IRB Bulletin:  Delay in Changing IRB Regulations

On January 17, 2018, the federal HHS Office for Human Research Protections (OHRP) announced a six-month delay in implementation of the revised IRB regulations.  January 21, 2019 was the new effective date and general compliance date.

On June 19, 2018, the implementation of the new rules was delayed until January 21, 2019.

The information in prior IRB Bulletins remains accurate, and the effective dates have been updated. 

For now, it is strongly suggested that the changes to informed consent described in IRB Bulletin 2 below be made in all future applications.  These do not conflict with the current regulations.

Please contact the IRB Chair, Dr. Jerry Hauselt (hauseltw1@southernct.edu) with any questions.  

IRB Bulletin 1: Important Changes to the Regulations Governing Human Subject Research

The federal regulations governing human subject research are changing effective January 21, 2019. 

There are some important new requirements that all researchers who work with human participants need to be aware of and implement in IRB applications submitted AFTER January 21, 2019. To facilitate the implantation of these rules, a series of emails will be sent to the entire campus. This series of IRB Bulletins will describe the changes that we will have to make to remain in compliance. It is expected that additional changes will be made after the January 21, 2019 date as more information and guidance on the regulations are released by the federal HHS Office for Human Research Protections (OHRP). Some of the changes, such as those relating to informed consent, can be implemented immediately by researchers should they so choose. All IRB Bulletins will be archived on the IRB website for future reference. Each IRB Bulletin will include a description of the change and a discussion of the impact of the change at Southern Connecticut State University as seen by the IRB Chair as of the date of the bulletin. Please note that the discussion will likely change as more information and guidance is issued by the OHRP.

REGULATION: All research reviewed by the IRB must conform to the new rules starting January 21, 2019.
DISCUSSION: The new rule, as it is called, will require adjustment for both researchers and the IRB, and being prepared and educated will make the transition as smooth as it can be. As we go forward, please note:

1. There will be changes to the IRB application to reflect what will need to be done, so researchers should download the application from the IRB website rather than rely on previously downloaded applications when new submissions are created.
2. The new rules apply ONLY to research submitted  AFTER January 21, 2019. All research reviewed and approved BEFORE January 21, 2019 does not need to be "updated" next year to conform to the new regulations, though it may be at the discretion of the IRB. This will be down on a case-by-case basis, and in consultation with the researchers.
3. While the new rules take effect on January 21, 2019, the SCSU IRB process will continue to adapt and changes as the rules are interpreted by the federal Office for Human Research Protections (OHRP) and other institutions after that date. The current SCSU review process, with only minor adjustments, will comply with the new rules, but there may be some opportunities for simplifying our application and review process as new information comes to light.
4. As we move forward, please contact the IRB Chair, Dr. Jerry Hauselt, with any questions.

IRB Bulletin 2: NEW Elements of Informed Consent

The federal regulations governing human subject research are changing effective January 21, 2019.

There are some important new requirements that all researchers who work with human participants need to be aware of and implement in IRB applications submitted AFTER January 21, 2019. 

The required elements of informed consent are for the most part unchanged. There are TWO new elements that the regulations say an informed consent document MUST have. They are:

CHANGE #1: REQUIRED: Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative 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.

DISCUSSION: We will have to slightly alter what we tell participants. Many consent documents already meet this standard, which seems only to impact where information is placed in the consent document, and is intended to simplify documents for participants. As of 10/12/2017, there is no clear definition of "key information", so investigators should use their best judgment. 

Please note that this is not meant to be a persuasive section- it should be factual, and avoid use of terms like "beneficial" and "important" in describing the research.

CHANGE #2: REQUIRED: Statement on future use of identifiable information.

Research that collects identifiable private information or biospecimens must include a statement about the future use of the data that will be collected. A statement that identifiers must be removed from the identifiable private information or identifiable biospecimens 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 legally authorized representative, if this might be a possibility; or 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. 

DISCUSSION: All consent documents need to include a statement about the potential future use of the data that will be collected. This applies only data that will be de-identified prior to the future use. Therefore, one of the following statements MUST appear on informed consent documents:

1. If the data (in a de-identified form) WILL OR MIGHT BE used in the future: "Identifying information will be removed from the data that will be collected, and the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent."
2. If the data (in a de-identified form) WILL NOT BE used in the future: "The information or biospecimens collected as part of this research, even if identifiers are removed, will not be used or distributed for future research studies."

These changes can be made immediately on new submissions. They will be REQUIRED after January 21, 2019.

All IRB BULLETINS  will be archived on the IRB website for future reference. Each IRB Bulletin will include a description of the change and a discussion of the impact of the change on SCSU as seen by the IRB Chair as of the date of the bulletin. Please note that the discussion will likely change as more information and guidance is ussed by the OHRP. Please contact Dr. Jerry Hauselt, IRB Chair, with any questions.

IRB Bulletin 3: Regulation: Consent exemption for screening, recruiting, or determining eligibility

The federak regulations governing human subject research are changing effective January 21, 2019.

There are some important new requirements that all researchers who work with human participants need to be aware of and implement in IRB applications submitted AFTER January 21, 2019.

Regulation: An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligability of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:

1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens. 

DISCUSSION: Note that this allows the collection of data without consent ONLY for purposes of determining eligibility for the research. The screening process (if a study includes one) must be fully described in the IRB Application, with copies of any screening tools included for review.

The application MUST include the informed consent document for those individuals who will be invited to participate in the research following screening. 

All IRB BULLETINS  will be archived on the IRB website for future reference. Each IRB Bulletin will include a description of the change and a discussion of the impact of the change on SCSU as seen by the IRB Chair as of the date of the bulletin. Please note that the discussion will likely change as more information and guidance is ussed by the OHRP.

Please contact Dr. Jerry Hauselt, IRB Chair, with any questions.

 IRB Bulletin 4: Regulation: Continuing review will no longer be required for minimal risk research

The federal regulations governing human subject research are changing

effective January 21, 2019.

There are some important new requirements that all researchers who work with human participants need to be aware of and implement in IRB applications submitted AFTER January 21, 2019.  

Regulation: Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

1. Research eligible for expedited review
2. Research reviewed by the IRB in accordance with the limited IRB review described in
3. Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

DISCUSSION: Only research that contains more than minimal risk and has been approved by a full IRB at a convened meeting will require continuing review. Continuing review may still be used for other types of IRB approvals, but the decision to do so must be justified and documented by the IRB.

This effectively means that there will be no expiration date for the large majority of studies which receive IRB approval. Any changes to the study would need to be reviewed and documented, but if no changes occur after the initial approval, continuing approval would not be necessary.

It is not clear what implication this may have on our operations. It is by the continuing review process that SCSU knows what studies are active and which have been closed. It may be that rather than requesting continuing review, researchers will be asked to submit a simple yearly status report and expected end date.