Because the central requirement for human participants research is that people participate voluntarily, the consent process is one of the more important parts of the research project. The process must assure that the potential participant understands the study and its risks and benefits and can certify his or her willingness to participate or decline to participate in the study. Under certain circumstance the IRB can waive or alter the informed consent process. Sample consent forms are available on the IRB website.
Information that must be provided to participants for informed consent can be found in the link to the federal regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.109
What about informed consent for anonymous surveys?
In some cases, a signed consent form is either inappropriate or unnecessary. According to Federal Regulations at 45 CFR Part 46.117c the IRB may waive this requirement if it determines either:
- There is a risk of breach of confidentiality and the only link between the participant and the research would be the consent document. In this case, the participant's wishes should be followed.
- The research presents no more than minimal risk of harm and involves no research that requires written consent outside the research context.
In general, on common survey research, where there is no more than minimal risk and anonymity is provided, a separate consent form is not needed. The survey itself can contain relevant information about the study. In this case, submitting the survey is an indication of consent. If the survey is being sent and returned through the Internet, participants should be alerted to how confidentiality is being protected. Researchers can block identifying information or arrange to have surveys returned by mail. If identification (through IP or email address) is possible, then steps taken to ensure confidentiality should be explained.
