Summer 2018
Update - Common Rule Change Will Go Into Effect January 2019
On Monday, June 18, 2018, we received notice from our regulators that DHHS along with other departments and agencies issued a to delay for an additional six months the general compliance date for changes recently made to the Common Rule. The implementation of the final revisions to the Common Rule are pushed back to January 21, 2019.
We will be required to continue to comply with the requirements of the pre-2018 version of the Common Rule. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 – January 20, 2019). The only burden-reducing provision that we would be interested in rolling out would be the removal of the requirement for expedited continuing review protocols. As planned previously, we would still require an annual update in lieu of a continuing review submission.
̽̽ will not be taking advantage of the burden-reducing provisions for this six-month period as implementation would require that we develop a separate tracking mechanism that allows identification of which protocols which fall under the New Rule versus the Old Rule for that six-month period.
We will plan to move forward with the Final Rule in its entirety in January 2019. As time nears, we will communicate procedures.
New Legislation
GDPR went into effect on May 25, 2018 and regulates the use, access, collection, and processing of all personal data from the European Economic Area (EEA). Sets of data to which GDPR applies is broader than that covered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). It applies to all personal data across all sectors of the economy, not only health care. There is no concept of a covered entity.
This will apply to US research in some instances. The Committee is working with the hospital on development of draft guidance. If you receive a question regarding GDPR, please contact our office for guidance.
On May 29, 2018 the federal Right-to-Try Act was signed. This law creates a pathway for terminal patients to access investigational drugs outside a clinical trial without FDA approval and without IRB review. This new law is currently under review by each institution. We will release guidance when that review is complete.
Template – Consent Form Injury Language Change
It was noted by ̽̽MC Billing Compliance that there was a slight contradiction in the language that needed to be addressed. The first paragraph states that “there will be no cost to you if the conditions listed below apply.” However, if those three conditions do not apply, we state that insurance may be billed. If insurance is billed, a copay may be required which would be considered a cost to the subject.
The tracked changes are below and are now included on our template for reference. This change in language applies to only new protocols going forward.
"What Happens If You Are Injured?
If you are injured or become ill as a result of being in this research, The ̽̽ Medical Center, the hospital partner of ̽̽, will provide reasonable and usual medical care for that injury or illness. There will be no cost to you if the conditions listed below apply to your injury or illness. These conditions are:
- The investigator determines that your injury or illness results from the research and not from your underlying condition or its usual treatment.
- You let the investigator know about the injury or illness when you first notice it; and
- You follow medical advice about proper treatment options for the injury or illness.
If the above conditions are not met, the ̽̽ Medical Center may claim payments for your medical treatment from the study sponsor or your insurance company when these payments are allowed. If we bill your insurance for this care, you will be responsible for any associated co-payments or deductibles.”
Policy/Procedure – Revisions
Recruitment Procedures
We have updated section 8.1.1. Elements Found in a Standard Protocol (opens in a new window), Plans for Recruitment/Screening/Retention. We have clarified the ways in which subjects can be approached in a respectful manner.
Pregnancy Consent
̽̽ IRB has posted under the Consent and HIPAA guidance section a new pregnant partner consent and authorization form (opens in a new window). Sponsors are sometimes interested in male research subject’s partners who become pregnant while the male subject is involved in a research study using an investigational drug. When a sponsor requests the use of or submits a pregnant partner consent form, please check the content against this new template to ensure that the required elements are included in the provided form. If there is no model consent form provided, you may use the one the IRB has developed.
Policy Update – Protocol Submission RPO Pre-Review Process
The Committees have been increasingly finding that protocol submissions are lacking sufficient information to conduct an adequate review and make the determinations required by regulations for IRB approval. In the case of a full review, this often leads to tabling the protocol, which requires the protocol and the PI’s response to subsequently come before another fully convened meeting. For expedited reviews, the Committee members are spending too much time teasing out what is missing from the submission.
In an effort to better use Committee resources, as of July 2018, all protocols will undergo a formal IRB Analyst pre-review. RPO Research Analysts are very adept at conducting pre-reviews of the protocol submission to determine whether the submission for IRB review is complete. If the Analyst finds that the submission is incomplete or lacks information necessary for a member to conduct a full or expedited review, they will withdraw the protocol submission from further review. The PI will be notified along with a list of requirements for a proper submission. Once an acceptable response is received, the review will continue. If the protocol requires full review, it will be placed on the next available agenda. This is similar to what granting agencies, such as NIH, do prior to accepting an application and moving it to the grant reviewer.
It is hoped that the pre-review process will speed up your approvals. Addressing issues prior to the meeting will allow board members to focus on substantive issues during the board meeting, rather than missing forms and contradictions within the submission. As such, there should be fewer revisions needed after a meeting since the majority of those will have been handled prior to the meeting.
Please reference our IRB Forms (opens in a new window) to obtain information about appropriate form submissions. Additionally, you should contact your IRB Research Analyst (opens in a new window) for assistance.