What is research?
In the Code of Federal Regulations (45 CFR 46.102(d)) pertaining to the protection of human subjects, research is defined as: “A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge”.
Generalizable knowledge means that research results or patterns found in a sample population will also be found in the wider population which the study sample represents.
Human Subject Research is research about living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. In this regard, at MRC, studies which involve data collection from identifiable sources such as medical records, registries, previously collected bio specimen samples etc. are also categorized as Human Subject Research though there is no actual interaction or intervention happening with the individual.
Research classification at MRC:1.
Engineering and technology
The biological or medical application of engineering principles or engineering equipment.
2.
Life sciences:
The scientific study of living organisms – such as microorganisms, plants, animals, and human beings.
Life sciences group has been sub categorized as below:
2.1 Basic Sciences
Fundamental scientific research aimed to improve scientific theories for improved understanding or prediction of natural or other phenomena.
2.2 Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
2.3 Epidemiological Research
To study how the environment, lifestyle and genetic factors affect health and the cause of disease. This knowledge is used to create methods and approaches for the prevention of disease and ill health.
2.4 Mixed Design
Studies involving retrospective as well as prospective collection of data/ bio specimens.
2.5 Registry
The registry is a system-defined database which collects specific health information from people or previous records.
2.6 Data ReviewStudies involving collection and analysis of existing data (at the time of study submission) from medical records, CRFs, registries etc.
2.7 Investigational Product Clinical Trial (Drugs / Devices)
Investigational drug includes any drug (approved or unapproved by the FDA) being used in research, other than the use of a marketed drug in the course of medical practice.
Investigational device includes any device (approved or unapproved by the FDA) being used in research designed to evaluate safety and effectiveness of that device.
Investigational product includes any investigational drug or investigational device or a combination of the two (“combination product”) being used in a research designed to evaluate the safety or effectiveness of the drug, device, or combination.
2.8 Novel Therapy Clinical Trial
Prospective biomedical or behavioral research studies on human participants designed to answer specific questions about new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices), biomedical or behavioral interventions.
2.9 Cohort Study
Groups of people with defined (same) characteristics are followed up prospectively to see whether an outcome of interest occurs.
2.10 Case Control Study
A study that compares patients who have a disease or outcome of interest (cases) with patients who do not have the disease or outcome (controls).
2.11 Cross Sectional Study
Type of observational study that analyses data collected from a population, or a representative subset, at a specific point in time—that is, cross-sectional data.
2.12 Systemic Review
A systematic review is a type of literature review that collects and critically analyzes multiple research studies or papers.
What are quality improvement studies?Unlike studies having clear interventions such as drugs, tests, and procedures that directly affect the biology of disease, and are the objects of study in most clinical research, quality improvement is essentially a social process. Improvement is an applied science rather than an academic discipline; its immediate purpose is to change human performance, rather than generate new, generalizable knowledge, and it is driven primarily by experiential learning. Like other social processes, improvement is fundamentally context dependent (specific to a given situation); it is reflexive, meaning that improvement interventions are repeatedly modified in response to outcome feedback, with the result that both its interventions and outcomes are always variable.
Quality Improvement studies are activities that focus primarily on the performance of local patient-care delivery, rather than the generation of new scientific knowledge.
Do QI studies require ethical review?
Quality improvement studies are regarded as a routine part of health care delivery and as a professional and organizational obligation. Hence they should have sound clinical governance. At HMC, the clinical governance pertaining to QI studies is the responsibility of the hospital facility. However these need to be confirmed as only QI and exempt from IRB review by MRC.
“Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false separation may result in under-protection of participants in QI projects and over-protection of participants within health care quality improvement research (QIR)”. (10.1186/s12910-015-0056-2)
Therefore all researchers are requested to consult with MRC through the support desk prior to conducting their studies. MRC assists in:
- Distinguishing QI studies from research studies
- Identifying when activities are both quality improvement and human subjects research
- Providing advice on any ethical requirements for protection of participants in QI studies
- Addressing approaches to implement accountability for the ethical conduct of QI studies
If a proposal is confirmed to be Quality Improvement by MRC then researchers shall proceed after obtaining approvals from the study specific/ related departments.
