CIP Course for Advanced Learners – Research with Vulnerable Populations and Consent Topics

This course provides advanced learners a topic-focused course on subject population and informed consent topics as well as 9 CE hours for CIP recertification.

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About this Course

The course is intended for currently Certified IRB Professionals (CIPs) seeking CIP continuing education (CE) credits for recertification. These modules were approved by the Council for Certification of IRB Professionals (CCIP) as advanced-level and eligible for CIP CE credits.

This course includes a topic-focused selection of CIP approved modules for recertification by education.

Learners can self-direct their training by choosing which and how many modules to complete in order to earn CIP CE credits.

Note: These modules (or a selection of them) may be part of an organization’s subscription.  If you are affiliated with a subscribing organization, it is recommended that you review the modules you may have access to via that subscription before purchasing this course.

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Language Availability: English

Suggested Audiences: Certified IRB Professionals (CIPs)

Independent Learner Price: $99 per person

Demo Instructions

Course Content

Consent and Biobanks and Associated Databases

Describes different consent approaches used for biobanks and associated databases, with reference to pertinent legal and ethical documents and regulatory requirements. Additionally, learners will review examples of key consent clauses (for example, linkage, return of research results and incidental findings, storage for future use, and access by researchers). Reviews the diversity, nature, and characteristics of biobanks and associated databases.

Recommended Use: Elective
ID (Language): 17254 (English)
Author(s): Bartha Maria Knoppers, PhD - McGill University; Ma’n H. Zawati, LLM - McGill University

Consent and Cultural Competence

Focuses on cultural competence, as it applies to developing consent processes, obtaining consent, and evaluating the appropriateness of the consent processes. Describes strategies for enhancing understanding of research among diverse populations and communities during the consent process.

Recommended Use: Elective
ID (Language): 17263 (English)
Author(s): Renee Holt, RN, JD, MPH - PATH; Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group

Informed Consent and Incidental Findings in Research with Human Subjects

Defines incidental findings (IFs) in human subjects research and covers how IFs should be managed in the informed consent process. Provides an overview of Institutional Review Board (IRB) and researcher responsibilities, as well as strategies for managing IFs in the consent process, including review of the research plan, IF management plan, and consent form language.

Recommended Use: Elective
ID (Language): 17342 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Consent and Subject Recruitment Challenges: Remuneration

Explores remuneration in research, regulatory requirements regarding remuneration to research subjects, how to distinguish between remuneration and reimbursement, and strategies to reduce the potential for undue influence. Also identifies ways of disclosing remuneration plans in consent and advertising materials.

Recommended Use: Elective
ID (Language): 16881 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra

Consent and Subject Recruitment Challenges: Therapeutic Misconception

Describes therapeutic misconception and identifies potential strategies researchers and institutional review board (IRB) members can use for reducing therapeutic misconception in the consent process. Identifies groups of people at risk for therapeutic misconception and their vulnerabilities. Also discussed are the related phenomena of therapeutic misestimation and therapeutic optimism.

Recommended Use: Elective
ID (Language): 17259 (English)
Author(s): Moore Rhys, CIP - Children's Hospital Los Angeles

Consent in the 21st Century

Explores how technology has impacted the informed consent process in the 21st Century, especially electronic informed consent (eIC). It covers technology and tools used in the recruitment and consent process, describes alternatives to paper-based informed consent forms, and explores confidentiality issues. It also reviews federal guidance concerning multimedia tools and eIC.

Recommended Use: Elective
ID (Language): 17060 (English)
Author(s): Jennifer Kucera, MS, CIP - University of Nebraska Medical Center; Sue Logsdon, MS, CIP - University of Nebraska Medical Center

Consent Tools Used by Researchers

Provides an overview of the potential barriers to informed consent and discusses strategies and tools that may be used to enhance and ensure research subjects’ understanding of study information, including subject capacity assessments, the teach-back approach, tools for child assent, use of framing and graphics, and video and multimedia presentations. Discusses ways to present research information to subjects in several simple, practical, and inexpensive ways.

Recommended Use: Elective
ID (Language): 16944 (English)
Author(s): Alan R. Tait, PhD - University of Michigan Health System

Consent with Subjects Who Do Not Speak English

Focuses on the role that language plays in developing consent processes and obtaining consent in study populations that do not speak English. It identifies challenges and strategies that researchers can use in the consent process when they are not fluent in the potential subject’s language, including the role of interpreters and the use of translations in obtaining consent and during the conduct of the study, and short form consent. It concludes with a discussion of the federal regulations and guidance covering recruitment and consent for subjects who do not speak English with particular attention to the role of the IRB and the responsibilities of researchers.

Recommended Use: Elective
ID (Language): 17260 (English)
Author(s): Gary L. Chadwick, PharmD, MPH, CIP - University of Rochester / HRP Consulting Group; Lisa Morris, MSTD - University of Massachusetts Medical School

Gender and Sexuality Diversity (GSD) in Human Research

Provides a starting point to develop cultural competency for human subject researchers and research team members, who will come in contact with subjects or prospective subjects of a variety of sexuality and/or gender identities. It is also meant to be a resource for institutional review board (IRB) members and administrative staff. It begins with a short overview of the constituent parts of the GSD community from a broad perspective, continues with a summary of the legal and social/cultural vulnerabilities faced by members of these groups and describes research considerations for members of these communities, and concludes with a discussion on what IRBs and researchers should do with respect to these populations.

Recommended Use: Elective
ID (Language): 16556 (English)
Author(s): M. Isabel Fernandez, PhD - Nova Southeastern University; Moore Rhys, CIP - University of California, Los Angeles; Jaime A. Arango, EdD, CIP - CITI Program

Illegal Activities or Undocumented Status in Human Research

Provides training and insight to researchers, administrators, and institutional review boards (IRBs) regarding added risks and challenges of conducting research with individuals who are engaged in illegal activities or who have undocumented status. Presents examples of vulnerable groups and identifies ethical considerations when including them in research. Also describes research design issues, recruitment methods, informed consent issues, and additional safeguards specific to research with groups of individuals involved in illegal activities or who have undocumented status.

Recommended Use: Elective
ID (Language): 16656 (English)
Author(s): Rebecca Dahl, RN, PhD - Children's Hospital Los Angeles; George Gasparis, CIP - The PEER Consulting Group

Research Involving Subjects at the End-of-Life

Persons at the end of life may be vulnerable for numerous reasons, including cognitive and physical impairments, which may progress as death approaches. It describes the ethical challenges of research with subjects at the end of life, including voluntariness and withdrawal from research. It also explains how cognitive impairment may impact vulnerability in end of life research and identifies strategies to overcome this challenge. Barriers to subject recruitment and special challenges for researchers and institutional review boards (IRBs) in assessing risk of harm and potential benefits in end of life research are also examined.

Recommended Use: Elective
ID (Language): 16658 (English)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center

Research with Critically Ill Subjects

Discusses ethical considerations and additional safeguards for critically ill subjects participating in research. Describes the reasons why critically ill persons may be considered "vulnerable" and how this vulnerability arises, why informed consent may be difficult to obtain in this vulnerable population, and ethical implications, the benefits, and the limitations of obtaining proxy consent. Identifies additional safeguards for protecting critically ill subjects participating in research.

Recommended Use: Elective
ID (Language): 16592 (English)
Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center

Research with Decisionally Impaired Subjects

Provides an overview of the nature and sources of decisional impairment. Discusses the obligations imposed on institutional review boards (IRBs) and researchers to ensure that appropriate protections are in place when research involves adult subjects who are or may be decisionally impaired and may have impaired consent capacity. Reviews additional safeguards, discusses assessment of consent capacity, and defines who can provide consent on behalf of an adult subject who lacks consent capacity.

Recommended Use: Elective
ID (Language): 16610 (English)
Author(s): Susan J. Delano, CIP - Research Foundation for Mental Hygiene, Inc.; Jeremy Block, PhD, MPP - Icahn School of Medicine at Mount Sinai

Research with Older Adults

Provides education and training regarding the conduct of research with older adults. It discusses information for both researchers and IRBs in order to begin the process of addressing underrepresentation of older adults in research, while at the same time providing critical information to consider when conducting research with this group. It also covers the demographic and social issues concerning the exclusion of older adults in research, barriers to inclusion, and research design considerations to enhance inclusion and protect this potentially vulnerable population.

Recommended Use: Elective
ID (Language): 16502 (English)
Author(s): Moira A. Keane, MA, CIP
 - Human Research Protections Consultant

Research with Persons who are Socially or Economically Disadvantaged

Discusses subject’s social and economic disadvantage as a potential vulnerability in research. Describes barriers to participation, the ethical and regulatory mandates for the inclusion of these populations in research, as well as the additional protections that may be used to minimize risk. It also explains considerations for IRBs and researchers when planning, reviewing, or conducting research with socially or economically disadvantaged persons.

Recommended Use: Elective
ID (Language): 16539 (English)
Author(s): Moira A. Keane, MA, CIP
 - Human Research Protections Consultant

Research with Subjects with Physical Disabilities & Impairments

Provides an overview of physical disabilities and impairments, and the obligations imposed on IRBs and researchers to ensure that appropriate research protections are in place when research involves subjects who are physically disabled and may require additional tailored protections. Additional barriers, vulnerabilities, and challenges that individuals with physical disabilities face when participating in research are identified. It also discusses safeguards and additional protections that IRBs and researchers can implement to protect this potentially vulnerable population, as well as ways to make research studies more accessible to individuals with physical disabilities.

Recommended Use: Elective
ID (Language): 16657 (English)
Author(s): Jeremy Block, PhD, MPP - Icahn School of Medicine at Mount Sinai Baruch College, City University of New York

Students in Research

This module addresses students as researchers and when students are involved in research as participants. It reviews the history and status of key research regulations, the Institutional Review Board (IRB) review process, and general best practices when conducting human subjects research. It provides best practices in creating an accurate, robust submission for IRB review and conducting responsible, ethical research.

Recommended Use: Elective
ID (Language): 1321 (English) , 1671 (Spanish)
Author(s): Andrea Rossing McDowell, MS, MA, PhD - Seattle University

Vulnerable Subjects - Research Involving Workers/Employees

Describes why workers/employees may be a vulnerable population when they participate in research, and the potential risks and benefits associated with research involving workers/employees. It also discusses protections that need to be afforded to workers/employees. It proposes that while workers/employess may serve as study subjects for political as well as scientific reasons, adequacy of the science and adherence to the Common Rule (45 CFR 46, Subpart A), are paramount.

Excerpted from: The Department of Energy Guidebook Creating an Ethical Framework for Studies that Involve the Worker Community and "Workers as Research Subjects: A Vulnerable Population", Susan L. Rose, PhD and Charles E. Pietri, BA from J. Occup Environ Med. 2002;44:801-805. Used with permission.

Recommended Use: Elective
ID (Language): 483 (English), 1720 (Spanish), 15944 (Korean)
Author(s): Susan L. Rose - University of Southern California (retired); Charles E. Pietri - Department of Energy


Who is eligible for earning CIP CE credits?

Certified IRB Professionals (CIPs) may earn CIP CE credits by completing eligible modules.

Which modules are eligible for CIP CE credits?

See CITI Program Advanced-Level Modules Eligible for CIP Continuing Education Credits for a complete list of CIP CE certified modules.

Are all modules in this course eligible for CIP CE credits?


How many CIP CE credits are available by completing this course?

Each successfully completed CITI Program advanced-level module represents half a CIP CE credit (0.5 credit). For example, a learner that completes 8 modules qualifies for 4 CIP CE credits.

What is the passing score requirement for CIP CE credits?

A minimum quiz score of 70% is required for each module.

How can learners document their CIP CE credits?

Learners who wish to apply the credits from approved modules toward their CIP recertification may submit their CITI Program Completion Report as documentation of their participation (the transcript page will have a record of each module and date completed). Completion Reports identify the learner’s name, and the module titles, IDs, completion dates, and quiz scores.

Where can learners find additional information about CIP recertification?

See CIP Recertification on PRIM&R’s website for additional information about CIP recertification.

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