Guidelines for Researchers

Any changes to the study protocol, investigator brochure, consent form, study instruments, and/or recruitment materials must be detailed on an Amendment form. Additionally, any changes to the LPI, PI, Co-investigator(s) and/or study coordinator must also be reported to the HiREB using an Amendment form.

Researchers must ensure that their study has continuous ethics approval.  This is done by submitting an “Annual Renewal” form via our eREB system. The Renewal must receive REB approval prior to the expiry date of the current ethics approval period.  Researchers are advised to submit their renewal applications 30 days prior to the expiry date.  […]

A Standing Appeal Board shall be established by the President to adjudicate any1 appeal of a decision reached by the McMaster University Research Ethics Board (MREB), or the joint Hamilton Health SciencesMcMaster Faculty of Health Sciences Research Ethics Board (HHSFHS REB) or the St. Joseph’s Healthcare, Hamilton Research Ethics Board (SJHH REB), provided that decisions rendered by the latter two REBs are specific to an appeal by a McMaster University faculty member under the auspices of their University appointment.

Clinical Trials Ontario (CTO) is an independent not-for-profit organization established with support from the Government of Ontario.  Their mandate is to work collaboratively with the clinical trials community, the public and strategic partners to improve Ontario’s clinical trials environment and attract clinical trial investment to the province, while supporting the highest ethical and quality standards.

A conflict of interest (COI) whether real, potential or perceived, arises when an individual in a position of trust has competing professional or personal interests.  Researchers and research staff should identify and manage COI to maintain the public confidence and trust and to maintain the independence and integrity of the research process.

As of April 1, 2017 the administrative fee has increased to $3,500 (Cdn) and is required for REB review of all industry-sponsored research projects reviewed by the Hamilton Integrated Research Ethics Board (HiREB), whether funding associated with the research project is administered through St. Joseph’s Healthcare Hamilton, McMaster University or Hamilton Health Sciences.

Some of the institutions for which HiREB provides ethics review require a letter from the REB in order to open a research funding account prior to obtaining REB approval. To request this approval, please provide the following information in an email sent to hireb@hhsc.ca: Recipient name, role/title and affiliation(s) Project title (as it appears on […]

Incidental Findings are unexpected discoveries made during a research study, but are not part of the research itself.

All research reviewed by HiREB requires a Local Principal Investigator (LPI). The LPI must be a staff member of, or have affiliation with, either St. Joseph’s Healthcare Hamilton, Hamilton Health Sciences or McMaster University.

Ethics review for multi-center research presents many challenges to researchers and REBs. In order to minimize the duplication of effort and the time delays associated with concurrent or serial ethics review, the following centers agree to participate in a coordinated ethics review process…

The research question and methodology must be presented in sufficient detail to permit evaluation of the scientific merit of the project.

For help in determining if your study is QA or research.

In the eREB electronic submission process we recognize obtaining resource signatures can be quite onerous.  We have prepared this resource signature document as a guideline.  As you know you are responsible to identify any area that may be impacted by your study and then obtain the signature from the Clinical Manager/Director.  Our plan is to […]

Depending on the nature of your submission(s), you may qualify for either an expedited or full board review.

All Data Safety Monitoring Board (DSMB)/Data Safety Committee (DSC) Reports must be forwarded to the HiREB as soon as hey are available.

Contact information for submission of sponsor agreement funds administered by Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton and McMaster Faculty of Health Sciences.

In order to facilitate the work of the HiREB, the Student Research Committee (SRC), a subcommittee of the HiREB, reviews student research applications. When an application is submitted, the HiREB makes the determination as to which committee will review that application.

It is the local principal investigator’s (LPI) responsibility to notify the HiREB using the Study Completion Report form when the study has been closed. The HiREB file may be closed when: a.   There is no further participant involvement; this means all contact with participants has ceased, and b.   All new data collection is complete and there […]