whether participants are drawn from University sources or from any other sources;

whether participants are paid or unpaid;

whether it is conducted on University property or at any other location;

whether it is conducted in a laboratory or in the field;

whether it is conducted in person or by some other means (e.g., mail, telephone, computer link);

whether information is collected via direct observation, apparatus, questionnaire, interview, or review of records not normally available to the public;

when it is conducted for teaching and demonstration purposes where students are either the subjects or the researchers.

If research procedures, material or equipment, or the dissemination of results could potentially produce physical or mental harm for the participant, the investigator must assess the magnitude and present justification for it to an appropriate Ethics Review Committee (ERC). Before approving the research, the committee must be satisfied that there is a reasonable expectation that the results will significantly increase understanding or will benefit human health/welfare. As the magnitude of the potential risk increases, it becomes increasingly important that benefits outweigh those risks.

Research may be viewed as being ethical when the benefits outweigh the risks and the participants' welfare is safeguarded. In balancing the issues raised by these interrelated considerations, recognition should be given to variations in perceptions regarding ethics from community to community and over time.

An assessment must be made of the degree of risk, minimal or significant, to a participant. A minimal risk is defined as one that is no greater than the risks of everyday life or of routine medical or psychological examinations. A significant risk involves potential physical or psychological harm to the participants or, in some cases, to the groups of which they are members. If the risk is considered greater than minimal, the investigator must decide whether a participant should be exposed to the procedure. If the procedure is to be undertaken, the investigator must inform the participant of the risk before initiating the study. Should adverse effects result from research procedures, the researcher has an obligation to assist the participant in appreciably reducing or reversing those effects.

The magnitude of the potential benefit of the proposed research must be appraised by an ERC. The evaluation should be based on a global assessment of the degree to which the research might further our understanding of a phenomenon. Researchers are encouraged to make sure that subjects benefit from participation in the research by such means as educational post-briefing.

Where possible, participants or their surrogates must give fully informed and voluntary consent to participation.

Where possible, participants must be guaranteed anonymity and their responses treated with confidentiality. Where exceptions must be made, participants must be informed about the degree of anonymity and confidentiality prior to being asked for consent, and such guarantees must be respected.

The investigator must establish a fair agreement with the participant which clearly expresses the participant's respective obligations and responsibilities before the participant decides whether or not to participate. Participants should be informed of the opportunity to withdraw at any time without penalty. The researcher must inform the participant of all aspects of the research that could reasonably be expected to influence the participant's willingness to participate. Any incentive offered to participants must not be so large as to become an undue inducement that would undermine the voluntariness of participation. Captive populations, such as prisoners or patients, must not be offered inducements that would unduly improve their situation or influence their relation to others. If the participants are students and are involved in research as part of their education, they must be given an opportunity to obtain equivalent experiences through alternative procedures. In all cases, the participant should be informed of a person who may be contacted in case of concerns, complaints, or consequences. Research with children or participants who have impairments that would limit understanding requires special safeguarding procedures. Normally, consent from these persons must be obtained and these persons must be informed that they are free at any time to withdraw from participation. In addition to assent from a child (if the child has the capacity to understand) consent must be obtained from parents or guardians of the child (under age of 18 years). However, a child's dissent will always override a parent's or guardian's consent, while a child's assent will never override a parent's or guardian's refusal to grant consent. Consent may not be required from participants when the research involves the use of documents, records, pathological or diagnostic specimens, or data already collected (i.e., secondary analysis) or public behavior. “Public” refers to behavior that occurs in a context in which an individual may expect to be observed, recorded or to provide information that may be released. If anonymity and confidentiality cannot be assured, participants must be made aware of this limitation and of the possible consequences before becoming involved. Any use of secondary data not in the public domain must be in compliance with these guidelines.

Researchers must be competent in their area of inquiry, and they must be familiar with appropriate ethical guidelines and with participant risks and the possible uses to which the results may be put in order to make responsible decisions. The responsibility includes the awareness of and efforts to avoid discrimination and biases in research practices and in the interpretation of findings (for example, biases related to race and gender). When in doubt about the application of these guidelines, the investigator is encouraged to consult with informed colleagues and supervisors.

The investigator must ensure that all individuals under the investigator's supervision have the training and competence needed to carry out their responsibilities. Principal investigators must ensure that all research personnel are familiar with the University Standards for the Protection of Human Research Participants and with applicable professional guidelines.

Adequate supervision of student research must be ensured, especially where risk or sensitive areas are present. Because the investigator is ultimately responsible, such supervision is imperative. Researchers will ensure that all research assistants and student investigators are familiar with the University Standards for the Protection of Human Research Participants and with applicable professional guidelines.

Participants have the following rights: to consent to participate without coercion; to be fully informed about the project, except in special circumstances noted earlier under concealment; to be provided with opportunity to assess risk, including individual risks and individual and societal benefits; to withdraw from the research without penalty or risk of any kind (including loss of agreed-upon monetary reimbursement or other incentives); to be fully informed of the degree of anonymity; to be fully informed during post-briefing when concealment has been used.