Informed Consent Process for Research Coordinators

Informed Consent Process for Research Coordinators
* 07/16/96 Informed Consent Process for Research Coordinators Bashi Ratterree, RN, BSN, CCRP, CRM Director Phyllis Carello, BS, CCRC, Research Study Coordinator Manager NIH CA P NIH NCRR UL *

Topics To Be Covered Elements of Informed Consent
* 07/16/96 Topics To Be Covered Elements of Informed Consent Common Consent Problems Issues with Writing Informed Consent Documents Identifying the correct consent templates HIPAA authorization forms Waivers of Authorization Obtaining Informed Consent Adults Decisionally Impaired Adults Adults with limited English proficiency Assent from Children Documenting Consent *

Regulatory Requirements: Elements of Informed Consent
* 07/16/96 Regulatory Requirements: Elements of Informed Consent 45 CFR Applies to all research conducted at OHSU 21 CFR 50.25 FDA regulated studies We aren’t going to discuss the regulations in depth in this class – it is covered in Darlene Kitterman’s two day study coordinator training. We just want you to be aware that there are regulations that cover the content of the consent form. The required elements are the same. *

Elements of Informed Consent
* 07/16/96 Elements of Informed Consent Statement that study involves research Description of reasonable foreseeable risks or discomforts Potential benefits to subject or others Alternative treatments/options Confidentiality of research records Compensation and/or medical treatment available if injury occurs Statement must be included for > minimal risk studies *

Elements of Informed Consent, Cont.
* 07/16/96 Elements of Informed Consent, Cont. Who to Contact In case of injury With questions regarding research subject’s rights For answers to questions about the research Participation is VOLUNTARY No penalty or loss of benefits if subject refuses to participate or withdraws Contact – need to include a contact for each, this may be the same individual or 3 separate people depending on the study. At OHSU the Research Integrity Office always needs to be listed as the contact for questions regarding subjects rights. *

Additional Elements of Informed Consent
* 07/16/96 Additional Elements of Informed Consent Risk for pregnant subject & embryo/fetus Circumstances for termination of participation Additional costs to subject Consequences of subject withdrawal and procedures for orderly termination If new findings affect willingness to participate Approximate number of subjects to be included For female subjects, are there any additional risks if I am or may become pregnant, or if I am nursing an infant? Can I be removed from the study? What happens if I later decide to quit the study? What are my responsibilities? Are there any costs associated with participating? What happens if new information is discovered in the middle of the trial that may make me change my mind about participating? Whom do I contact if I have additional questions? How many other subjects will participate in the study? If you follow the OHSU consent templates and following the instructions you shouldn’t have trouble including the required elements. *

Common Audit Findings Failure to include required elements of consent
Failure to include additional elements of consent when appropriate Language is too complex Failure to describe procedures completely Failure to describe treatment alternatives Exculpatory language in consent documents Failure to obtain IRB/IEC approval before use Failure to document Informed Consent

Writing a Great Consent Form

* 07/16/96 Lay Language Per 46 CFR 116 consent must be given in a language that is understandable to the subject or representative 8th grade reading level Tips on reading level are available on the IRB policies and procedures webpage: Don’t rely exclusively on Microsoft Word readability stats *

* 07/16/96 Lay Language, Cont. Written in native language or orally translated if subject isn’t fluent in English Short Form Translated consent document Formatting, grammar, and spelling are important for readability and understanding We will talk in detail about the short forms and translating consents when we talk about obtaining consent later. Spell check, read the document out-loud, have the neighborhood 8th grader read it, but make sure there aren’t errors in grammar that affect the subjects ability to read the document. We have seen consent forms with redundant sentences, cut an paste errors, changes that weren’t accepted appropriately and it makes for messy reading. If subjects are distracted by typos they might miss the important stuff. Also your IRB analyst won’t like if it they have to correct all of your spelling errors. *

* 07/16/96 Exculpatory Language Per 45 CFR consents cannot include language that waives or appears to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence Don’t use terms like: “I understand” “The study has been fully explained to me” Likely the subject won’t “understand” all of the medical information and you won’t likely be explaining all of the analysis to be done so “fully explained” would be inaccurate. *

Consent Templates Always use one of the OHSU IRB approved templates
* 07/16/96 Consent Templates Always use one of the OHSU IRB approved templates Select the template appropriate for your study and follow the instructions Cancer studies – use OCI templates Non-Medical Intervention, Education, Health Promotion Research – use low risk template Studies with clinical procedures – use barcoded consent and HIPAA authorization forms Study involves genetics – use genetic consent templates Investigator intends to use photos, recordings for teaching, publications, advertising – use a media consent form for complete list of templates When to use which template: OCI templates – if the study requires OCI review Low Risk Template - Can also be used for studies recruiting subjects with low literacy levels. Bar-coded template – use if anything is going through the OHSU hospital system. The consent form must then be in the medical record and the barcode helps ensure it gets there. Genetic – use if you are analyzing genetic information. If you are unsure, call your IRB analyst. Can be your only consent form or an additional one for subjects who agree to be in a genetic sub-study. Media – Instructions at the top of the template are very clear. This sample media consent form is used when media (e.g., a photograph, video tape, or audio interview) is collected from a subject and used for outside purposes such as teaching, advertisement, and publication If you photograph subjects for internal use only, (i.e., a large study and a photo will help ID your participants) you do not need a media consent form. Low risk consent & authorization – From the template: Consent & Authorization Form for Non-Medical Intervention, Education, Health Promotion Research Protocols, and for Subjects with Low Literacy *

Confidentiality and HIPAA
HIPAA is a federal law but the implementation of HIPAA is institution specific There are several types of HIPAA authorization Research authorization, authorization for obtaining existing records outside OHSU, waiver of authorization, Research Involving Only Decedents' Information OHSU has a form for each type of authorization Research authorization and authorization for obtaining records outside of OHSU are the only types of authorization given directly by a research participant Each institution across the US that uses and discloses protected health information is subject to HIPAA, but was allowed to implement it in their own way. A HIPAA research authorization form approved by the OHSU IRB cannot be used at any other institution as it only applies to OHSU.

How many consent and HIPAA authorization forms do I need?
* 07/16/96 How many consent and HIPAA authorization forms do I need? Not always easy to tell Use a combined Consent and HIPAA authorization when: No sample/data banking Use a separate consent and HIPAA authorization form When study involves banking When study involves optional genetic testing *

* 07/16/96 How many consent and HIPAA authorization forms do I need? Sub-study consent vs. tiered consent? No hard and fast rule – general guidance Consider using a tiered consent when a sub-study is simple and the purpose matches the overall study design (e.g. extra blood draws for a PK study) Consider using a separate sub-study consent if you are only asking a subgroup of study participants to take part there are several additional procedures/risks or the purposed is different Tiered signatures section – use when there are participant options, e.g. For Banking Use of samples for this study only Use of samples in the future but contact me Use of samples in the future no need to contact me. Can also use a tiered consent for participation in optional study procedures (e.g. extra blood draw). *

Screening Consents provide a brief description of the study – subject consents to be screened for the study only Still requires a detailed consent for the entire study that is presented to prospective subjects that meet the inclusion exclusion criteria Generally used when there are minimal risk screening procedures and the screen failure rate is expected to be high Advantage – saves time Disadvantages: Additional documentation and subjects may decide not to participate when they receive the full consent form

* 07/16/96 How many consent and HIPAA authorization forms do I need? Assent is required for children ages 7-17 when the children are able to understand Assent template is available on the OHSU IRB website List the same investigators as on the consent form Adult assent is also required under certain circumstances, such as with decisionally impaired participants, No template is available and it is usually incorporated into the consent form as a separate signature line We will talk about obtaining assent from children later in the presentation *

Confidentiality and Privacy of your protected Health Information Not use name or identity for publication or publicity purposes Will be assigned a study code number, if applicable List who can review and or copy research records Know whether or not you can use a combined consent/HIPAA authorization HIPPA forms can be imbedded into the OHSU CI consent, or they can be submitted as separate documents. These can be found at

* 07/16/96 Confidentiality and HIPAA Table of health information to be used or disclosed Be sure to indicate everything you may be using: medical records for recruitment, lab reports if sample analysis is done, all procedures Purposes for using/disclosing PHI A. To learn more about the disease B. To facilitate treatment, payment, operations C. To comply with federal or government regulations D. To place in a repository or “bank” – only list if you plan to bank samples for future use. Saving samples to be assayed in batch form or to be re-assayed in case of error is not “banking” What is meant by TPO – this is HIPAA speak for hospital operations (e.g. insurance billing) not subject payment. So unless your subjects’ insurance is going to be billed for research procedures you don’t have to list purpose B. *

PHI with additional regulatory protections AIDS/HIV, Drug/alcohol, Mental health, Genetics Must have subjects initial these items on the form in addition to the usual signing if you wish to use this data How long will you continue to use and disclose PHI? The study is completed – be sure to say “after all data analysis is complete” Indefinitely – the safest response

This form authorizes the investigator to use the data they’ve collected Persons authorized to use and disclose protected health information (PHI) Generally people within OHSU who will see uncoded data (OCTRI nursing staff, lab staff) Persons authorized to receive PHI People who will receive data, disclosed by the people listed above

Commercial Development
* 07/16/96 Commercial Development Required if the investigators plan (may be in the distant future) or think there is a possibility they may develop commercial products based on collected samples If you don’t include this subjects would need to be reconsented at a later date for use of their samples OHSU genetic consent template boiler plate language Important that patient has a number to call if they are uncomfortable talking with PI or coordinator *

Consent Language Negotiations for Industry Sponsored Research
* 07/16/96 Consent Language Negotiations for Industry Sponsored Research Consents must be approved by the sponsor before they are submitted to the IRB The IRB of record is the final authority on the content of the consent documents that is presented to the prospective study subjects If you have difficulties you can ask the IRB for assistance in your discussions with the sponsor. Sometimes it is difficult to negotiate consent language with the sponsor/CRO. Liability language is a common sticking point. Sometimes you can go directly to the Sponsor if you are having problems negotiating consent language with the CRO. It is not uncommon for it to take a Sponsor or CRO weeks to respond when you send them a consent to review. *

* 07/16/96 Waiver of Consent With IRB approval the consent process may be altered in special circumstances ( Minimal risk research A short form may be signed to document an oral consent process The requirement to document informed consent may be waived Some required elements may be altered or waived The requirement to obtain consent may be totally waived More than minimal risk research Waiver of requirement to document consent Oral consent process with use of a short form to document consent. Exception from informed consent requirements for emergency research We aren’t going to talk in detail about this today. The IRB has a guidance document you can read to discuss. IRB may waive documentation requirement for minimal risk research: if the research involves no procedures for which written consent is normally required outside of the research context The IRB may require an IRB approved information sheet Consent process still occurs but no signature is obtained IRB may waive documentation requirement for more than minimal risk research: If the only record linking the subject and the research would be the consent document Breach of Confidentiality is the main risk of the study *

Waivers of Authorization
* 07/16/96 Waivers of Authorization The IRB may approve a waiver of authorization for research activities with the following purposes: preparing a research protocol; developing a hypothesis; writing a grant application; or identifying subjects or records of subjects who may be recruited for the research. Data cannot be shared outside of OHSU Data requested must be necessary to conduct the research See HIPAA Activities Preparatory to Research *

Waivers of Authorization
To approve a waiver, the investigator must establish: The research involves no more than minimal risk to the subjects; Waiver will not adversely affect the rights and welfare of the subjects; The research could not practicably be conducted without the waiver; The research could not practicably be conducted without access to and use of the PHI; The use or disclosure of the PHI involves no more than minimal risk to the privacy of the subjects as a result of: Adequate plan to protect the PHI from improper use and disclosure; Adequate plan to destroy any identifiers contained in the PHI at the earliest opportunity Adequate written assurances that the PHI will not be reused or re-disclosed to any other person or entity,

Consent Form Review Checklist
* 07/16/96 Consent Form Review Checklist Correct and Current consent/HIPAA template(s) used HIPAA form either embedded or attached, correct agencies listed Spell check done Grammar/Sentence structure check done 8th grade language used Information included is consistent with the protocol and other study documents Does it make sense: clearly written, understandable Charts/tables (if any) are clear, easy to read and match the protocol Risk section (for the drug) matches IB/protocol/package insert Cost section matches billing schedule/budget/contract Reviewed by PI Updated version/revision date *

Consent Form Review Remember that OHSU has some language that must be used. Always check the instructions for Consent & Authorization form for latest boiler plate language

Obtaining Consent

Informed Consent Is an Educational Process
* 07/16/96 Informed Consent Is an Educational Process Before a subject may be enrolled in a clinical trial he/she must be provided with information regarding the trial have the opportunity to consider this information and ask questions subsequently agree to participate in the trial What is adequate time to consider participation? If a minimal risk study – same day may be fine. For a cancer trial the subject will probably need more time to consider all of their options. *

Decisionally Impaired Adults
PI/MD investigator needs to make the determination regarding the potential subjects ability to consent/assent There are differing levels of impairment Fluctuating decisional impairment - e.g. mental illness Progressive decisional impairment - e.g. early stages of Alzheimer's Limited decisional impairment - e.g. limited capacity but still able to object or assent Complete decisional impairment - e.g. later stages of Alzheimer’s disease or unconsciousness due to trauma

Decisionally Impaired Adults
Need subject assent and Authorized Representative for Research (ARR) consent. The subject may designate an ARR when the subject has no decisional impairment or may be identified by the investigator in the same manner that he or she would determine a decision maker for health care treatment.

Consenting subjects with Limited English Proficiency (LEP)
Two options Option 1 Written Consent translated into language that the subject understands Must be approved by IRB and bear the IRB approval stamp If person obtaining consent does not speak the subject’s language interpreter must facilitate informed consent Subject, investigator (person obtaining consent), witness (interpreter) sign the informed consent

* 07/16/96 Consenting subjects with Limited English Proficiency (LEP) Option 2 Oral presentation by interpreter of the informed consent information In conjunction with translated short form IRB approved written summary of what is presented orally (OHSU IRB requires full consent to be translated) Required by IRB when study targets population in which there is high or certain likelihood of encountering non-English speakers. *

Using a Short Form Subject reads IRB approved/stamped short form Interpreter reads standard informed consent in subjects language Interpreter facilitates any of the subject’s questions to investigator Interpreter relay’s investigator’s overview of study Subject signs the short form, investigator signs the standard consent form and the interpreter signs both the short form and the summary

Short consent form templates are available in several languages and a HIPAA authorization form is available in Spanish on the IRB website Targeting non-English speakers vs. enrolling them incidentally, If you are not targeting non-English speaking participants, the IRB will let you submit without a short form if you say up front that you will submit one upon identifying a potential participant

Child Assent Encouraging the child’s involvement in decision-making is done out of respect for their rights as individuals and the desire to give them a sense of ownership in what happens during the trial.

Child Assent If a child is capable of assent and the IRB requires
Assent be obtained before the child can participate in the research if the child dissents from participating in research, even if his or her parents or guardian have granted permission, the child’s decision prevails. However, the regulations 45 CFR (a) state that the IRB may waive the assent requirements If the intervention or procedure involved in the research holds out the prospect of direct benefit that is important to the health or well-being of the children and If the intervention is available only in the context of research.

* 07/16/96 Child Assent If a child assents to participate in research, and parental permission has not been waived by the IRB, the permission of the parents or guardian is also required before the child can be enrolled in the research OHSU has a policy regarding when minors can consent for themselves The OHSU Institutional Review Board (IRB) may allow for those 15 years of age or older to consent for themselves in the following circumstances: • There is the potential of benefit to the child and; • Procedures involved in the research are not different from existing treatment for which the minor would by state law be able to consent or, in the event of a non-treatment research study, the procedures are low risk or a minor increase in minimal risk and; • Parental consent is not in the best interest of the child or would not be possible to obtain. • The research otherwise meets the federal requirements for research with children. *

Informed Consent Video
* 07/16/96 Informed Consent Video The Informed Consent Zone There will be pauses so that we can discuss how the consent process is going. *

Standard of care or Research?
* 07/16/96 Standard of care or Research? VS *

Informed consent process
* 07/16/96 Informed consent process Study aims , procedures, risks and benefits. *

Talking too fast Slow down get feed back to make certain knows *
07/16/96 Talking too fast Slow down get feed back to make certain knows *

Alternatives to participation
* 07/16/96 Alternatives to participation X Can choose not to participate will not effect their relationship with clinical physician or OHSU if decides not to participate *

* 07/16/96 Lay Language 8th grade level *

* 07/16/96 Cost benefit ratio Benefits, risks, costs, compensation *

* 07/16/96 Time to consider Talk to others spouse significant others and/or family *

Who to call if questions

Presentation of Informed Consent
* 07/16/96 Presentation of Informed Consent Consent subject in a room not in the hall or waiting area. Have participant read consent form if they have not done so previously. If possible have participant sit across from you with consent form facing them Point to each section and go over content Make good eye contact Speak slowly enunciate each word this will slow you down Verify participant understands what is going to happen to them and what side effects they could incur Paraphrase back *

Informed Consent Practicum
Demonstration

* 07/16/96 Your Turn! Groups of is the investigator/coordinator; 2nd person participant; and the 3rd person take notes to give feedback. *

Documenting Informed Consent
Consent process starts when subjects are initially contacted, so start documenting! Advertising and Phone screening is considered the part of the consent process IRB needs to be aware of who is consenting subjects – make sure the IRQ is up to date

* 07/16/96 Documenting Informed Consent Use IRB approved/stamped consent form Signed & dated by subject and person obtaining informed consent at the time of consent DO NOT date for the subject!!!!!! Some sponsors require PI sign all consents in addition to person obtaining consent Both parents may be required to sign for pediatric studies If research presents more than minimal risk and offers no prospect of direct benefit to child participants Short form: stating all elements of informed consent presented orally to subject. Witness needed. If you have IRB approval to obtain consent over the telephone the dates of the subjects and the person obtaining consent won’t match. However you must write a progress note outlining the content of the conversation and the date and time it occurred. *

Provide a copy of consent(s) to subject Document that a copy was provided Copy doesn’t have to be signed by regulation but you need to follow what you told the IRB If there are any OHSU clinical procedures, you must send a copy to medical records

Witness signatures aren’t required by OHSU IRB unless you are translating the consent If you have a witness signature line you are required to have a witness sign Per OHSU IRB the witness must be present for the entire consent process

* 07/16/96 Documenting Informed Consent 21 CFR and specifically required to document that consent was obtained prior to study participation Progress note is required if consent obtained same day as study procedures and timing of consent isn’t evident Time on consent form isn’t enough unless all study procedures are noted with the time Good Practice to write a progress note Some sponsors want a date and time on the consent form. This isn’t necessarily adequate documentation that consent was obtained prior to study procedures unless the time of each procedure is also noted. *

* 07/16/96 Documenting Informed Consent Check the consent document closely!!!!! Did the person obtaining consent: Provide the correct versions of the consent/HIPAA to the subject? Date their signature with the correct date? Did the subject: Sign all of the appropriate consent documents (consent, HIPAA authorizations) Initial every page (if required by sponsor)? Initial the appropriate sections of a tiered consent Initial the appropriate lines on the HIPAA authorization if study involves genetic, HIV status, drug/alcohol treatment If sponsor requires PI to sign all consent forms – remind your PI to date their signature the day they sign it. NO BACK DATING!!!! What do you do if notice any of these problems after the subject has left the building? Document what occurred Determine if it is reportable to the IRB (now or at continuing review) Reconsent subject if possible (determine if it is appropriate to do so at the next visit or sooner) Determine if you can use the data collected Learn from your mistakes – re-educate staff if necessary *

Informed Consent Process for Research Coordinators

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