It is important to decide what type of study you are planning to conduct. This is necessary because the definition and characterisation of your research will guide many of your operational steps and also help inform you of what regulations and guidelines you need to follow.
In characterising your study you need to consider what type of research study you are planning and also consider the risk and complexity of your protocol. These two elements will define many of your requirements in terms of operational needs and also complying with regulatory requirements.
A well formulated research question or hypothesis will help define the most appropriate study design.
Your first consideration is whether you are planning a research study, or if your research is actually a service evaluation or audit?
Research can be defined by the following;
1. Is testing a hypothesis
2. Has a clear question, aim and objective
3. Is collecting data (information) that is not normally collected as part of routine or standard clinical care and practice
4. May involve collecting samples that are not normally collected as part of routine or standard clinical care
5. May involve allocating groups or individuals to an intervention
Conversely, audits or service evaluations are defined as;
1. Analysing existing data that was conducted as part of clinical care (this might include questionnaires or surveys)
2. That the purpose of this evaluation is to either make a judgement on existing standards or practices or to inform on existing standards or practice. There is no hypothesis or research question
Activities that can clearly be defined as an audit or service evaluation do not normally require review by an ethics committee. However, if the data is to be published, or if there is any query between whether the planned work is an audit or research, then ethical review would be advised. Most ethics committees have a minimal risk process for such situations.
Once you have determined that you are planning a research study then this needs further defining to guide your operational planning and protocol development.
Clinical Research studies are normally defined as clinical trials or observational studies. Clinical trials being interventional and observational studies as being non-interventional.
In a non-interventional studies (or observational studies), subjects are generally observed for specified period of time and their outcomes are measured.
There are three main types of observational studies:
Cohort Studies and
Case Control Studies
Which type of design depends upon the question. Descriptive studies, such as case control and cross-sectional studies are used for generating hypotheses, whereas analytical designs such as cohort studies can be used when a causal relationship needs to be determined. There can be difficulty in distinguishing between an audit and descriptive studies. The most simple rule is to ask whether any information is being collected that is not normally obtained within standard practice.
Clinical Trials, or interventional studies involve a planned change in the natural course of events, i.e., subjects receive a medicine or other type of intervention and their outcomes are measured.
The World Health Organisation’s definition of a clinical trial is helpful, and is used by the international committee of journal editors. This definition is as follows;
A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.
Research Regulations and Guidelines
If you are conducting a clinical trial then you need to follow the principles of ICH-GCP (http://www.ich.org/products/guidelines.html). You can take an eLearning course in Good Clinical Practice, available in several languages here: https://globalhealthtrainingcentre.tghn.org/good-clinical-laboratory-practice/
You will also need to register your trial (for more information, see: https://globalhealthtrials.tghn.org/articles/guidelines-clinical-trial-registration/).
The ICH-GCP guidelines will help you structure and write the protocol. However a risk and complexity analysis is recommended to help you interpret and apply ICH-GCP to your specific study. A clinical trial or study can be very simple and minimal risk and therefore many of the ICH-GCP requirements do not apply, particularly if there are no investigational products being used.
If your study is observational then a risk and complexity analysis is still helpful as some observational studies may be more complex that a clinical trial, and be more dangerous, especially if highly invasive sampling techniques are being used, or potential sensitive questions are being asked.
The basic principles of IHC-GCP also serve observational studies well and hence many regulatory authorities insist that ALL clinical research studies apply ICH-GCP. The basic principles set out to ensure the data is valid, that the question can be answered by following a robust and appropriate protocol and that the study was conducted ethically and safely. These are sound principles for all types of clinical research.
All clinical research should be reviewed by an ethics review committee and often there are also institutional research review committees, and many countries also have national research committees, especially for clinical trials. Therefore it is important to determine what regulatory review is required in the location that the research is planned.
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