researchers to decide. I believe I have addressed the topic in the above responses.
9. Can you provide examples where an opt-out approach may be useful?: 
As a lay member of a HREC none come to mind. However, I remain open minded and with stringent prior vetting by a HRCE a case may arise. In which event it must be on a case by case decision of the HEC.
General Comments
Comments: 

I applauded the improved use of medical history to further the advance of medical knowledge in order to improve medical treatments.  However, I believe all research must conform to the laws governing research.  Where such regulations no longer meet needs and fail to reflect current society’s moralities then I support change.  However, until there is a change I want us all to comply with the rules.   If the rules are outdated, change them; but have full lay representation in that debate.

Last week I attended a community workshop looking at informed consent around diagnostic imaging.   During that workshop I pointed out that the laws around medical treatment and medical treatment involving research were not the same in all States.   That was unknown by the NGO who arranged the workshop and was taken as an anomaly that had no influence on the final deliberations.    In WA, as an example, if the person is unable to give consent (unconscious/ not in a mental state to do so) the next of kin can give consent to medical treatment.  However, in the same situation the next of kin cannot give consent to the patient being included in a research project.            

I have deep concerns over some of the definitions used in the Glossary of Terms.  I have made a note and strongly recommend for safety and to reflect community values that some changes be made.  Below are my recommendations and ‘adjustments’. 

Glossary of Terms

AHEC Australian Health Ethics Committee

Consent: A person’s or group’s agreement to participate in research As a lay member of a HREC I disagree with this as an acceptable or appropriate definition of consent.   My objection is to the inclusion and equal standing of an individual and a ‘group’.   The individual can consent, that I agree on.   I object that consent over an individual, or individuals, can be ethically acquired.  This does not even go to examine if this group agreement arose from a religious or political or some other subgroup within society.   Will that group agreement have to be (a) unanimous?   Will that group agreement be acceptable when it’s by majority?  A majority of what proportion, 51%; 60%; 70%; 90% what?

Was the group agreement binding on the individuals without coercion?  (We have known examples were some religious groups where free choice has been known to be the interpretation of their leaders.  However, this concern is not limited to religious groups alone. )

There is in fact no single body upon which physical examination can be performed.   Group is 100% of the time made up of individuals.   Each individual can give consent.   By accepting this version of the definition of consent to be inclusive of a group we fail to maintain the right of the individual.   That is what is unacceptable to include in any definition, of informed individual consent.   It open the door to consent that is removed from the individual to something not defined- the group agreement.

Data: Pieces of information

Epidemiological study: a study of the distribution and determinants of disease frequency in human populations

Ethical Review: review of research or related activities by an Human Research

Ethical Committee: (HREC) or other authorised body

Exempt from ethical review In accordance with 5.1.22 of the National Statement Institutions may choose to exempt from ethical review research that:

(a) is negligible risk research (as defined in paragraph 2.1.7, page 18)

(b) involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

Explicit consent: A person or group’s explicit agreement, based on adequate knowledge and understanding of relevant material, to participate in research. As a lay member of a HREC I disagree with this as an acceptable or appropriate definition of Explicit Consent; please refer to above under ‘Consent’.    The issue ad objection is the inclusion of ‘group’ anything around consent.  Other that when each individual has given his/her consent they may for convenience of language grouping be considered a ‘group of people’.  However, the group cannot, and should not, be considered to be able to give consent to anything.  

HREC Human Research Ethics Committee

Inconvenience A minor negative accompaniment or effect of research, less serious than discomfort. As a lay member of a HREC I disagree with this as an acceptable or appropriate definition of inconvenience.  Who is to determine what is a minor anything?    Surly not the vested interests engaged in the research.  Such a situation would be a conflict of interest and potentially undermine the project and should cause every person the subject of that trial to question the ethics of those undertaking the research.    I accept that there can occur a situation when an unforseen issue may arise.   That questions if the matter was unforseen how well was the research application considered in its preparation.  The interests of every person who has given consent or who is under a waiver to participate in the research most continue to be under the protection of the HREC who gave the original approval.    Without exception any, and every, issue of ‘a minor negative accompaniment or effect of research, less serious than discomfort’ must be referred back to its approving HREC for an exemption.

Limited disclosure Not disclosing to research participants all of the aims and/or methods of the research. As a lay member of a HREC I disagree with this as an acceptable or appropriate definition of limited disclosure.    The definition of this has to be it is not allowed without prior exceptional approval from two (2) different HREC and that approval is confined to two (2) application that cannot be touted around to find two (2) approvals.   If the dual approvals are not given the application for the research has to be listed as failed and cannot be resubmitted without the prior filed notice being attached.

From the perspective of a lay member of a HREC I strongly assert that there has not been an informed consent whenever there has not been full prior disclosure to the individual.      

Page reviewed: 28 March, 2014