Informed consent process


Published on

Informed consent process

  • Be the first to comment

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Informed consent process

  1. 1. Informed Consent Process Dr. Ghiath Alahmad
  2. 2. Is Informed Consent a Form or a Process?
  3. 3. IRB Submission Flow Chart Principle Investigator Submission Department IRB review IRB Office IRB Meeting Approved Incomplete: Put On Hold Refer to PI and/or Medical Writer Complete: Add to Meeting Agenda Modification Requested: Back to PI Missing Elements Goes to IRB Chair or IRB Meeting Industrially Funded: Wait for Indemnification to Clear APPROVAL RELEASED TO PRINCIPLE INVESTIGATOR Missing Elements Consent Revision Needed Refer PI to Medical Writer
  4. 4. Need to know! • Informed Consent is a process - not just a form. • Informed Consent is necessary to conduct ethical research. • Informed Consent is the fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act.
  5. 5. Need to know! • Informed Consent is government regulated • The IRB is responsible for ensuring policies are being followed. ▫ Reviewing of the Informed Consent form, is it…?  Clear, easy-to-read, accurately reflects the project ▫ Reviewing the process of obtaining Informed Consent  Who, what, where, when, and how…….
  6. 6. What rules do I follow? National Regulations Research Ethics Guidelines Institutional Policy Sponsor Request
  7. 7. Authoring the Informed Consent Form
  8. 8. Do not do!Do!  Use complicated terms  Write above an 8th grade level  Put or leave unnecessary information in the form  Forget “Respect” for subjects  Write simply  Use small words  Include details  Describe timeframes  Use standardized language  Define risks  Define acronyms Many (Do`s) & (Don`ts) need to be considered in processing the Informed Consent. Conclusion SCENE Authoring the Informed Consent Form
  9. 9. More Do’s • See the examples • Use the glossary ▫ • Use the standardized text ▫ Instead of This Use This Empty words Along the lines of Like For the purpose of For For the reason that Since Because On the basis of By Difficult words Currently Now Demonstrate Show Effectiveness Success Following After Indicate Show Prior to Before Terminate End
  10. 10. Various terms • Patient Information Sheet ▫ Provides only the information • Informed Consent Form ▫ Used to document consent Both integrated in to one document called the Informed Consent Form
  11. 11. Research Consent Document Consent Document Consent Discussion
  12. 12. Avoid informal speech Limit medical terminology Research Consent Document • Language that is easily understood • Language must be appropriate to the population being studied • Language translators should be qualified and IRB authorized Readability Consider comprehension as well as readability
  13. 13. Research Consent Document
  14. 14. • When do you need a witness? • When presenting the informed consent document orally • If required by the IRB • Who can be the witness? A person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial, who attends the informed consent process… Research Consent Document
  15. 15. Discussion Review Concerns Time Signatures Informed Consent Process Discussion between the physician and the participant Review of information by research nurse/ coordinator All questions and concerns addressed Allow adequate time Signature obtained
  16. 16. Informed consent must be obtained prior to any protocol specific testing being conducted. If protocol specific testing done the same day as informed consent document signed, must be clear documentation of the chronological order in the medical record. Informed Consent and Screening Procedures
  17. 17. Interview Where? • Choose a quiet, private, safe place to talk to the prospective subject ▫ An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject shall be in language understandable to the subject or representative.
  18. 18. Interview Who? Who can conduct the Interview to obtain Informed Consent? The PI A sub investigator A study staff person, listed with the IRB, whom the investigator has documented is fully aware with the study and is able to answer subjects questions.
  19. 19. Re - Consenting Participants must be informed about any new information that may affect their willingness to take part in the research.
  20. 20. Informed Consent & Vulnerable Populations Unable to make free informed consent Can be easily forced or have limited freedom
  21. 21. Vulnerable Populations Children Prisoners Non-English (Arabic) speaking persons Pregnant Women and fetuses Cognitively Impaired Financially impairedTerminally ill
  22. 22. DO NOT enroll prisoners unless you check with the IRB first Informed Consent & Prisoners Prisoners, due to the lack of control of their circumstances are considered vulnerable There MUST be a prisoner representative on the IRB if a prisoner is enrolled If a person becomes a prisoner during a trial, notify the IRB immediately Must state that risks for prisoner in this study same as for a non-prisoner
  23. 23. Informed Consent & Pregnant Women The purpose of the study is to meet the health needs of the mother The father is not reasonably available The pregnancy is the result of rape
  24. 24. Informed Consent & Cognitively Impaired The signature of Representative Cognitive impairment mental retardation dementia coma individual’s Capacity to give informed consent Persons with diagnosed cognitive impairment such as mental retardation, dementia, and coma, can participate in research. This type of research must specifically address how an individual’s capacity to give informed consent will be determined. The signature of a legally authorized representative will be required
  25. 25. Informed Consent & Cognitively Impaired Cognitive Impairment Regains ability Re-consent
  26. 26. Informed Consent & Sedated Patients As a rule, consent should not be obtained from a sedated or anesthetized patient for an elective procedure—let the sedative wear off! If delay is not feasible, consent should be obtained from a surrogate. Anesthetized patient Research can`t be delayed Surrogate
  27. 27. Informed Consent & Non-English Speakers Get an interpreter! Witness Translator’s name should be noted in the medical record
  28. 28. Understandable Language Non-English speaking subjects may not be excluded on the basis of language The IRB requires a translated consent document be submitted with the original protocol for approval. It is the investigator’s responsibility to ensure that the translation is accurate. Informed Consent & Non-English Speakers
  29. 29. A copy of the consent document must be given to each subject Verbal translation of the consent document must not be replaced with for a written translation. Informed Consent & Non-English Speakers
  30. 30. Informed Consent & Special Cases
  31. 31. informed consent process (on the child’s behalf) the parent/s or legal guardian Participant under 18 y Informed Consent Minors
  32. 32. Informed Consent Minors Age >/=18 Subject and Person obtaining consent sign the IC Parent/Guardian, witness, and Person obtaining consent sign the IC Child Age 7-12 – Verbal Assent Only Child Age 13-17 – Written Assent Required Yes No
  33. 33. • Waiving (omitting) or altering some or all the basic elements of informed consent, including the entire informed consent process Waiver of Informed Consent • Minimal risk • Rights and welfare of participants protected • Research not possible without a waiver • Appropriate information provided
  34. 34. Revocation of Consent • Patient may revoke at any time, either orally or in writing. • If revoked during a procedure, the procedure should be terminated as soon as reasonably possible.
  35. 35. Telephone Consent Telephone consents are acceptable, but they must be well documented.
  36. 36. Informed Consent in a Teaching Situation 1. Have the attending physician and house staff visit the patient together, prior to the procedure. Clarify the resident’s role in the procedure to the patient and his/her family. 2. Spell out the resident’s qualifications to reinforce patient confidence.
  37. 37. 3. Clarify that the attending physician will be present at all times in a directly supervisory capacity and that he/she is the responsible doctor. 4. Inform the patient of the identity of personnel in the operating room. 5. Prepare for some patients to insist on the attending physician performing the procedure. Informed Consent in a Teaching Situation
  38. 38. End of Study • The process of informed consent does not end once the participant signs • It is the PI’s responsibility to keep the participant updated on study changes • IC does not obligate participant to finish the trial
  39. 39. • Participant needs to be given a copy of the IC after signing the form • At each interaction, the investigator must reassure ▫ Voluntary participation continues ▫ New information is given to the subject End of Study
  40. 40. • Are subjects provided with overall/individual results? • Do you plan on keeping their contact information for future studies? • Do you plan on giving them your contact information for future problems? End of Study
  41. 41. The Informed Consent Process Finished when the study is closed and final reports are issued! End of Study