Delay of Revised Common Rule and Revised UConn Health IRB Policies
Implementation of the revised version of the Federal regulation governing federally funded/supported research (i.e. 45 CFR 46, also known as the Common Rule) has been delayed until July 19, 2018. In spite of this delay, the UConn Health IRB has moved forward with implementing several changes that aim to reduce regulatory burden on investigators while still offering protection to research participants, complying with current regulatory requirements and being prepared to comply with the revised requirements.
Several IRB forms, templates and policies have been revised. Understanding the reasons for these changes, what has been changed and to what type of research these changes apply may aid investigators in complying with IRB polices as well as with federal regulations.
The following table lists the UConn Health IRB polices that have been changed, a description of the change and the IRB forms that have been modified due to the policy revisions.
|Name of the Revised Policy||Description of the Policy Change||IRB Forms changed due to this Policy Revision|
|2011-008.0 -Informed Consent – Forms||This policy has been revised to include the additional elements of consent put forth in the revised version of 45 CFR 46.
These elements, while currently optional, will become required for Federal Funded /Supported (FFS) research only if the proposed revised regulation is implemented. If implemented these elements will be required for FFS research initially approved after the effective date of the regulation or for FFS research approved prior to the effective date of the revised rule that is still enrolling subjects and that is being transitioned to review under the revised rule.
While the applicable regulatory criteria for consent will be used as the general premise for all consent forms, when the research is not federally funded or supported, nor subject to FDA oversight, the IRB may exercise judgement when determining if the elements of consent have been appropriately addressed.
New elements of consent:
* The prospective subject or the LAR will be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and will be given an opportunity to discuss that information.
* The ICF must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
* Informed consent as a whole presents information in sufficient detail relating to the research, and is be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or LAR’s understanding of the reasons why one might or might not want to participate.
*One of the following statements if the research involves the collection of identifiable private information (IPI) or identifiable biospecimens (IB)
(i) A statement that identifiers might be removed from the IPI or IB and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility; OR
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
* A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
* A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
* For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
|Policy 2011-008.1 – Informed Consent – Process||This policy has been changed so that the IRB may approve a non-federally funded or supported research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruitment or determining the eligibility of prospective subjects without the informed consent of the prospective subject (and without the need for waivers or alterations), if either of the following conditions is met:
· The investigator will obtain information related to screening, recruiting or determining eligibility through oral or written communication with the prospective subject.
· The investigator will obtain identifiable private information or identifiable biospecimens for the purpose of screening, recruiting or determining eligibility by accessing records or stored identifiable biospecimens.
* In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records /specimens will be reviewed.
* The investigator may delegate the review to designated UConn Health research staff.
* Appropriate measures must be in place to protect the confidentiality of the data being utilized.
If the revised regulation is implemented in July this provision will be extended to federally funded/supported research.
Electronic Informed Consent (eIC) Process
The investigator should give to the IRB access to the e-consent platform to review the usability of the eIC materials to ensure that they are easy to navigate and that the user may navigate forward or backward within the system, or stop and complete the process at a later time. The investigator must also ensure there is a mechanism in place whereby subjects may ask and obtain answers to questions.
When eIC is proposes subjects must still be provided the option of the consent process occurring in person using a paper based consent form.
|Text in the IRB application in the section regarding confidentiality has been revised to make it clear that the provisions for protecting the confidentiality of the data as described in the IRB application extend data collected during screening.
|Policy 2011-008.2 – Informed Consent – Waivers and Alterations||This policy has been changed to incorporate the new requirement for a waiver or alteration of consent. Per the new requirement, if the research involves using identifiable private information (IPI) or identifiable biospecimens (IB), the investigator must explain why the research could not practicably be carried out without using such IPI or IB. This element is now applicable to all research requesting a waiver or alteration.
This policy also now includes new option to grant a waiver of documentation of consent for non-federally funded or supported research. This new option may apply when the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and there is an appropriate alternative mechanism for documenting that informed consent was obtained. The IRB will evaluate alternative mechanisms on a case-by-case basis based on information put forth by the PI. If the revised regulation is implemented in July this provision will extend to federally funded / supported non-exempt.
|Request for Full or Partial Waiver Informed Consent
|Policy 2011-008.5 – Informed Consent – Providing and Obtaining Informed Consent
|This policy has been modified to allow obtaining consent from a “next of kin” for adults who are not mentally retarded.
If the potential participant does not have an appointed legally authorized representative (e.g., individuals designated as having power of attorney for health care, individuals designated as health care representatives) next-of-kin for adults who are not mentally retarded can consent on behalf of a prospective subject as defined in institutional policy 2012-05 titled Legal Representative for Health Care Decisions.
|Policy 2011-023.0 – Educational Requirements.||This policy has been changed so that human subjects protection training for all research (exempt, expedited, full board or facilitated review), will be verified for all study personnel at the time of initial approval and on an individual basis at the time a request for modification is received to add a person to the study. In order for training to be considered current it must have been completed within the past three years.
|Policy 2011-009.3 –Institutional Review Board – Expedited Reviews||This policy has been changed so that continuing review may not be required for non-federally funded/supported, non-FDA regulated research.
When continuing review is not required, the approval period for an expedited study will be from the date of approval through the expected completion date of the project. If necessary the PI may submit an expedited request for modification to continue the study beyond that date.
Frequently Asked Questions Related to CITI Training, IRIS System and Facilitated Review
I completed my CITI human subject’s protection training recently. Should I submit my CITI Training Certificate to the IRB?
If an external investigator completed CITI training through another institution, s/he must submit proof of having completed human subject’s protection training to the IRB because the IRB does not get automatically notified of such completions.
If the investigator is affiliated with UConn Health, he/she does not need to submit a certificate of completion. The IRB staff receives the CITI Training certificates one day after individuals have completed the training. Designated IRB staff enter the course completion information into a master training list (Excel) posted in the IRB website and into IRIS. This master training list (Excel) is updated every two weeks. Therefore, investigator should check this list often. In order for the IRB to update the training records in the IRIS system investigators affiliated with UConn Health must have logged into IRIS at least once. Therefore, investigator who have never before log into IRIS should do so right after they have completed the CITI Training. To log into IRIS investigator should click on the following link: https://imedris.uchc.edu , enter their UConn Health network credentials in the ID and PW boxes found in the IRIS logging page, and click on Log in.
I am going to submit an application to UConn Health IRB for review and approval.
Do I need to request an account in IRIS?
Every individual who is affiliated with UConn Health can use the UConn Health ID and password to log into IRIS. Therefore, individuals affiliated with UConn Health (faculty, staff, students, residents, and fellows) do not need to request an account in IRIS.
On the other hand, individuals external to the UConn Health will need to request an account in IRIS. To do so the external investigator must complete the online request form accessible from the IRIS home page. Investigators must complete all the required fields on the form indicating why the account is necessary and with whom at UConn Health he/she will be working. The IRB designated staff may contact the person in UConn Health to confirm that the creation of this account is necessary. Accounts will be created within 1-2 business days.
I have completed an application for IRB review in IRIS. I do not see the sections that allow me to attach documents for review? What should I do?
Unfortunately, the IRIS system currently has a glitch that does not transition the application form to the submission package where you can attach documents. Follow the steps listed below when you get to the last section of the application for initial review and you see a sign stating: “Study Application Completion. You have completed the Study Application process. Click here to go to the …”
- click on the “Back Button” ( located in the upper right hand corner)
- Click on “Study Assistant” menu
- click on “My Studies” sub-menu,
- Open the study, and there you will find Section 1- Submission Packet to the Review Board.
- Click on “Save and Continue to the Next Section” to build the following sections of the forms that will allow you to attach documents.
I am affiliated with UCONN Health (e.g. faculty member, student, employee, or resident, fellow) and I will be part of a study conducted at another institution. That institution has reviewed and approved the study. Do I need approval from the UConn Health IRB?
Yes, if you are affiliated with UConn Health and you are acting in that capacity, your involvement in a research study engages UConn Health in the research and therefore the UConn Health IRB must be involved. However, as opposed to conducting a formal review the UConn Health IRB may elect to rely on the IRB of the other institution. To determine if the UConn Health IRB will do this you, you must submit an application for facilitated review to the UConn Health IRB. By submitting this application you will obtain an official determination from the UConn Health IRB as to whether oversight for the study will be deferred to the external IRB. In order for the UConn Health IRB to defer oversight a written agreement must exist between to the two institutions. This agreement is referred to as an IRB Reliance Agreement. Investigators may contact the IRB to determine if such an agreement is in place or needs to be established.