IRB — General Principles

All researchers conducting original research are responsible for protecting their subjects from the risk of unreasonable harm

• The principal investigator has initial responsibility for determining whether such a risk exists. In assessing risk, the principal investigator should follow the guidelines of the relevant professional organization(s) and, where appropriate, the guidelines of governmental funding and regulatory agencies. If there are any doubts about risks, the principal investigator or his/her supervisor should contact the IRB Chair for assistance

No student should conduct research without the expressed support of a faculty supervisor.

• Faculty members supervising student research are responsible for introducing students to Centre's Policy on Protection of Human Subjects. The faculty member is also responsible for supervising research undertaken by students in the context of his/her courses or program curriculum

At a minimum, research activities at the College should conform to the following standards:

1. Protection of Human Participants Training:

• All researchers involved in a study, even if they will not be directly involved in working with human subjects, must have a certificate on file with the executive secretary demonstrating that they have successfully completed the National Institutes of Health "Protecting Human Research Participants" training module, available at: http://phrp.nihtraining.com/users/login.php

2. Informed Consent:

• Prior to subject participation, the principal investigator must explain the objectives of the research, the procedures to be followed, the associated risks, and the potential benefits. Investigators may not use individuals as subjects unless the subjects or their legal guardians freely consent to participating in the study and fully understand the consequences


• Though a researcher may make the case for using oral consent, subjects should signal their agreement to participate by signing a written consent form. In the case of electronic or online surveys, the participants may indicate their agreement by making an electronic entry (e.g., check box, radio button) in response to the statement "I have read the consent form and willingly agree to participate." The requirement for written or electronic consent may be waived by the IRB if the research involves no or only minimal risk, or if the consent form will be the only evidence linking the subject to the research and the primary risk of harm is to the subject's privacy


• Anonymous surveys do not require written consent, though the explanations of the research protocol that are standard on written consent forms should be included at the beginning of the survey. Consent to participate is implied when a subject completes and returns the survey. Anonymous data can be obtained by using questionnaires that are returned by mail (in envelopes with no return address or other identifying markers), by ballot box, by the collection of surveys that are returned to the researcher as a group and at the same time, or internet surveys using software that renders it virtually impossible to connect answers with respondents


• Research involving deception compromises a subject's ability to give true informed consent. The IRB will consider requests to waive some of the requirements for informed consent for research that intentionally involves deception, but only if all of the following criteria are met:
  
  
  1. The research cannot be done without the deception
  2. The potential value of the research outweighs any potential risks to the subject
  3. The subjects are informed of the true nature of the research as soon as possible
  4. The research involves no more than minimal risk

• In some cases, revealing the purpose of the study prior to participation may undermine the study's design. In these cases, the researchers must provide a mechanism for debriefing the participants on the purpose of the study and allow them to have their questions regarding the study answered

3. Confidentiality:

• Investigators must respect the privacy of their subjects. Investigators must protect confidential information and must advise subjects in advance of any limits on their ability to ensure that the information will remain confidential


• If the data gathered by a student researcher is not anonymous, the IRB recommends that the data be turned over to the faculty supervisor, who will then become responsible for either properly storing the data for three years, or ensuring that the data are destroyed. If a student plans to continue the research or use the data in future projects, he or she may request permission from the IRB to retain the data. Permission is contingent on the student's agreement to protect the confidentiality of the data

4. Coercion:

• Subjects, including students who are participating in classroom experiments or faculty scholarship, may not be induced to participate by means or in circumstances that might affect their ability to decide freely. When course credit is offered for participating in research, some other mechanism to earn that credit must be made available to students who choose not to participate as human subjects. Alternative mechanisms for earning credits and the rewards for participating in research should be in line with the burden imposed by participating in the research to avoid presenting an undue influence on a person's ability to freely choose to participate (or not).


• Researchers must inform subjects that they are free to withdraw from participation in the research at any time. Subjects who indicate a desire to withdraw must be allowed to do so promptly and without penalty or loss of benefits to which he/she is otherwise entitled. This condition must be clearly stated as part of the informed consent statement. In the case where participation is linked to a student's earning course credit, the participants must be given an alternative option to earn the course credit that is equivalent in time and effort so that they do not feel unduly pressured to participate in research

5. Disclosure:

• Upon request, an investigator must disclose the source of support for the research to a subject.