Voluntary informed consent, a prerequisite for participation in research, is a process and a document. The informed consent process is about the protection and respect for research subjects. The consent process varies according to the level of review and nature of the research.
In all cases, the informed consent process/document must:
- Be presented in language easily understood by the subject
- Minimize the possibility of coercion or undue influence
- Allow subjects with sufficient time to consider participation
- Allow subjects to refuse or discontinue participation at any time
- Distinguish between research and standard medical care
- Be appropriately presented for the subject’s physical, emotional and psychological capacity, and vulnerable status
- Assure that subject understands what participation entails
Required elements of informed consent:
- Purpose and procedures involved in the research
- Alternatives to participation
- All foreseeable risks and discomforts to the subject (e.g. physical injury, psychological, social, or economic damage).
- Benefits of the research to society and the individual subject
- Person to contact for answers to questions or in the event of a research-related injury or emergency
- In the state of California subjects must be presented with a copy of the Experimental Subject’s Bill of Rights
Waiver of one or more elements of informed consent may be permitted by the IRB for some research activities if appropriate.
The following are types of informed consent: consent, parental permission, assent, verbal, short form, information/fact sheet, waiver of documentation of informed consent, and waiver of elements of informed consent.
Informed Consent Templates
Informed Consent in Human Subjects Research
This booklet provides an overview of informed consent: its importance, required elements of consent, the consenting process, and documenting consent.
Recommendations on Certificates of Confidentiality (from OHRP Secretarial Advisory Subcommittee)
To submit confirmation of training to OPRS
- Be sure to include your Full Name and Email Address when prompted
- Results will be sent to OPRS automatically
- OPRS will send confirmation to the email address provided
To navigate through the quiz
- Enter your Full Name and Email Address (to access quiz without submitting name to OPRS, enter “guest” for name and “firstname.lastname@example.org” for email address when prompted).
- Click on the answer you wish to select.
- Click on “Answer” button on bottom of page to submit your answer.
- If the answer is correct, click “OK” button and repeat steps 2-4.
- If the answer is incorrect, you have another attempt to select the correct answer.
- After you have completed the quiz, you can review your answers by clicking on “Review Quiz”.
- To retake the quiz, exit and restart presentation. Skip ahead to the test and re-enter your Full Name and Email Address.