Ethical Foundations and Requirements
Currently, the threshold for a determination is the same for both waiver AND alteration of informed consent, which arguably limits the options of the IRB when determining what the consent process will be for a given study (McKinney et al. 2015). Some have suggested that new standards are necessary to enable pragmatic research while ensuring the protection of patient’s rights and interests (McKinney et al. 2015).
With non-disclosure (i.e., if consent is waived), no attempt is made to notify or request permission for people whose information will be used or who may be affected by a trial.
Case Example: Lumbar Image Reporting With Epidemiology (LIRE)
Lumbar Image Reporting with Epidemiology (LIRE) is designed to test whether inserting epidemiological evidence (essentially representing the normal range) in lumbar spine imaging reports will reduce subsequent diagnostic and therapeutic interventions, including cross-sectional imaging (MR/CT), opioid prescriptions, spinal injections and surgery (Jarvik et al. 2015). As part of their justification for a waiver of patient consent in the Project Summary, the investigators cite that the project is minimal risk and will not adversely affect the rights and welfare of the subjects, and that the research could not practicably carried out without a waiver [because there is no easily implementable means of obtaining consent and there is a large study population (~250,000)] AND:
“4.1.3c By informing primary care providers and patients of the study, we risk invalidating the results. If providers and patients are aware of the intervention but are allocated to the control group, they may nevertheless change their behavior.
4.1.3d The risk of contacting subjects is greater than the risk of the study procedures. The risk for breach of patient confidentiality increases when subject contact information is maintained for the purposes of contacting patients for their consent. It is our opinion that this increased risk far exceeds the risk to subjects associated with the insertion of epidemiologic data into the radiology report interpreted by their provider (Jarvik 2013).”
Even when a waiver of consent is granted, some investigators provide individual notification and may offer an opportunity to opt out as a mechanism to preserve autonomy. For example, in the Time to Reduce End Stage Renal disease (TiME) trial (described in Section 3), all patients initiating treatment with maintenance hemodialysis at participating facilities were provided with written information that includes the trial sponsor, the purpose of the trial, how the trial will affect dialysis session duration, the treating physician’s role, a description of the transmission of de-identified patient data to the University of Pennsylvania, a statement that no additional testing will be performed for the trial, and a toll-free telephone number to contact with questions or to opt-out of participation.
- Informed Consent
- Alternative Approaches to Disclosure and Authorization
- Non-disclosure of Research Activities
- Data on Different Approaches to Disclosure
- Appendix: US Regulatory Agencies
- Appendix: Regulatory Frameworks
- Appendix: Institutional Regulatory Oversight
- Appendix: Emerging Regulatory Issues
Jarvik JG. 2013. LIRE Supplementary Material.
Jarvik JG, Comstock BA, James KT, et al. 2015. Lumbar Imaging With Reporting of Epidemiology (LIRE): protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. doi:10.1016/j.cct.2015.10.003. PMID: 26493088
McKinney RE, Beskow LM, Ford DE, et al. 2015. Use of altered informed consent in pragmatic clinical research. Clin Trials. 12:494–502. doi:10.1177/1740774515597688. PMID: 26374677.