Guidelines for the Use of Clinical Facilities for Research

OVERVIEW

Dental operatories at the Clinic may be used for research. Researchers must have an appointment at the Faculty of Dental Medicine and Oral Health Sciences and a licensed dentist must be present when patients are seen. Note that, though research is a priority for the Faculty of Dental Medicine and Oral Health Sciences, undergraduate clinical training is prioritized at the Dental Clinic.

Researchers will be billed according to the Fee Chart for Research Conducted at the Dental Clinic. The fee chart should also be used to estimate budget costs when completing research grant applications. The fees may be modified from time to time without notice.

The Faculty recognizes that some researchers have limited funding. In this case, researchers may apply for funding through the Faculty’s annual seed fund competition.

CLINICAL FACILITIES

The following are available to researchers:

1. Patient charts: All patients must be entered in the Faculty’s patient management software, ABELDent, and a procedure note must be included in the patient’s chart whenever they receive treatment. Only clinic staff (i.e., receptionists) are permitted to create dental charts. Research projects will be charged a one-time fee to create charts based on the number of anticipated patients. These fees will be based on clinic staff’s hourly rates. Only treatment information can be stored in ABELDent. Researchers must have their own secure databases in which to store research-related information. Researchers who want to run queries on the clinic’s patient records will be charged an hourly rate.
2. Operatories: Two operatories are available for research. There is a basic rental fee per half-day session. Fees include supplies required for the cleaning and asepsis of the operatory and basic operational items, e.g., gloves, procedure masks, disposable air/water syringe tips, and suction tips.
3. Hand instruments and handpieces: Hand instruments and handpieces can be rented from the Clinic for research. Sterilization, repairs, and processing are included in the rental. If researchers want instruments to be reserved for their exclusive use, they will need to purchase them.
4. Imaging: Charges for radiographs and other images (intra-oral radiographs, panoramic radiographs, lateral or anteroposterior cephalographs or CBCT) are per use. Only a licensed dentist can prescribe radiographs and must be on site when they are taken. Only dentists with the required number of hours of training can take CBCTs. Researchers must inform the Clinic in advance when they wish to take radiographs.
5. Other facilities (video recording, preclinical lab, etc.) and materials: Researchers may request the use of other facilities in the Faculty. These requests will be reviewed on a case-by-case basis. Please note that if the research requires materials not currently in use at the Clinic or materials that are expensive, the researcher may purchase these items themselves.

Researchers are responsible for purchasing and paying for materials and supplies that are not included above. Purchases will be made via the Dentistry Store in Marketplace using the FOAPAL associated with the research project.

Clinic staff are not available for chairside assisting. Clinic staff will only be involved in the creation of patient charts, imaging, and greeting patients at the front desk. Researchers must hire their own research assistants and other staff (hygienists or dental assistants) to conduct research. Please contact hr.dentistry [at] mcgill.ca (HR Dentistry) for more information on hiring.

REQUIREMENTS FOR USING CLINIC FACILITIES FOR RESEARCH

1. Scientific Review. All projects that involve using the Clinic for research must have undergone scientific review. Projects that are funded by CIHR, FRG, NSERC, or a similar agency have already been reviewed and do not need to be reviewed internally. Projects that have not been already reviewed (ex., by a funding agency) will be required to undergo a full scientific review by 2 peers. Please consult the Scientific Review Committee Guidelines for more information and anticipate a delay of 5 weeks for the review process. This review is required for IRB approval.
2. IRB approval. Note that the consent form must include a statement that the patient understands that they should continue to see their regular dentist for regular checkups and that participation in the study does not replace these regular checkups in any way. Please also ensure that the patient provides their regular dentist’s name and contact information. Consult the Ministère de la santé et des services sociaux’s Standard legal clauses for information and consent forms for clinical trials for more information.
3. Dental license and proof of malpractice insurance.

REQUESTING CLINIC ACCESS

To request clinic access, researchers must submit the following to the Faculty of Dental Medicine and Oral Health Sciences’ research2.dentistry [at] mcgill.ca (Research Administrator). The Research Administrator will respond to any questions researchers have. The Clinic’s leadership or staff are not responsible for carrying out research activities.

1. Funding Prerequisite for Research Conducted at the Dental Clinic
2. Additional Information Required to Use Clinical Facilities for Research
3. Request for Use of Clinical Facilities for Research.
4. Proof that the researcher meets the requirements listed in Section III
   1. results of internal scientific reviews OR award letter
   2. IRB approval notification, participant consent form, and email used to recruit participants if they were recruited from the clinic
   3. dentist’s license
   4. proof of malpractice insurance

Researchers will also need to provide the Research Administrator with a list of research participants and their contact information.

The Associate Dean of Clinical Affairs will only be in touch with the researcher about next steps (e.g., scheduling) after funding sources have been confirmed and, if required, the Scientific Review has been completed.

REMINDERS

• Before clinical research can begin, research projects must have been approved by an appropriate ethics review process. Researchers are bound by research ethics.
• Researchers who have a license to practice as dentists in Québec are legally and ethically bound by applicable ODQ regulations.
• Researchers are ethically and financially responsible for treating any complications that arise from the treatment a research patient receives. Researchers must refer a patient (ex., to the participant’s regular dentist) if the researcher notices that the patient has an oral health problem during the course of the research.
• Researchers who wish to recruit patients from the Clinic patient database must follow the Protocol for Access to Patient Data.
• Research patients who were not recruited from the McGill Dental Patient database must be informed that their participation in the study does not provide them with the right to become a regular patient at the Dental Clinic.
• Researchers will not automatically have access to the Clinic’s computers. They will need to be added to an ABELDent group before they can sign in.
• Everyone who sees patients in the study, even if they already teach in the clinic, will need to take an orientation course to use Clinic equipment and software and to learn and follow clinical protocols.
• The Guidelines for the Use of Clinical Facilities for Research may be modified for specific periods of time (e.g., a pandemic). In such situations, public health and infection control protocols may limit access to clinical facilities and/or require additional safety protocols.

* Researchers should follow these guidelines when submitting applications to funding agencies and subsequent requests for IRB approval.