Personal Data + Privacy

Health Information

Use of Health Information in Research

NetCare

The Alberta Netcare Portal (ANP) is a health information repository provided by Alberta Health that contains the secure and confidential health information of all Albertans. The ANP is available to all recognized healthcare providers to aid in providing a healthcare service to their patients.

More information related to the use of NetCare in research should be obtained directly from the Institution that has oversight over the records that you will be accessing (ie. AHS, Covenant Health etc).

Alberta NetCare Information Exchange Protocol

Researchers are required to adhere to the Alberta NetCare Information Exchange Protocol (IEP), the Health Information Act, and the policies of participating custodians when using NetCare for research purposes.

Eligibility

Information from NetCare may be eligible for use in research only where such research requires explicit consent to participate from the individual who is the subject of the information. This is a rule specific to the IEP for NetCare. Researchers who are doing a study where they have requested and obtained a waiver of consent from the REB to conduct the research, cannot use NetCare as a source of data for the study (i.e. retrospective chart review where no consent is obtained from the people whose records you will be reviewing).

Case Reports

"Research is an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation."

REB Review Not Required

Writing a report on a unique or interesting clinical case would not fall within the definition of research requiring REB review per the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). This would be the case to the extent that these reports are simply anecdotal accounts of individual cases.

The writing and/or publication of individual case reports may raise issues related to privacy and confidentiality and related to the consent of the subject of the case report, which a clinical care provider must consider. Guidance related to issues such as these may be sought from a privacy officer of the responsible data custodian, or from the REB as a starting point for further referral.

REB Review Required

Where a physician seeks to use data collected for non-research (clinical) purposes in order to answer a research question, it is considered 'secondary use of information not intended for research;' as such, it falls within the definition of research and would require REB review. An example would be the analysis of 3 or more case reports to answer a specific research question.

TCPS 2 provides guidance regarding secondary use of identifiable information for research purposes within Articles 5.5 and 5.6.

Chart Review Guidelines + Instructions

Retrospective + Prospective

A Retrospective Chart Review evaluates patient data that already exists in the subject's medical record at the time the project is submitted for initial REB review. The patient data does not result from the research activity.

A Prospective Chart Review evaluates patient data that does not yet exist in the subject's medical record at the time the project is submitted for initial REB review.

REB Review Requirements

A chart review is generally considered to be human participant research and therefore REB review and approval is required PRIOR to commencing chart review activities. Depending on the custodian of the medical records you wish to access, additional administrative, operational or research agreements must be in place prior to accessing the data.

The use of health information in the conduct of research-related activities requires the review and approval of the REB. Use of the health information for quality assurance/improvement activities may not require REB review. The determination that the project is indeed QA/QI should be sought from the REB prior to accessing the data. In most cases, chart reviews are dealt with via a delegated ethic review process. On rare occasions, such as the collection of sensitive data, the study may have to be reviewed at the full board.

Obtaining Informed Consent

Waiver of Consent

It's a common misconception that consent is not required for chart reviews. While in most cases this may be true, the researcher must first request a waiver of consent from the REB. Under the Alberta Health Information Act (HIA) the HREB is mandated to determine the requirement for individual consent. The researcher must provide a sufficient and detailed rationale for why it would not be reasonable, feasible or practical to obtain individual consent.

Requesting a Waiver

At minimum, the researcher should address the following when requesting a waiver of consent:

the research involves no more than minimal risk to the subjects,
the waiver or alteration will not adversely affect the rights and welfare of the subjects,
the research could not practicably (feasibly) be carried out without the waiver or alteration,
whenever appropriate, the subjects will be provided with additional pertinent information after participation,
the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions.

Outlining Rationale

A common error researchers make is to restate their waiver request. In order to ensure a waiver is granted it is necessary to demonstrate how the waiver request applies to the research, particularly how the research could not practicably (feasibly) be carried out without the waiver or alteration.

Researchers should consider the following when outlining their rationale:

Sample size. Is the sample size too large to contact all individuals or is it small enough that contacting individuals is feasible?
The dates on the medical records. Many individuals may be lost to follow up from older medical files whereas it may be possible to contact individuals who recently received medical care.
The impact of contact for consent. Depending on the nature of the medical condition under study, will contact from the research team cause undue stress to the individual?
Consent may introduce bias. Where the population is small and requiring consent may put the scientific integrity at risk.

Consent is Required

Where the rationale cannot be sufficiently demonstrated, the REB may determine that written informed consent is required. This is almost always the case in prospective chart reviews where an investigator intends to review the charts of all patients within his/her practice. In this situation, the REB will likely determine that the investigator should obtain written informed consent since there will be an opportunity for patients to be consented during a scheduled clinic visit (consent is feasible and practical).

Tips for a Successful Application

All relevant sections up to Section 4.1 of the application should be completed. In particular, Section 2.1 should contain a detailed description of the research including the plan for analysis.
Section 2.2: Select Chart Review/Review of Health Data, which will branch to Section 2.15.
Section 2.15: Question 4.0 asks about the date range of the medical records. This question is designed to determine if the project is retrospective or prospective. The question is NOT asking about when the study team will physically be accessing the charts but rather, what are the dates on the medical records that will be reviewed.
Section 2.15 Question 5.0 if you select NO - a detailed rationale for why you believe it is not reasonable, feasible or practical to obtain informed consent. It is NOT acceptable to state - "retrospective chart review."
Both a research proposal/protocol and a data collection sheet containing all variables to be extracted from the charts must be appended in the Documentation Section.