The three types of informed consent described in Section 1 can be at odds when thought of in the context of a comprehensive research policy. This is because they acknowledge these three underlying premises at the same time:

1. Participants have a right to know that their data and specimens might be stripped of identifiers and used for future research (under informed consent); and
2. Participants have a right to opt out of future identifiable research (under broad consent); however,
3. If researchers do not ask participants for consent in the first place, a waiver of consent for minimal risk and de-identified research does not adversely affect their rights (Lynch et al., 2019).

The tension between these three premises, and the general use of a waiver of consent for PCTs, highlight a difference in the respect for participant autonomy as between (1) participants whose data was generated/used via research that included a comprehensive informed consent process including consenting to future de-identified research as compared to (2) participants whose data was generated/used via a PCTs with a waiver of consent where explicit informed consent for future de-identified research was not obtained.

Even when datasets are made from data made up of contributors who “consented” via the conditions mentioned above, the “risk” of future use of these data is based on whether the data are de-identified or not. Stated a different way, all data – whether the participants provided full consent and gave consent to future de-identified research or there was no explicit  consent at all – are treated the same on the basis of whether or not they are identified, not whether or not the contributors actually consented.

Identified vs. de-identified is not a consent-sensitive assessment, as shown in the figure. Therefore patients whose data are systematically collected and analyzed under the auspices of a PCT with a waiver of consent may simultaneously be a) unaware they are involved in a research protocol and b) have not consented to share the underlying primary data generated in this research for future research as IRBs require of other studies involving human participants. Some of the information could be highly sensitive, such as containing information about opioid use, HIV status, and other information that could cause harm if used inappropriately. The next section, Respect for Persons and Data Sharing, explores the impact of waivers/alterations on fulfilling the ethical obligation of respect when sharing data.