POPLAR guidelines for clinical sites supporting research

 

Introduction to Research

Why do Research?

Physicians in the non-academic community setting have not typically been involved in clinical research, both because of their own time and resource constraints and logistical challenges of conducting research at satellite locations.  However, this is changing due to technical advances and the realization of the benefits clinical research in this setting has, for the provider, the patient, and the researcher.  For the provider, being active in research helps them stay at the forefront of patient care, allowing potentially more care options, and provides intellectual stimulation.  The patient has the ability to access care that may otherwise not be available and the researcher is able to increase the diversity of participants involved in the research, reducing bias in the study sample and thus generating accurate, broadly applicable results.

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Types of Research

Retrospective Research

Rather than collecting new data, retrospective designs leverage information that already exists, like medical records.  This approach can allow for a broad examination of a variety of questions, such as looking at a specific disease, treatment, procedure, performance of specific care providers, or broad demographic questions.  In this example, researchers used EMR data to examine if COVID-19 affected access to primary care differently based on socioeconomic status.

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Prospective Research

A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor(s). The study usually involves taking a cohort of participants and observing them over a period of time.  A clinical trial is a prospective study watching for outcomes after participants receive an intervention designed to manipulate the presence or absence of the outcome.  The PRINCIPLE Trial in the UK is an example of an adaptive clinical trial studying COVID-19 treatments that heavily leveraged an extensive family practice network to quickly evaluate the efficacy of COVID-19 treatments during the pandemic.

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Quality Improvement

Quality improvement (QI) is similar to research in some ways but has some important distinctions.  While research is looking to generate new knowledge by testing hypotheses, QI attempts to bring about immediate improvements in health delivery in particular settings, using a systematic, data-driven approach.  It can be thought of as taking information learned via research and applying it to your specific context.  QI has a different regulatory structure from research, especially in terms of ethics obligations to those involved in the process and is rarely published in the same way as research projects.  Here is an example from a family health team that outlines what aspects of care they are trying to improve, why they picked those items, and how they are measuring success.

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Data Infrastructure

The Tri-Agency Statement of Principles on Digital Data Management promotes excellence in data management practices, outlining expectations regarding RDM, and the responsibilities of those involved. These principles emphasize the importance for data to be stored in secure formats, and for data to be stored in a manner that enables preservation of and access to the data after the research project is completed. 

In Ontario, the Personal Health Information Protection Act (PHIPA) 2004 regulates the collection, use, and disclosure of personal health information, stressing the importance for appropriate measures of data storage and security relative to the level of data sensitivity. All researchers must comply with this legislation.

The Principal Investigator (PI) will handle most of the data infrastructure requirements for the study. Clinics will generally not retain research data themselves and will already have in place appropriate safeguards due to overlapping clinical needs.

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Computer Storage

What is expected from the clinic?

• Ensure that all computer systems storing confidential data are password protected. 

• All computers should be locked when an employee steps away from their computer. 

• Ensure computer software is up to date, including anti-virus software.

• For files that are accessed and updated over time, it is best practice to save updated versions of the data, with previous versions kept in an archived folder on the secure server.

What we can do to help.

• Individual files containing confidential study data should be password protected, encrypted, or stored on an encrypted drive. The PI can provide appropriate file templates.

• Participant identifiable information should not be stored on the local computer’s hard drive. The PI will provide access to a secure data storage system. 

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Physical Security

What is expected from the clinic?

• Paper documentation of participant identifiable information (e.g., signed consent forms) will be stored in a locked filing cabinet, in a locked office.  Access to buildings, rooms, cabinets where data, computers, media, or hardcopy materials are held is controlled.

What we can do to help.

• The PI will provide secure electronic and/or physical data from one site to another.

• Some studies may have equipment or pharmaceuticals that may require secure storage on site.  Work with the PI to determine how to meet the specific study requirements.

 

Data Retention

• The PI will let you know of any need to keep copies of data at you clinic once the information has been transferred to the PI.  Generally, you will not need long-term storage for data.

Another data security consideration is that external research staff may come to your clinic as part of the research study.  They may need space to work while there and potentially access to patients, data sources, including the EMR.  Consider how best to accommodate these needs for each research project.

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Research Ethics

Research ethics is a formalized concept that delineates the rights and responsibilities for participants in, and conductors of, research on humans, the details of which can be found in the Tri-Council Policy Statement.  Since research is attempting to understand something unknown, there are inherent risks of harm to participants in research that research ethics policies attempt to mitigate.  This is done by having an independent Research Ethics Board (REB) review all research being proposed in their catchment area to ensure ethical principles are being applied and that the risk of the research is minimized as much as possible and is commensurate with the potential knowledge to be gained.

What is expected from the clinic?

• publicize research (e.g. on practice notice boards, in patient information leaflets and/or on the practice website)

• For most studies, the initial invitation to patients to participate in research should come from within their circle of care.   The clinic will be involved in this, though discuss with the PI/Site Lead how research staff can support this process.  Typical methods include sending letters to patients from the clinic or having a clinician introduce the researcher to the patient.

What we can do to help.

• Handle all REB submissions and correspondence

• For most studies, research staff will seek informed consent from participants

• Assist with introduction letters, etc.

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Financial Requirements

Some studies will have funds available to clinic sites to support their participation in research.  Much of these funds will come from government or private granting agencies, which often have accounting requirements for the funds.  These funds are generally disbursed to sites in one of two ways.  In one case, the funds are sent to the site and then spent by the site, which may have accounting requirements associated with it.  The other is for the site to invoice the study coordinating centre for milestones or services rendered (e.g. receiving ethics approval or recruiting participants).  This mechanism has less accounting overhead but requires the clinic to do the work prior to receiving funds.  Discuss with the PI what method will be used for the study and how the clinic will implement it.

Another consideration is staff time, which may or may not be funded by the study.  Clinicians, allied healthcare professionals and administrative staff time may be required to support research activity.  It is important to discuss what staff support will be needed for a given project and identify who will do the work and how it will integrate with their clinical duties.

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