Institutional Review Boards (IRBs) require researchers to obtain informed consent from participants before conducting research. This helps ensure that individuals understand the risks and benefits of participating in research and can make informed decisions about whether or not to participate.
To streamline the informed consent process, many institutions have developed recruitment and informed consent procedure templates. These templates provide a step-by-step guide for researchers to follow when obtaining informed consent from participants. Templates vary from institution to institution but typically include the following components:
Steps for Informed Consent:
**1. Participant Recruitment**: Researchers identify potential participants and provide them with basic information about the study. This typically includes the purpose of the study, the procedures involved, the time commitment required, and any potential risks or benefits.
**2. Consent Form**: Researchers provide participants with a consent form that outlines the details of the study. Participants should be given ample time to review the form and ask any questions before signing and agreeing to participate.
**3. Witnessing**: A third party, such as a research assistant or staff member, witnesses the participant’s signature on the consent form. This helps ensure that the participant fully understands the consent form and is consenting voluntarily.
**4. Notification**: Researchers notify participants of any changes to the study that may affect their participation. This includes any changes to the procedures, risks, or benefits.
Documenting and Storing Consent Forms:
**1. Retention**: Once obtained, consent forms should be securely stored in a locked location or password-protected digital file. Researchers should retain the forms for the period of time specified by the IRB.
**2. Access**: Only authorized researchers should have access to the consent forms. Participants have the right to access their own consent forms at any time.
**3. Destruction**: Consent forms can be destroyed after the retention period has expired or when the study is complete and all data has been analyzed.
Conclusion:
Recruitment and informed consent procedure templates offer a valuable tool for researchers to streamline the informed consent process. By following the steps outlined in these templates, researchers can ensure that they are obtaining informed consent from participants in a manner that meets ethical and regulatory standards.
It is important to note that recruitment and informed consent procedures may vary depending on the specific research project and the institution conducting the research. Researchers should consult with their IRB for guidance on the specific requirements that apply to their research.
