5.6 Psychological and behavioural
Main inclusion criteria
Development of psychological and behavioural interventions including
- cognitive behavioural therapy, electro-convulsive therapy, counselling, therapy and social interventions
- testing in model systems
Advice on research activities
It is difficult to develop behavioural and psychological interventions without involvement of human participants.
Use 5.6 Psychological and Behavioural for studies involving the development and testing of new behavioural therapies and psychological interventions in pre-clinical and model settings.
Examples include preliminary qualitative work (e.g. literature reviews, discussions with patients and practitioners) development of the techniques/technologies to be used in the therapy (e.g. questionnaires, computer programmes). Testing may involve human participants and still considered 5 Treatment Development if few in number, involve volunteers (not patients), and/or are clearly identified as preceding formal pilot studies and clinical trials.
Use 6.6 Psychological and Behavioural for studies involving human participants in direct clinical applications.
These will typically involve both pilot studies on small numbers of patients to assess viability of new treatments, and larger phase I-IV clinical trials which formally evaluate new or modified treatments against existing procedures.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.6 Psychological and behavioural | 5.6 Psychological |
HRCS_RA_5_6 |
Related external links
Common Scientific Outline (CSO) – 5.6 Complementary and Alternative Treatment Approaches
Main inclusion criteria
Discovery and development of interventions including:
- radiobiology, radiotherapy, radioimmunotherapy, radiosensitisers, microwaves, ultrasound, laser and phototherapy
- development of delivery systems
- investigation of mechanisms of action and side effects
- testing in in vitro and in vivo model systems
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.5 Radiotherapy and other non-invasive therapies | 5.5 Radiotherapy |
HRCS_RA_5_5 |
Related external links
Common Scientific Outline (CSO) – 5.1 Localised therapies – Discovery and development
Main inclusion criteria
Development of surgical, obstetric and dental interventions including:
- histocompatability, transfusions, transplantations including xenograft studies and bone marrow transplants
- mechanisms of recovery, tolerance, rejection and side effects including infection
- testing in in vitro and in vivo model systems
Advice on research activities
Includes obstetrics and dental research and tissue grafts, whole organ or bone marrow transplants.
Includes all aspects of research related to development of surgery and surgical procedures.
Includes studies on understanding transplant tolerance and rejection.
Includes invasive mechanical procedures.
Excludes cell grafts, cell transplants and cell therapies which will involve transplantation but should only be coded as 5.2 Cellular and gene therapies.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.4 Surgery | 5.4 Surgery |
HRCS_RA_5_4 |
Related external links
Common Scientific Outline (CSO) – 5.1 Localised Therapies – Discovery and Development
Main inclusion criteria
Discovery and development of medical devices including:
- implantable devices, mobility aids, dressings, medical equipment and prostheses
- biological safety assessments and investigation of adverse events
- sterilisation and decontamination of equipment or surfaces
- testing in in vitro and in vivo model systems
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.3 Medical devices | 5.3 Devices |
HRCS_RA_5_3 |
Main inclusion criteria
Discovery and development of cellular, tissue and gene therapies including:
- gene therapy, stem cells therapy, in vitro fertilisation and tissue engineering
- Fecal microbiota transplantation (FMT)
- development of delivery systems
- development of culture systems
- testing in in vitro and in vivo model systems
Advice on research activities
This code is suitable for studies involving in vivo stem cell research particularly tissue regeneration or repair of damaged tissue and generation of stem cell lines.
Cell therapy studies involve a transplantation process but they should not be coded as 5.4 Surgery too. An exception to this is surgical transplantation of bone marrow stem cells for cancer treatment, which is considered a similar process to organ transplantation, and should therefore be coded as 5.4 Surgery.
Excludes basic developmental biology of stem cell fate which should be coded as 1.1 Biological.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.2 Cellular and gene therapies | 5.2 Cell and gene therapy |
HRCS_RA_5_2 |
Related external links
Common Scientific Outline (CSO) – 5.3 Systemic Therapies – Discovery and Development
Main inclusion criteria
Identification and development of pharmaceutical small molecules, therapeutic vaccines, antibodies and hormones including:
- drug screening and development of delivery systems
- mechanism of action including side effects and drug resistance
- pharmacogenetics, prediction of genetic variation and responses to drugs
- testing in in vitro and in vivo model systems
Advice on research activities
In general this code should be used to characterise therapeutic targets rather than for their initial identification. It includes mechanism of action but should not be used to code studies where agonists or inhibitors are used as part of the methodology to understand the mechanism of other systems.
Includes mechanism of action and resistance to therapeutics. This includes characterisation of antibiotic resistance genes and mechanisms in bacteria which should not be coded as 2.2 Physical risks for cause of disease.
Includes studies predicting responses to therapies.
Includes studies of nutritional supplements used as treatments for disease.
Excludes studies focused on the potentially chemopreventative / health protective effects of specific nutrients, probiotics and nutritional supplements, which should be coded 3.3 Nutritional Prevention.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 5.1 Pharmaceuticals | 5.1 Pharmaceutical |
HRCS_RA_5_1 |
Related external links
Common Scientific Outline (CSO) – 5.3 Systemic Therapies – Discovery and Development
Main inclusion criteria
- development and/or distribution of resources for use by the research community including equipment, cell lines, tissue and DNA banks, and informatics systems
- infrastructure support for research trials, networks, consortia and centres
Official terminology
|
Full name of code |
Short name | Unique ID |
| 4.5 Resources and infrastructure (detection) | 4.5 Resources |
HRCS_RA_4_5 |
Related external links
Main inclusion criteria
Studies investigating population screening programmes including:
- feasibility studies, pilot studies and trials
- evaluation of effectiveness, benefits and economic evaluation
- impact on health services and policy issues
- models of population surveillance
Advice on research activities
Population screening of specific target population groups e.g. bowel cancer screening, foetal ultrasound screening.
This code is not suitable for individual diagnostic screening procedures e.g. brain scans.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 4.4 Population screening | 4.4 Screening |
HRCS_RA_4_4 |
Related external links
Common Scientific Outline (CSO) – 4.3 Technology and/or Marker Testing in a Clinical Setting
Common Scientific Outline (CSO) – 6.2 Surveillance
Main inclusion criteria
Studies investigating impact of screening and factors affecting uptake including
- attitudes and beliefs including cultural and religious practices
- issues relating to gender, age and ethnicity
- genetic counselling and decision making
- psychological, social and economic factors
- development, implementation and evaluation of interventions to promote screening including policy, education and communication
Official terminology
|
Full name of code |
Short name | Unique ID |
| 4.3 Influences and impact | 4.3 Influences |
HRCS_RA_4_3 |
Related external links
Common Scientific Outline (CSO) – 4.3 Technology and/or Marker Testing in a Clinical Setting
Main inclusion criteria
Testing and evaluation of markers and technologies in humans for use in detection, diagnosis, prediction, prognosis and monitoring in clinical, community or applied settings including
- assessment of sensitivity, efficacy, specificity, predictive and prognostic value, reproducibility and safety
- medical devices, imaging, diagnostic and predictive tests
- evaluation of diagnostic models, methods and methodologies in clinical or applied settings
Advice on research activities
Includes clinical and applied testing in humans, once verified in the laboratory, often in a trial or studies that involve a group of people.
Excludes pre-clinical investigation of potential diagnostics, which can include patient samples if they are being used in the diagnostic development phase. Such studies should be coded 4.1 Marker discovery.
Official terminology
|
Full name of code |
Short name | Unique ID |
| 4.2 Evaluation of markers and technologies | 4.2 Marker evaluation |
HRCS_RA_4_2 |