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Informed Consent Process

Informed Consent Process. Maria Gloth, CCRC. Objectives. The Belmont Report:  Application of the basic ethical principles applied to Informed Consent Components of and Process for obtaining Informed Consent Documentation of the Informed Consent Process. The Belmont Report:   1979.

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Informed Consent Process

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  1. Informed Consent Process Maria Gloth, CCRC

  2. Objectives • The Belmont Report:  Application of the basic ethical principles applied to Informed Consent • Components of and Process for obtaining Informed Consent • Documentation of the Informed Consent Process

  3. The Belmont Report:   1979 • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Framework for understanding research regulations • Ethics Principles:  1.  Respect for Persons 2.  Beneficence   3.  Justice

  4. The Belmont Report Ethical Principles 1. Respect for persons • Provide sufficient information • Comprehension • Voluntary participation 2. Beneficence • Do no harm • Maximize possible benefits and minimize possible harm 3. Justice • Equitable selection of subjects • The benefits and burdens of research are fairly distributed

  5. Purpose of the research Duration of the study Frequency of visits Procedure Findings Risks  Benefits Alternatives Confidentiality Compensation for Injury Who to Contact Right to refuse or withdraw Voluntary participation Basic elements of Informed Consent

  6. Additional Elements • Risks related to pregnancy • Anticipated reasons for termination from a study • Costs • Consequences of withdrawal • New Findings • Number of subjects • Payment

  7. Delegation of Responsibilities • Principle Investigator may delegate the duty of obtaining informed consent to appropriate clinical site research personnel (sub-I’s, CRC, etc.) • Principle Investigator is responsible for assuring that any designee is knowledgeable about the research study and the consent process

  8. Principle Investigator Responsibilities • Ensuring that the Informed Consent form is written in language that subjects can comprehend.   A consent form should not have language that is exculpatory or that waives or appears to waive any subject rights. • Obtain IRB approval of the Informed Consent form at the time of IRB approval of the prospective study (and with any subsequent modifications to the consent form). • Obtain consent in compliance with 21 CFR Parts 50 and 56. • Obtain consent only once potential subjects have had time to consider participation and time to review details of the study as provided in the Informed Consent form.

  9. Principle Investigator Responsibilities • Subjects may have questions after their consideration and review of the Informed Consent form that need to be addressed and adequately answered. • Time permitting, asking a potential subject to bring the Informed Consent form home to discuss the study with family or friends. When this time courtesy can be extended, it should be documented. • The investigator is responsible for ensuring that consent is obtained before any study-related procedures are performed.

  10. Informed Consent Process • Is the potential subject capable of providing informed consent? • Is a legally authorized representative (LAR) needed? Is a witness needed? • Provide the potential subject with all study-related information • Provide sufficient time for the potential subject to read the information provided in the Informed Consent form/other materials • Provide ample time for the potential subject to ask questions about the study and about alternatives

  11. Informed Consent Process • Answer any questions to the potential subject’s satisfaction and ensure he/she has comprehended the information • Provide ample time for the potential subject to decide whether or not to participate in the study • The Informed Consent form should be signed & dated by the subject or the LAR and by the person obtaining consent. • A copy of the completed Informed Consent form must be provided to the subject at the time of consent. The original should be kept with the subject’s study binder.

  12. Documentation Documentation of Informed consent begins with documentation of conversations had with potential subjects prior to and leading up to obtaining written consent.

  13. Documentation Documentation should state that no study-related procedures were initiated or completed prior to the consent form being appropriately executed.

  14. Documentation • Consent is an ongoing conversation—consent is not finished once the Informed Consent form is signed • At each study visit or encounter the Principle Investigator or designee obtains verbal agreement that the subject wishes to continue participating in the research project • This ongoing consent should be documented in the encounter note

  15. Documentation The current IRB-approved version of the Informed Consent form must be used when consenting a subject. The re-consent process follows the same procedure and documentation guidelines, and the subject must be provided with a completed copy of the Informed Consent form at the time of re-consent.

  16. Summary • The Belmont Report:  Application of the basic ethical principles applied to Informed Consent • Components of and Process for obtaining Informed Consent • Documentation of the Informed Consent Process

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