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MODEL OF A STANDARD CONSENT FORM (Page 1 of 3) The following model of an Informed Consent Form contains all elements required by law, with instructions to assist you in the development of the consent.

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How to fill out the Standard Consent Form online

This guide provides a clear and structured approach for filling out the Standard Consent Form online. By following these steps, users can navigate the form easily, ensuring that all necessary information is accurately provided.

Follow the steps to complete the Standard Consent Form online.

  1. Click the ‘Get Form’ button to access the Standard Consent Form and open it for editing.
  2. Fill in the project title at the top of the form, clearly stating the name of the study you are conducting.
  3. Provide an invitation to participate, stating a brief description of what the study entails and the names of the investigators involved.
  4. Explain the basis for subject selection by stating why participants have been chosen, including any criteria for exclusion.
  5. Describe the overall purpose of the study in simple language to help potential participants understand its importance.
  6. Outline the procedures that participants will undergo, detailing each test or task, the frequency of procedures, and the total time commitment required.
  7. List potential risks and discomforts participants may face, including physical, psychological, social, legal, and economic risks.
  8. Mention any potential benefits to the participants or others from the research, making it clear that these benefits are hoped for but not guaranteed.
  9. Discuss alternatives to participation, clearly indicating feasible options for those who choose not to participate.
  10. If applicable, describe any compensation for participation, ensuring that it does not unduly influence participation.
  11. Assure confidentiality by stating how participant information will be handled and whether it will be shared.
  12. If relevant, address any potential injury or costs associated with participation, including information on treatment for research-related injuries.
  13. Clarify the voluntary nature of participation and the process for withdrawing consent at any time without penalty.
  14. Provide contact information for inquiries and explain the significance of maintaining transparency throughout the research.
  15. Finally, users should sign and date the consent form where indicated, ensuring to also include the witness signature if required.
  16. Save changes, download, print, or share the completed form as needed.

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If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.

The consent form must include: A statement that the study involves research. ... Purpose of the research. ... Procedures. ... Risks or discomforts to the subject. ... Benefits of the research to the subject. ... Treatment Alternatives. ... Costs of Participation. ... Confidentiality.

Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.

Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.

I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study.

There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency.

A statement that the study involves research, an explanation of the purposes of the research, the expected duration of a subject's participation, a description of the procedures to be followed, and if applicable identification of any experimental procedures.

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