Informed consent for Researchers - PowerPoint Presentation

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Informed consent for Researchers

version: February 2021

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Example

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Someone you don’t know hands you a cup of tea.

Questions that may come to mind:

Who made this tea?What is in this tea?Why was I given this tea?Prospective participants may have similar questions when you ask them to participate in research.Consent is a process that helps them understand you, your study, and why you’re doing it.

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Outline

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History of Informed Consent

Overview of Consent – It’s a Process!

What belongs in Consent DocumentsBroad Consent Special Considerations for Vulnerable Subject PopulationsWaivers of Consent

Other Resources

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History of informed Consent

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Human subjects research has a troubled history

Tuskegee syphilis study harmed subjects when researchers deceived them & withheld treatment

This led to creation of the National Commission, which was charged with establishing a code of research ethics

In 1979, the Belmont Report issued ethical guidelines for HSR

Prompted the U.S. expansion of federal regulations.

Informed consent – the History

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Belmont Report Principles

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Overview of Consent

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Informed Consent: A basic Overview

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Image/figure taken from CITI program

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Introduction to Consent

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Respect for persons

How would you feel if you were told that you MUST participate in research?

Most potential participants expect to be respected as autonomous individualsParticipants have the right to make informed decisions about what will and will not be done to them and what (if any) personal information will be shared with others

It’s important to communicate that participation is voluntary and prospective participants can quit at

any

time.

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Introduction to Consent

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Federal regulations guide the informed consent process.

Regulations outline specific elements of consent that researchers are required to communicate to participants.

Regulations also require clear, concise, understandable language and prioritization of key information.Regulations allow for special circumstances when the consent process cannot or should not be documented if it is in the participant’s best interest or does not impact their rights. i.e., in cases where the consent form is the only record linking a subject’s identity to his or her data or participation

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Other terms and Elements

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Incentives

-

payments/gifts offered to participants for their participationMust be described during the consent process & conditions under which participant will receive partial/no paymentRecruitment vs. Enrollment

- Recruitment involves seeking out participants for your study. It may involve phone calls, flyers, or e-mails. Enrollment is the process of actually providing them with informed consent. Both recruitment and consent documents and processes must be approved by the IRB.

Exculpatory language

: participants may not be asked to waive

or even appear to

waive

their rights, OR be asked to waive the researcher, sponsor, or institution from liability

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informed consent Checklist

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Informed consent Process

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Consent is a process

!

When completed, consent is

voluntary

agreement from participants to enter into the study.

Participants may withdraw at any time, so consent is

only

to begin the study.

Questions for consenters:

Am I answering questions such that they understand what their role would be in the study/research project?

Am I giving participants sufficient time to make decisions? Do they feel rushed, pressured, or anxious?

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Back to Example

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For obtaining consent with tea, you would want them to easily understand:

What the tea is made of

How it was madeHow long it should take to drink itThat they do not have to drink the tea, BUT if they do want it, they are allowed to stop drinking it at any time

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Documenting Consent

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Documentation serves as a record that confirms that the consent process happened and was conducted appropriately by the researchers.

Forms are typically signed by the participant or their Legally Authorized Representative (e.g., parent, legal guardian)

The IRB may approve an oral consent process completed via:Phone

Online

Face-to-face

Or electronic formats for consent forms and signatures may be used if approved by the IRB.

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What belongs in consent documents

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Key information

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The Consent document should begin with a “key information” section – the executive summary of the consent document.

This section should provide a concise overview of the study details, and the rest of the document expands on it.

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Tea…. Again

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Additional Elements of Consent

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***Required for specific circumstances, such as

greater than minimal

risk research.***

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Broad Consent

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What is Broad Consent?Broad consent is an

alternative

to specific informed consent in certain circumstances

It is useful when collecting information or biospecimens with the intention to store

for future research purposes.It is NOT a waiver of consent, but an alternative process.broad consent21

When can I use it?

Permissible only for storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens.

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What is required for broad consent?

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A subset of the basic elements of informed consent.

Specifically, it must include:

Statements of risk Description of benefits Confidentiality

Voluntary nature of research

Commercial profit statement

(

when applicable

)

Whole genome sequencing statement

(

when applicable

)

Henrietta Lacks: This Photo

by Unknown Author is licensed under

CC BY-SA-NC

The IRB may not omit or alter any of the requirements of broad consent.

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Therefore, researchers and IRB must carefully track which participants have given broad consent.

The current responsibility for this documentation rests with the PI.

If you indicate on an IRB application that you are using secondary data and you request a waiver of consent, you will be prompted to answer two questions:

1. Was this data collected with broad consent in place?

2. Did anyone refuse to grant broad consent?These questions ensure the IRB does not violate regulations in granting a waiver.The IRB & broad consent

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**

The

IRB is not permitted to grant a waiver of consent

if broad consent has previously been declined by a participant.**

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Special Considerations for vulnerable subject populations

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Subject: “What am i signing up for?”

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What does your study population look like?

Prepare consent material that fits the subjects’:

Language level

Reading level

Is your study complex and/or difficult to understand?

Explanation of the study info is crucial. Consider this a conversation with the participant, not just a monologue performance.

Don’t just ask the participant if they understand! Instead, say: “Explain to me what you think you’re signing up for.”

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The time and setting may influence the consent process and whether subjects feel free to choose whether to participate.

Examples:

Adolescents whose parents are in the room

Minors among a group of other minors being recruitedAthletes recruited by their coachEmployees asked to participate by their employerPrisoners recruited by law enforcement officials

setting

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Time

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Participants should have ample time to consider study participation, especially for:

Studies with greater than minimal risk

Studies that concern sensitive and/or personal information

Study compensation should not be so high that they override other considerations

Is my incentive too coercive?

That depends on the:

research context

financial status

emotional resources of the subjects

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What if my subjects are unable to consent?

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Legally Authorized Representatives (LAR)

A LAR is an individual, judicial, or other body authorized under law to grant permission on behalf of a prospective participant for their participation in research activities.

For studies involving minors, a LAR is typically a parent or legal guardian

.

All typical consent processes apply, but the participant is not consenting him or herself because of limited capacity (e.g., cognitive impairment or developmental stage).

BUT

you may still be required to receive assent (agreement) from the individual!

What this look like may vary from tacit verbal agreement to reading body language

The IRB can help you determine the appropriate assenting procedure for your subject population.

Assent templates are available on the IRB website.

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Protect the welfare and rights of those who may be susceptible to coercion, undue influence, or unable to legally consent for themselves. Whether a participant is “vulnerable” may depend on context.

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Examples:

Which study populations are particularly vulnerable?

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Protections for Vulnerable Subjects during consent

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Special protections typically involve considerations such as:

Accommodating the decision-making capacity of potential participants

Requiring parental permission from parent(s)/guardian(s) for children Considering whether incentives and environment present an undue influenceExamples:$100 compensation for study participation may lead lower SES individuals to be compelled (out of desperation) to participate despite their discomfort and/or unwillingness to otherwise do so. Employees may feel compelled to participate if their supervisor requests that they do.

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Consent for different Levels of Review

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Full Board & Expedited Review

Consent forms must be approved by reviewer.

Use of a Villanova template is required.

Any changes must be reviewed and approved.

Must be date stamped by ORP.

Exempt Review

Approval of consent forms is not required by regulations, but is best practice and is done at Villanova.

Consent forms do not need to be stamped by ORP.

Exception:

Exemptions 7&8 require broad consent which must be approved by the IRB and stamped.

Consent templates can be found on the

IRB website.

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WAIVERS

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Waivers of Consent

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Sometimes researchers need to omit or provide very limited information about what will happen during a research study in order to remove the possibility of compromising their data.

Sometimes a full consent process is impractical and removing some burden may be in the participants’ best interest.

If informed consent is important and required, are any variations allowed?

Yes!

Waivers and alterations are allowable under specified circumstances.

Waivers and alterations must be:

Justified (by the PI)

Approved (by the IRB)

Documented (by both the PI & the IRB)

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Criteria for waivers

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Criteria for Waivers

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deception & Incomplete disclosure

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Deception and incomplete disclosure of information may be necessary to avoid response bias. Both may require a waiver or alteration of consent depending on what information is withheld.

Outright deception (giving false information) may be justified to investigate a phenomenon that might not present realistically if participants are informed.

Ex

: Subjects may be told a study is about visual perception, when it is about susceptibility to peer pressure from confederates

Sometimes researchers may not tell participants the whole story about what they will be lookin

g for in a study, but they do not deliberately mislead them.

Ex: Subjects are told about the general purpose of a study but not with enough detail to reveal the specific objective or hypotheses.

Deception

Incomplete Disclosure

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Deception

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If researchers intend to deceive participants about the nature or purposes of their research,

and

They want to use exemption category 3 (benign behavioral interventions):

Informed consent documents must include notice of the deception.

Participants must prospectively authorize this deception or the research cannot be exempt under this category.

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Waivers of documentation of consent

Researchers can avoid documenting consent (i.e. not capturing a signature)

only when one of the three scenarios below apply and the waiver is approved by the IRB:

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Summary of waivers

(in practice)

No consent or altered consent template with missing required elements;

Ex:

Secondary analysis of existing data (but not if broad consent was initially requested and denied)

Deception

Consent, but no written signature;

Ex:

Minimal risk online research with “I agree/I disagree” checkbox instead of signature

Sensitive data where breech of confidentiality could be dangerous



domestic abuse, illegal immigration

Waiver or Alteration of Consent

Waiver of Documentation of Consent

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Other Resources

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Consent form and assent templates are available on the IRB website IRB required CITI training is an excellent reference source to review regulations and ethical best practices.

Social/Behavioral Basic Course

Responsible Conduct of Research Course

IRB members and ORP staff are always available to answer questions, provide consultation, and review consent scenarios with research staff.

What Other Resources are available?40

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References

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HHS OHRP website:

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html

CITI Program

https://www.citiprogram.org/