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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: 
32
This submission reflects the views of
Organisation Name: 
University of Southern Queensland HREC
Personal Details
Specific Comments
Comments: 
1. Introduction to Section 3
  • Page 4, 1st paragraph/1st sentence:  It is suggested that “research” may be considered quite broad.  Perhaps reiteration that “research involving humans, their tissue, and their data…” would assist researchers to self-identify the full range of human research (noting that many ‘one-time’ ethics consumers may not read the general introduction to the National Statement and may miss this information).  It has been the experience of this committee that human data is often overlooked as being inclusive in human research.

     

  • Page 4, 4th paragraph (i):  It is suggested that further reference to the Chapters referred to in this paragraph be included so that researchers may self-identify which may be important to their research conduct requirements.  For example Chapters 3.2 Use of human biospecimens in laboratory based research, 3.3 Genomic research, and 3.4 Xenotransplantation research.

     

  • Page 4, 4th paragraph (ii):  It is suggested that benefits could be placed before risk to provide a more positive approach to how ethics be considered.  That is, if ethics and research integrity (in general) is to move from the ‘risk aversion’ approach to be a more reflective practice approach (AHRECS, 2016), focusing on the benefits may assist researchers to initiate conversations in this fashion.

     

  • Page 5, 1st paragraph:  Suggest include “involves [human] biospecimens…”, in order to avoid any confusion with general laboratory work.

     

  • Page 5, 3rd paragraph and dot points:  Suggest using Chapters and associated names in full wherever mentioned to ensure that researchers are making the correct associations.  See also feedback for Page 4, 4th paragraph (i).

 

  • Page 5, 4th paragraph:  Would reference to the Chapter (currently 4.7) Aboriginal and Torres Strait Islander Peoples also be referenced in this section?

     

  • Page 5, last paragraph:  It may be unclear to researchers of the relevance of consulting the NHMRC’s Statement on Consumer and Community Participation in Health and Medical Research.  Perhaps inclusion of a sentence or two to identify why, and when this would be likely would be helpful.  It has been the experience of this committee, that if researchers feel that something is not relevant to them, or are in doubt, they may be likely to avoid a requirement all together.

2. Chapter 3.1

Chapter 3.1: The elements of research

Introduction

 

  • Page 6, 2nd paragraph:  Consideration of how the analysis of human data is to fit within the “wide range of methods and practices”?  Suggested that this could be reworded to reflect “…interventional, experimental, observational, and/or analytical in nature…”

 

  • Page 6, 8th (last) paragraph (i):  Perhaps also protocols for dealing with distress that may be experiences by a participant following their participation in the research could be included.  It is suggested that researchers and reviewers be mindful (or be required to think about) the experience that an participants is “left with”, not only the experience acquired through the data collection/conduct process.

     

  • Page 6, 8th (last) paragraph (ii):  It is agreed that researchers should have sufficient training to help them in making predictions about participant experiences.  However, will this be something that will be provided at a national level by the NHMRC?  It is unclear what ‘sufficient’ may represent, who/whom is making this determination, and who/whom is responsible for the provision of the training.

     

  • Page 7, 1st paragraph:  Are the ‘core’ principles here the ‘guiding ethical’ principles outlined in the National Statement, or something else? 

     

Element 1:  Research scope, aims, themes, questions and methods

 

  • Well done.  This element is nicely set out and maintains a logical flow.

 

Element 2:  Recruitment

 

  • Page 10, 1st paragraph:  Suggest that dot points be used for the elements listed to assist in readability.

 

  • 3.1.11:  To avoid confusion and for consistency with key questions and/or other questions, suggest revision of text.  It appears this section is using “selection” to refer to screening participants, with the “selection” in 3.1.12. to refer to the choice of recruitment strategy.  Therefore, suggest wording be revised to be “… criteria for selection screening participants.”  OR “… criteria for selection and/or excluding participants.” in this section.

     

  • 3.1.12:  Following on from feedback provided for 3.1.11., is it necessary to include “conduct of” in this section?  At this time, the project is still proposed, therefore only the ‘selection’ of the recruitment strategy would perhaps be relevant. 

     

  • 3.1.13:  Depending of use of terminology in 3.1.11 (i.e. ‘screening’ or ‘inclusion/exclusion’), review terminology use in this section.  For example, if ‘screen used’, then revise this section to be along the lines of ‘The criteria used to screen the potential participant pool….”.

     

  • 3.1.15. (i):  Suggest use of ‘reviewer’ versus ‘research ethics reviewer’ for consistency with use throughout remainder of document.

     

  • 3.1.15 (ii):  It is unclear how ‘self-determination’ is to be used in the context of this section.  Perhaps a more lay description could be used here?

 

  • 3.1.16 (b):  Could it be further defined that the ‘risks related to recruitment’ referred to here are ethical risks, as opposed to methodological risks?  It is the experience of this committee that this is often misconstrued and responses provided around ensuring that sufficient participant numbers are obtained, versus the risk that may be encountered to individual participants as a result of the recruitment strategy chosen.

     

  • 3.1.16 (f):  Is co-researchers used here to represent ‘others’, such as organisations/associations/employers that may intervene in the recruitment process in some way?

     

Element 3:  Consent

 

  • Page 13, 1st paragraph:  Suggest reference to “see also Chapter 4.7 Aboriginal and Torres Strait Islander Peoples.”

 

  • Key questions:  Where use of chapters is included, suggest full reference to chapter and what it refers to be included.  For example Chapter 2.2. General requirements for consnt and 2.3 Qualifying or waiving conditions for consent.

     

  • Key questions (last question):  Perhaps reference to ‘the future use’ of the data here would assist researchers to clarify that ‘other purposes’ includes this.

     

  • 3.1.25:  Is there a word missing here?  “The approach taken to [obtain] consent of participants…”

     

  • 3.1.26:  Suggested revised wording to avoid double use of ‘that’:  “…recognise that research involving multiple methods or….” versus “..recognise that research that involves multiple…”

     

  • 3.1.27:  It is unclear on what basis ‘supervisors of participants’ have been singled out as requiring to know who has been approached about participating.  Similarly, if third parties are aware of who has chosen to participate, should participants also be made aware if the third parties will be made aware of who has “been chosen” to participate, if this is an element of the research design?  Perhaps reword to be “… which individuals have chosen (or been chosen) to participate.”

  • 3.1.28:  Whilst agreed to in principle, it is unclear how this would be effected in practice.

 

  • 3.1.30:  It is agreed that the sentiments of this section are progressing in the right direction.  Research has demonstrated that long information sheets tend to be skimmed, skipped, and or missed all together.  However, when read in reference to section 2.2.2 – 2.2.6., these guidelines appear to be contradictory in what researchers are expected to provide.  For example, if all requirements in 2.2.6. are provided, then by nature of outlining the information in a coherent manner, the information/consent document becomes quite long.  It is suggested that section 2.2.2 – 2.2.6 may need to be slightly revised to adequately capture the essence of the revised elements in Chapter 3.1.

     

  • 3.1.31:  Bearing in mind that written consent forms are normally signed and returned to a researcher, perhaps thought could be given to “information that is provided to a participant alongside the consent strategy” be considered.  This information can be retained by the participant and referred to at any time prior to, during, or after their participation. 

     

  • 3.1.32:  It is agreed that the research should advise on provision of summary research outcomes.  However, it is suggested that the specific mechanisms be removed as this may provide a “minimum” effort that researchers aim to achieve.  If this is left open, innovative responses and conduct may be encouraged and implemented.

     

  • 3.1.31 & 3.1.32: Consideration should also be afforded by researchers and reviewers to how an individual participant’s details be registered to receive information about the project outcomes, particularly if the collection of the data is in an anonymous fashion.

     

  • 3.1.34:  This clause is a little awkward and unclear.  Is this perhaps asking “for research that is likely to generate information with hereditary implications, consent processes should be designed to observe the requirements outlined in Chapter 3.5  Genomic research”?

     

  • 3.1.35:  It is noted that the intent here is most likely to include the unobvious data collections.  However, it is suggested this might then exclude the obvious withdrawal of data.  Suggested rewording around “ … withdrawing consent, including with respect to withdrawal of their data.  This includes data that has been collected without identifiers or where identifiers have been removed.”  This will also assist researchers in considering the ownership of the data collected (which has been a constant source of re-education for researchers associated with our committee.)

     

  • General:  Consideration of inclusion of a discussion that for some observational methods (such as Internet Derived Data), that waiving the requirement for consent may be a valid option for maintenance of homeostasis of group dynamics.

 

Element 4: Data Collection and Management

 

  • p. 15, 3rd paragraph:  .  Suggest ‘However use of this data may raise…”

 

  • 3.1.40: ‘recognise’ versus ‘recognize’.

     

  • Suggest 3.1.42 and 3.1.41 be swapped.  That is consider that anonymisation may not be required, before taking care to protect identities may be a more logical decision sequence.

     

  • 3.1.41:  Suggest revision of wording, for example “Unless participants have agreed that their identity may be revealed (e.g. in research outputs), researchers should take additional care to ensure sensitive participant information provided (e.g., research projects that focus on member of small communities, or key individuals), is not inadvertently identified through research practices such as dissemination of research outputs.  This may require practices such as obscuring participant details through use of codes, pseudonyms, and similar in the data collection, presentation, and/or dissemination of research output processes.

     

  • 3.1.42:  Perhaps the ‘process of removing all personal identifiers’ versus ‘non-identifiability of data’?  Also options that will be undertaken to remove personal identifiers should be outlined to participants as part of the consent process.

     

  • 3.1.43:  Suggest breaking into a couple of sentences to assist with readability.

     

  • 3.1.44:  It is unclear of the context of this section.  As written, it does not appear to make sense.

     

  • Internet – derived data – General

     

    • Noted that there are numerous international definitions used, e.g. Internet Research (IR) in USA; Internet-Mediated Research (IMR) in UK; Internet-Based Research (IBR) in Canada, etc..  Whilst the term “Internet derived data” encapsulates what is being referred to, consideration could be provided to the introduction of yet another IR(*) term in the international arena.

    • Definition to be included in the Glossary.  Suggest one similar to the one provided by Hewson, et. al., 2013 in British Psychological Society’s Ethical Guidelines for Internet-Mediated Research is a good starting point.

    • Public (or semi-public) may require some further definition/clarification as to what this means in the context of these guidelines.  Does this mean the legal definition, or perhaps the ‘perception of the participant/Internet author’?  Schultze & Mason, 2012, p. 309 provide a guide to public versus private spaces that look at dimensions such as the size of the group, purpose of communication, social status of the online community, intended audience for contribution, membership policy, norms and expectations, and content storage and accessibility that may prove useful to researchers and reviewers in determining this.

    • Are individuals ‘permitting’ the use of their material or are they being requested to consent to it being used (depending on the research design/method)?  If considered to be publically available data, then will addressing copyright and privacy legislation be sufficient, or is there a social/moral requirement for researchers to go beyond this?  When specifically, does an Internet user become a human research participant (if they have not consented to this prior to posting on the Internet).

    • Unoffically, researchers have been reported to break the terms and conditions of, for example, Facebook, through the creation of fictitious accounts.  Is there an ethical obligation here, or is this more ‘research integrity’?

       

  • 3.1.45:  Could a researcher provide a ethically defensible plan to collect data from the Internet unobtrusively, i.e. where they will not alert the individual/group members of the research (with approval to waive the requirement from consent, of course).

     

  • 3.1.49: Consideration to the right to analyse/use/and re-use?

     

  • 3.1.50: It is unclear which/whose policies and guidelines.  Perhaps these may be omitted here?

     

  • 3.1.52:  ‘ authorised’ versus ‘authorized’.

     

  • 3.1.52: Is the suggestion here that if individuals are not identified then ethical review would not be required?

     

  • 3.1.55:  Suggest ‘late or long-term health related effects’ may require definition within the Glossary.

     

  • 3.1.56: Would this also be in line with legislative requirements?

     

  • 3.1.57:  It is unclear how this requirement would be effected in practice.

     

  • 3.1.58:  Consider if this constitutes ‘boundary’ creep.   That is, if this is to be an ethical review, this section is now suggesting that ethical reviewers are also required to be IT consultants.  It is also unclear what ‘secure service’ and appropriate access controls’ represent here.

     

  • 3.1.63:  Add ‘s’ to researcher.

     

  • 3.1.64:  Consider adding example, e.g. through matching of reported data, and/or size of reported data bins.

     

  • 3.1.66:  Suggest break into two sentences to assist with readability.

     

Element 5:  Communication of research findings or results

 

  • p.20, 2nd paragraph:  ‘…taken to the communication of findings….’

 

  • p.20, 2nd paragraph:  It is unclear who the traditional custodians are referring to here.

     

  • p.20, 3rd paragraph:  ‘planned and anticipated’  versus ‘planned or anticipated’?

     

  • Key questions:  Suggest additional question be included around what support will be provided in the event of adverse results.

     

  • 3.1.67:  Suggest Chapters and names be included together and in full, e.g. Chapters 3.4 Human biospecimens and 3.5 Genomic research.

     

  • 3.1.68:  Recommend that the ‘ethically defensible plan’ in this section be labelled more accurately to differentiate it from the one outlined in Chapter 3.5.   For example the “Plan to disclose or withhold research findings and/or results”, and that cross reference to section 3.1.68 be incorporated so that it is clear what is to be included in the plan.

     

  • 3.1.69:  include ‘an ethically defensible plan to disclose or withhold research findings and/or results should:

     

  • 3.1.68:  What is the researchers ‘duty of care’ here?  Perhaps an additional point (i) outline the research team’s duty of care to disclose research findings and/or results to a third party (see also 3.1.69 to 3.1.71).

     

  • 3.1.68:  Should consideration also be provided to outlining the support mechanisms if an adverse event arises?

     

  • 3.1.69:  It is unclear of ‘relative’ benefits.  Perhaps this can be omitted?

     

  • 3.1.71:  It is assumed that ‘reviewers’ here is referring to the ‘respective HREC/s’?

     

Element 6:  Dissemination of project outputs and outcomes

 

  • p.22, 1st paragraph: Suggest  ‘may also make’ versus ‘ will be to make’.

 

  • 3.1.74:  Agree with the sentiments of this section.  However this will add to the consent process.  Considerations should also be provided to whether this may be known at the commencement of the project.

     

  • 3.1.75: ‘in language that can be readily understood by them’ versus ‘in understandable language’.  Suggest also that examples may be provided.  For example, provision of a journal article to non-academic participants would not be considered in readily understood language for this participant group.  Researchers should also consider that multiple outputs may be required to address differing participants groups within a research project.

 

Element 7:  After the project

 

  • p.23, 1st paragraph:  Suggest consistent use of terminology.  For example ‘future use of data’ versus ‘later use’.

 

  • 3.1.76:  Suggest ‘retention’ versus ‘storage’ to be in line with key questions used above.

     

  • 3.1.76:  Suggest addition of additional point (c)  comply with relative national and state legislative requirements.

     

  • 3.1.78:  Suggest ‘minimum retention period’ versus ‘requisite period’.   Also violate the National Statement principle of respect and Australian Code for the Responsible Conduct of Research requirements.

 

3. Chapter 3.5

Chapter 3.5 Genomic Research

 

  • p.25 Introduction.  7th paragraph:  Consideration of revising wording (or inclusion of wording) “high risk”.   This may inadvertently cause confusing with risk assessments (outlined in Chapter 2.1: Risk and benefit).  Perhaps something along the lines of “Genomic research involving Indigenous peoples in Australia and internationally requires additional ethical consideration that involves relevant and on-going community consultation and active agreement on the part of communities and traditional owners to ensure research practices value and protect cultural diversity.”

 

  • 3.5.5:  It is unclear what “disclosure of information” is being referred to here.  Further detail may be required.

     

  • 3.5.9:  Would this requirement be necessitated in all cases?

     

  • 3.5.12:  Suggest this be revised to be an absolute. For example:  “Participants should be advised that where publication or funding requirements conditions may require submission…..”

     

  • Suggest that 3.5.15 be moved ahead of 3.5.14, so that the ‘opt-out approach’ is covered initially, then the ‘waive requirement of consent approach’ to ensure a logical flow of decision making (see following comments also.)

     

  • 3.5.14:  It is taken that this section is actually discussing a ‘waive requirement of consent approach’.  Therefore, it is suggested that it be reworded to be as such.  For example “A waiver of the requirement of consent approach can only be considered if:  (a) the data or information to be….; (b) prior consent was provided…; etc.

     

  • 3.5.14 (a):  It is suggested that ‘collected’ may be redundant in this context.

     

  • 3.5.14 (b):  It is suggested that ‘prior consent for the use of the genomic data’ be added.

     

  • 3.5.16:  It is unclear who the ‘other people’ referred to are.  Are these family members?  If yes, then it is suggested that this be included here.

     

  • 3.5.16:  First sentence could be broken into two to assist with readability  Perhaps also include it ‘may’ not be practicable, as this currently suggests this would always be unfeasible (?).  The terms ‘family member’ and ‘pedigree’ have been introduced;  it is suggested these be defined in the Glossary.

     

  • 3.5.16:  Last sentence – It is unclear where, and/or to whom, the researchers are ‘acknowledging’ the self-reported data may not be accurate or complete.  Would this be to the participants, in depositing to a biobank, dissemination of findings, etc.?

     

  • 3.5.17: Introduction of relatives (which is defined in Glossary).  How does this differ from family members, which has previously been referred to?  Also, it is noted that the participant may contact the researcher if their preferences changes.  Do the family members/relatives have any entitlements here?

     

  • 3.5.19: For consistency, is this families, family members, or relatives?

     

  • 3.5.22:  It is unclear what ‘informational materials’ are being referred to here.

     

  • 3.5.24:  This is a very long sentence.  Perhaps this can be broken up to assist with readability?

     

  • 3.5.25:  Perhaps revise wording for consistency, for example:  “Researchers should take special care to protect the privacy of genomic research participants ensuring genomic information is not misused to stigmatise or discriminate against them unfairly.”

     

  • 3.5.27:  Should consideration also be given go whether the genomic data may yield historic familial information when determining the retention period (for example, in the case of that outlined in 3.5.37)?  How would consent that has been provided for the future use of the genomic data factor into this decision?  Suggest inclusion of wording “…retained for at least the minimum legally required period, and one that permits for the verification…”.

     

  • Element 5:  Communication of research findings or results: General comments

     

  • Proofing required for consistent use of terms (e.g. if using ‘genomic research findings and/or individual results’) throughout this section.  This is referred to in quite a number of different ways.

     

  • Reference to ‘ethically defensible plan’ (i.e. used inconsistently throughout Chapter 3.5).  This is also referred to in the Chapter 3.1.  These appear to be quite different plans, therefore perhaps they could be labelled differently to avoid confusion.  For example, the plan in this section (e.g. in 3.5.33; heading p.32; 3.5.29.2, etc.) could be referred to as the “plan for returning genomic research findings and/or individual results”  

     

  • 3.5.30: Suggest inclusion of reference. “Refer also to 3.39.6 to 3.5.39.10” (as it was unclear when this was first introduced of the meaning).

     

  • 3.5.31:  Should an appropriate lay summary document/report be made available where genomic research findings and/or individual results are being returned?  It is suggested that if yes, that contact details of appropriately qualified individual/s to provide support in interpretation/support would also be required on such a summary/report.

     

  • 3.5.32:  Suggest NATA be included in full before acronym introduced.

     

  • 3.5.33:  Suggest inclusion of a Figure and reference (versus, decision tree ‘below’), as the figure is on its own page and not below.  Perhaps revise wording to be “..should refer to the decision tree in [title of figure], Figure X, and the guidance in this section for developing a plan to return genomic research findings and/or individual results”.

     

  • 3.5.34:  Perhaps the plan is to contain (versus would benefit from) a link with a clinical service, etc.?  Also will this information be communicated to a participant, family member etc., for their access?

     

  • 3.5.35:  Grammar for individual/organisation (?).  Perhaps “Genomic research findings and/or individual results significant to the health of a participant or relative should be returned by the appropriate clinical service .  Where such a service is not available,…….”

     

  • Decision tree p. 31. Suggest add figure number, and consistent reference.  Include NATA in full if possible (or * footnote).

     

  • Title, p. 32. Introduction of ‘potential’ return of findings.  Suggest revision to be consistent with context of this section, e.g. ‘genomic research findings and/or individual results’.

     

  • 3.5.39.1: Introduction of disclosure and non-disclosure.  Suggest rewording to “…manage the return of genomic research findings and/or individual results…” for consistency.

     

  • 3.5.39.2: Distinguish ‘ethically defensible plan’ from that referred to in Chapter 3.1.

     

  • Suggest 3.5.39.4 & 3.5.39.5 be swapped, so that description of information distinctions are listed first, then the requirement for researchers to describe the returnable findings second.  This may form a more top-down logical approach (?)

     

  • 3.5.39.3 (as is currently numbered):  Suggest consistency of terminology and removal of ‘potential’.

     

  • 3.5.39.7: Suggest revision of wording “Where there will be any return of findings to participants genomic research finding and/or individual results are to be returned to participants, they should be advised researchers should advise the participants as to which findings…”.  Revise options (a) to (d) accordingly to match revised introductory wording.

     

  • 3.5.39.8:  It is unclear here if a biobank is the mechanism where genomic data is to be stored or if this is the entity that is undertaking the collection/management/storage/return of research findings and/or individual results.  Further clarification (and or definition within the Glossary) may be required.

     

  • 3.5.39.9:  Should consideration be evidence of awareness and commitment to abide by such institutional policies/procedures?  Awareness in and of itself may be deemed insufficient.

     

  • 3.5.39.14 & 3.5.39.15:  Suggest inclusion of ‘genomic research findings and/or individual results communication process’ for clarity of what is being communicated.

     

  • 3.5.39.15:  Introduction of an ‘authorised decision maker’.  Who might this include?

     

  • 3.5.39.22:  Which resources are being discussed here?  Further clarification should be included, together with an indication of who would normally be responsible for any associated costs.

4. Section 5

5.1.6:  Revise “Chapter 3.5: Human genetics” to “Chapter 3.5 Genomic research”

5. Glossary

Suggest the addition of the following definitions:

 

  • Family member/s
  • Internet derived data
  • Late health effects
  • Long-term health effects
General Comments
Comments: 
  • The USQ HREC commends the revision of Chapters 3.1, 3.2, and 3.3 to incorporate aspects of ethical consideration pertaining to each phase of the research conduct cycle, and which are applicable to the majority of all forms of research.

     

  • Outlining the links between research scope, aims, themes, questions, methods and ethical considerations is welcomed.  This has traditionally been an area where questions have been  raised by both researchers and HREC members.  Further guidance is likely to provide clearer areas of responsiblity.  This is likely to provide a HREC with some agency to consult with an applicant around the sufficiency of the justification for a project to ensure that it meets the requirement of research merit more effectively.

     

  • The links from each element to the relevant overarching ethical principle/s is helpful and anticipated to assist researchers (and reviewers) in making the ‘big picture’ connections in ethical thinking and all being well, resulting research conduct.

     

  • The inclusion of key questions within each element section will assist researchers to focus on what will be required as part of the research conduct and how this fits with ethical considerations.

Page reviewed: 10 July, 2018