CPE 91社区 Research Policies & Procedures

19 November 2003

Definitions & Policies

1. CPE 91社区 recognizes a distinction between Observers and Investigators. Observers are defined as those individuals who, for the purposes of the collection of data, must observe the children in their natural environment in the Centre, but will have no direct interaction with the children.
Investigators are defined as those individuals who, for the purposes of collection of data, must have direct interaction with the children or implement a change in the children鈥檚 environment.

2. All Observers and Investigators are required to submit for approval, a detailed proposal to the Research Committee at the centre. Further details of required elements are provided in the Procedures section. Approval is valid for one year; renewals may be considered.

3. Observers & Investigators whose proposals have been approved by the Research Committee must wear a nametag at all times on the premises, indicating their role (i.e., observer, investigator).

4. If research takes place in a room that is unsupervised by a staff member, two researchers must be present at all times.

5. At the conclusion of data collection and analysis, a copy of any written results is required for the Centre. In addition, a 1-2 page letter for parents and staff informing them of the results in lay terms is required. The investigator/observer must also be prepared to meet with parents or staff if they so request.

6. Unless otherwise specified in the consent form, video or audio tapes must be destroyed within one year of completion of the research project.

7. All Investigators must abide by 91社区鈥檚 policy on the Ethical Conduct of Research Involving Human Subjects and the .

Any breach of the research guidelines will result in an immediate cessation of the ongoing project and cancellation of any additional projects involving the implicated investigator until an extensive review of the incident has been completed.

8. CPE 91社区 reserves the right to terminate a project at any point at the discretion of the Executive Director or any member of the Board of Directors.

Procedures

1. All proposals, whether for Observation or Investigation, must include a completed CPE 91社区 application form (attached), an executive summary, and relevant consent forms (in English and French, as relevant).

2. For proposals requiring Observation, the executive summary should provide a clear description of the study, including an explanation of the purpose and procedures, duration of observation, numbers and ages of children and classes implicated, any foreseeable risks to confidentiality, etc. No additional prior approval is required before submission to the Research Committee (by way of the Executive Director鈥檚 office of CPE 91社区).

3. Proposals requiring Investigation, whether submitted by a researcher internal or external to 91社区, must first be reviewed and approved by the most appropriate 91社区 research ethics committee. Ethics approval from committees external to 91社区 or to its affiliated hospitals is not acceptable.

For research in the health sciences, please see the guidelines and submission deadlines for the Faculty of Medicine鈥檚 Institutional Review Board (IRB).

For research in other domains, please contact the relevant ethics committee in your area or lynda.mcneil [at] mcgill.ca (Ms. Lynda McNeil), Research Ethics Officer, Research Grants Office, James Administration Building, who will direct your proposal to the appropriate committee (see www.mcgill.ca/research/researchers/compliance/human聽for more details).

4. Once your research proposal has been approved by the relevant ethics committee, please submit 7 copies of the application form, executive summary, full proposal (for research requiring Investigation), consent form(s), and ethics certificate to the CPE 91社区 office for distribution to the Research Committee members.

5. The Research Committee will review the proposal to ensure that the proposal is compatible with the Centre鈥檚 philosophy, policies, and procedures, that no risks to participants may be foreseen, and that confidentiality is respected.

Four review outcomes are possible: acceptance, acceptance pending revision; resubmission; rejection. Committee decisions will be reached by consensus; if any individual member strongly objects to a proposal with cause, it will be rejected.

6. CPE 91社区 receives numerous research proposals each year; thus, you may expect a reasonable delay prior to the initiation of an approved project. In some cases, despite ethical acceptability, we may be unable to accommodate research proposal requests due to other commitments.

7. Once a proposal has been accepted, the Applicant will be contacted by the Executive Director to set up a meeting in order to introduce the Observers/Investigators to the educators. The methodology, including any necessary change in the daily routine, curriculum, schedule, activities, or physical set-up of the environment, will be clarified with the educators. Changes will only be made if they introduce a minimum of disruption and/or enhance the program quality. A schedule for completion will also be set up. Please note that research at the centre is generally completed between the hours of 8:30 and 10:00am or 3:30 and 4:30pm.

The Executive Director will emphasize to the Applicant that, although a parent has signed a consent form permitting his/her child to participate, the Observer/Investigator must also gain the children鈥檚 confidence/assent (see suggested guidelines attached). This requires that the Observer/Investigator complete a preliminary visit of 2-3 hours with the group prior to the initiation of the research project. It also requires that the Investigator explain to the children their involvement in the protocol in developmentally appropriate language and respond sensitively to children鈥檚 questions.

Despite the receipt of a signed parental consent form, no child may be forced to participate against his/her wishes. If a child refuses to participate after two or three verbal requests, the Investigator must exclude that child from his/her study.

When removing a child from a classroom, the Investigator(s) must inform the educator and provide an indication as to when they anticipate the child鈥檚 return. The educator must also be explicitly informed upon the child鈥檚 return.

8. Any changes to the research protocol must be submitted in writing prior to their implementation. If such changes are of a substantive nature, re-review by the pertinent ethics committee is required, followed by re-review by the Research Committee. During review of major or minor changes, the project will be suspended until the changes have been approved. The Centre reserves the right to discontinue a project if it does not approve of the proposed changes. The Centre also reserves the right to disallow the use of collected data for any purposes other than those originally stipulated, if the changes are not deemed appropriate.

9. As noted elsewhere, at the conclusion of each research project, Observers/Investigators are requested to provide a copy of any written results to the Centre. In addition, a 1-2 page letter for parents and staff informing them of the results in lay terms is required. The investigator/observer must also be prepared to meet with parents or staff if they so request.

Recommended ways of obtaining a child鈥檚 assent to participate or to continue participation

• Use statements such as: 鈥淚 am talking with most of the children in your class this week; are you ready to take your turn now?鈥� or 鈥淚 would like you to take a turn now; can you leave this activity and come with me?鈥�
• If the child indicates verbally or nonverbally an unwillingness to participate, say 鈥淚 will check back later to see if you are ready.鈥�
• If a child becomes inattentive, encourage continued participation with statements such as: 鈥淚 have only one or two more questions I would like you to answer鈥� or 鈥淥ne more try and then you will finish鈥�.
• If a child becomes uncooperative and/or distressed, try to comfort and reassure him/her and return him/her to the classroom. Inform the educator about the child鈥檚 distress so that the educators can also comfort and reassure the child.