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Documentation of the Informed Consent Process. USC Office for the Protection of Research Subjects (OPRS)

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(1)

Documentation of the

Informed Consent Process

(2)

Session Overview

Highlights:

• Purpose of Informed Consent (IC) • IC Process and Documentation • Witness and Dates on IC

• HIPAA Authorization

• Significant New Information and Findings (SNIFs) • IC Errors or Omissions

• Double-Checking IC Documentation • IC Audit Findings

(3)

Purpose of Informed Consent

Consent (“autonomy” from the Belmont Report)

• Protects human subjects

• Ensures subject understand the study and are

informed about its risks, benefits and procedures

• Provides subject an opportunity to ask

questions

• Allows subjects to voluntary decide

whether or not to participate in research

(4)

Informed Consent is a Process

This presentation is focused on IC

documentation, however:

• Remember that Informed Consent is not just a

form…it’s a process that involves ongoing exchange of information

• Subjects must be informed about changes or new information about the study that may affect their willingness to participate

(5)

Informed Consent Process

• Use the current IRB-approved, stamped consent

for the study

• Provide subject or Legally Authorized

Representative (LAR) a consent Form in his/her language (or use Short Form Process)

• Ensure subjects/LARs have sufficient time to

consider participation, free of coercion or undue influence

• Provide subject/LAR an opportunity

(6)

Informed Consent

Documentation

• Subject/LAR must sign and date the form

• Person Obtaining Consent must sign and date

the form

• Provide a copy of the signed consent to the

subject/LAR

• Document in the subject’s chart or medical

record that consent was obtained and file the Consent Form in subject’s records

• Document use of a translator on

(7)

Short Form Process

• When non-English speaking subjects are anticipated in

a study, the consent form should be translated in the subjects’ language

• Use the Short Form Process for the unexpected

enrollment of subjects when a consent is not available in the subject’s language

• A witness and translator must be present during the

consent process (translator may serve as witness)

• CA Subject Bill of Rights in the subject /LAR’s

language (if applicable) *Tip: see pg 1 of consent

• Short Form and Subject Bill of Rights templates are

available in thirteen languages on the HSIRB

(8)

Short Form Process

• Subject /LAR is presented with a copy of the

Short Form and Bill of Rights (if applicable) in a language he/she understands

• Translator orally translates the current, IRB

approved study consent in the subject’s/LAR’s language in the presence of a witness

• Ensure subjects/LARs have sufficient time to

consider participation, free of coercion or undue influence

• Provide subject/LAR an opportunity to ask

(9)

Short Form Process

Documentation

• Subject/LAR dates and signs the Short Form and

Subject Bill of Rights, if applicable

• Witness dates and signs the Short Form and

Consent

• Person Obtaining Consent dates and signs the

Consent

• Subject /LAR receives a copy of the signed Short

Form, Bill of Rights (if applicable) and Consent

• Document that consent was obtained from the

subject/LAR in the subject’s chart or medical record and file Short Form, Bill of Rights (if applicable) and Consent in subject’s chart

(10)

Conditional IC Process

• Certain conditions (e.g., illiteracy, blindness) may impede documentation of subject consent

• Conditional consent process can be utilized • A witness must be present during the consent

process

• Ensure subjects/LARs have sufficient time to

consider participation, free of coercion or undue influence

• Provide subject/LAR an opportunity to ask

(11)

Conditional IC Process

Documentation

• Subject makes a “mark” on the consent form, if

possible

• Witness signs and dates consent form

• Person Obtaining Consent signs and dates

consent form

• On consent form, note the method used for

communicating with subject and the means by which subject communicated agreement

• Subject receives a copy of the signed consent • Document that consent was obtained from the

subject in the subject’s chart or medical record and file Consent

(12)

Consent Witness

• Not required unless using the Short Form or the

Conditional Process

• Additional considerations may be imposed by:

• FDA and ICH GCP: “impartial witness” when the

subject or LAR is illiterate

• Study sponsor • Institutional

• Refer to the study protocol, investigator, sponsor

(13)

IC Documentation

Tip sheet available at:

http://www.usc.edu/admin/oprs/private/docs/hsirb/forms/Consent_and_Short_Forms_Final.pdf

*if consent includes California Subject Bill of Rights, subject must sign Bill of Rights (1st page) and consent (last page)

(14)

Dates on Informed Consent

• Signature dates of person obtaining consent and

subject or LAR do not have to match (e.g.,

investigator may sign and date consent during process and subject may sign and date consent after discussion with relatives)

• Subject or LAR must sign and date consent

before any study procedures are conducted (FDA-regulated studies: if subject signs consent on the day study procedures begin, subject chart should document that consent was obtained prior to study procedures)

• Check sponsor guidelines • Do not “back date” consent!

(15)

HIPAA – Privacy Rule

• Protected Health Information (PHI) is any

identifiable health information relating to a subject’s physical or mental condition or payment for health care (18 elements)

• If your study accesses (or creates) PHI, subjects

(or LARs) must sign a HIPAA form in addition to informed consent

• Changes to the HIPAA form cannot be made

unless the Office of Compliance has approved these changes

(16)

HIPAA Waivers

The IRB may grant the following waivers:

• Partial HIPAA waiver - for screening, recruiting

and identifying participants (very common)

• Full HIPAA waiver – if use or disclosure of PHI

involves no more than minimal risk to subject, the research could not practicably be conducted without the waiver and the research could not

practicably be conducted without access to and use of PHI (rare)

Remember: without a HIPAA authorization or waiver, researchers cannot utilize PHI data!

(17)

Significant New

Findings/Information (SNIFs)

• Except when necessary to eliminate apparent

immediate hazards to subjects, the IRB must review and approve SNIF

• Subjects must be informed about SNIFs that may affect their willingness to continue participation • SNIF must be presented to subject in his/her

language

Don’t forget to make arrangements for non-English speaking subjects (e.g., originally consented with a translated consent or short form)

(18)

IC Errors or Omissions

• If an error is made on the consent:

Strikethrough the mistake with a single line, write the correct information next to it and initial and date the correction (i.e.,

original entry must be visible)

• If an entry was inadvertently omitted:

Initial and date any entry made after the consent process

(should be done by person making entry)

(19)

IC Version vs. Approval /

Expiration Dates

IC Approval Date and Expiration Date

Located on right margin of each consent form page.

Includes IRB study number and valid date range. Ensure

that subjects are provided a current, IRB-approved consent.

IC Version (HSC) or Date of Preparation (UPC)

Located on the footer of the consent form. This reflects the date the consent was last updated, NOT the approval or

(20)

Double-Check IC

Documentation

Remember to check:

• Consent expiration date • Consent version date

• Fill-in sections of consent • Names, dates and signatures • HIPAA Authorization

• Copies of consent/HIPAA provided to subject/LAR • Copies of consent, Short Forms, Bill of Rights and

HIPAA were filed in subject’s medical record, as applicable

• Documentation that subject/LAR agreed to participate in

(21)

Approved Documents in

iStar

To access Approved Documents (consent forms, HIPAA forms, recruitment materials, etc)

(22)

Additional Considerations

• Study personnel must complete educational

requirements based on study (e.g. Human Subjects

Training, HIPAA, GCP)

• New study personnel must be trained on study procedures including the consent process

• Regular communication ensures study team is aware of changes in the study and consent documents

• If there is a lapse in IRB approval for the study, the study team cannot proceed with study procedures

(23)

IC Audit Findings

Most common:

• Use of expired consent

• Use of older version of consent • Missing entries on consent

• Signature date errors

Other:

• Study staff fill-in subject or LAR sections of consent • Consents are not handwritten (e.g., dates stamped) • Use of one consent for multiple subjects

(24)

Informed Consent templates and Short Forms: http://www.usc.edu/admin/oprs/hsirb/forms/

OPRS Informed Consent in Human Subjects Brochure: http://www.usc.edu/admin/oprs/private/docs/oprs/broc hures/IFC_Booklet.pdf HSIRB Website: http://www.usc.edu/admin/oprs/hsirb/w.usc.edu/admin/ provost/oprs/training/videos.html

Resources

(25)

Contacts

http://www.usc.edu/admin/provost/oprs

Health Sciences Campus

General Hospital, Suite 4700 1200 North State Street

Los Angeles, CA 90033 Tel: (323)223.2340 Fax: (323)224.8389 E-mail: irb@usc.edu

http://www.usc.edu/admin/provost/oprs/hsirb/

University Park Campus

837 Downey Way

Stonier Hall, Room 224a

Los Angeles, CA 90089-1146 Tel: (213)821.5272

Fax: (213)821.5276 E-mail: upirb@usc.edu

http://www.usc.edu/admin/provost/oprs/upirb/

Office for the Protection of Research Subjects

3720 South Flower, Third Floor Los Angeles, CA 90089-0706 Tel: (213)821.1154 Fax: (213)740.9299 E-mail: oprs@usc.edu http://www.usc.edu/admin/provost/oprs/ Office of Compliance 3500 Figueroa St.

University Gardens Building, Room 105 Los Angeles, CA 90007

Tel: (213)740.8258 Fax: (213)740.9657

E-mail: complian@usc.edu

(26)

Jennifer Hagemann, MS

(27)

Program started on May 2008

Human Subjects Protection Program

Accreditation (AAHRPP)

Not-for-cause audits

Criteria: random but…

High volume of studies

Vulnerable population

New investigators to USC

Format: 2-3 hours, review 2-6 studies, focus:

(28)

7% 9% 11% 11% 13% 20% 30% 39% 72% 0% 10% 20% 30% 40% 50% 60% 70% 80% Protocol Non-Compliance Personnel-Related Issues Lack of Communication with IRB Lack of Communication with FDA Miscellaneous HIPPA Form Lack of Documentation IRB Application Discrepancies

Consent Findings by Percentage P ro bl em A re as

(29)

Consent + HIPAA form Issues: no documentation of consent; use of unapproved consent;

missing subject name, signature, or signature date; missing PI signature; use of wrong HIPAA form; HIPAA form not signed by subjects; required fields not completed in HIPAA form

IRB Application Discrepancies: discrepancies between IRB application and study

procedures; unable to locate approved documents in iStar; study personnel different from those in application; personnel obtaining consent is different from that in application

Lack of Documentation: no documentation of subjects meeting inclusion/exclusion criteria;

no regulatory binder or substantial documentation missing

Personnel-Related Issues: lack of GCP training; lack of personnel; lack of personnel

oversight

Lack of Communication with FDA: personnel listed on Form 1572 form differs from IRB

application; missing information in Form 1572; lack of annual progress report for investigator-initiated studies

Lack of Communication with IRB: done in untimely manner; study closure report not

submitted; protocol deviations not reported to IRB

Protocol Non-Compliance: differences between protocol and study procedures;

inclusion/exclusion violations

Miscellaneous: potential for subject coercion; funding not distributed to proper channel,

investigator unaware of consent requirement for all subjects and study closure responsibilities

(30)

FDA:

FDA-regulated research (drugs, biologics,

devices)

http://www.fda.gov/ICECI/EnforcementActions/Bioresearch

Monitoring/default.htm

OHRP

: human subjects research, normally those

funded by Health and Human Services (HHS)

http://www.hhs.gov/ohrp/compliance/index.html

Study Sponsor:

for-cause, non-compliance

IRB for-cause:

non-compliance, whistleblower,

deficiencies in IRB submissions, lapses in IRB

approval

(31)

Socio-Behavioral vs. Biomedical Research

Templates

* (http://www.usc.edu/admin/oprs/research/rc)

Study / Regulatory Binder*

Participant files

Source Documentation (e.g., physical exam, survey, ECG)

▪ Case Report Forms

▪ Notes to file

▪ Calendar / Subject Visit log*

▪ Consent documentation

(32)

Train staff

:

initial and ongoing; maintain log

Meet regularly

:

discuss new developments,

procedures, revised consents

Maintain open communication lines

:

ensure

team members know whom to contact when

unexpected or adverse events occur

Standardize procedures

:

study procedures

should be consistent and systematic for all

participants (e.g., assessments, recruitment, consent)

Participate in educational meetings

:

specific to

field (e.g., symposia) and institution (e.g., IRB

(33)

Form Templates

USC

http://www.usc.edu/admin/oprs/research/rc

Partners

http://www.partners.org/phsqi/vrb/files/index.htm

UCSF

http://hub.ucsf.edu/regulatory-binder

USC IRB and OPRS website

(34)

Investigator Tips – HSC IRB

USC Institutional Review Board (IRB) Sandy Jean, MS

(35)

Overview

• Recruitment of Participants

• Retention of Research Records

• Confidentiality and Security of Research Records • What Happens After Your Study is Approved?

• Amendments

• Continuing Review • Reportable Events

(36)

Recruitment

• Recruitment is the first step in consent process • Respect privacy during recruitment

• IRB reviews and approves recruitment materials • Tips for recruitment advertisements

• DO:

– State that it is research

– State what is involved (very brief)

– Add department name, USC name or approved logo, IRB number, version date

(37)

Recruitment

• DON’T:

– Overstate benefits of participation

– Emphasize payment for participation or free services – Use the word “treatment” if your study involves

(38)

Recruitment

• Cannot pay a bonus or finder’s fee for referrals to

your study (USC policy)

• Cannot coerce students or employees into

participating

• Avoid appearance of coercion:

• Post recruitment flyers in public areas rather than

directly approaching students or employees

• Have another investigator obtain consent from

(39)

Confidentiality

• Collect the minimum amount of personal info you

need to achieve your study objectives

• If possible, record data anonymously

• If not, record and label data with a random code

instead of an identifier

• The master list matching up code numbers with names

(or other identifiers) must be stored in a secure place, separate from the coded data

(40)

Confidentiality

• Can data be shared with others?

• Only as described in the IRB application and as

disclosed to participants in the informed consent

• Handle your participants’ data the way you want

your own sensitive info handled

• HIPAA Privacy Rule

• Violation of HIPAA rules can lead to fines

(41)

Security of Records

Paper:

• Store in locked file drawers, locked office/storage area • Restrict access to research staff (as identified in the

IRB application)

• Restrict copying of study documents and data

Photos and Recordings:

• Alter identifying features as early as possible • Transcribe and destroy recordings

(42)

Security of Records

Electronic:

• User name and password required to access data files • Restrict access to research staff

• Restrict copying of electronic files

• Mobile storage devices (laptops, stick drives) must be

password protected and encrypted

“USC requires all laptops and mobile storage devices that are paid for with university funds and/or used for USC business purposes to be encrypted. We strongly encourage you to avoid storing any sensitive data on such equipment altogether.”

(43)

Record Retention

How long should you keep research records?

• USC policy = 3 years after research is completed • FDA-regulated products (drugs/devices) = 2 years

after product is approved / sponsor stops testing

• Sponsor may have additional requirements

(44)

IRB Review after Approval

Reminder - Principal Investigator and Faculty Advisor Responsibilities

• All staff are properly trained and licensed

• Won’t change protocol without IRB approval first

• Will use only current, stamped consent for enrollment • Faculty Advisors:

• Meet with student regularly to monitor study progress

• Arrange for another faculty member to accept responsibility

if unable to supervise the student personally

(45)

IRB Review after Approval

Now what?

Ongoing responsibilities to IRB:

• Amendments – whenever you want to make changes to the study

• Continuing Review – annually • Reportable Events – as needed

(46)

IRB Review after Approval

Amendments

• Submit amendment for IRB approval BEFORE *

implementing changes (add/change procedures, eligibility criteria, informed consent or recruitment materials; or sponsor requires changes)

• Open an amendment application in iStar:

– Describe changes in amendment application – Edit study application

– Wait for IRB approval

(47)

IRB Review after Approval

Significant New Information

If you learn new info that could affect participants’ willingness to continue in the study, you must tell them (as promised in the informed consent)

Usually involves new risks or new procedures Prepare “Significant New Information/Findings”

form (template available)

Submit an amendment to IRB

After IRB approval, provide form and discuss with participant

(48)

IRB Review after Approval

Continuing Review (CR)

Unless your research qualifies as “exempt” your IRB

approval will expire every year. You must submit an annual CR to keep the study open. CR is a review of the research activities over the past year.

• You will receive reminders about study expiration • Open a CR application in iStar:

– Provide info requested (enrollment to date, participant

complaints or withdrawals, study progress)

– Submit to IRB at least 1 month before study expires

(49)

IRB Review after Approval

Study Closure

When all research activities done (including all data analysis), submit “Final Report” to close study

• Open a CR application

• Select the “Final Report” option • Provide info requested

(50)

IRB Review after Approval

Reportable Events

What problems must be reported to the IRB?

• Adverse Events

Participant experiences a side effect that is unexpected, serious, and related to the research

• Unanticipated Problems (place participants, research

staff, or others at greater risk of harm than was previously known)

Laptop containing data is stolen or lost

(51)

IRB Review after Approval

• Protocol Deviations

Enrollment of a participant who was ineligible

Procedures missed or performed outside of window

Expired or wrong consent form used to enroll participant

• Procedure:

Open a Reportable Event application in iStar

Select type of event

Provide info requested

IRB will either acknowledge or request more info (including a corrective action plan)

(52)

training/videos.html

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