No risk or Low risk

Is my study a No risk or a Low risk study?


FNASREC deals with zero/ no-risk and low-risk studies in the Faculty of Natural and Agricultural Sciences that are not health-related.
The scientific review committee (internal committee in a School or Department that are subject matter experts) plays a central role in ensuring that the quality and potential ethical risk are promoted in the faculty. The committee needs to make sure that the proposed research meets the discipline’s requirements and suggests the relevant REC and the risk level. 
The research proposal must include the details necessary for the REC to confirm the essential aspects of the research methods that might have ethical implications. The first aspect to consider is if the research topic falls outside the auspices of FNASREC. If the subject matter is human health and the research aims to speak to and inform health bodies or publish in health journals, the study must be submitted to HREC. This is true even if the risk level is zero. If animals or animal products are directly involved in the study, they must be submitted to Animcare or Animprod. If unsure, you should consult FNASREC.
The second consideration of the research proposal is the risk level. All aspects of risk need to be clearly articulated in the research proposal. The proposal also has to state how that risk will be managed. The following includes components of research that will impact the study’s risk level: human participants in the study, any direct involvement of animals, any potential impact on the environment, any sensitive topic or data set. Sufficient details should be provided in the research proposal to convince FNASREC that the risk level does not exceed their mandate (No/Low-Risk review). The strategies to manage the risk should also be mentioned specifically.

Currently, proof of relevant ethics training is required for low-risk studies submitted to FNASREC . This training outlines the potential risks and how to address them.

 

FNASREC only deals with No risk and Low risk studies 

 

ZERO/ NO RISK
This is a non-exhaustive list of criteria that may be considered as NO RISK by FNASREC - given that the topic falls within the domain of the Faculty of Natural and Agricultural Sciences:

  1. Systematic reviews/Literature reviews.
  2. Postal/surveys with validated questionnaires.
  3. Document/artefact analyses without identifiable human participants.
  4. Unidentifiable electronic surveys.
  5. Public observation without interaction or intervention.


LOW RISK
This is a non-exhaustive list of criteria that may be considered as LOW RISK by FNASREC - given that the topic falls within the domain of the Faculty of Natural and Agricultural Sciences:

  1. Face-to-face surveys by means of validated interview schedules.
  2. Documented data or analyses with identifiable human participants.
  3. Questionnaire or instrument development.
  4. Interventions based on professional, scientific based protocols.
  5. Document/artefact analyses with identifiable human participants.

 

FNASREC does not deal with health-related, Medium or High Risk studies 

 

LOW RISK BUT HEALTH-RELATED
The formal definition of 'health-related' is: Health-related research refers to any research conducted by disciplines other than health disciplines about topics or participants within the field of health or investigating or striving to improve the bio-psycho-social well-being of human participants.
This is a non-exhaustive list of criteria that may be considered as HEALTH-RELATED LOW RISK - and will not be reviewed by FNASREC:

  1. Simple bio-physical research with humans.
  2. Bio-physical research with no drugs involved.
  3. Bio-physical research not involving human tissues or drugs.
  4. Research involving retrospective medicine usage and other clinical data.
  5. Health system research using structured survey forms.

 

MEDIUM RISK
This is a non-exhaustive list of criteria that may be considered as MEDIUM RISK - and will not be reviewed by FNASREC:

  1. Research with people suffering from psychological conditions that affect their cognitive, behavioural, or social functioning so that they cannot take informed decisions.
  2. Research involving sensitive ethical dilemmas in society.
  3. Collaborative health research involving people/animals.
  4. Multi-centre health studies involving people/animals.
  5. Long-term health studies exceeding one year in duration.
  6. Umbrella health projects involving human participants.
  7. Research involving face-to-face psycho-social contact with participants e.g. interviews, focus groups.
  8. Any psycho-social intervention studies individually or in communities.
  9. Non-clinical research/research with vulnerable communities/people (older persons and their caregivers, patients and health-care professionals, students and teachers, persons with life-threatening diseases and their care givers, people living with HIV, wards of the state and guardians or care-givers, employees and employers, prisoners and the relevant prison authorities, members of the SA Defence Force and their supervisors, children, mentally ill persons, special care with women – no clinical research with pregnant women or foetuses, own direct students).
  10. Umbrella bio-physical projects with humans using no drugs.
  11. Research involving blood, hair, sputum and/or urine human samples.
  12. Research involving tissue samples collected for diagnostic/cosmetic surgery purposes now wanting to be used for research.
  13. Research budget not higher than R999 999 per annum and not lower that R250 000.00 per annum.
  14. Interventions based on professional, scientific base protocols.

 

HIGH RISK
This is a non-exhaustive list of criteria that may be considered as HIGH RISK - and will not be reviewed by FNASREC:

  1. Research with human participants involving drugs/drug interventions.
  2. Research involving more than blood and sputum, or human tissue samples.
  3. Research involving biological samples more invasive than blood, urine, sputum, and/or hair.
  4. Any Clinical research/research with children.
  5. Research with people suffering from psychological conditions that affect their cognitive, behavioural, or social functioning so that they cannot take informed decisions.
  6. Research involving interventions more invasive than sampling of human blood.
  7. Any research done that is outside of the researcher's field of expertise can be seen as high risk. The competence of the researcher within this specific field will be a determining factor for the risk assessment of the research.
  8. Clinical research involving human participants with research-related medical or psychopathology.
  9. Clinical research involving vulnerable human participants, including foetuses, children, pregnant women and mentally impaired persons.
  10. Research involving sensitive ethical dilemmas in society.
  11. Research on vertebrate animals involving surgical procedures, excessive pain or excessive stress.
  12. Research involving primates or domesticated animals.
  13. Research involving any pathogen.
  14. Research that may affect public or environmental safety or sensitive ecosystems.
  15. Research budget higher than R1 million per annum.
  16. Any research deemed to present potential high risk for whatever reason by any applicant or committee.