Guidelines for Informed Consent Statement

What is an IRB consent form?

The consent form provides potential research subjects with sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.

General Guidelines

For procedures requiring oral consent, using the following consent template can ensure informed consent. A script that is shorter and more conversational may be more acceptable. As evidence that the participant's acceptance is received and he/she is aware of the following information:

  • Research Title/ Project Title.
  • Authors Names/ PI Name - Affiliation.
  • Statement that the study involves research.
  • Study purpose: What the study is about?
  • Introduction- who is the caller/interviewer, affiliation, organization.
  • What will the participant be asked to do - as well as the amount of time the participant will spend (include any follow-ups that you plan to do) If applied, any compensation and information need to be collected to make that payment (mailing address, email address, etc.).
  • The voluntary nature of participation in the study would include the following:
  1. Risks and discomforts: (If exist)

If there are no known risks, it should be stated

  • Legal risks (e.g., possibility of discovering activities that may require reporting to authorities, possibility of being arrested).
  • Social or economic risks (e.g., loss of confidentiality; effect on financial standing, employability, or insurability).
  • Emotional risks (e.g., feelings of sadness or anxiety).
  1. Benefits

If there are no direct benefits, it should be stated.
The expected benefits to society or scientific knowledge. For example, Information that may benefit other people now or in the future should be described.

  • Taking notes or recording the data should be clarified to participants.
  • Whether the information collected will remain confidential or it is planned to keep identifiers with the research data, it should be stated (if the address is collected, will that be kept separate from the survey responses).
  • Contact information for the researcher and/or the IRB should be provided to participants.
  • Ask if the participant has any questions that you can answer.
  • Ask explicitly- do you agree to participate in this research? And record the response.

Depending on the nature of the research/ project and the participant pool, the researcher may offer other information to assure that participants are fully informed about the study and any risks or benefits from participating in it.

Declaration after conducting the results

Any research describing a study involving humans should contain this statement. Please add “Informed consent was obtained from all subjects involved in the study.” OR “Not applicable.” for studies not involving humans.