Table 2 Checklist of the steps required for the return of IRR.
From: A practical checklist for return of results from genomic research in the European context
1. Decide which IRR to return | ||
Consider the nature of IRR | Consider the context of result return | Consider the practicalities of RoR |
□ Clinical study vs population-based research □ Clinical utility/health significance and medical actionability □ Urgency and severity of the results □ Potential impact on participants (eg. psychological impact, presence of an intervention) □ Benefits and harms of RoR □ Analytical and scientific validity, incl. positive/predictive value, and false positive rates □ Limitations on test validity and interpretation □ Quality and external review process (e.g., UKAS certified laboratory) □ Involve clinical expertise in decisions | □ Participant needs, preferences, values □ Age of study population, if relevant. □ Potential return to minor participants becoming adults □ Vulnerability of study population, ability to make decisions about RoR, and access to health care (e.g., in LMI countries) □ National good practice guidelines □ Country-specific resources to support RoR □ Obligations for RoR beyond research scope/after study completion □ Obligations to search for SF | □ Disclosure pathway and timeframe □ Clarifying role of treating physician in RoR □ Privacy and confidentiality issues □ Possibility to recontact participants □ Infrastructure for data storage and future analysis □ Sustainability of resources and feasibility of RoR □ Logistical requirements for RoR and training of staff □ Research aims that may potentially be compromised if RoR |
2. Develop a plan for return of results | ||
Include: | ||
□ Types of results to be generated (primary, secondary, unsolicited findings) and how (e.g., techniques to be used) | ||
□ Types of results to be returned | ||
□ Justifications for returning or not returning results | ||
□ How informed consent will be obtained | ||
□ Processes for clinical assessment and validation of results, (if applicable) | ||
□ Reference to relevant institutional policies relating to RoR | ||
□ Timing, frequency, and duration of return | ||
□ Mechanisms to locate expertise for RoR | ||
□ Mechanisms to handle potential requests for RoR | ||
□ Mechanisms to return results to participants and by whom | ||
□ Possible psychological effects of RoR | ||
□ Mechanisms to secure safety of participants | ||
□ Whether approval from data access committee will be needed to return results and role of data protection officers | ||
□ The responsibilities of researchers after disclosure | ||
□ The potential role of associated biobanks in RoR process | ||
□ Budget, resources, and infrastructure to support RoR | ||
□ Include plan in funding application, scientific review, and ethics application to REC | ||
□ Factor in time for REC amendment if required | ||
3. Obtain participant consent to return results | ||
Provide information in the informed consent about: Background and rationale | ||
□ Study purpose, including uses of samples for genetic research | ||
□ Distinction between research and clinical care | ||
□ Likelihood of RoR, limitations of RoR and rationale for RoR | ||
□ Types of results that may be fed back (including unanticipated and unsolicited findings) | ||
Management of RoR | ||
□ How results will be disclosed, by whom, when, and frequency of RoR | ||
□ Conditions under which urgent results may be fed back | ||
□ Procedure for collecting the participant’s consent to communicate results to his/her health care provider and/or place results in medical records | ||
□ Possibility that consent may be sought at multiple time points to enable participants to reassess decisions regarding RoR | ||
□ Possibility for participants to request results | ||
□ Possibility for participants to be re-contacted and procedure for consent to re-contact | ||
Implications for participants | ||
□ Potential risks of RoR, e.g., physical, psychological, unanticipated risks | ||
□ Potential benefits of RoR, e.g., commercial profit, access to tests, preventative treatments | ||
□ Possibility of accessing clinical/genetic counselling services | ||
□ Possibility of follow-up, e.g., investigations and interventions | ||
□ Potential implications of RoR for the participants’ relatives | ||
□ Possibility of sharing results with relatives in case of participant death | ||
Privacy and confidentiality issues | ||
□ Procedures for privacy and confidentiality protection and data de-identification | ||
□ Risks of potential re-identification of genetic information | ||
□ Limits of confidentiality and risks of confidentiality breaches | ||
□ Plans for data security and sample storage and management | ||
□ Country specific discrimination laws | ||
Secondary and third-part use | ||
□ Data access by other researchers for secondary research | ||
□ Possibility to choose whether to allow secondary use of data | ||
□ Data access by third parties | ||
□ Role of industry | ||
□ Data sharing on open access platforms | ||
Study contacts for questions and additional information | ||
Requirements of biobank/registry (if applicable) | ||
4. Collect and analyse data | ||
□ Use tests necessary to answer the research question | ||
□ Include clinicians with expertise in handling clinically significant genomic findings | ||
□ Inform researchers about procedures to deal with UF | ||
□ Search for SF if easy to carry out the additional analysis | ||
5. Confirm results | ||
□ Establish utility and accuracy of test | ||
□ Ally with experts to validate results, e.g., accredited lab/repeated testing multidisciplinary teams | ||
□ Involve participant to confirm analytical validity (e.g., to collect additional sample for result validation) if necessary | ||
6. Disclose research results | ||
□ Identify results provider for IRR (e.g., primary health care provider) or consider direct return to participant | ||
□ Consider the use of emerging technologies for IRR | ||
□ Check skills and qualifications of results provider (e.g., skills documentation) | ||
□ Ensure participant is promptly informed about IRR | ||
□ Tailor information to the needs and preferences of participants | ||
□ Inform participants about meaning and implications of results, and level of uncertainty and provide a written summary of the results | ||
□ Discuss implications of RoR for the participant’s relatives | ||
7. Follow-up and monitor | ||
□ Consider avenues for follow-up (e.g., medical specialists/clinical services) and provision of clinical referral, and inform participants | ||
□ Monitor the effects of communicating IRR | ||
□ Evaluate the management of IRR policy | ||
