/Docs/G/GA4GH/Ethics-Review-Recognition-Policy/Form/004.md
| Note.Version | = | Version POL 004/v. 2.0: TBD | ||
| Note.OriginURL | = | https: docs.google.com/document/d/1up49vAjekacy5jvMxYT2KhE-0PIr7VwjQiNRJNhRGjY/edit (before edits ) | ||
| Note.Publisher | = | Global Alliance for Genomics and Health: | ||
| Ti | = | Ethics Review Recognition Policy | ||
| sec | = | {Preamble.Sec}{Acknowledge.Sec} {Rev.Sec} | ||
| Preamble.Ti | = | Preamble | ||
| Preamble.1.sec | = | This document is the Global Alliance for Genomics and Health’s ({Def.GA4GH.sec}’s) Ethics Review Recognition Policy. It builds on the mission of the {_GA4GH} and provides greater direction for the interpretation of the {_GA4GH} Framework for Responsible Sharing of Genomic and Health-Related Data (the “{DefT.Framework}”). | ||
| Preamble.2.sec | = | Research ethics committees ({Def.REC.sec}s) review the ethical acceptability of research involving human participants. The steady growth of internationally collaborative, data-intensive, and population-based research projects has drastically increased the number of ethics reviews undertaken. Yet, there has not been a co-evolution of the ethics review system. This has led to an exacerbation of duplicative and potentially inconsistent ethics reviews. While some countries have enacted single ethics review policies within their jurisdiction to reduce the administrative burden, prevent delays, and reduce risk of inconsistency, no country as yet permits multi-site research with approval from a {_REC} outside the jurisdiction. | ||
| Preamble.3.sec | = | There is thus a need to establish an ethics review recognition policy {_Framework}. This Policy is intended to inspire confidence in the adequacy of an ethics review from another jurisdiction on the basis of equivalent requirements of ethics review. In turn, this enhances the responsibility of the research enterprise and adds to its credibility and quality. Ethics reviews undertaken in light of this Policy would reflect sufficiently similar procedural approaches to the assessment of the ethical acceptability such that duplicative ethics reviews can be reduced. | ||
| Preamble. | = | [G/Z/paras/s3] | ||
| Context.Ti | = | Context | ||
| Context.Purpose.Ti | = | Purpose | ||
| Context.Purpose.1.sec | = | Supplementing the {_Framework}, the purpose of this Policy is to provide {_Essential_Element}s for the ethics review process of multi-jurisdictional research involving health-related data (including genomic data and data derived from samples) so as to both foster recognition of extra-jurisdictional ethics reviews and improve the consistency thereof, as well as to promote efficient and responsible health-related data sharing for human health and wellbeing. | ||
| Context.Purpose.2.sec | = | It is hoped that this Policy will be useful to those charged with drafting national, local, and institutional regulations and policies, as well as international, regional, or national accreditation systems, such that the possibility of ethics review recognition between competent research ethics committees ({_REC}s) can be enhanced. | ||
| Context.Purpose. | = | [G/Z/ol/s2] | ||
| Context.Tools.Ti | = | Resources | ||
| Context.Tools.1.sec | = | Tools and resources have been developed by the {_GA4GH} to support its Policies. They have been designed to be in accordance with the Foundational Principles of the {_Framework}, and are provided to assist with data sharing, interoperability of consent forms, and metadata procedures among {_REC}s. The latest tools and resources developed by the {_GA4GH} may be found on its website. | ||
| Context.Tools.2.sec | = | Additionally, in reviewing the ethical acceptability of multi-jurisdictional research involving health-related data, the World Health Organization’s Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants and the International Compilation of Human Research Standards, compiled by the U.S. Office for Human Research Protections ({_OHRP}), should be considered. | ||
| Context.Tools. | = | [G/Z/ol/s2] | ||
| Context.sec | = | |||
| Context. | = | [G/Z/Base] | ||
| Differ.Ti | = | Managing Differences in Ethics Principles, Polices and Norms | ||
| Differ.Intro.sec | = | Differences in the content or application of ethics principles, policies, or norms between jurisdictions should not be unduly considered as a barrier to achieving ethics review recognition. Such differences impacting on the review of a research application should be identified, and the mandatory or non-mandatory status of the principles, policies, or norms where they originate should be determined. | ||
| Differ.Mandatory.Ti | = | Mandatory Status | ||
| Differ.Mandatory.sec | = | The constraining character of ethics principles, policies, or norms that are mandatory in one jurisdiction should be respected in regard to this jurisdiction. The differences should be managed with inventive solutions to prevent undue exclusion of data that could undermine the research or diminish the value of its results. Innovative solutions to manage these differences could be implemented by many stakeholders (e.g. researchers, {_REC}s, institutions, regulatory authorities, government) at many stages of the process (e.g. research project development, formal establishment of a recognition system, {_REC} review, etc.). Solutions may include an ad hoc harmonization agreement from a competent body or a specific exception applicable to a jurisdiction. | ||
| Differ.Non-Mandatory.Ti | = | Non-Mandatory Status | ||
| Differ.Non-Mandatory.sec | = | Differences in ethics principles, policies, or norms that are not mandatory in one jurisdiction may be formally managed before the ethics review assessment (e.g. through an agreement on recognition). In the absence of such prior formal arrangement, these differences should be managed by {_REC}s in accordance with accepted international ethical principles that protect and promote human dignity and human rights (e.g. the Universal Declaration on Bioethics and Human Rights). Management of these differences could involve harmonization for all the jurisdictions involved or a specific exception for one jurisdiction. | ||
| Differ.Liability.Ti | = | Liability | ||
| Differ.Liability.sec | = | Liability of institutions and individuals arising from ethics review recognition should not be unduly considered as a barrier to implementing recognition. Risk of liability related to recognition should be managed as any comparable liability risk, that is, according to the actual level of risk involved. The level of risk associated with ethics review recognition should be fairly evaluated in the context of all the liability risks usually assumed by the institutions or individuals. Risk management can be achieved through regulations, agreements, monitoring, and insurance. | ||
| Differ.sec | = | {Differ.Intro.sec} | ||
| Differ.Mandatory. | = | [G/Z/Base] | ||
| Differ.Non-Mandatory. | = | [G/Z/Base] | ||
| Differ.Liability. | = | [G/Z/Base] | ||
| Differ. | = | [G/Z/Base] | ||
| Essence.Ti | = | Essential Elements of Ethics Review to Foster Recognition | ||
| Essence.Intro.1.sec | = | The following {Def.Essential_Element.sec}s establish a common effective baseline of the ethics review process for multi-jurisdictional research involving health-related data. This should ensure trust in the ethics review process followed in another jurisdiction and thereby recognition of the decision rendered by a {_REC} from this jurisdiction. The {_Essential_Element}s are intended to complement and build upon existing human rights instruments, laws, regulations, guidelines, and practices. They are not intended to supersede any human rights instruments or national laws and regulations. | ||
| Essence.Intro.2.sec | = | All stakeholders (namely researchers and research institutions, research sponsors/funders, governments and other regulatory or quasi-regulatory bodies including managing authorities of {_REC}s, {_REC}s, research participants, and communities) should work together and contribute to achieving each of these {_Essential_Element}s in function of their capacity, authority, and responsibility. | ||
| Essence.Intro. | = | [G/Z/ol/s2] | ||
| Essence.Norm.Ti | = | Norms, Authority and Independence | ||
| Essence.Norm.1.sec | = | Norms of conduct in the ethics review and continued oversight of the research by {_REC} should be established. These norms should be publicly accessible. | ||
| Essence.Norm.2.sec | = | Adequate authority and independence of the {_REC} should be assured. | ||
| Essence.Norm.3.sec | = | {_REC}s and their members should be free to make decisions on the ethical acceptability of a research application, and must be free of institutional (public and private), commercial and political influence, as well as real or perceived conflicts of interest. | ||
| Essence.Norm. | = | [G/Z/ol/s3] | ||
| Essence.Resource.Ti | = | Resources | ||
| Essence.Resource.sec | = | {_REC}s should be resourced sufficiently such that they can carry out their mandate professionally in respect of the {_Essential_Element}s of ethics review recognition. | ||
| Essence.Competence.Ti | = | Competence | ||
| Essence.Competence.1.sec | = | {_REC}s should have professional competence regarding the ethics review of health-related data research, including adequate expertise or experience with such research, and should be well-informed of its specific ethical considerations. The latter may be accomplished through seeking advice from specialist referees. Terms of reference for referees should be established prior to any such consultation. | ||
| Essence.Competence.2.sec | = | {_REC} members should demonstrate competency through completion of continued education/training, and accreditation if possible, to meet these professional standards. This training should inform members of developments in ethics, science, policy and technology that are relevant to the ethics review of research involving health-related data. | ||
| Essence.Competence.3.sec | = | Rules and composition (e.g. qualifications) of {_REC} membership should be publicly available, though names of {_REC}s members do not have to be. | ||
| Essence.Competence. | = | [G/Z/ol/s3] | ||
| Essence.Diligence.Ti | = | Diligence | ||
| Essence.Diligence.sec | = | {_REC}s should make their decisions with diligence and communicate with diligence their requests and decisions to researchers, committee members, and other {_REC}s. | ||
| Essence.Form.Ti | = | Procedures and Forms | ||
| Essence.Form.1.sec | = | Harmonization of procedures and forms required for ethics review should be promoted to minimize the administrative burden for researchers. | ||
| Essence.Form.2.sec | = | Information and requirements related to research application submission procedures should be publicly accessible. | ||
| Essence.Form. | = | [G/Z/ol/s2] | ||
| Essence.Proportional.Ti | = | Proportionate Scrutiny | ||
| Essence.Proportional.sec | = | Scrutiny of {_REC} review should be proportionate to the actual and potential scale, benefits, risks, complexity and particularities of each research application under review. | ||
| Essence.Transparent.Ti | = | Transparency | ||
| Essence.Transparent.1.sec | = | A registry of {_REC}s that operate in a particular legal jurisdiction (i.e. geographic area) should be established and be made publicly accessible and continuously updated. | ||
| Essence.Transparent.2.sec | = | Written, clear, reasoned decisions of an unfavourable ethics review opinion or rejection should be provided by {_REC}s to research applicants. All decisions should be kept on file. | ||
| Essence.Transparent.3.sec | = | Subject to confidentiality agreements and as the case may be, copies of a {_REC} decision or opinion letter for a multi-jurisdictional research project involving health-related data should be made available to the other {_REC}s involved in reviewing the same project. | ||
| Essence.Transparent. | = | [G/Z/ol/s3] | ||
| Essence.Process.Ti | = | Natural Justice and Equity | ||
| Essence.Process.1.0.sec | = | In order to maintain confidence in the evaluation and recognition systems, {_REC}s should apply norms of natural justice (due process). {_REC}s should treat applicants equitably and subject them to a fair process of ethics review. This includes the possibility for the applicants: | ||
| Essence.Process.1.1.sec | = | to be heard (e.g. attendance of applicants at {_REC} meetings to provide additional information and to answer questions); | ||
| Essence.Process.1.2.sec | = | to receive a timely, reasoned, ethics-based, and understandable decision; and | ||
| Essence.Process.1.3.sec | = | to ask for a revision of a final decision to the same {_REC} or to appeal to another {_REC} (with appropriate communication between the original {_REC} and the {_REC} receiving the appeal) or competent authority (e.g. managing regulator of {_REC}s, national bioethics council). | ||
| Essence.Process.1. | = | [G/Z/ol/s3] | ||
| Essence.Process.2.sec | = | {_REC}s should be subject to monitoring of their procedures by competent authorities. | ||
| Essence.Process.3.sec | = | {_REC}s should publish and make publicly available a summary of their final decisions, whether favourable or otherwise. | ||
| Essence.Process. | = | [G/Z/ol/s3] | ||
| Essence.Supervise.Ti | = | Research Oversight | ||
| Essence.Supervise.sec | = | {_REC}s should maintain risk-adapted and ongoing ethical oversight of the research they approve, such as requiring researchers to submit periodic reports and to publish findings within a reasonable time period following the research project’s conclusion. | ||
| Essence.Vulnerable.Ti | = | Vulnerable Populations | ||
| Essence.Vulnerable.sec | = | Ethics review of research with health-related data from vulnerable populations should involve ethics committee member(s) or consultation of specialist referee(s)/advisors with specific expertise on research with such populations. | ||
| Essence.Indigenous.Ti | = | Indigenous Peoples | ||
| Essence.Indigenous.sec | = | {_REC}s involved in oversight of research with indigenous peoples should seek to partner with tribal advisory boards, elders, or intertribal {_REC}s, where applicable, to ensure community-level research protections that are in line with indigenous values and priorities. | ||
| Essence.sec | = | {Essence.Intro.Sec} | ||
| Essence.Resource. | = | [G/Z/Base] | ||
| Essence.Diligence. | = | [G/Z/Base] | ||
| Essence.Proportional. | = | [G/Z/Base] | ||
| Essence.Supervise. | = | [G/Z/Base] | ||
| Essence.Vulnerable. | = | [G/Z/Base] | ||
| Essence.Indigenous. | = | [G/Z/Base] | ||
| Essence. | = | [G/Z/Base] | ||
| Common.Ti | = | Common Elements of Ethics Review | ||
| Common.0.sec | = | In reviewing the ethical acceptability of an application for multi-jurisdictional research involving health-related data, due regard should be given to the following: | ||
| Common.1.sec | = | Expertise and experience of investigator(s); | ||
| Common.2.sec | = | Role of the sponsor(s); | ||
| Common.3.sec | = | Research protocol (e.g. study design; dissemination of findings/feedback to participants; documentation issues); | ||
| Common.4.sec | = | Prior ethics review; | ||
| Common.5.sec | = | Study context and site(s) information; | ||
| Common.6.sec | = | Specific health-related data research issues (e.g. relevant regulatory approvals); | ||
| Common.7.sec | = | Conflict of interest (e.g. financial, organizational, personal); | ||
| Common.8.sec | = | Consent process (e.g. participant identification and solicitation, information provided, type of consent used – written, explicit, broad, etc.; assent in cases of minors or adults with incapacity; withdrawal); | ||
| Common.9.sec | = | Potential risks and harms for participants, communities, and society; | ||
| Common.10.sec | = | Potential benefits for participants, communities, and society; | ||
| Common.11.sec | = | Adequate assessment of the scientific value; | ||
| Common.12.sec | = | Privacy and confidentiality (e.g. protection, access, control, security, retention, disposal of the data; at the stage of publication; compliance with relevant privacy/data protection regulations); | ||
| Common.13.sec | = | Considerations for vulnerable populations; | ||
| Common.14.sec | = | Funding (e.g. participant compensation; researcher compensation/benefit; sufficiency and source of funding); | ||
| Common.15.sec | = | Evidence of training, education, or experience about the ethical conduct of research involving health-related data; | ||
| Common.16.sec | = | Legacy of the project-generated data, i.e. a plan for how the data generated by the project will be stored, archived, and become accessible for new research; and | ||
| Common. | = | [G/Z/ol/s16] | ||
| Implement.Ti | = | Implementation Mechanisms and Amendments | ||
| Implement.1.sec | = | Organizations and bodies supporting this Policy should take all reasonable and appropriate measures, whether of a regulatory, contractual, administrative or other character, to give effect to this Policy and promote its implementation, monitoring, and enforcement. Procedures and policies should be transparent and accessible. Attention should be paid to the interrelation of this Policy with other {_GA4GH} Policies (e.g. Consent Policy, Data Privacy and Security Policy, Accountability Policy) and the Data Sharing Lexicon. | ||
| Implement.2.sec | = | Any entity or individual supporting this policy may propose one or more amendments to the present policy by communicating the amendments to the {_GA4GH}’s Regulatory and Ethics Work Stream ({Def.REWS.sec}). The {_REWS} shall publicly circulate such amendments for comments and possible inclusion in this policy. | ||
| Implement.3.sec | = | The {_REWS}, in collaboration with organizational members and other {_GA4GH} Foundational and Technical Work Streams, will track the adoption of this policy and its application. The {_REWS} will also routinely review the policy’s provisions, be aware of advances in basic research and technology, and ethical and legal developments, and attempt to ensure that this policy is fit for purpose. | ||
| Implement. | = | [G/Z/ol/s3] | ||
| Acknowledge.Ti | = | Acknowledgements | ||
| Acknowledge.sec | = | This policy was developed by the Regulatory and Ethics Work Stream of the {_GA4GH}, and is the result of the collaborative work, comments, and input of many individual and organizational contributors. | ||
| Acknowledge. | = | [G/Z/Base] | ||
| Rev.Ti | = | Policy Revision History | ||
| Rev.0.sec | = | Policy Number/Version | Date Effective | Summary of Revisions |
| Rev.1.sec | = | POL 004 / v. 1.0 | 13 February 2017 | Original document |
| Rev.2.sec | = | POL 004 / v. 2.0 | TBD | Policy revision |
| Rev. | = | [G/Z/tb/c/1] | ||
| Rev. | = | [G/Z/tb/r/2] | ||
| Rev. | = | [G/Z/tb/0-N-00] | ||
| Rev.00.sec | = | |||
| = | [G/Z/Base] | |||
| Note.DefinedTerm.Link | = | |||
| _GA4GH | = | GA4GH | ||
| _REC | = | REC | ||
| _Framework | = | Framework | ||
| _Essential_Element | = | Essential Element | ||
| _OHRP | = | OHRP | ||
| _REWS | = | REWS | ||
| Note.DefinedTerm.Anchor | = | |||
| Def.GA4GH.sec | = | {_GA4GH} | ||
| Def.Framework.sec | = | {_Framework} | ||
| Def.REC.sec | = | {_REC} | ||
| Def.Essential_Element.sec | = | {_Essential_Element} | ||
| Def.REWS.sec | = | {_REWS} | ||