HEALTH ETHICS COMMITTEE

Application form for applications other than clinical trials

Code number (for official use only)

Research identification

Fill in as appropriate

Research involving medicinal products / medical devices / surgical procedures Undergraduate dissertation

Postgraduate research Full title of the research:

Specify course being followed: Name of foreign & local supervisors:

Name of institute where student is registered as student: Protocol code number, version and date:

Sponsor identification

Is the research funded in any way by industry?

Name and address:

Work telephone numbers:Fax number:

Email address:

Contact person name (if applicable):

Applicant details - These are the details of the legal applicant who signs the form.

Tick as applicable
Sponsor
Principal researcher for single centre research
Coordinating researcher for multi centre research
Person / organisation authorised by the sponsor
Person or organisation name and address:
Telephone numbers of home and places of work:
Fax number: / Email address:
Contact person name:
2
Ministry for Health

General information

Specify the medical condition: Main objective of the research:

Secondary objectives of the research (if applicable): Principal inclusion criteria:

Principal exclusion criteria: Primary end points:

Estimate of the duration of the research from to Design of the research:

Sampling (give details if applicable):

Potential risks: Potential benefits:

Balance of risks and benefits: Patient Protection Measures:

Sites where research is going to be carried out:

Ministry For Health / 3

Population of subjects

Age span

Fill in as appropriate

Male / Female

Healthy volunteers / Patients

Women of childbearing potential / Pregnant women / Nursing women Emergency situations - If yes, specify:

Subjects incapable of giving informed consent - If yes, specify: Other vulnerable populations:

Planned number of subjects:

Researcher details (copy and fill in for each researcher / supervisor)

Fill in as applicable

Principal researcher for a single centre research:

Coordinating researcher for a multi-centre research:

Site researcher for a single / multi-centre research:

Name:

Profession:

Institution department name and address:

Telephone numbers of home and places of work:

Mobile number:Pager number:

Fax number:Email address:

Sponsor’s duties which are carried out by third parties (if applicable)

Organisation department name: and address

Contact person name:

Telephone number:

Details of duties:

Ministry for Health / 4

Declaration by the applicant

(including terms and conditions for approval in terms of the Data Protection Act)

Research title

I confirm that / confirm on behalf of the sponsor that (delete as appropriate):

All information submitted in this form and appended documentation is true and correct.

Any changes occurring during the study (including documents) shall be submitted to the Health Ethics Committee if so required by the same ethics committee. This may necessitate an authorisation before such a change can be implemented. In this case all documentation pertaining to the amendment which is submitted shall be true and correct.

The end of study report will be submitted to the Health Ethics Committee within 15 days from finishing.

The study will be conducted according to the protocol and applicable requirements including data protection as deemed necessary by the Health Ethics Committee including data protection.

Personal data shall only be collected and processed for the specific research purpose. The data shall be adequate, relevant and not excessive in relation to the processing purpose.

All reasonable measures shall be taken to ensure the correctness of personal data.

Personal data shall not be disclosed to third parties who are not signatories and may only be required by the Health Ethics Committee or the supervisor/s for verification purposes. All necessary measures shall be implemented to ensure confidentiality and where possible, data shall be anonymised.

Unless otherwise authorised by the Health Ethics Committee, the researcher shall obtain the consent from the data subject (participant/respondent) and provide him with the following information: The researcher’s identity and habitual residence, the purpose of processing and the recipients to whom personal data may be disclosed. The data subject shall also be informed about his rights to access, rectify, and where applicable erase the data concerning him.

The Health Ethics Committee may process my personal data for the purpose of evaluating my request and other matters related to this application. I also understand that I can request in writing a copy of my personal information. I shall also request rectification, blocking or erasure of such personal data that has not been processed in accordance with the Act.

Signature of applicant (as detailed in page 2)

Print nameDate

Ministry for Health / 5

Annex 1 - Documentation to be submitted with application

Tick if / Tick if not
supplied / applicable

One printed copy of the documents described below (including this annex after being completed)

Disk with electronic copy of all documents listed below including this annex after being completed. The disk should also contain a copy of the filled in application form

Bank receipt of payment (the Research study should be written on it)

Covering letter

Application form

If the applicant is not the sponsor, a letter of authorisation enabling the applicant to act on behalf of the sponsor

List of other bodies to which the application has been submitted and copy of opinion (example Foreign Institutions’ Ethics Committee)

Subject related

Informed consent form (Maltese & English languages)

Subject information leaflet (Maltese & English languages)

Arrangements for recruitment of subjects

Protocol related

Protocol with all current amendments

Staff related

CV of the investigators

Information about supporting staff in each site

Ministry For Health / 6

Finance related

Provision for indemnity or compensation in the event of injury or death attributable to the research

Any insurance or indemnity to cover the liability of the investigator and sponsor

Compensation to subjects

Compensation to investigators

Agreement between sponsor and research sites

Agreement between investigators and research sites

Agreement between sponsor and investigator

Other

Contact numbers of investigators. All local investigators participating in the conduct of the research should make themselves available and accessible to the Health Ethics Committee

Letter signed by Head of department(s) / Consultant(s) concerned when patients / relatives and / or records of their department are involved.

Details of publication policy

Licensing status of drugs / medical devices

Ministry For Health / 7