Privacy and Health Research. Consent scenarios in secondary research


Research projects may be seen as falling into scenarios such as the following, which overlap but nonetheless may be helpful in structuring rationales regarding identifiability and consent. This scheme is proposed here in the hope that it will attract discussion and development.

Scenario A: Data-subjects have given consent to a future secondary use, under specified conditions.

A straightforward example would be an expected follow-up study to review outcomes. Increasingly, investigators are trying to anticipate future uses, and are seeking appropriate consent when they collect the data. If done properly, this should be acceptable. Ideally, scope of use and time-limits should be specified.

Scenario B: Although data-subjects have not given consent to a secondary use, the purposes of the secondary use are similar to those for the original use, and protections can be assured.

The judgment on this will vary by circumstances. An assessment must be conducted, taking account of benefits and risks, for instance, and perhaps asking whether, ultimately, members of society who are similar to the data-subjects (such as people suffering from the same illness, or having similar vulnerabilities) are likely to benefit from the research.

Some insights on such a similar-use principle may be derived from experiences with the U.S. Privacy Act's "routine use" provision.

Scenario C: Although data-subjects have not given consent to a secondary use, that use is judged to be minimally intrusive, an protections can be assured.

If this appears to be the scenario, an assessment must be conducted. Of course there are issues of who does the assessing, and by what criteria. Again some precedent may exist. The U.S. Federal Common Rule (§_.101(b)(4)) authorizes Institutional Review Boards to "waive the requirements to obtain informed consent provided the IRB finds and documents that:

  1. the research involves no more than minimal risk to the subjects;
  2. the waiver... will not adversely affect the rights and welfare of the subjects;
  3. the research could not practicably be carried out without the waiver...; and
  4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Scenario D: Data-subjects have given broad consent to unspecified future secondary uses.

Often such consent is considered to have been secured when people sign contractual care agreements with health-care organizations or insurers. But, as Ruth Faden was quoted on page 40 of this Report as saying, broad unqualified consent to unspecified purposes is neither reassuring nor protective. Even if waivers exist on file somewhere, specific informed consent should be sought if possible. If that is not possible, a partial corrective is to ensure that identifiable data will be handled only within a defined research group, under defined protections.

In countries having national healthcare systems, there may be misunderstanding or disagreement over whether a person, simply by the act of availing himself of service, implies consent to unspecified future research on the resulting data.

The statutes governing the U.S. Medicare and Medicaid programs allow analysis of the data under very controlled conditions—so long as the research purposes accord with the purposes of the programs studied, and specified procedures are followed and safeguards enforced.

In some situations researchers seek group or community consent, or approval to approach individuals to request consent, via public meetings and discussions with group or community leaders.

Scenario E: Data-subjects have not given consent to a secondary use,and the impact on privacy is not necessarily negligible.

Unless the circumstances are compelling against it—such as if the research concerns a public-health emergency—new informed consent probably should be sought.

All of the above scenarios concern data that are personally identifiable. For secondary research: If data truly are anonymized, consent should not be an issue; if data can be transposed through an effective key-coding process into non-identifiable form, again consent should not be an issue.