Ethical Review Process

Amendments

Information for researchers about changes to research after ethical approval has already been given.

• Amending a study that already has ethical approval
• Change of Principal Investigator
• Change of Lead Investigator for a Multi-region study for the purposes of ethical review
• Change of Co-investigator (including registrars and study co-ordinators)
• Adding sites

Amending a study that already has ethical approval

Submit a written request to the ethics committee that gave ethical approval explaining what the amendment is and why it is required. Include a new version of the information sheet and consent form if required and a new protocol if there is one for the study. If the amendment includes an increase in the number of participants being recruited, if applicable, a new Form A or B is required.

Ensure it is clear what the changes are either in a covering letter or by including a clear summary of the changes. Researchers will be advised as soon as possible if an amendment requires a new application to be submitted.

If a revised information sheet/consent form is included, ensure that the changes are tracked or highlighted on the documents. A brief description in the covering letter is helpful.

Ensure any information provided has the study title and ethics reference number clearly marked. If submitting to the Multi-region Ethics Committee, please provide three copies of all papers.

Change of Principal Investigator

If the new principal investigator is a current co-investigator then recruitment may be ongoing. The following documents need to be provided to the appropriate ethics committee and may be approved by the Chairperson under delegated authority:

1. Updated information sheet/consent form.
2. Updated indemnity agreement.
3. Part 4

If the new principal investigator is not a current co-investigator, then recruitment should cease until the following documentation has been approved or noted by the Committee or Chairperson:

1. Details of the new investigator as per page 1 of the application form.
2. Updated information sheet/consent form.
3. Updated indemnity.
4. Part 4.
5. Locality assessment.

Change of Lead Investigator for a Multi-region study for the purposes of ethical review

The lead investigator for New Zealand of a company sponsored study has been given the role in consultation with the sponsor and the other sites.

The purpose of the role is to provide the information to the ethics committee for the initial ethical review and ongoing ethical review, to co-ordinate the information from all New Zealand sites and to ensure that all sites are informed of information relating to the study for example, that ethical approval letters are distributed, serious adverse event and other safety information is provided to all sites and all investigators are aware of any new information.

If the lead investigator is no longer a principal site investigator on a multi-region study, he/she may continue as lead investigator if:

1. the sponsor supports this and provides any indemnity required (written confirmation provided to the Committee)
2. the sites agree to the lead investigator continuing in this role
3. the/she will be available to provide information to the committee and other sites in a timely manner.

Change of Co-investigator (including registrars and study co-ordinators)

All changes of investigators, including registrars and study co-ordinators must be notified to the Committee. The information sheet should be checked to see whether any details need to be updated and if this is required, a new version submitted for approval.

Adding sites

To add one or more sites or recruit in new regions, the principal researcher needs to forward a request to add an additional site or region to the ethics committee that has already approved the study.

The following details are required.

• Details of the additional investigators (amended application form Part 1, pages 1 - 2)
• Evidence of Māori consultation for each new site (unless the new site is covered by previous consultation)
• Part 4 for each new site
• New form A or B (if applicable)
• Locality assessment for the new site(s)
• Updated information sheet/consent form(s) for all sites (including for those sites already approved if there is ongoing recruitment).
• Any new advertising or letters of invitation not previously approved for exisiting sites

If the addition of sites will mean more participants than was approved in the original application, justification of this amendment must be provided.


Page last updated: 26 September 2008