Personal Health Information Act (PHIA)

Guidance Document: Impracticability June 26, 2013

Defining impracticability

Impracticability is an important concept for researchers and members of Research Ethics Boards to understand and apply when considering compliance with the Personal Health Information Act (PHIA). PHIA has described impracticable as a “degree of difficulty higher than inconvenience or impracticality but lower than impossibility.” This document is intended to provide some practical guidance for applying this definition.

The Department of Health and Wellness has provided a toolkit for custodians of personal health information.1 The PHIA Toolkit describes circumstances where it may be impracticable to obtain consent to use personal health information. The description is based on recommendations from the Canadian Institutes of Health Research and includes the following circumstances:

  • size of population or
  • proportion likely to have relocated or died since data were collected or
  • lack of existing relationship

such that:

potential for introducing bias (affecting validity and/or defeating purpose of study) or “the additional financial, material, human, organizational and other resources needed to obtain consent could impose a hardship or burden on the researchers or organization, so burdensome that the research could not be done.”1,2

During the transition to the new legislation, it may be challenging to interpret impracticability in a consistent way. Any consideration of waiving the requirement for consent to access personal health information must weigh the overall benefits of the research with the potential risk of harm from a possible infringement on privacy and confidentiality.3 Should a decision be made to waive the consent requirement for accessing personal health information, research teams must still meet all other expectations and requirements of the Research Ethics Board. For some studies, it may be reasonable to separateconsent for access to personal health information for purposes of screening for eligibilityfrom consent to participate in the study.

Examples

Minimal risk to patients with important potential benefits to public:

  • Population-based surveillance study of emerging infectious diseases based on routinely collected laboratory findings.

Resources required to contact large study population makes it impossible to conduct study:

  • Use of de-identified administrative hospitalization data to study the costs associated with a specific diagnosis or intervention.

Significant risks to validity of study outweigh minimal risks to patient (e.g., high proportion re-located):

  • Health record review of students from out-of-country who have sought care in the Emergency Department (ED) over a 10-year period to determine patterns of ED use by non-resident students.

Seeking consent for accessing health information may cause undue distress to patient and/or family:

  • Requesting consent to screen health information for eligibility in a study that offers a promising therapeutic option may be very distressing to the patient if it is determined that (s)he isn’t eligible.

Suggestions and guidance forrequesting a waiver of consent to access PHI for research purposes

  1. General considerations that apply to screening and study participation

The least amount of information that is required to meet the study objectives is being used.

The personal health information will be provided in the most de-identified form.

There are adequate safeguards in place to protect the privacy of individuals.

The scientific validity of the study will be threatened because the consent requirement may result in bias for one or more of the following reasons:

  • Many of the participants may be difficult to locate or contact.
  • Many of the participants may have died since their personal health information was collected.
  • There is a reasonable possibility that those who consent to have their personal information accessed will differ systematically from those who do not consent.
  • The study outcomes are such that not having access to all subjects would affect the statistical findings.

The potential benefits of being screened for eligibility and/or being invited to participate in a study outweigh the risks associated with accessing personal health information without consent.

There is a potential risk that attempts to secure consent to access personal health information will introduce additional threats to privacy by having to link otherwise de-identified data with identifiers in order to be able to contact individuals to seek consent.

It will be difficult to contact patients directly because there is no existing or continuing relationship with them.

The sample size is so large that the additional resources needed to obtain consent make it unreasonably difficult such that the research cannot be done. Resources include financial, material, human, and organizational and other resources.

There is public interest and/or important potential benefits of this research.

  1. Additional considerations for screening patients for eligibility to participate in a study

The screening process cannot reasonably be completed without using personal health information.

The participant group under investigation has a high death rate and/or there are other clinical factors that may cause undue distress (or risks to health and well-being) for the patient and/or their family members if they were to be contacted for screening purposes.

The study for which the patient is being screened for eligibility includes an investigational product(s) or procedure that is considered by their attending physician to be a reasonable therapeutic option.

The department/division/clinic has standard operating procedures and mechanisms to obtain consent from patients to have their personal health information screened for eligibility to participate in research.

References

  1. Toolkit for Custodians: A Guide to the Personal Health Information Act. Halifax (NS): Department of Health and Wellness; 2013. Available from:
  1. CIHR Best Practices for Protecting Privacy in Health Research. Ottawa (ON): Canadian Institutes of Health Research; 2005. Available from:
  1. Secondary Use of Personal Information in Health Research: Case Studies. Ottawa (ON): Canadian Institutes of Health Research; 2002. Available from:
  1. Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A et al. Impracticability of informed consent in the Registry of the Canadian Stroke Network. NEJM 2004;350:1414-1421.
  1. Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC. Written informed consent and selection bias in observational studies using medical records: systematic review. BMJ 2009;338:b866. Doi:10.1136/bmj.b866

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