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Research News from the IRB
May 2, 2019   •  View Online

This monthly newsletter is brought to you by the Institutional Review Board and is intended to provide important updates and information that may affect members of the research community. For previous editions of the newsletter and other communications, click here.

HRPP News

Recruiting non-English Speaking Participants: New Requirement for Short Form Method of Consent

As a result of these efforts, the HRPP has changed the requirements for certain types of research that use the short form method of consent. These changes will go into effect on July 1, 2019:

  • For studies that are greater than minimal risk and participation in the study is planned to last 30 days or more, the researcher must obtain a certified translation of the study’s full, IRB approved consent document (long form) within 30 days of the initial consent via the short form method.
  • After IRB approval for a modification, the researcher must provide a copy of the translated long form to the participant and/or legally authorized representative. The IRB may require, in some circumstances, that the researcher, with an interpreter, reconsent the participant using the translated long form.
  • The researcher must also obtain documentation of consent for optional study participation, using the translated long form or by providing a plan for documenting optional study consent to the IRB for review and approval.
  • The translated long form should be used for all other non-English speakers of that language going forward and the short form method for that particular language should no longer be used.

New Cost Language Included in the Consent Template

A work group was convened to discuss the participation cost language in the consent template, and institution-wide expectations for research participation cost coverage when a research participant is billed for research related activities that will not be covered by the study, sponsor, or insurance. The group recommended an immediate change to cost language in the consent template in an effort to provide greater clarity to potential participants about the costs of research participation. This language was shared with the HRPP Advisory Committee in April and is part of the Toolkit release. Other recommendations by this workgroup, including the identification of a resource for participants in navigating insurance companies, is being reviewed by the institution. 

IRB News

Toolkit Updates

Documents in the HRPP Toolkit Library are changed periodically in response to feedback from the community, changes in best practices for human research protections, and institutional, local, or federal regulatory changes. To view all requests and decisions, access the archive of Monthly Toolkit Meeting Summaries.

See Toolkit Changes for greater detail on the changes released in March:

  • Updated Investigator Manual (HRP-103) to include information about research involving students, non-English speakers, fetal tissue, potentially hazardous agents, and human gene transfer. Guidance regarding re-consent was also added.
  • Revised Protocol Templates (HRP-580 and HRP-590) to include additional instructions for research involving non-English speaking participants.
  • Revised IRB Standard Operating Procedures (HRP-090, HRP-091) to include requirement to translate the study consent if the short form method of consent is used in greater than minimal risk research where participation will last longer than 30 days after initial consent.
  • Updated the Consent Templates (HRP-582, HRP-592) to replace the language and instructions for the cost section and updated the witness signature block.

Research Community Feedback

IRB leadership review responses received from the Research Community Survey on a monthly basis to determine if changes or improvements are needed. Many changes have been made in response to survey feedback that may or may not be visible to the research community. To foster transparency, responses and actions taken will be included in this and future newsletters. 

Feedback Received:
"I don't like the new translator requirement. It seems inappropriate for bilingual teams like ours that are seasoned in working in our language context. It would be great if teams can register a member that can vouch for the integrity of translations, and we can just reference this member in the IRB protocol, instead of submitting a separate document." 

IRB Response:
The HRPP recognizes that it may be advantageous to the study team and the research participants to allow a study team member who is fluent in a language other than English to translate study documents. In June 2018, the HRPP updated the Investigator Manual (HRP-103) to instruct researchers that will not use a commercial vendor to provide a letter from the translator that includes information about their expertise as it relates to the study topic, and fluency and experience with the given language. The HRPP also released a Certificate Attestation (HRP-574) template to help with this letter requirement.

IRB Submission Tips

When Do I Use the Determination Form?

Do not use the Determination Form to get an exempt determination from the IRB. This form is only meant for projects that may not meet the definition of human research. The Investigator Manual outlines under “What if I’m not sure my project requires IRB Review?” some of the activities that are likely not to be human research. However, even these activities could fall under the definition of human subjects research based on unique characteristics of the project. To get a determination from the IRB about whether your project constitutes human research, complete and submit the Determination Form (HRP-503) in ETHOS. An IRB analyst will evaluate your submission based on the criteria listed in the Human Research Determination (HRP-310) worksheet. If the project is human research, the IRB Analyst will provide instructions on next steps.  

Educational Opportunities

The following are upcoming educational opportunities. See the Events page for additional opportunities.

Research Involving Non-English Speakers

May 24, 2019 12 – 1:30 p.m., Moos Tower 1-450

Courtney Jarboe, HRPP assistant director, education and outreach, will review best practices for the involvement of non-English speakers in research. This session will also highlight new requirements that will go into effect on July 1, 2019. Register

Vulnerable Populations: Principles and Practice

May 24, 2019 12 – 1:30 p.m., Moos Tower 1-450

Debra DeBruin, Ph.D., interim director of the Center for Bioethics, and Michelle Biros, MD, vulnerable populations advisor for the IRB, will address vulnerability in principle and practice. This session will discuss what it means to be vulnerable in research and will apply this understanding to case studies to highlight ethical considerations for the conduct and development of a research protocol. Register

Five-Day Boot Camp for Clinical Research Coordinators

June 24 – 28, 2019

The ACRP CRC Boot Camp provides over 50 hours of foundational knowledge specific to the role of the clinical research coordinator (CRC). Facilitated by ACRP professionals, this intensive five-day program allows CRCs to practice what they learn and afternoon activities are structured around typical, real-life scenarios faced by CRCs. To apply for the ACRP Boot Camp, you must complete this application form by end of day, May 10. Read the announcement.

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