CITI informed consent

2 parts of informed consent process

Informed consent: - provides information to subjects that recognizes their autonomy and allows them to weigh benefits vs. risk of participation, AND - documents the process of informed consent, records the subject's or subject's LAR's agreement to participation

Determine when waivers are appropriate.

--minimal risk--impracticable w/o compromising study--waiver won't adversely impact participants' welfare--debriefing--primary risk is confidentiality breach and consent form is the only identifying information

limits of confidentiality

-breaches in data--mandatory reporting

Identify methods for ensuring comprehension of consent.

-ensuring free choice by giving subjects the ability to choose away from influencing figures (such as parents, coaches, employers, etc) with adequate time and info to choose; compensation should also not be so large as to be coercive--accessible language--

Basic elements of information provided for informed consent

-explanation of research and commitment required --potential risks/discomfort--potential benefits--disclosure of alternatives--confidentiality disclosures--compensation for potential injury--contact for questions--statement that participation is voluntary and at will, with no consequences for withdrawl--info on potential future usage of data

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

A waiver of the requirement for documentation of informed consent may be granted when:

Provide potential subjects with information at the appropriate reading comprehension level.

As part of the consent process, the federal regulations require researchers to:

Legally Authorized Representative (LAR)

an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, LAR means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research (Protection of Human Subjects 2018).

Distinguish between consent as a process and the documentation of consent.

documentation = signature OR oral agreement w/ an impartial witness

Broad consent

prospective consent for unspecified future research using identifiable private information or identifiable biospecimens.

Vulnerable

subjects in research studies vulnerable to the possibility of coercion or undue influence.

Key information

the concise and focused information presented at the beginning of a consent discussion that is most likely to assist an individual in understanding the reasons why or why not to participate in the study.

discussion of compensation in ads

-should not be misleading -- considers vulnerability (including economic) of participants--font size/bolding can't be used to emphasize payment

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

Distinguish between consent as a process and the documentation of consent. Recognize the elements of consent. Determine when waivers are appropriate. Identify methods for ensuring comprehension of consent.

Learning goals