Consent Tips - University of Virginia



Consent Tips

DEFINTIONS:

Oral (Verbal) Consent: this means that you will talk with the subject and they will verbally agree to participate. No document (consent form) is used. The language used in the federal regulations to describe this situation is “Waiver of Documentation of Consent” meaning there is no consent form document to document that consent was obtained.

Written Consent: this means that you will talk with the subject, and allow them time to read or have read to them a consent form document. If the person agrees to participate in the study they will sign the consent form document.

No Consent: this means that you will use information from a person without getting their agreement to use their information. The language used in the federal regulations to describe this situation is “Waiver of Consent” meaning there is no consent form document and you will not be informing the person that their information is being used in research.

PREPARATORY TO RESEARCH

There are certain activities, in preparing for research, that can be done without IRB approval. For information see Activities That Can be Done Under the HIPAA Preparatory to Research Criteria.

USE OF DATA AND/OR SPECIMENS AND CONSENT ISSUES

Waiver of Consent no consent at all) should only be sought when obtaining consent is truly impracticable. You should assume that with much research that obtaining consent is possible; impracticable means more than inconvenient or expensive. Note: the notice in surgical informed consents concerning retention of discarded tissue does not fully meet federal criteria for research consent.

|Scenario |May Waiver of Consent (No consent) be Approved? |How to Answer Consent |

| | |Questions in Protocol |

| | |Builder |

|Retrospective* use of data and/or specimens |Yes-per 45CFR46.116 if: |If ALL additional criteria |

|*Retrospective: Specimens were collected for clinical |obtaining consent would be impracticable. |from the middle column of |

|care and are in a clinical lab such as pathology at the|In retrospective use, where a large number of specimens are sought and/or it would be |this table apply you may |

|time the protocol is written and approved by the IRB. |difficult to locate the patients, obtaining consent may be viewed as impracticable. If data |answer YES to question C |

|Data were collected for clinical care and are in |and/or specimens are sought from a smaller group of known patients, obtaining consent may be |below when you get to it in|

|medical records. |practicable even if inconvenient. For other considerations in determining if consent is |protocol builder. |

| |impracticable, please see below. | |

|May be given to researcher with a code or with HIPAA |data will not be submitted to FDA (must be approved under 21CFR50.23 or 21CFR50.24) | |

|identifiers. |data does not include use of psychotherapy notes (45CFR164.508) | |

| |results will not be given back to patient | |

|If specimens and or data are given with no code and no |study will not involve more than minimal risk to the subjects (45CFR46.116) (e.g. will be | |

|HIPAA identifiers this is not considered human subject |used for high risk genetic testing and the samples are not de-identified ) | |

|research and no IRB approval is required. |not getting consent will not affect the rights and welfare of subjects (45CFR46.116) (e.g | |

| |doing controversial research) | |

|Prospective* collection of specimens or specimens and |Yes-per 45CFR46.116 if: |If ALL criteria from the |

|data. |obtaining consent would be impracticable. |middle column of this table|

|*Prospective: Specimens will be collected for clinical|In prospective use, it is less likely that obtaining consent will be deemed impracticable. |apply you may answer YES to|

|care AFTER the protocol is written and approved by the |However, where a large number of specimens that are primarily collected for clinical care and|question C below. |

|IRB. |are also sought to be used for research and/or it would be difficult to locate the patients, | |

| |obtaining consent may be viewed as impracticable. When data and/or specimens are sought from| |

| |a smaller group of patients, obtaining consent may be practicable even if inconvenient. For | |

| |other considerations in determining if consent is impracticable, please see below. | |

| |data is not to be submitted to FDA (must be approved under 21CFR50.23 or 21CFR50.24) | |

| |data does not include psychotherapy notes (45CFR164.508) | |

| |results will not be given back to patient | |

| |study will not involve more than minimal risk to the subjects (45CFR46.116) (e.g. will not | |

| |be used for high risk genetic testing ) | |

| |not getting consent will not affect the rights and welfare of subjects (45CFR46.116) (e.g | |

| |doing controversial research) | |

|Retrospective* AND Prospective* collection of specimens|Yes-per 45CFR46.116 if: |If ALL criteria from the |

|or specimens and data. |obtaining consent would be impracticable. |middle column of this table|

| |In retrospective AND prospective use, it is likely that obtaining consent will be deemed |apply you may answer YES to|

|*Retrospective: Specimens were collected for clinical |impracticable specifically in situations where not obtaining all the information might affect|question C below. |

|care and are in a clinical lab such as pathology at the|the statistical outcome. However, when data and/or specimens are sought from a smaller group | |

|time the protocol is written and approved by the IRB. |of patients, obtaining consent may be practicable even if inconvenient. For other | |

|Data were collected for clinical care and are in |considerations in determining if consent is impracticable, please see below. | |

|medical records. |data is not to be submitted to FDA (must be approved under 21CFR50.23 or 21CFR50.24) | |

|*Prospective: Specimens will be collected AFTER the |data does not include psychotherapy notes (45CFR164.508) | |

|protocol is written and approved by the IRB. Specimens |results will not be given back to patient | |

|are collected for both clinical care and research use. |study will not involve more than minimal risk to the subjects (45CFR46.116) (e.g. will not | |

| |be used for high risk genetic testing ) | |

| |not getting consent will not affect the rights and welfare of subjects (45CFR46.116) (e.g | |

| |doing controversial research) | |

| | | |

*Considerations and Examples

*Factors that may affect the practicality include:

• The sample size required is so large (e.g. population –based studies, epidemiology trials) that including only those samples/records/data for which consent can be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions would be skewed.

• The subjects for whom records would be reviewed are no longer followed and may be lost to follow-up.

• Ethical concerns created by risk of creating additional threats to privacy by having to link otherwise de-identified data with identifiers in order to contact individuals to seek consent. Or there is a risk of inflicting psychological, social or other harm by contacting individuals or families.

• Research looking at issues such as outcomes/morbidity data where not having access to all subjects would affect the statistical outcome.

• Researcher not involved in the clinical care of the patient/subject. Not aware of when sample will be collected or if the patient will have any sample left over after clinical care is completed.

Examples of the types of protocols where obtaining consent might be practicable:

• Researcher from cardiology plans to do prospective chart review of patients seen in the cardiology clinics over the next 3 months. Patients will be physically in the clinic and would therefore be practicable to consent.

• Researcher / surgeon plans to collect left over tissue obtained during surgery for use in research. Patients will be physically available and may be consented for the research at the same time they are consented for surgery.

Examples of the types of protocols where obtaining consent might be impracticable:

• Research looking at issues such as outcomes/ morbidity data where not having access to all subjects would affect the statistical outcome.

• The subjects for whom records would be reviewed are no longer followed and may be lost to follow-up.

• Ethical concerns created by risk of creating additional threats to privacy by having to link otherwise de-identified data with identifiers in order to contact individuals to seek consent. Or there is a risk of inflicting psychological, social or other harm by contacting individuals or families. (e.g. chart review study of patients with history of spousal abuse- data would be taken from medical records in a de-identified manner or as a limited data set (dates are only HIPAA identifier collected.) Would create greater harm to require researcher to collect identifiers to enable them to obtain consent.

• Bench researcher needs red blood cells left over after clinical labs are run. Study will not involve an FDA regulated drug, device or biologic. Blood may be drawn at any one of several different venipuncture labs. Researcher not aware of which patient might have a sample left over. Patient may have left UVa by the time the researcher is notified the sample is available. Needs identifiers to be able to compare research result with clinical lab result. IMPORTANT: If study involves an FDA regulated drug, device or biologic, need to refer to FDA regulations at 21CFR50 regarding consent. If study involves an in vitro device using left over specimens the FDA Guidance on Informed Consent for InVitro Diagnostic Device Studies Using Leftover Human Specimens should be followed.

• It states: FDA intends to exercise enforcement discretion as to the informed consent requirements ( e.g. would agree with no consent) if an in vitro diagnostic device investigation is performed and ALL of the following are true:

a) The investigation meets the IDE exemption criteria at 21 CFR 812.2(c) (3).

b) The study uses leftover specimens, that is, remnants of specimens collected for routine clinical care or analysis that would have been discarded. The study may also use specimens obtained from specimen repositories or leftover specimens

that were previously collected for other research purposes.

c) The specimens are not individually identifiable, i.e., the identity of the subject is not known to and may not readily be ascertained by the investigator or any other individuals associated with the investigation, including the sponsor. If the specimen is coded, it will be considered to be not individually identifiable if neither the investigator(s) nor any other individuals associated with the investigation (OK for specimens to be linked and coded by a person in the micro lab who is not a member of the study team) or the sponsor can link the specimen to the subject from whom the specimen was collected, either directly or indirectly through coding systems.

d) The specimens may be accompanied by clinical information as long as this information does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor.

e) The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation.

f) The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information.

g) The study has been reviewed by an IRB in accordance with 21 CFR Part 56, except as described in section 7 of this guidance document.

• Researcher wishes to analyze samples from pathology collected over the last 2 years from patients with advanced melanoma. Very probably that a large number of the patients are now deceased- making obtaining consent impracticable.

• Researcher wishes to analyze retrospective data that was collected from a research study conducted 5 years ago for which subjects with early Alzheimer’s. Quite probably that these subjects now have advanced Alzheimers’s and would be unable to consent.

• Retrospective and/or prospective collection of data outside of medical records into a database to be used for future research AND any of the following:

• Quality Improvement

• Clinical Care and stored in such places as departmental databases

• National Registries required by groups such as clinical societies.

• Certification or licensure

Steps that may be taken to allow a waiver of consent (no consent- verbal or written obtained_)

• Specimen and clinical information collected at the same time and then taken to research lab with NO HIPAA IDENTIFIERS and No LINK back to any HIPAA identifiers. Would be reviewed by the IRB-HSR under an expedited review process with no consent required.

• Limit identifiers to items allowed in a Limited Data Set (full dates/ address info smaller than a state) . No consent would be obtained as this as this is a Limited Data Set and does not include identifiable information requiring a Waiver.

Consenting Options:

• Written consent using standard IRB-HSR template developed with Protocol Builder

• Verbal/Oral consent. Researchers are strongly encouraged to document in the research file that verbal/oral was obtained. Keep in mind that if data collected includes health information a written HIPAA Authorization will be required in addition to a brief written paragraph explaining the study.

ONLY VERBAL CONSENT

Example: In your study you will ask potential subjects sitting in a waiting room if they would be willing to complete a survey. You will then verbally describe the study to them. If they state that they would be willing to participate, you will ask them the survey questions.

NOTE: If you need to review charts first to determine who to talk to about the study answer this question NO.

A waiver of documentation of consent/verbal consent cannot be used for:

• any study involving high risk genetic testing in which samples are not de-identified. 

• any use or disclosure of psychotherapy notes for research purposes. .

How to Answer Questions:

| Do you plan on getting ONLY verbal consent (Waiver of Documentation of Consent) for the entire study? |YES |

You will not receive any additional questions regarding consent.

VERBAL CONSENT AND NO WRITTEN CONSENT

Example: You need no consent from the subject (Waiver of Consent) to do a chart review/use CDR to identify qualified subjects. You will record contact information for the potential subjects. You may or may not collect additional health information. You will then call the subjects to ask them to participate in a questionnaire over the phone. While talking with them you will explain the study and they can verbally agree to be in the study (Waiver of Documentation of Consent). You will analyze the information obtained for the study.

How to Answer Questions:

| Do you plan on getting ONLY verbal consent (Waiver of Documentation of Consent) for the entire study? |NO |

|Do you plan on getting verbal consent for part of this study (Waiver of Documentation of Consent) and performing another part of the study without consent of the subject (Waiver of |YES |

|Consent)? | |

You will not receive any additional questions regarding consent.

NO CONSENT

Example: You will do a retrospective chart review/use CDR to obtain identifiable health information of subjects with a certain diagnosis. The information will be analyzed and used in a poster presentation. The subjects will not be contacted or notified that their information has been used in research.

How to Answer Questions:

|Do you plan on getting ONLY verbal consent (Waiver of Documentation of Consent) for the entire study? |NO |

|Do you plan on getting verbal consent for part of this study (Waiver of Documentation of Consent) and performing another part of the study without consent of the subject (Waiver of |NO |

|Consent)? | |

|Are you requesting that NO CONSENT (verbal or written) be obtained from the subject for the entire study (Waiver of Consent)? |YES |

You will not receive any additional questions regarding consent.

NO CONSENT AND WRITTEN CONSENT

Example: You will need no consent from the subject (Waiver of Consent) to do a chart review/use CDR to obtain contact information and retrospective health information on the qualified subjects. Health information from all subjects will be used in the analysis. You will contact a subset of the subjects to ask them if they would be willing to have a blood draw for research purposes. A written consent will be signed prior to the blood draw.

How to Answer Questions:

|Do you plan on getting ONLY verbal consent (Waiver of Documentation of Consent) for the entire study? |NO |

|Do you plan on getting verbal consent for part of this study (Waiver of Documentation of Consent) and performing another part of the study without consent of the subject (Waiver of |NO |

|Consent)? | |

|Are you requesting that NO CONSENT (verbal or written) be obtained from the subject for the entire study (Waiver of Consent)? |NO |

|Do you plan on getting no consent for part of the study (Waiver of Consent) and a written consent for another part of the study? |YES |

You will not receive any additional questions regarding consent.

VERBAL CONSENT AND WRITTEN CONSENT

Example: You will have a consent form for a study, but need verbal consent for certain screening procedures that may be done prior to the subject signing a consent form.  Examples might include asking a subject to come fasting for their first screening visit, or asking the potential subject to hold certain medications prior to the first screening visit 

A waiver of documentation of consent/verbal consent cannot be used for:

• any study involving high risk genetic testing in which samples are not de-identified. 

• any use or disclosure of psychotherapy notes for research purposes.

How to Answer Questions:

|Do you plan on getting ONLY verbal consent (Waiver of Documentation of Consent) for the entire study? |NO |

|Do you plan on getting verbal consent for part of this study (Waiver of Documentation of Consent) and performing another part of the study without consent of the subject (Waiver of |NO |

|Consent)? | |

|Are you requesting that NO CONSENT (verbal or written) be obtained from the subject for the entire study (Waiver of Consent)? |NO |

|Do you plan on getting no consent for part of the study (Waiver of Consent) and a written consent for another part of the study? |NO |

|Do you plan on getting VERBAL CONSENT for ONLY a PART of this study (waiver of documentation of consent) and will obtain a signature on a consent form for the main part of the study? |YES |

You will not receive any additional questions regarding consent.

ONLY WRITTEN CONSENT

EXAMPLE: A consent form will be signed by the subject prior to any study procedures.

• If the Clinical Data Repository (CDR) is used to identify potential subjects and obtain their contact information answer this question NO

• If a chart review is done to identify potential subjects and their contact information is collected answer this question NO.

• You plan to use discarded tissue from the patient obtained during an operation. The study team members are also members of the surgical team.

• You plan to do a prospective collection of data from flowsheets at the patients’ bedside.

• If subjects will be approached in a waiting room and asked if they meet the criteria for enrollment and then asked if they would like to participate- answer this question YES.

How to Answer Questions:

|Do you plan on getting ONLY verbal consent (Waiver of Documentation of Consent) for the entire study? |NO |

|Do you plan on getting verbal consent for part of this study (Waiver of Documentation of Consent) and performing another part of the study without consent of the subject (Waiver of |NO |

|Consent)? | |

|Are you requesting that NO CONSENT (verbal or written) be obtained from the subject for the entire study (Waiver of Consent)? |NO |

|Do you plan on getting no consent for part of the study (Waiver of Consent) and a written consent for another part of the study? |NO |

|Do you plan on getting VERBAL CONSENT for ONLY a PART of this study (waiver of documentation of consent) and will obtain a signature on a consent form for the main part of the study? |NO |

|Do you plan on getting a written consent for the entire study? |YES |

You will not receive any additional questions regarding consent.

Additional Resource:

FAQ: What’s the difference between waiver of consent and waiver of documentation of consent?

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