HRPP Training – Session TwoMichelle Brignac, CIP

Human Research Protection Program Manager

Consent Process

• Informed consent may only be obtained from subjects who have the legal and mental capacity to give consent. For subjects without that capacity, consent must be obtained from a legally authorized representative.

• The researcher must give either the participant or the representative adequate opportunity to read the consent document before it is signed.

• The informed consent process shall be sought under circumstances that minimize the possibility of coercion or undue influence.

• The informed consent information must be presented in language that is understandable to the subject (or legally authorized representative).

• The person administering the consent must sign and date the consent.• In accordance with the American Disabilities Act, Pennington Biomedical

Research Center will provide any assistance in to any subject with a disability.

• For subjects that are illiterate, an impartial witness to the subject will sign as a reader unless the subjects legally authorized representative is present.

Consent Process

• The ICF may not include exculpatory language which the subject is made to waive or appear to waive their legal rights.

• The investigator is ultimately responsible for ensuring that each prospective subject is adequately informed about all aspects of the research and understands the information provided.

• Federal regulations do not specify how far in advance of study entry a subject can provide consent. The amount of time required by a subject to make a decision would presumably depend upon the nature of the study, taking into consideration the degree of risk, potential benefits, alternatives, and desire to consult with family. For the sake of clarification, consents are current for 30 days but it may be prudent to review information contained in the consent document with the research subject prior to initiating any research procedures.

Basic Elements of Consent

• An explanation of the research and purpose• Description of benefits to the subject• The alternative procedures or treatment that might be available to the

subject.• Explanation of confidentiality of records • More than a minimal risk an explanation of medical treatment in case of

research related injuries. Who will pay for the injury.• IRB and Investigator contact information for the subject to voice concerns

or ask questions.• A statement that participation is voluntary.• A statement that the particular treatment or procedure may involve risks

to the subject, which are currently unforeseeable.• Pregnancy related risks, if the subject were to become pregnant• Circumstances under which the subjects participation may be terminated

by the Investigator without regard to the subject’s consent.

Basic Elements of Consent

• Any additional costs to the subject that may result from participation in the research

• The consequences of a subject’s decision to withdraw from the research• Procedures for orderly termination of participation by the subject.• A statement that significant new findings developed during the course of

the research which may relate to the subject’s willingness to continue participation will be provided to the subject

• The approximate number of subjects involved in the study• A statement that the monitor, the auditor, the IRB, and the regulatory

authority will be granted direct access to the participant’s original medical records for verification of clinical trial procedures or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written consent form, the participant or the participant’s legally acceptable representative is authorizing such access.

• The approval of the IRB.

Basic Elements of Consent

For research regulated by FDA:• A statement that informs the subject of the possibility that FDA may

inspect the records.• For applicable clinical trials, the following statement notifying the

subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This website will not identify you. At most, the website will include a summary of the results. You can search this website at any time.”

• Investigational New Drug Application (IND) submitted to FDA is not required to contain a copy of the consent document. For significant risk devices, the consent document is considered to be a part of the investigational plan in the application for an Investigational Device Exemption (IDE). Any substantive changes to the document made by an IRB must be submitted to the FDA (by the sponsor) for review and approval.

Documentation of ICF

• The subject must personally sign and date an IRB approved consent form.• The informed consent process must be conducted in person, this includes

reading and signing the consent.• Pennington Biomedical does not allow for obtaining informed consent

over the phone or by mail• In addition to signing the consent document, the subject or

representative should enter the date of signature on the consent document to permit verification that consent was actually obtained before the subject began participation in the study.

• If the consent is obtained on the same day as the subject’s involvement in the study begins, the subject’s medical records/source documentation should document that consent was obtained prior to participation in the study.

• Participants or participant’s legally authorized representative will be given adequate time to read the consent document before it is signed.

Documentation of ICF

• The subject must personally sign and date an IRB approved consent form.• The informed consent process must be conducted in person, this includes

reading and signing the consent.• Pennington Biomedical does not allow for obtaining informed consent

over the phone or by mail• In addition to signing the consent document, the subject or

representative should enter the date of signature on the consent document to permit verification that consent was actually obtained before the subject began participation in the study.

• If the consent is obtained on the same day as the subject’s involvement in the study begins, the subject’s medical records/source documentation should document that consent was obtained prior to participation in the study.

• Participants or participant’s legally authorized representative will be given adequate time to read the consent document before it is signed.

Documentation of ICF

• A copy of the signed and dated consent document will be provided to the participant or the participant’s legally acceptable representative, a copy placed on all of the appropriate records, and the original signed consent document should be retained in the study records.

Withdrawal from Study

• When a participant withdraws from a study, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the participant the option of having data removed.

• A researcher may ask a participant who is withdrawing whether the participant wishes to provide continued follow-up and further data collection subsequent to their withdrawal from the interventional portion of the study. Under this circumstance, the discussion with the participant distinguishes between study-related interventions and continued follow-up of associated clinical outcome information, such as medical course or laboratory results obtained through non-invasive chart review, and address the maintenance of privacy and confidentiality of the participant's information

• The researcher must obtain the participant’s consent for this limited participation in the study (assuming such a situation was not described in the original consent document). The IRB must approve the consent document.

Withdrawal from Study

• If a participant withdraws from the interventional portion of a study and does not consent to continued follow-up of associated clinical outcome information, the researcher must not access for purposes related to the study the participant's medical record or other confidential records requiring the participant's consent. However, a researcher may review study data related to the participant collected prior to the participant's withdrawal from the study, and may consult public records, such as those establishing survival status.

FDA

• It is the FDA policy that participant data collected up to the time of withdrawal must remain in the data set in order for the study to be scientifically valid.

Waiver of ICF

3 Types of Waiver of ICF:

• Waiver or modification of consent

• Waiver of parental permission

• Waiver of written documentation of consent

Waiver or Alteration of ICF

The investigator may provide to the subject a consent, which does not include or which alters one or all of the required elements.

Two Options:

• Public benefit or service programs• Other research (must meet all 5 criteria)

Waiver or Alteration of ICF

Option 1 (Government Program Evaluations)

• The study is an evaluation of a public program of services, is subject to governmental approval, and is evaluating procedures for obtaining benefits, changes in the program, or methods or levels of payment to be made under the program, AND

• The research cannot practicably be carried out without the waiver or alteration

Waiver or Alteration of ICF

Option 2 (Other Research)

• The research cannot present more than a minimal risk

• Cannot adversely affect the rights and welfare of subjects

• Must have a significant rationale• Cannot involve non-viable neonates• The research cannot be subject to FDA regulation.

Waiver of Parental Permission

Option 1: Used for typically minimal risk studies

• No more than a minimal risk• Will not adversely affect the rights and welfare of

subjects• Research can not be carried out without a waiver• Research does not involve non-viable neonates• Research is not subject to FDA regulation

Waiver of Parental Permission

Option 2

• The research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children)

• An appropriate mechanism for protecting the children who will participate as subjects in the research will be substituted (such as a court-appointed guardian)

• Research is not subject to FDA regulation

Waiver of Documentation of ICF

Option 1

• Conducting interviews with street gang members about illegal gang activities. The only record of the name or other identifying information of the subject would be the signed consent form and knowledge of an individual’s participation or information provided could lead to potential legal, social, or physical harm

• The only record linking the subject and the research would be the consent document

• The only risk would be potential harm resulting from breach of confidentiality

• Each subject will be asked whether the subject wants documentation linking the subject with the research. The subjects wishes must be governed.

• Research is not subject to FDA regulation.

Waiver of Documentation of ICF

Option 2• Using anonymous survey consent or conducting telephone interviews

with political staffers about how recent fundraising rules have changed the campaign process and no questions are being asked that could result in potential embarrassment, personally or professionally

o The research presents no more than minimal risk of harm to subjects

o Research involves no procedures for which written consent is normally required outside of the research context.

Privacy Vs. Confidentiality

Privacy

refers to a individual’s right to control access to him/herself. This includes access to the individual’s personal information as well as access to their body or their biological specimens.

The federal regulations define ‘private information’ as “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record).”

Privacy Vs. Confidentiality

CONFIDENTIALITY

refers to how private information provided by individuals will be protected by the researcher from release. Describing just how the confidentiality of research information will be maintained is an important element of the consent process.

While the term ‘Confidentiality’ is not formally defined in the federal regulations, the regulations make it clear that investigators have an obligation to inform research subjects:• how their data will be used,• who will have access to it,• what procedures will be put in place to ensure that only authorized individuals will

have access to the information, and• the limitations (if any) to these confidentiality procedures

Privacy Vs. Confidentiality

Privacy Applies to the Person

Confidentiality Applies to the Data

Unanticipated Problems

Adverse Events Unanticipated

Problems

SAE’s

Unanticipated Problems (including

SAE’s and AE’s) involving new or

increased risk

Require prompt reporting to the IRB, and sponsor, if applicable, and the FDA, if

applicable.

For the IRB to review the Unanticipated Problem• Unexpected• Related or possibly related • Serious