Part 3 of 3 part series: Informed consent: Documentation

1. Part 3 of 3 part series: Informed consent: Documentation Wendy Lloyd BA, LPN, CIP,CCRP Regulatory Compliance Analyst

2. Regulations and IRB Policies • Suggestions of what to include in the documentation • Citations when documentation is not present • Examples of documentation of the consent process Objectives:

3. If you didn’t document it, you didn’t do it!

4. 7/20/11- 915AM Pt Alert and Oriented X 3, skin W and D, VS stable, Resting quietly. Able to assist with bathing minimal amount. SOB during exertion. Incision 1 ½ inches wide and 2 ¾ inches long. Drainage is light green color. DrsgΔ per MD orders. WLloyd LPN 118 PM Pt complained of incision pain and given percocet X 2 WLloyd LPN 515 PM Patient ambulated ½ length of hall with minimal SOB. No c/o pain offered. WLloyd LPN 822 PM DrsgΔ per MD orders. Minimal amount of purulent drainage noted. Pt tolerated drsg change well. Pt afebrile with VSS. Family at bedside. WLloyd LPN 1125 PM Patient requested pain medication for migraine headache. Percocet X 2 provided. Patient laying in bed with lights out. Call light within reach. WLloyd LPN 120 AM Patient resting quietly in bed with eyes closed. WLloyd LPN Remember when…

5. Check boxes almost replace narrative charting Today…

6. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. • A copy shall be given to the person signing the form. • (b) Except as provided in paragraph (c) of this section, the consent form may be either of the following: • (1) A written consent document that This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or • (2) A short form written consent document presented orally Regulations 45 CFR 46.117

7. The person obtaining consent should document the consent process in the participant’s medical record or the participant’s research record. This may include: • How consent was obtained; • The participant’s level of comprehension ; • The participant’s decision-making capacity at the time of consent; • The time given for the participant to consider the research and whether others were involved in the decision-making; and • Identify who was present during the consenting process. IV.b.I.F Procedure for Documentation of Informed Consent for Human Subjects Research

8. (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: • (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; OR • (2) That the research presents no more than minimal risk of harmto subjects and involves no procedures for which written consent is normally required outside of the research context. 45 CFR 46.117 (c) Waiver of documentation

9. Yes, unless both the process and documentation of the process has been waived Document Process Do we still have to document the consent process if waiver granted?

10. (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consentprovided the IRB finds and documents that: • The research involves no more than minimal risk to the subjects; • The waiver or alteration will not adversely affect the rights and welfare of the subjects; • The research could not practicably be carried out without the waiver or alteration; and • Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 45 CFR 46.116 (d) general requirements of informed consent

11. Research Chart • Electronic Medical Record (StarPanel) • Progress Notes • MD dictation • CRC chart Where documentation of consent may occur:

12. Assure all documentation is consistent with: Medical history and hospital records MD dictation Clinic & office charts Lab results Communications (telephone and emails) Checklists Flow charts Diaries Research charts Drug dispensing records Procedure reports (UGI, CT, XRAY, EKG etc.)

13. What to document

14. Private exam room • Orally presented consent document information • Consent explained over telephone How consent obtained

15. Did child appear to want to participate • Did the subject appear to understand • Did subject ask questions, • Was subject able to reiterate • the main purpose of the study, • procedures, • risks, • frequency of visits • etc. The participant’s level of comprehension

16. Alert and oriented • Comatose • Under influence of medication • Decreased level of consciousness The participant’s decision-making capacity at the time of consent

17. Allowed time to review • Subject allowed to take the consent home to review • Mailed consent to subject prior to office visit • Consent read and explained to subject • Consent email/faxed • No original signed consent due to subject faxed consent back to office Time given for participant to consider the research

18. Family member present • Subject alone • Mother and father present • Surrogate • LAR • Translator Identify who was present during the process

19. Double barrier pregnancy methods • Pregnancy test results • Wash out periods for previous medications • Diary reviewed Special study requirements or circumstances

20. State that a copy of the consent was given to the person signing consent

21. Document consent obtained prior to study procedures conducted What came first, The chicken or the Egg?

22. New information- new consent • Legally authorized Representative • Health Care Decision Maker • Subject physically unable to sign consent (i.e. bandaged hands, loss of limbs, contact isolation etc.) • Subject not able to read a consent form (i.e. illiteracy, vision-impairment) • Signature illegible • Screen failure • Change in cognitive status • Ward of the state • Subject becomes incarcerated • Birth control (double barrier) • Non english speaking consent process Special circumstances require more documentation

23. Date of re consent • Subject reviewed consent • Revisions verbally explained to the subject • Subjects verbally agrees to continue participation • Copy of revised consent given to subject Re-consenting requires the same documentation

24. Subjects desire to continue, • Entire consent process and copy given • Subjects revocation: • The health care provider to whom the patient communicates a revocation is responsible for documenting the revocation in the Patient’s medical record and • for informing the rest of the health care team about the revocation. The patient becomes competent! Document:

25. Every time you have an interaction with a subjects • Contact for recruitment purposes • Emails • Telephone calls • Face to face interactions • Assessment of adverse events each visit • Assessment of cognitive status each visit • No family available to consent • During visit desire to continue in the research When is it time to document?

26. Certificate of Confidentiality • Waiver of DOCUMENTATION approval from the IRB Is it ever ok not to document the process?

27. Key Points Remember, organizing your paperwork can be as important as dispensing the right drug. Researchers protect human subjects by having paperwork in order. Tell a story in chronological order that is accurate and factual Keep files secured Locked cabinet/room Password protected access

28. Examples of documentation

29. Informed Consent Worksheet • Date of Consent:_________ Name of Study: ____________IRB Study Number:_______________ • Patient Name:_____________ Patient MRN:____________ Study ID#:_____________________ •  The following has been explained to the potential study subject, and the subject has been offered the opportunity to ask questions regarding the study: • TOPICCOMMENTS • Purpose of the study _________________________________ • Qualifications to participate _________________________________ • Location and participants _________________________________ • What will happen during the study _________________________________ • Risk and benefits _________________________________ • Study related injury or illness _________________________________ • Alternative treatments _________________________________ • Confidentiality _________________________________ • Study costs _________________________________ • Compensation _________________________________ • Who to contact with questions _________________________________ • Voluntary participation _________________________________ • Termination of participation _________________________________ • Questions or comments: __________________________________________________________________ • Does the patient state an understanding of the study and procedures and agree to participate? • ___yes ___no •  _____________________________________ __________________________ • Person administering consent Date / Time  • Signed copy given to patient? ___yes ___no Copy in patients chart? ___yes ___no

30. DMID Protocol: xx-xxxx Site: Vanderbilt University Medical Center Date: ____________ Subject Initials: ____________ Subject ID: ____________ This subject is here for the Screening Visit. The subject was given a copy of the IRB approved consent form dated 13Jun2011. The subject was given ample time to read the consent and ask questions. All questions were answered per the subject’s satisfaction, and the subject denied any further questions or concerns. The consent was signed and dated by the subject and the study staff, and a copy was given to the subject. The consent was signed and dated prior to any study procedures being performed. Eligibility criteria and medical history were reviewed, and a complete physical exam was performed by _____________________ and vital signs were obtained. A blood draw was obtained by ___________________________ per Vanderbilt policy. The subject verbalized understanding that they will be contacted with results of the screening labs, and will then be scheduled for the enrollment visit. The subject was given contact information to contact the study staff with any questions or concerns. Signature:____________________________________________Date:________ Template Screening Visit Example

31. Patient presents today to Screen for the PANTHER study.  He is well versed in this protocol and self-admittantly has read/reviewed the consent many times.  We met about two weeks ago and had a face-to-face meeting (with his wife present) and discussed the study and I answered all his questions. Today he is here to screen and states that all his questions have been answered.  He voluntarily signed the consent.  He agrees to participate in all the associated sub-studies except Sub-Study # 4 (HRCT comparison) preferring to not be exposed to more radiation than necessary for diagnostic purposes.  He has a copy of this consent. Screening Visit Narrative

32. 11/28/2010: • 1 PM: Received referral from Lee Smith, M.D. of subject’s intended participation in clinical research study, M04-691, A double-blinded….. • Subject and significant other seen in GI clinic and verbally reviewed consent form; explained the purpose of the study, benefits to subject and mankind, expected duration of participation, subject risks and inconveniences, subject accountability for clinic visits and recoding of weekly diary, confidentiality and ability to withdraw from study at any time without penalty or loss of treatment or benefits, compensation and coverage for injury while involved in study and emergency contact information. Subject given time to review consent form and ask questions. • Questions regarding prep or flex sigmoidoscopy on Day 1 and how results of the study could be obtained answered. • Subject signed consent form and was given a copy. To begin screening on 12/1/2010. Documentation example

33. TRAUMA RESEARCH PROGRESS NOTE Date:__________ Patient was seen today for Day (ENTER 1-14, 30, End of Treatment, TOC, LFU, discharge, End of Study) visit. All procedures performed per protocol. Patient is unable to provide consent at this time secondary to medical condition. Family is (available / unavailable) at bedside. We will continue to follow this patient closely. ENTER FREE TEXT HERE SIGNATURE Example of on study visit documentation

34. Correct errors based on • Institutional policy (corrections and approved abbreviations) • Departmental SOP’s • Sponsor SOP’s • ICG-GCP (4.9.3) • initialed, and explained • should not obscure the original entry (i.e., an audit trail should be maintained); • Cross error out with a single line 6/14/98 WL • Ptclaims pain to back shoulders… • NO backdating What if I make a mistake?

35. Problems that occur when documentation is non-existent

36. All required signatures and dates not completed at time of consent or completed with different dates • Multiple consent documents for same patients with no explanation why • Signatures of subject and consenting person on different dates • Consent and study procedures on same date • Copy of consent provided to subject not documented • Check boxes within the consent incomplete • Crossed out sections or white out used in the IRB approved consent • Unable to locate consent for subject on study • Person consenting the subject did not sign the form Audit findings at sites

37. Failure to obtain written informed consent or back-dating • Sloppy records (e.g. erase, white-out) • Creating fake records or subjects • Altering subject diaries to reflect a positive outcome • Destroying study records or FDA findings

38. Common Deficiencies • Inadequate consent 51% • Protocol Non-adherence 31% • Records Inadequate/Inaccurate 26% • Drug Accountability Inadequate 20% • IRB deficiencies 11% • Investigator Failure to report Adverse Events FDA Inspection http://www.irbforum.org/documents/documents/Module4.pdf

39. ….a number of my signatures and parent signatures as well as initials on consent forms were forged presumably by my research nurse • Documentation of the consent process missing CAP • Research staff educated in various topics including institutional policies and good clinical practice • Documentation template per PI: that XX study was explained, questions were answered (if any), subject agreed to participate and signed the consent form, the date and time of consent/assent (filled in by the consenting individuals), all option sections were completed (if any), and a copy of the signed and dated consent form was given to subject and placed in the medical record FDA Warning letter Dated back to 2008

40. In summary

41. Consistent, • Concise, • Chronological, • Continuing, • Complete Good documentation is:

42. Include any and all research encounters • Should occur immediately to recall as many details as possible • Should include the nature, discussion and outcome of each research encounter • Should be included in the research and/or medical record and be kept confidential • Should be legible, factual and thorough • Include a copy of the consent document given to the subject • If applicable, include withdrawal or discontinuation with the reason(s) • Include as many details as possible regarding adverse events and any events leading up to an adverse event whether it is deemed related or not • Should tell a story from beginning to end Documentation Do’s:

43. Contain white out • Obscure original entry • Back date • Fabricate the information • Delay charting • Assume people know your process and what you did Documentation Don’t’s

44. Take credit for ALL you do and tell the story Documentation is up to YOU

45. Documentation of informed consent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.27 Office for Human Research Protections (OHRP) informed consent tips http://www.hhs.gov/ohrp/policy/index.html http://answers.hhs.gov/ohrp/search/results?q=informed%20consent OHRP informed consent FAQ http://answers.hhs.gov/ohrp/categories/1566 Vanderbilt IRB Policy http://mcapps01.mc.vanderbilt.edu/IRB/policy&procedures.nsf/(WebTableOfContents)/8AF759048966C29D86257731005ECD1F?OpenDocument Helpful resources:

46. If you have additional comments or questions feel free to contact me Wendy Lloyd Wendy.lloyd@vanderbilt.edu 615-936-7106