Minimal Ethical Risk Registration Process
Minimal risk review has been introduced as part of KCL’s endeavour to ensure that the ethics review process for research involving human subjects is in proportion to the ethical risks of a research project. The process does not involve an ethics review conducted by the Research Ethics Office or the College Research Ethics Committee. The principle behind the minimal risk registration process is that the applicant and their supervisor (where appropriate), are able to determine via the checklist within the registration form, if their research is eligible for minimal risk.
IMPORTANT NOTICE: As of 6th March 2018 all new Minimal Risk Registration Forms should be submitted in REMAS, the College's online submission tool. The Research Ethics Office will only continue to accept Minimal Risk Registration PDF forms until Friday 23rd March. After this date researchers will be advised to recomplete their registration form in REMAS.
Key Points about Minimal Ethical Risk Registration
Am I eligible for Minimal Risk Registration?
Please read the following key points before commencing with the submission of a Minimal Risk Registration Form:
- Your registration form will not be subject to ethical review by CREC, therefore the onus on determining that your research is suitable for minimal risk registration and that measures are put in place to mitigate any risks to participants is with the researcher (and their supervisor where appropriate).
- As part of the registration process, researchers will be asked to confirm that they have read and will adhere to the KCL Minimal Ethical Risk Guiding Principles document. It is advisable to read through this document before commencing with submission of a registration form
- Whilst registration forms will not be subject to ethical review, the Research Ethics Office will assess eligibility for minimal risk registration upon submission of the form, by cross checking form answers with the study outline provided. Therefore you must not begin your research until you receive confirmation of registration from the Research Ethics Office. You do not have clearance to commence your research until you receive this confirmation.
- If you make any significant changes to the research design of your study after submitting your registration form, you must complete a modification request form which will prompt you to revisit the checklist to ensure that your study is still suitable for minimal risk registration. If the modification will mean that your study is no longer eligible for minimal risk registration a ‘Full Application Form’ must be submitted for ethical review before the change can be incorporated.
- Any study registered as minimal ethical risk may be subject to random audit by the Research Ethics Office. Full details of what is required for the audit process are outlined in your registration letter.
- If you begin your research before receiving registration confirmation, conduct research of a higher ethical risk under a minimal risk registration, do not adhere to the guiding principles for minimal ethical risk research, this will be considered research misconduct and will be addressed under the CREC Policy and Procedure for Research conducted without Ethical Approval.
Submitting a Minimal Risk Registration Form
The Minimal Risk Registration Process is available to all staff and student researchers across the College.
The registration form is made up of a series of risk checklist questions which will either allow you to proceed to register your study as minimal risk, direct you to the 'Full Application Form' if your study is not eligible for minimal risk or advise you that no ethical clearance is required for your study.
For a quick way to establish the likely risk level of your research study and therefore if it may be eligible for the Minimal Risk Process, please use our 'What is the risk level of my research?' tool.
Before submitting a minimal risk registration form, please read the Key Points about Minimal Ethical Risk Registration above, which includes the Minimal Ethical Risk Guiding Principles document.
Participant Recruitment Documents
To submit a Minimal Risk Registration form you should:
1. First log into REMAS with your KCL 8 digit staff/student number and your KCL outlook account password.
2. Once logged in, choose the 'create project' option and select 'Minimal Risk Registration Form' from the drop down list. The system will then ask you a series of filter questions to determine if your study is eligible for minimal risk registration.
4. If completion of the minimal risk filter questions determines that your research is eligible you will be asked to confirm that you have read the Minimal Ethical Risk Guiding Principles document. Once you have confirmed this you will then be asked to provide a basic overview of the study aims, who the intended participants are and what they will be asked to do you.
5. Once completed you will be asked to electronically sign the form in order to submit the form for registration (this is done by entering your KCL email address and password). If you are a student you will also be asked to enter your Supervisor's email address so that a request can be sent to them to also sign the form for authorisation. Once the form has been signed it will be locked and automatically submitted for registration.
Once submitted, the Research Ethics Office will cross check the form answers with the study outline provided. Providing the study is deemed eligable you will receive a letter of registration from the Research Ethics Office within 3 working days of submission and no further ethical clearance will be required.
It is important that you read and store the registration confirmation letter. It contains your research ethics reference number, and important information about what you may be asked if your research is selected for audit.
There are no deadlines for Minimal Risk Registration submissions and no submission closure period. Registration forms can be submitted at any time throughout the year.
We will continue to accept minimal risk registration with the old PDF form until Friday 23rd March. After this all submissions will need to be made through REMAS. If you have any questions please contact the Research Ethics Office.
Modifying a Registered Minimal Risk Study
Where possible study participants should be given written information sheets and consent forms to sign. It is advisable to follow the KCL templates and guidance found at the links below:
It is recognised that there are instances when it is more appropriate to provide a verbal or brief email overview of your research instead of a written information sheet. Such instances include, but are not limited to, interviewing elite professionals, instances where it is not culturally appropriate or when participants are approached in a busy environment (i.e. on a busy street) and it is impractical to expect participants to read a written document. If you are providing verbal information you must follow the guidance provided at the link below:
Minimal Risk Registration Audit
Researchers should complete a modification request form if they are making any significant changes to their research aims and objectives, data collection methods, participant groups, recruitment methods or consent process that were not outlined in their original minimal risk registration form. Researchers should wait until they receive confirmation of modification registration before incorporating the changes to their study
If the proposed changes to the study mean that you should change you answers to any of the low risk or high risk criteria question in your original Minimal Risk Registration Form, a modification request cannot be submitted and a new 'Full Application Form' for ethical approval must be submitted.
Modifying a study registered in REMAS: To submit a Modification Request Form in REMAS, researchers should log into their REMAS account, select the corresponding minimal risk study from the project title list and then choose the 'Create Sub-Project' and choose 'Modification Request Form'
Modifying a study registered via PDF submission: If you had previously registered your project by submitting a PDF form, the following Modification Request Form should be submitted to firstname.lastname@example.org.
Minimal Risk Modification Request form for pre REMAS registered studies
All research registered through the Minimal Risk Registration process may be subject to audit, to ensure that only research of the appropriate risk level is being registered. The random audit procedures will be outlined in the confirmation of registration email that provides your Research Ethics Office Review number.