National Rehabilitation Hospital

Research Protocol

Protocol for Ethical Approval of Research Proposal Submitted to The National Rehabilitation Hospital

Procedure to be followed in order to obtain ethical approval to undertake research

The National Rehabilitation Hospital would like to support all research undertaken in the hospital.  In order to protect the patient, the researcher and the hospital ethical and legal guidelines must be followed when undertaking research.

The following provides an outline of the process and the documentation required in obtaining Ethics Committee approval.

Step 1

Persons wishing to undertake research must first inform the relevant Head of Department and the Consultant in Charge of the area affected by the research.

  1. The research proposal must be submitted as per the National Rehabilitation Hospital Research Application Form – Version 5.5 or available from the secretary to the Ethics Committee.
  2. The Principal Investigator and the Co-investigator/s must sign the Declaration Page.  Only named and approved Principal Investigator and co-investigator(s) may carry out the research described in the protocol.
  3. If any of the researchers are from an external organisation e.g. university or health board they must first consult with the Consultant in Charge of the area affected by the research and he/she must sponsor the researcher. Complete the National Rehabilitation Hospital Research  Application Form.  The Consultant must be the Principal Investigator in the study and the external researcher as Co-investigator.
  4. If a non-consultant hospital doctor (NCHD) nurse, student, therapist or other member of staff wishes to undertake research with human subjects, a National Rehabilitation Hospital Consultant must sponsor him/her.  The sponsor will be the Principal Investigator and the staff member listed as the Co-investigator.
  5. The Ethics Committee must be notified in writing when Co-investigator(s) are added or removed from the protocol.
  6. The Investigators must submit written confirmation from their insurer that they have sufficient indemnity to carry out research outside their normal work.
  7. External Investigators must submit written confirmation of their indemnity cover.
  8. The Clinical Risk Manager will submit this to the National Rehabilitation Hospital insurers for confirmation that the indemnity cover is sufficient.
  9. All applications must include the following supporting documentation.

Supporting Documentation

  1. CV of Principal Investigator (max 2 pages).
  2. CV of Co-Investigator’s (max 2 pages).
  3. Informed consent form to be used in the study.
  4. Copy of Professional Liability Insurance (persons not covered by CIS).
  5. Copy of additional Indemnity Cover where applicable.
  6. A cover letter including the name, address, phone and fax numbers, e-mail address of the Principal Investigator and of the Co-Investigator/s.
  7. Research proposal/ study summary/ protocol/ clinical investigational plan (max. 2 pages).
  8. Assent form to be used in the study (if applicable).
  9. Information Leaflets to be used in the study (if applicable).
  10. Letter from the Head of Department supporting the research (if applicable).
  11. If the focus of the study is to investigate/ evaluate medical device enclose relevant CE mark certificate (if applicable).

Step 2

Submit the following to the Chairman of the Medical Board at the National Rehabilitation Hospital.

  1. Completed Research Application Form.
  2. Declaration Page signed by the Principal Investigator and the Co-Investigator(s).
  3. All supporting documentation.

The recommendations of the Medical Board must be in writing to the Principal Investigator and copied to the Co-Investigator(s).

Step 3

Following Medical Board approval the Principal Investigator or where the Principal Investigator is the sponsor the Co-Investigator must submit all documentation to the Chairman of the Operational Management Committee at the National Rehabilitation Hospital.

The submission must contain the following:

  1. Completed Research Application Form.
  2. Declaration Page signed by the Principal Investigator and the Co-Investigator(s).
  3. The supporting documentation.
  4. Letter of approval from the National Rehabilitation Hospital Medical Board.

Following approval at the Operational Mangement Committee Committee the Chairman must inform the Principal Investigator in writing and the research proposal can be submitted to the Ethics Committee.

Step 4

Submit 14 copies of all documentation to the Secretary of the Ethics Committee at the National Rehabilitation Hospital.

1. Completed Ethics Committee Checklist, which includes inclosing the following documentation:-

  • Completed Research Application Form.
  • Declaration Page signed by the Principal Investigator and the Co-Investigator(s).
  • The Supporting documentation.
  • Copy of the letters of approval from the Medical Board and the Operational Management Committee.

The Principal Investigator and Co-Investigator(s) will be invited to attend the Ethics Committee. The Principal Investigator must be available to attend the Ethics Committee meeting at which the research project is proposed.

At this meeting the researchers will be required to provide an outline of the research being undertaken and answer questions raised by the committee.

The research can only proceed pending the recommendations of the Ethics Committee, which will be forwarded in writing to the Principal Investigator and copied, to the Co-Investigat-or(s).

If changes are recommended the Chairman before proceeding with the research must approve these.

Step 5

  1. Where the Principal Investigator is a sponsor the Co-Investigator(s) must report to the Principal Investigator during the research. This information should be communicated to the Ethics Committee – all research in progess is discussed at each Committee meeting.
  2. On completion the Clinical Risk Manager must check that all informed consent forms are in the patient’s medical record or designated area if specified.