4Remember when… WLloyd LPN 7/20/ AM 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. Drsg Δ per MD orders. WLloyd LPN118 PM Pt complained of incision pain and given percocet X 2 WLloyd LPN515 PM Patient ambulated ½ length of hall with minimal SOB. No c/o pain offered. WLloyd LPN822 PM Drsg Δ per MD orders. Minimal amount of purulent drainage noted. Pt tolerated drsg change well. Pt afebrile with VSS. Family at bedside. WLloyd LPN1125 PM Patient requested pain medication for migraine headache. Percocet X 2 provided. Patient laying in bed with lights out. Call light within reach. WLloyd LPN120 AM Patient resting quietly in bed with eyes closed.WLloyd LPN
5Today…Check boxes almost replace narrative charting
6Regulations 45 CFR(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
7IV.b.I.F Procedure for Documentation of Informed Consent for Human Subjects Research 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; andIdentify who was present during the consenting process.
845 CFR 46.117 (c) Waiver of documentation (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 harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
9Do we still have to document the consent process if waiver granted? Yes, unless both the process and documentation of the process has been waivedDocumentProcess
1045 CFR 46.116 (d) general requirements of informed consent (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 consent provided 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; andWhenever appropriate, the subjects will be provided with additional pertinent information after participation.
11Where documentation of consent may occur Research ChartElectronic Medical Record (StarPanel)Subject trackerMD dictationCRC chart
12Assure all documentation consistent with: Medical history and hospital recordsMD dictationClinic & office chartsLab resultsCommunications (telephone and s)ChecklistsFlow chartsDiariesResearch chartsDrug dispensing recordsProcedure reports (UGI, CT, XRAY, EKG etc.)
14How consent obtained Private exam room Orally presented consent document informationConsent described over telephone
15The participant’s level of comprehension Did the subject appear to understandDid subject ask questions,Was subject able to reiteratethe main purpose of the study,procedures,risks,frequency of visitsetc.
16The participant’s decision-making capacity at the time of consent Alert and orientedComatoseUnder influence of medicationDecreased level of consciousness
17Time given for participant to consider the research Allowed time to reviewSubject allowed to take the consent home to reviewMailed consent to subject prior to office visitConsent read and explained to subject
18Identify who was present during the process Family member presentSubject aloneMother and father presentSurrogate
19State that a copy of the consent was given to the person signing consent
20What came first, The chicken or the Egg? Document consent obtained prior to study procedures conducted
21Special circumstances require more documentation New information- new consentLegally authorized RepresentativeHealth Care Decision MakerSubject 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 illegibleScreen failureChange in cognitive statusWard of the stateSubject becomes incarceratedBirth control (double barrier)Non english speaking consent process
22Re-consenting requires same documentation Date of re consentSubject reviewed consentRevisions verbally explained to the subjectSubjects verbally agrees to continue participationCopy of revised consent given to subject
23the patient becomes competent! Document: Subjects desire to continue,Entire consent process and copy givenSubjects revocation:The health care provider to whom the patient communicates a revocation is responsible for documenting the revocation in the Patient’s medical recordandfor informing the rest of the health care team about the revocation.
24Times to document Every time you have an interaction with a subjects Contact for recruitment purposessTelephone callsFace to face interactionsAssessment of adverse events each visitAssessment of cognitive status each visitNo family available to consent
25Is it ever ok not to document the process? Certificate of ConfidentialityWaiver of DOCUMENTATIONapproval from the IRB
26Key PointsRemember, 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 factualKeep files securedLocked cabinet/roomPassword protected access
28Informed 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:TOPIC COMMENTSPurpose 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 / TimeSigned copy given to patient? ___yes ___no Copy in patients chart? ___yes ___no
29Template Screening Visit Example DMID Protocol: xx-xxxxSite: Vanderbilt University Medical CenterDate: ____________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:________
30Screening Visit Narrative 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.
31Documentation example 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.
32Example of on study visit documentation 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
33What if I make a mistake? Correct errors based on Institutional policy (correctionsand approved abbreviations)Departmental SOP’sSponsor SOP’sICG-GCP (4.9.3)initialed, and explainedshould not obscure the original entry (i.e., an audit trail should be maintained);Cross error out with a single lineex: 6/14/98 WLPt claims pain to back shoulders….
34Problems that occur when documentation is non- existent
35audit findings at sites All required signatures and dates not completed at time of consent or completed with different datesMultiple consent documents for same patients with no explanation whySignatures of subject and consenting person on different datesConsent and study procedures on same dateCopy of consent provided to subject not documentedCheck boxes within the consent incompleteCrossed out sections or white out used in the IRB approved consentUnable to locate consent for subject on studyPerson consenting the subject did not sign the form
36FDA findingsFailure to obtain written informed consent or back-datingSloppy records (e.g. erase, white-out)Creating fake records or subjectsAltering subject diaries to reflect a positive outcomeDestroying study recordsor
37fda letter Dated back to 2008 a number of my signatures and parent signatures as well as initials on consent forms were forged presumably by my research nurseDocumentation of the consent process missingCAPResearch staff educated in various topics including institutional policies and good clinical practiceDocumentation 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
39Good documentation is: consistent,concise,chronological,continuing,complete
40Documentation Do’s: Include any and all research encounters Should occur immediately to recall as many details as possibleShould include the nature, discussion and outcome of each research encounterShould be included in the research and/or medical record and be kept confidentialShould be legible, factual and thoroughInclude a copy of the consent document given to the subjectIf 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 notShould tell a story from beginning to end
41Documentation Don’t’s Contain white outObscure original entryBack dateFabricate the informationDelay chartingAssume people knowyour process and whatyou did
42Documentation is up to YOU Take credit for ALL you do and tell the story
43If you have additional comments or questions feel free to contact me Wendy Lloyd
44Observe the consent process You know you want to:Volunteer to have your consenting process observedContact Wendy Lloyd by phone ( ) or byin advance or just prior to consenting