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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: 
31
This submission reflects the views of
Organisation Name: 
Centre for Law and Genetics University of Tasmania
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

Introduction

 

We suggest that the second half of this ‘introduction’ is better seen as guidelines rather than introductory provisions, and should be revised as such.

 

Guidelines

 

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

3.1.2(D)            This provision requires qualification as it is overly broad. It currently could include benefits which are not relevant to an ethical risk/benefit analysis: for example, the potential inclusion of financial benefits as a benefit to which participants could attach significance but which many would not consider to be ethical as a counterbalance to physical risks.

 

3.1.2(F) It may be helpful to include “run-in” or “wash out periods” here, perhaps as (iii), during which tie no treatment is given.  

 

Element 2: Recruitment

 

3.1.17 “Intended” should be “likely to be of any therapeutic benefit.”

 

3.1.20 The CLG is not clear on the value added by this provision and suggest deletion.

 

3.1.23 The CLG is not clear on the value added by this provision and suggest deletion. If the provision is retained, it should not be applicable to low risk or social science research.  

 

3.1.24  This could be moved to earlier in the section to improve the logical flow, as a suggestion follow the chronological order.

 

 

Element 3: Consent

 

General comments:

-        given the shift towards shorter more effective and clear consent forms, this section appears lengthy and contains overly prescriptive circumstances and should be revised to be more in line with principle-based regulation (in line with our overall comments). This is especially important for non-clinical research covered by these provisions; and

-        recognition of different levels of consent is not clear – implied- specific, dynamic etc. We suggest that inspiration could come from the original National Statement (using the wording).

 

3.1.25/3.1.26 These appear more useful as introductory text rather than principles, given they do not impose requirements for a particular type of conduct.

 

3.1.27 This might also be introductory text. This is an example of where order of provisions should be improved given it seems unusual to consider third parties before participants themselves.

 

3.1.30 This provision should be revised to have short-form consents as the preferred default but permit longer consent forms in the case of particularly complex situations. It is also important that the consent form and associate information may be in forms other than writing e.g. electronic means. This might be part of this provision or a separate provision.

 

3.1.32  The word “appropriate” doesn’t appear to add value in this provision. The CLG is also of the view that the contents of the provision following “outcomes of the research” were unnecessary.

 

3.1.36 This requirement is only applicable in quite specific circumstances (e.g., research designed to collect information on unlawful behavior)– for all other research it is potentially unnecessary contributing to the proliferation of lengthy consent forms.

 

Element 4: Data Collection and Management

 

General comments:

-        this section contains a good explanation of what data collection is but we would suggest some restructuring to promote the logical flow of provisions (e.g., by going through the chronology of research); and

-        with regard to the apparent disparity between privacy legislation and National Statement terminology, we prefer the definitions used here.

 

3.1.38-3.1.40   These provisions function largely as introductory text rather than guidelines.

 

3.1.39 Recognising the change in identifiability of data over the course of time provides a useful addition to the National Statement.

 

3.1.42  Over and above the provision as written, it would be useful to also note the potential ethical benefits of identifiability (or re-identifiability), e.g. for return of results. As a drafting matter, this provision should be expressed in the positive rather than as a double negative.

 

3.1.52 This provision appears unnecessary. It is unclear why an HREC would ever approve research that is inconsistent with participant consent or the principle of respect. If kept, it should form part of the introduction.   

 

3.1.55 Where using biological samples: (1) It needs to be clear that there is no obligation on researchers to perform tests after the conclusion of research; and, (2) it should be clear how this sits with either return or destruction of samples at the end of a project, which is common, e.g., for research with Indigenous persons.

 

3.1.60 This provision also needs to also recognise the benefits of data sharing to make sure that socially identifiable ancestral groups are not excluded from the benefits of research. 

 

3.1.61 This could be introductory text.

 

Element 5: Communication of research findings or results

 

3.1.68(b)          This should require information about which kind of findings or results are returnable since it will be impossible to know the specific results in advance.

 

3.1. 68(h)         This word “desired” may not be feasible here. Perhaps it would be better to simply make provision for a participants’ right not to know.

 

 

Disclosure to third parties of findings or results

 

Introduction        This provision should be more general, e.g., “There are situations where research have an obligation to disclose findings and results to third parties.”

 

3.1.69 Cross references are needed to the extensive provisions that have been inserted governing the disclosure of genetic research findings.

 

3.1.70 This should be reworded and (a) and (c) removed. “The Researchers should be aware of situations where they are legally compelled to release findings or research. They should advise participants of the potential for this to occur.

 

Element 6: Dissemination of project outputs and outputs

 

General comments:

-        this section appears to be inconsistent with the section on data collection and management.

-        as a general comment, the section would benefit from more concise principles and greater clarity.  Consistent heading throughout could assist with this.

-        this section needs clear cross-references to relevant provisions regarding initial consent and approval of the project.

-        this section is incorrectly named given it includes requirements about data storage that apply throughout the life of a research project.

 

3.1.75  We agree that this is an important provision although “Understandable language” could be more clearly phrased. The language should be sufficiently clear and simple for participants to understand.

 

3.1.74 – 3.1.75            It is not often possible for researchers to provide time frames for publishing outputs. These provisions should be amended to reflect this.

 

3.1.76 It is not advisable to conflate the issues associated with storage and disposal in one provision. These should be treated independently. Each might have separate legal obligations and should be in separate sub-clauses.

 

3.1.77 We suggest that the National Statement provide stronger support for data sharing, e.g., that “Consistent with NHMRC and ARC policies, researchers should support sharing of data and materials. This should be facilitated by the research plan and other documentation.”

3. Chapter 3.5

Chapter 3.5: Genomic Research

 

Introduction

 

p.25 Second last paragraph: “Genomic research is considered to be high risk…[for] research involving Indigenous peoples”.  Care should be taken to ensure that Indigenous people are not excluded from benefits of scientific progress.

 

p.25 last paragraph: Much genomic data and material is inherently identifiable, therefore, care needs to be taken about accepting it as “non-identifiable” and, on this basis, “low risk.”

 

Guidelines

 

Element 1

 

3.5.1    The CLG disagrees with this principle on the basis that it points researchers towards the use of inferior research techniques. The CLG would suggest that where a researcher can obtain more information with superior techniques, then this should be attempted. If more information is the result, this of itself is not a negative. This statement has ways to deal with management of additional (and or clinically important) information. We suggest this provision is at least removed but preferably reversed.

 

3.5.1- 5.5.3      These are not prescriptive and should be revised to be introductory text.

 

Element 2

 

3.5.4    The CLG disagrees with the premise of this principle. The fact that research has implications for relatives does not mean that they automatically become research participants. The CLG suggests deleting the provision altogether or changing it into an introductory statement advising in a textural way that information gathered may have implications for relatives that need to be addressed.

 

3.5.5    Our comment in relation to 3.5.4  extends to disclosure.

 

3.5.6    It may be that a researcher is better placed to make a disclosure than a family member. A family member should not be a gatekeeper to participation in research, especially in the context of extended family situations as this may infringe on an individuals right to participate in a research project.

 

3.5.7    It is unclear why this should be part of review of a research plan.

 

3.5.8    This seems better placed as introductory text. It is also unclear how it fits with 3.5.6.

 

3.5.9    The word “appropriate” is unhelpful here.

 

Element 3:

 

3.5.11 This provision needs to be consistent with the understanding that researchers are not required to reanalyze genetic information after the conclusion of a study.

 

3.5.16 Self-reported information (given by participants about themselves or their family members) may not be accurate or complete whether it is family history or other health related information. This is not an ethical consideration and should be deleted.

 

Element 4:

 

3.5.18 This should be removed as it does not appear to add value beyond the introductory text.

 

3.5.20  “Intention” not to link or match data is not sufficiently strong to constitute non-identifiability. It should either be “impossible” to do so or there should be a contractual agreement to this effect.

 

3.5.21 This is predicated on the fact that only de-identified information is relevant to databases – there is likely to be many data sets that are identifiable for which this provision is not well suited.

 

3.5.23 This should be revised to read that: “Researchers receiving genomic information should not undertake nor permit attempt to re-identify the material or information unless permitted under the approved research plan.”

 

3.5.25  Reinstate previous wording from National Statement as it was preferable.

 

3.5.26 Consistent with other comments about ARC and NHMRC policies to share data, this section should be reworded to restate “researchers may share genomic information provided that” and continue with options (a) , (b) and (c). This is consistent with modern research genomics practices.

 

3.5.27-29         These provisions are otiose. These are all dealing with storage, which has already been dealt with and should be cross referenced as such.

 

Element 5

 

3.5.30 This is not a statement but perhaps introductory paragraph.

 

3.5.31 This is a strong principle and requires further development: “Raw genomic data should not generally be returned to participants.”

 

3.5.33 This should also be in an introductory paragraph.

 

3.5.34 The ethically defensible plan covers this already. This provision should be removed.

 

3.5.34-3.5.36   Any plan to return research findings will require an ethically defensible research plan which should set out specification of the analysis and delivery of findings. This section could include a list of the types of people or professions that could be relevant e.g., patients clinician or genetic counselor.

 

3.5.37  This seems to require reconsent and reanalysis which is inappropriate. This should be removed.

 

Decision Tree

 

-        The CLG supports the idea of a decision tree and its general formulation but has a couple of more specific comments.

  • for review of findings “Consult HREC re: establishment ….”. The CLG is concerned about whether HRECs have the appropriate expertise to consider the listed matters. There should be thought about how to address this through additional support services (e.g., the proposal in Andrew J Darnell et al, ‘A Clinical Service to Support the Return of Secondary Genomic Findings in Human Research’ (2016) 98 The American Journal of Human Genetic 435-441); and
  • consideration should also be given to reliance on established lists of variants for return, e.g., the ACMG list at a given point in time.

-        The tree does not capture the situation where return of research findings is not expected but information comes to light that should be returned (providing a default provision of non-return where the protocol doesn’t address return of findings). This should be addressed.

 

Guidance for the Development and Evaluation of an Ethically Defensive Plan for the Potential Return of Findings and individual Results from Genomic Research

 

Step 1: Determination of Whether Findings Will Be Returned

 

Determination of Whether Findings Will Be Returned

3.5.39.6           This statement is untrue and inconsistent with definitions of “genetic” and “genomic” provided in this National Statement. This provision should be deleted.

3.5.39.9           This provision is unnecessary and it’s unclear how an HREC should be satisfied of researcher compliance. The provision should be removed.

3.5.39.11         This is unclear and “any relevant distinctions between different types of validity” should be removed or clarified.

3.5.39.12         This may be very difficult for an HREC to assess.

3.5.39.16         This appears impossible to know in advance.

5. Glossary

Glossary

 

We disagree with the definitions of both “Genomic research” and “Genomic data.”

This should address problems including:

 

-        genomic should be consistent in both contexts.

-        genomics should be defined

-        genomic Research and Genomic Data should be defined in light of this; and

-        the definition of genomic is too narrow and excludes reference to individual genes as included in the definition of genomic research. It is not consistent with use of the terms under e.g. Element 4.

 

General Comments
Comments: 

General Comments

 

The Centre for Law and Genetics (CLG) is pleased to be given the opportunity to provide feedback on the changes to the National Statement.

 

Overall, the CLG:

-        in terms of formatting, comments positively on the use of boxes and call outs. These are an effective and useful addition to the statement.

-        in terms of structure and formatting, suggests that there would be some benefit in reordering and use of  consistent headings throughout the sections (e.g., separating out contextual information from guiding principles). A coherent and shared structure throughout elements would also assist researchers, ethics committees and other users to locate relevant provisions and understand the statement.

-        in terms of content, suggests that the sections would be improved by stronger principles based ‘overview’ provisions. Many of the provisions of the revised Statement are fine grained and overly prescriptive rather than providing overarching principles. This can lead to ‘rule based’ rather than ‘principle based’ interpretation and subsequent loopholes in the regulatory structure;

-        further, with respect to content, advises there should be clearer division between substantive and procedural provisions throughout. In addition to promoting the general overarching principles (mentioned above) this would also improve the usefulness of procedural provisions as it would clearly highlight where specific processes are required and

-        finally, advises that there should be much more of a logical flow of provisions across the document. ie in chronological order from conception of research through to post-research project provisions. This requires revision, including ensuring that duties assigned to HRECs related to ethical conduct of research are not conflated with research governance requirements.

Page reviewed: 10 July, 2018