Human Participant Research Guidelines & Forms

Core Principles for Ethical Conduct of Research Involving Humans

Free, informed and ongoing consent of research participants is grounded in the core ethical principles of Respect for Persons, Concern for Welfare, and Justice. Respect for Persons recognizes the right of an individual to exercise his or her own judgment, and to freely choose without interference. In some cases, Respect for Persons means the moral obligation to protect those with developing, impaired, or diminished autonomy. The principle of Concern for Welfare requires that participants be given sufficient information to be able to adequately assess the risks and potential benefits of their participation in a study. Contributing factors to the risks and potential benefits include information on privacy and control of information or materials provided by the participant, as well as the identification of possible physical, psychological, economic or social discomforts. Justice refers to the obligation to treat all people with equal respect and concern, and to ensure that the benefits and burdens of participation in a research study do not fall unduly on any particular group of individuals. In applying the principle of Justice, researchers must take into consideration the vulnerability of participants (whether caused by limited capacity to understand relevant information presented to them or limited access to social goods such as rights and opportunities or imbalance of power that may exist in the relationship between the researcher and the participant).

Please consider these core principles when preparing your human research application for ethical review. Information requested in the application form is required for the HSRC to conduct the ethical review of your research study. Examples of informed consent forms are also provided below; additional examples will be added as they become available.

Human Research Application Form and Informed Consent Checklist

Application for Ethical Review of Human Participant Research

Informed Consent Checklist

Samples of Recruitment and Informed Consent Materials

The examples below have been selected to show a few of the many possible variations on recruitment and informed consent; applicants are strongly encouraged to personalize the examples to ensure that they are appropriate for your specific research participant pool.

Recruitment Materials and Scripts

Recruitment Poster

Email Recruitment for Online Survey

Telephone Recruitment for Phone Interview
 

Informed Consent

Assent Form (for minor participants)

Parental/Guardian Consent Form

Letter of Invitation: Online Survey

Letter of Consent:_Telephone Interview

Letter of Consent:_Videorecording

Human Research Study Reporting Requirements

Researchers conducting studies with human participants must submit an annual status report for studies exceeding one year in length or an end-of-study report for projects lasting less than one year. Reports are to be submitted to susan.entz@uleth.ca.

Annual Report: Human Research Annual Report and Renewal Form

End-of-Study Report: Human Research End-Of-Study Form

Guidelines

Guidelines for Submission of a New Application for Ethical Review of Human Research

Guidelines for Submission of an Amendment to an Approved Human Research Protocol