Below is an informed consent template that you may use as a guide.
SFU Sample Consent document.docx
It is important to remember that informed consent is a process, not a piece of paper. You need to provide your participant with sufficient information that they can make a voluntary and informed decision about their participation in your research project. Ideally, this is a conversation that you will engage in with you participants. The signed document is a public acknowledgement of this discussion and your subject's willingness to participant in your research project.
Below are the recommended elements of a consent document, taken from the federal regulations [45 CFR 46.116]
- A statement that the study involves research
- An explanation of the purposes of the research
- The expected duration of the subject's participation
- A description of the procedures to be followed
- Identification of any procedures which are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
- Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
- Each page should be numbered (i.e., Page 1 of 5)
- Your Approval Date, End of Study Date, and your entire unique IRB Number will be stamped at the bottom of each page upon IRB Approval.
NOTE CHANGES
The university is allowing the resumption of research at this time. However, any face to face research MUST include what measures the researcher(s) is/are taking to comply with COVID guidelines requiring face coverings, social distancing, etc. This includes a release of liability against Saint Francis University.
IF YOU PLAN TO CONDUCT FACE TO FACE RESEARCH, you must add the following language to your protocols within the application and informed consent document. Please email the IRB directly at irb@francis.edu for any questions. Any proposals or consents submitted that DO NOT have these elements (IF APPROPRIATE) will be rejected.
Participation Statement
In addition, each participant in the study must wear a mask or face covering and appropriately social distance (at least 6 feet apart) to protect against the spread of COVID-19. Any participant who has symptoms of COVID-19 or who has been exposed to someone who had tested positive (exposure defined by the CDC as face-to-face contact less than six feet apart and without a mask for 15 minutes or more) will not be able to participate.
Risks/Discomforts
Precautions have been put in place to prevent the spread of COVID-19 but the researchers acknowledge the potential risks of getting sick after gathering in a group. By signing this form, you agree to release the researchers and Saint Francis University from liability due to the pandemic. The researchers do not foresee any additional risks or discomforts that could result from your participation.