INFORMED CONSENT

INFORMED INFORMED CONSENTCONSENT

The Ethical PrincipleThe Ethical Principle

The RegulationsThe Regulations

The DocumentThe Document

The ProcessThe Process

What Should It All Mean What Should It All Mean To Me?To Me?

The Ethical PrincipleThe Ethical Principle

• The Belmont Report outlines The Belmont Report outlines three basic ethical principles:three basic ethical principles:– Respect for PersonsRespect for Persons– BeneficienceBeneficience– JusticeJustice

Which principle supports informed Which principle supports informed consent?consent?

Respect For PersonsRespect For Persons

Respect for Persons Respect for Persons carries with it a carries with it a

number of number of responsibilities for a responsibilities for a

researcher.researcher.

Respect for PersonsRespect for Persons

Respect the person’s autonomy.Respect the person’s autonomy.The person has the right to make The person has the right to make decisions for him/herself. decisions for him/herself.

The person has a right to The person has a right to information that will help them information that will help them make that decision.make that decision.

The person has a right to enough The person has a right to enough time to make a decision without time to make a decision without feeling coerced.feeling coerced.

The person has a right for The person has a right for information to be presented in a information to be presented in a language and in words they can language and in words they can understand.understand.

What Information What Information Does a Person Need Does a Person Need in Deciding Whether in Deciding Whether

to Participate in to Participate in Your Study?Your Study?

Information For Potential Information For Potential SubjectsSubjects

• They need to know that it is research!They need to know that it is research!• They need to be told what is the They need to be told what is the

purpose of doing the research.purpose of doing the research.• They need to know how long they will They need to know how long they will

be expected to participate in the be expected to participate in the research.research.

• They need to know what you plan to do They need to know what you plan to do and what are they going to be expected and what are they going to be expected to do.to do.

• They need to know which of the They need to know which of the procedures are experimental and if procedures are experimental and if applicable how that might differ from applicable how that might differ from anything they would undergo if they anything they would undergo if they didn’t participate.didn’t participate.


• They need to know what They need to know what potential potential risks or discomfortsrisks or discomforts they may they may experience as a result of experience as a result of participating in your study.participating in your study.Need to address not only any Need to address not only any physical physical risk to the participant but risk to the participant but also any also any emotionalemotional or or psychologicalpsychological risk or discomforts risk or discomforts they may experience and any risks they may experience and any risks to a person’s ability to get or to a person’s ability to get or retain retain employmentemployment, get , get insuranceinsurance, , be be arrestedarrested, or be , or be sued.sued.


• They need to know what potential They need to know what potential benefits they may receive by benefits they may receive by participating. BEWARE – do not participating. BEWARE – do not overstate any potential benefits! And, overstate any potential benefits! And, acknowledge that they may not receive acknowledge that they may not receive any benefits, if that is the case.any benefits, if that is the case.

• They need to know if there are any They need to know if there are any alternatives available to them should alternatives available to them should they choose not to participate.they choose not to participate.

• They need to know whose going to see They need to know whose going to see the information they provide. (You the information they provide. (You need to be comprehensive in need to be comprehensive in describing individuals, agencies, etc describing individuals, agencies, etc that will have or may have access to that will have or may have access to the data. )the data. )

Information For Information For Potential SubjectsPotential Subjects

• If the study involves greater than If the study involves greater than minimal risk, the potential subject minimal risk, the potential subject needs to know whether there will be needs to know whether there will be any compensation and any compensation and medical/psychological/social medical/psychological/social services available to them.services available to them.

• They need to know that their They need to know that their participation is 100% voluntary. participation is 100% voluntary. They won’t be forced to participate They won’t be forced to participate and they won’t be forced to stay in and they won’t be forced to stay in the study, should they want to the study, should they want to withdraw at any time.withdraw at any time.


• They need to know who they They need to know who they can call or contact to ask can call or contact to ask questions about:questions about:– Things that occur in the researchThings that occur in the research– Their rights as participants in Their rights as participants in

the researchthe research– Who to contact should they Who to contact should they

become distressed, physically or become distressed, physically or emotionally injured.emotionally injured.


• You might also want to tell potential You might also want to tell potential subjects:subjects:– That there may be risks about which you That there may be risks about which you

are currently unaware;are currently unaware;– That there may be certain circumstances That there may be certain circumstances

that may cause you to terminate their that may cause you to terminate their participation;participation;

– That there may or may not be additional That there may or may not be additional costs associated with their participation;costs associated with their participation;

– How many other people are participating How many other people are participating in the study;in the study;

– That if new findings become available That if new findings become available during the research that would impact during the research that would impact their willingness to continue their willingness to continue participation, you will share that participation, you will share that information with them.information with them.

The Consent ProcessThe Consent Process

The consent process begins The consent process begins when you begin recruitment when you begin recruitment of subjects. of subjects.

Informed consent does not Informed consent does not end with the signing of a end with the signing of a document.document.


How do you show respect for How do you show respect for persons in each of these persons in each of these

situations?situations?

•Information gathered to identify Information gathered to identify potential subjects?potential subjects?

•Information provided in flyers?Information provided in flyers?

•Information provided in published Information provided in published ads?ads?

•Information provided when Information provided when contacting the potential subject?contacting the potential subject?


The consent process is an The consent process is an on-going, dynamic on-going, dynamic “conversation” with your “conversation” with your subject to ensure:subject to ensure:• the person understands the person understands what’s being asked of what’s being asked of him/her;him/her;• that the person has an that the person has an opportunity to ask opportunity to ask questions; andquestions; and• that the person truly that the person truly

wants to continue inwants to continue in the the study.study.


Are there times when it is not appropriate to have a consent process?

How do I inform the IRB that the process is not appropriate?

Request for Waiver of Request for Waiver of Consent ProcessConsent Process

The IRB may waive the consent The IRB may waive the consent process if the following process if the following conditions exist:conditions exist:

• the study involves no greater than the study involves no greater than minimal risk;minimal risk;

• the rights and welfare of the subjects the rights and welfare of the subjects would not be adversely affected;would not be adversely affected;

• the research could not be practicably the research could not be practicably carried out without the waiver;carried out without the waiver;

• when appropriate, subjects will be when appropriate, subjects will be provided pertinent information after provided pertinent information after participation is completed.participation is completed.

Documentation of Documentation of Informed ConsentInformed Consent

The consent form is one of the The consent form is one of the most important ways to most important ways to document your respect for document your respect for persons.persons.

Informed Consent Informed Consent DocumentDocument

Common problems found Common problems found during IRB review include:during IRB review include:•Information is not presented in Information is not presented in terms the average terms the average person person understands (usually 8understands (usually 8thth grade level); grade level);•Typographical or grammatical Typographical or grammatical errors; errors; •All of the procedures are not All of the procedures are not included;included;•The risks are not appropriately The risks are not appropriately described;described;•The benefits are overstated; andThe benefits are overstated; and•The person isn’t told that they are The person isn’t told that they are participating in research!!!participating in research!!!


Are there times when Are there times when documentation of documentation of

informed consent is informed consent is not appropriate?not appropriate?


There are times when signed consent is There are times when signed consent is not absolutely required and not absolutely required and documentation can be waived.documentation can be waived.

Waiver of documentation requires a Waiver of documentation requires a formal request to the IRB with formal request to the IRB with justification that the study is:justification that the study is:

• The study poses no greater than The study poses no greater than minimal risk;minimal risk;

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

• The principal risk would be harm The principal risk would be harm resulting from breach of resulting from breach of confidentiality; andconfidentiality; and

• Each subject is asked whether Each subject is asked whether he/she wants documentationhe/she wants documentation..

Request for Waiver of Request for Waiver of Documentation of Documentation of

ConsentConsent

Typically, whenever possible, the Typically, whenever possible, the IRB will ask that you provide a IRB will ask that you provide a letter to the participant that letter to the participant that contains all of the elements of contains all of the elements of informed consent. This can informed consent. This can serve as a cover memo for a serve as a cover memo for a survey, be provided at the survey, be provided at the beginning of an interview, or be beginning of an interview, or be sent subsequent to a telephone sent subsequent to a telephone research procedure.research procedure.

What if my subject What if my subject population is not fully population is not fully

autonomous?autonomous?

Certain “vulnerable” populations Certain “vulnerable” populations are not considered totally are not considered totally autonomous and therefore must autonomous and therefore must have someone else sign informed have someone else sign informed consent for them. Examples of consent for them. Examples of these populations include these populations include children, individuals with limited children, individuals with limited mental capacity, or individuals mental capacity, or individuals under acute stress or sedation. under acute stress or sedation.

Parental PermissionParental Permission

Children are not considered Children are not considered autonomous individuals (unless autonomous individuals (unless they meet the definition of they meet the definition of emancipated). However, we want emancipated). However, we want to respect them as individuals. To to respect them as individuals. To use children in research, you must use children in research, you must first obtain the permission of the first obtain the permission of the parent(s) and then obtain assent parent(s) and then obtain assent from the child.from the child.

Minors (children) are defined as Minors (children) are defined as those individuals under the age of those individuals under the age of 18 years.18 years.

Emancipated Minors

• Individuals under 18 years of age that are considered emancipated (therefore able to give consent for themselves) include:– Minors declared emancipated by the courts– Minors who are married or have been married– Minors who are pregnant and are being asked to participate in research about pregnancy or impacts the well-being of the mother or her unborn baby

Verbal and Documented Verbal and Documented AssentAssent

Children participating in research Children participating in research should be given the opportunity to should be given the opportunity to agree to that participation. agree to that participation.

For children under 7 years of age, For children under 7 years of age, it is an informal process.it is an informal process.

Children 7 – 12 years of age, assent Children 7 – 12 years of age, assent is verbally obtained and is verbally obtained and documented in the research documented in the research records.records.

Minors 12 – 17 years of age, should Minors 12 – 17 years of age, should be given the opportunity to be given the opportunity to

document their assent ondocument their assent on an IRB an IRB approved assent form.approved assent form.

Where do I go and Where do I go and What do I do?What do I do?

USF on-campus mailing:USF on-campus mailing: MDC35MDC35 Off-campus mailing: USF Division of Off-campus mailing: USF Division of Research Integrity and ComplianceResearch Integrity and Compliance

12901 Bruce B. Downs Blvd. 12901 Bruce B. Downs Blvd. MDC35MDC35Tampa, FL 33612Tampa, FL 33612

Hand delivery:USF Division of Research Hand delivery:USF Division of Research Integrity and ComplianceIntegrity and Compliance

University Technology CenterUniversity Technology Center3702 Spectrum Avenue, Suite 1553702 Spectrum Avenue, Suite 155Tampa, FloridaTampa, Florida

Fax number:Fax number: (813) 974-5618 (813) 974-5618 Call us at:(813) 974-9343Call us at:(813) 974-9343Visit our web site: Visit our web site:

http://www.research.usf.edu/cs/irb.htmhttp://www.research.usf.edu/cs/irb.htm

INFORMED CONSENT

Documents

Transcript of INFORMED CONSENT