Meaning and content of the informed consent form (ICF)

The informed consent form (INF) is crucial for informing participants in clinical trials and protecting their rights. In this article, we explain step-by-step how to create such a form.

1. Determine the purpose of the form

The informed consent form is designed to provide volunteer participants in clinical trials with comprehensive information about the research and obtain their consent. The primary purpose of the form is to protect the rights of volunteers, ensure their participation in the study, and inform them of all potential risks throughout the process.

2. Know your target audience

The language of the form should be appropriate for the target audience, i.e., clear and free of medical jargon. The educational level, age group, and possible medical history of the volunteers should be taken into account. Especially in the case of children, parents or guardians should also be informed.

3. Identify the parts of the form

The BGOF should contain the following main sections:

• Name and purpose of the research: It should explain what the research is, what its purpose is, and how long the volunteer's participation will last in accordance with that purpose.

• Volunteer rights: It should be emphasized that the volunteer has the right to withdraw from the research at any time and that doing so will not result in any penalties or loss of rights.

• Treatment and methods: The treatments to be used in the study, the procedures to be performed on the volunteer, and possible invasive methods should be explained.

• Risks and side effects: The risks and discomforts that the research subject may be exposed to should be clearly stated. If the research is conducted on pregnant women or children, the specific risks for these groups should also be stated.

• Alternative treatment options: The patient should be informed of other treatment options and their potential benefits and risks.

• Confidentiality and data protection: It should be explained how the identity of volunteers will be protected and that their identity will be treated confidentially if the research results are published.

4. Provide detailed information

Each section of the form should contain sufficient explanations so that subjects understand exactly what they are consenting to. In particular, risks, side effects, and the subject's responsibilities should be clear and unambiguous.

5. Explain the volunteer’s rights

The subject's rights, such as the right to withdraw from the study, confidentiality of their identity, and compensation, should be clearly explained. Oral explanations should be provided to ensure the subject fully understands these sections.

6. Collect signatures from the research team and volunteers

The final section of the form must contain the signature of the subject who has been informed of their participation in the study. The signatures of the researcher who informed the subject and, if applicable, any witnesses must also be obtained. For pediatric patient groups, the signatures of the parents or guardians are also required.

7. Make special arrangements for pediatric studies

When conducting research with children, the information and consent process should be adapted to the child's age group. Written informed consent forms should be prepared for children 9 years and older, and written consent should be obtained for children aged 3 to 8, if possible.

8. Revise and approve the form

The completed form must undergo several review processes to ensure its accuracy and completeness. Each page of the form must contain the date, version, and page number. After revision, the form must be submitted to the relevant authorities for approval.

9. Present the form to the volunteer

Finally, make sure the volunteer understands all the details when you present the form. Answer any questions the volunteer may have and provide additional explanations if necessary. After the volunteer signs the form, give them a copy and keep a copy for your records.

10. Make sure the form is constantly updated

It is important to inform subjects of any new information or changes that may arise during the research period and to update the form. Make any necessary updates to the form based on the new information and repeat this process if consent needs to be obtained again.

By following these steps, you can prepare the informed consent form (IFR) and ensure that volunteers participate in the research in an informed manner (FIND IT IN KAD-DD-13_IFR…). https://www.titck.gov.tr/faaliyetalanlari/ilac/klinik-arastirmalar