UConn Health’s Human Subjects Protection Program Receives Reaccreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
The Association for Accreditation of Human Research Protection Programs (AAHRPP) completed a site visit at UConn Health in April 2019. During this visit, IRB members and staff, investigators and study coordinators, and others involved with research oversight were interviewed, and study research records were reviewed. In June 2019, the AAHRPP Council on Accreditation awarded full reaccreditation to UConn Health’s Human Subjects Protection Program (HSPP), confirming that all standards for re-accreditation were fulfilled. This reaccreditation is for five additional years. The final report issued by AAHRPP commends the HSPP for demonstrating an unusually high degree of integration among the areas responsible for research oversight.
Documentation of Consent
Unless the requirement to document consent has been waived by the IRB, the IRB approved consent form must be signed and dated by the subject (or legally authorized representative) and the person obtaining consent.
Notes in a research chart that indicate on-going discussions with the subject at subsequent study visits may supplement documentation of the initial informed consent process.
The following are examples of issues found with documentation of consent during recent internal audits at UConn Health.
- The date of consent differs between the subject and the person obtaining consent.
- The date of consent is left blank by the subject and/or the person obtaining consent..
- The date of signature is incomplete or incorrect.
- The informed consent form is missing the signature of the person obtaining consent.
- The person obtaining consent enters the date of the subject’s signature.
- Consent for participation obtained from legally authorized representatives when the study approval requires the subject to provide consent.
- Consent was obtained by people not approved as consenters by the IRB.
- Subjects consented with expired consent documents.
- Consent forms containing a correction to the signature and/or date which obscured the original entry.
To ensure consent is appropriately documented the following points should be considered:
- The principal investigator and study team members should use the most recently approved stamped and dated consent form when obtaining consent.
- Subjects should sign the consent form in the presence of, and at the same time as, the consenter.
- Persons obtaining informed consent should review the forms once they are signed/completed and before the subject leaves that day, to ensure that all signatures and dates are properly entered on the forms.
- In the event that a form is found to be incomplete (e.g., a date is missing) if the error is not discovered while the subject is present, the research staff should prepare a note to file attesting to the fact that they witnessed the signing of the form, and the date that it was signed. The original consent form must be retained, and the subject should make the corrections at the earliest opportunity.
- Any problem with documentation of informed consent should be reported to the IRB using a problem report form within five days of becoming aware of the non-compliance.
- Approved consenters should review HSPP Policy 2011-008.1.pdf – Informed Consent – Process and Policy 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent
Guidance for Posting Clinical Trial Consent Forms
Last January 2019, the revised version of 45 CFR 46, the federal regulation for the protection of human subjects in research, which is also known as the Common Rule, went into effect. One of the revisions requires that for any clinical trial conducted or supported by a Common Rule department or agency, one IRB-approved consent form that was used to enroll subjects be posted on a publicly available federal website within a specific time frame. UConn Health IRB has posted a Guidance for Posting Clinical Trial Consent Forms to help the research community to fulfill this obligation.
IRB Forms – Update
Investigators should always use the latest version of the IRB forms posted in the IRB website. Listed below, are the forms revised during the past three months. Within the parenthesis is the date when forms were revised.
- Instructions for Requesting Reliance Upon Advarra IRB.docx (4/24/2019 – template consent language updated per Advarra requirement)
- Confirmation of Resources for Inpatient Stays.docx (4/25/2019 – added comment section in sign-off area)
- Request for Full or Partial Waiver Informed Consent.doc (4/25/2019 – added note that approval of waiver not applicable to information/samples if original consent stated there would be no future use of information/samples)
- Application Appendix A.doc (CRC Resource Request) (5/21/2019 by CRC)
- Application Checklist for Initial and Continuing Review Full Board.docx (6/25/2019 – changed pharmacy contact)
- Application Checklist for Initial Exempt Application .doc(5/1/2019 – removed CICATS references)
- Application Checklist for Initial and Continuing Review Expedited .doc (6/25/2019 – changed pharmacy contact)
- Application Checklist to Request Facilitated Review for Industry or Cooperative Group Sponsored Study, or study utilizing the SMART IRB Initiative.docx (6/25/2019 – changed pharmacy contact)
- Main Consent Form Template .doc (6/12/2019 – changed reference Health One to EPIC, added reminder about mobile device security, rather than instructional text/samples about when FDA/DHHS/Sponsor can inspect records changed to “as may be applicable” and reference all three.)
- HIPAA Authorization to Use and Disclose.doc (6/28/2019 – deleted instructional text at top of form)
- HIPAA Authorization to Use and Disclose – Spanish.doc 6/28/2019 )
Personnel Changes to the Scientific Review Committee
Dr. Doug Peterson who has served as the Chair of the Scientific Review Committee (SRC) for over a decade has stepped down as Chair. Dr. Julie Wagner is now the SRC Chair and Dr. Peterson will continue to serve on the SRC as a member until November 1.
The following three faculty members have been appointed to serve on the SRC.
- Dr. Efthimia Ioannidou, Professor/Clinical, Periodontology
- Dr. Ivo Kalajzic, Professor/Basic Science, Center for Regenerative Medicine
- Dr. Tannin Schmidt, Associate Professor/Basic Science, BioMedical Engineering
In Memoriam – Pamela Engelson Colwell
Our dear friend and colleague, Pamela E. Colwell (Pam) passed away on Wednesday, June 26, 2019. Pam worked for the IRB for the last 15 years as a Regulatory Specialist and IRB member. Pam was an amazing team member, taught multiple IRB members, and played a pivotal role in the implementation of the iRIS submission system. Please refer to the following link for information regarding services and memorial donations. http://northhavenfuneral.com/obituary/pamela-engelson-colwell/