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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

ID: 
15
Personal Details
First Name: 
Merle
Last Name: 
Spriggs
Specific Comments
Comments: 
2. Chapter 3.1

Element 1: Research Scope, Aims, Themes, Questions and Methods

  • 3rd para. Re. reviewers must “acquaint themselves with methods or areas of practice with which they are unfamiliar or that are novel”.Agreed, but it is also important to note that this does not mean that all unfamiliar or novel methods are ethically appropriate (e.g. researchers recruiting and conducting research on their own children) or that aspects of some methods are without problems.  Ethical issues still need to be examined.
  • 4th para. Re range of relationships between participants and researchers and reference to co-researchers where the line between participant and researcher gets blurredIt is important that this does not send the message that accepting a particular methodology eliminates  the need to identify ethical issues or complexities with that method.   (Eg. I am writing up results of one aspect of some interviews with researchers and chairs of Human Research Ethics Committees which is about ethical complexities for child co-researchers.  This is part of a research project on the ethical considerations of using research participants as co-researchers – a project awarded funding by the University of Melbourne Office for Research Ethics and Integrity in its Ethics and Integrity Development Grant Scheme). The point is that while a research methodology can have benefits, there can also be difficulties.
  • Re researchers having a duty to inform participants whenever they are acting in a professional rather than a research role. True, but wording should reflect that it applies only when both the professional and research roles are unavoidable.  The wording, as it stands, implies that having both roles is acceptable or the norm. 
  • Page 6. Last paragraph. Re “… risks to both participant and researcher”. It is the role of others, not the HREC to deal with risks to researchers, unless it is a participant/co-researcher engaged in data collection under instruction by a researcher.
  • General comment re chapter 3.1 Introduction. Particularly in relation to paras 5, 6 and last para.  Ideally, researchers should have sufficient training to identify topics which may lead to distress and they should be able to reflect and identify the impact they have on participants but sometimes their vested interest in doing the research, lack of adequate training or adequate supervision (if a student researcher) means that sometimes they will not identify these things.  This highlights the important role reviewers have in identifying issues that are missed or overlooked. Some comment/emphasis on this important legitimate role might be useful.

Guidelines


Element 1: Research Scope, Aims, Themes, Questions and Methods

 Re. 3.1.1 (g) “Whether or not the project has been reviewed by a formally constituted academic, scientific or professional review process”.   Change “the project” to “the project in its current form …”.  Explanation – The project may have been reviewed and funded by eg.  ARC or NHMRC and awarded less funding than requested, resulting in changes to the project. 

 Re. 3.1.2. (e). The meaning of the following wording is not clear – with the result that it could be interpreted in a number of ways: “For such research to be ethically acceptable, the known risk to participants must be lower than for research in where there are likely benefits …”

 Re. 3.1.9 – In terms of payment to institutions by drug companies sponsoring research, one way for researchers to provide assurance that payment will not adversely influence conduct, findings and publication of the research is to require information about  limitations on publications and details of payments to institutions in the PICF - in clear unambiguous language.   

 

Element 2: Recruitment

3.1.10 – meaning is unclear.

 3.1.12 – Not clear what this means

 3.1.13 – An illustrative example would help e.g. excluding women or children may mean that these groups end up without suitable treatments or being prescribed treatments untested in these groups.

 3.1.14 – what is entailed in having “due regard” for culture, traditions and beliefs?

 3.1.15 – what are examples of over-researched participant populations?

 3.1.16 (f) – re participants being “recruited by co-researchers unfamiliar with the guidance provided by this National Statement”. There are some distinctions to be made.   The mining of relationships is something that can affect voluntariness in the recruitment process.  Training of co-researchers for their role in recruitment and getting consent is a separate issue that should be addressed separately.  A co-researcher needs to have training about voluntariness and informed consent and should be following proper informed consent procedures. Nevertheless, the existence of the prior relationship can affect voluntariness and will not be eliminated with training – it’s often the reason co-researchers are sought. 

 3.1.17 Seems to be some confusion between research and treatment

 3.1.19 – Re ‘researchers and reviewers’ weighing the seriousness of the condition and the risks etc.  Not clear what this point is trying to capture. How is this about recruitment?  Primarily, it would seem that this is a matter for the patient/participant rather than researchers and reviewers to decide. 

 3.1.21 – Add reviewers to this i.e. “Researchers and reviewers should consider …”

 

Element 3: Consent

 3.1.25 (c) re “including relevant cultural sensibilities” – Wording should make it clear that this is not to be interpreted as a justification not to inform. 

 3.1.26 – re egsadd longitudinal as well as qualitative designs

 3.1.30 (a) re. “written information should not be unduly long or complex, even for complex interventions.  In reducing length, it is very important not to leave off information about risks and implications of taking part. 

 3.1.30 (b) – explain what is meant by “tiered information”

 3.1.31 – And, the issues are different where the participants are children, and whether the children are sick or well.   

 3.1.32 – re summary of the outcomes of the researchParticipants should have the option to choose this.  It should be made directly available to them.  They should not have to ask for it because they would not know when.

 3.1.33 – re continued access.  This information needs to appear early and prominently in the PICF with the potential benefits and risks where it can be factored into the decision to take part or not, not left to the end.   


Element 4: Data Collection and Management

 Data Identifiability

The preferred terminology is that which is consistent with the current National Statement.  The National Statement terminology is needed for the research context – for the reasons given in 3.1.44 of the revision i.e. “With advances in genomic knowledge and data linkage and the proliferation of biobanks, biospecimens and, in some cases, the data associated with them should always be regarded as, in principle, re-identifiable.” It is important for research participants to understand the implications of their involvement.  The term “de-identified” is misleading in the research context.  The term misleads both participants and researchers.

 Internet-derived data

There must be some situations where internet derived data can be used in research, qualify for a waiver but also not need to undergo HREC review. For a good consideration of the conditions that qualify internet research as exempt from ethics review, see Queens University. 2008 revised 2016. Research involving Digital Data Collection. Appendix 1 Criteria for ethics review. (This lists 8 criteria which must all be met to qualify as exempt from ethics review – it was previously called the Draft Exemption Policy). Available at:  http://www.queensu.ca/urs/sites/webpublish.queensu.ca.urswww/files/files/Research%20Involving%20Digital%20Data%20Collection_FINAL_2016FEB25.pdf (accessed 3 January 2017)

 Data management

3.1.49 Re “Researchers should reach mutual agreements with collaborators regarding the ownership, storage location, right to access, right to analyse/use and right to produce research outputs based upon stored data/biospecimens …” The implications of these things need to be in the PICF as they impact on the willingness of participants to take part, particularly where parents are consenting on behalf of children.  Who will ensure that promises made in consent forms are upheld? Who is the data custodian?  What is the extent and what are the limits of the data custodian’s role?  (Some of this may be covered in the section on Banking and sharing of data – but the reader may not refer to that section)

 3.1.52 and 3.1.53 How are these reconcilable with 3.1.49 – which suggests sharing of data is something arrived at by mutual agreement between researchers and collaborators?

3.1.55 – re keeping records long enough to trace participants regarding late or long-term health-related effects emerging.  Who, if anyone, is responsible for checking this? And, is this reconcilable with 3.5.39.7(d)?

3.1.59  Should read “Researchers and reviewers should recognise that expectations with regard to security and access should be proportional to the associated risks and ethical sensitivity of the research”  (Otherwise, the wording seems to imply that reviewers can sometimes be being excessively demanding with regard to security and access. It goes both ways. Researchers can sometimes become desensitised to the level of risk in their own research).  

Banking and sharing of data

3.1.65 – It would be helpful to explain why it cannot be used in research that is exempt from ethical review

 

Element 5: Communication of research findings or results

 Re. Introductory section, second paragraph.  Change “… can be a benefit, but it can also be a source of risk (e.g. psychological, social, legal).” to  “…can be a benefit, but it can also be a harm (e.g. psychological, social, legal).”

 Re “traditional custodians” – this could be confused with some kind of “data custodian” – it would be good to make the distinction clear. 

 

Element 6: Dissemination of project outputs and outcomes

No comments


 Element 7: After the project

No comments

4. Section 5

5.2.18 - Participants need to be informed about “the details of any capitation payments to researchers or clinicians”.  Giving them the “option of knowing” is not enough.  Apart from participants’ deference to researchers, a lot of people would find this a difficult thing to ask with the result that they are unlikely to ask.  Providing this information to participants will also assist with 3.1.9 and also 3.1.2 (d).    

5. Glossary

"Co-researcher"  -  The co-researcher examples are useful but the definition of "co-researcher" itself may be too broad.  There are different ethical implications when a participant/co-researcher is collecting data and recruiting participants to when they are involved in the planning and design of a project or they are part of an advisory group. 

I am leading a project in which I have conducted key informant interviews with Australian researchers and chairs of Human Research Ethics Committees on ethical considerations of using research participants as co-researchers. We are in the final stages of this project.  The main outcome will be a set of questions HRECs should ask (that will also be informative for researchers) and a training seminar for HRECs. Funding for this project comes from the University of Melbourne Office for Research Ethics and Integrity in its Ethics and Integrity Development Grant Scheme.  

 During the recruitment for our project it was apparent that there is a lack of clarity and there is complexity in defining co-researcher research. Getting the terminology right is one of the aims of our study.  Below is the definition we started with and then some points that have come out in the course of our study:

 Working definition:  A participant/co-researcher is someone who meets the criteria for participating in a particular research study or is a peer of the participant population (e.g. children or people with a disability), who actively collects data from other participants.  They may also access or recruit other participants. Participant/co-researchers are recruited for their ‘insider perspective’.  They are not the initiators of or responsible for a research project.

 Other points:

  • They most likely do not have formal training in research.  To become a co-researcher they are given training.
  • Being a co-researcher is not just being a research assistant that is recruited from a participant population, although if then used to help with recruitment, perhaps it is.  
  • Employing co-researchers it is not an affirmative action process.
  • The use of co-researchers is consistent with the expectation of funding bodies that increasingly expect researchers to work with consumer or user groups. Sometimes the term co-researcher is used to highlight this involvement or to suggest a kind of equality between participants and researchers. Nevertheless,  the term is more appropriate when the person has an active role such as collecting data or recruiting others.  

 The key things are:

  1. They meet the criteria for participating in a study (or they are a peer of the participant population), and
  2. they collect data from other participants – and/or they may recruit other participants

The main point is that when the term is used in the guidelines such as in 3.1.6, it can add confusion or complexity where it is not needed.  There is a difference between the input of those eg.  who have an advisory role from those who are involved in data collection and\or recruitment.

 

"Genomic data" – Explain "’omic’ research”

 

 

3. Chapter 3.5

Guidelines

Element 2: Recruitment

 3.5.9 re. “…they should consult with appropriate community representatives”.  The addition of “also” would help, so that it is clear that is not a substitute for consulting with individuals. 

 Element 3: Consent

3.5.12 . Participant should also be advised of the implications these publication or funding requirements can have, especially where it is a parent consenting on behalf of a child. 

 Element 4: Data Collection and Management

3.5.20 – re no intention to link or match.  How can that be guaranteed? Can it be guaranteed?

 Element 5: Communication of research findings or results

 3.5.39.7 (d) – How is this reconcilable with 3.1.55 and 3.5.39.26?

Decision tree

Re. the branch (part of an approved research project) and where the protocol does not permit the return of any findings from the research.  This will work for new projects but it may not be appropriate to declare “Do not return findings” for an older project where this cannot be ethically justified e.g. a finding of urgent clinical significance. (This could relate to 3.1.55)

 

Page reviewed: 10 July, 2018