May, 2018 - Printable Version
I am very pleased to announce that the UIC Human Subject Protection Program (HSPP) has received full Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) reaccreditation! This accreditation is an important designation that reflects the highest quality by which the UIC OPRS and HSPP operates. The purpose of engaging in the accreditation process is to evaluate the ethical, regulatory and quality standards for human research. The AAHRPP seal places UIC among the world’s most respected, trustworthy research organizations.
I would like to take this opportunity to thank the many UIC faculty, staff and students who helped support the reaccreditation process. At the exit interview, the AAHRPP site visitors were very complementary of the research knowledge and commitment of UIC investigators and support staff to conduct high quality human research. I sincerely thank everyone involved in this important process!
Common Rule Update
Some of you may be wondering what has happened to the revised common rule. On April 19, 2018, The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”).
The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018. Federal departments and agencies later published an interim final rule delaying the effective and general compliance date for the 2018 Requirements until July 19, 2018.
This NPRM is intended to provide regulated entities additional time for the preparations necessary to implement the 2018 Requirements. If finalized, the NPRM would generally require regulated entities to continue to comply with the requirements of the current Common Rule (the “pre-2018 Requirements”) until January 21, 2019.
This means that OPRS may not implement any of the proposed changes to the common rule until January 21, 2019. We will keep the UIC research community informed of any further changes to the proposed rule and the implementation and compliance dates as the information becomes available.
That said, OPRS is committed to implementing burden reducing measures consistent with ethical standards, research regulations and applicable laws. Please take a few moments to read about some of the recent changes within OPRS. We are particularly excited to announce the release of a new institutional policy that will lengthen the IRB approval period for certain types of research.
I wish each of you every success in your research endeavors.
Contributed By Charles Hoehne and Barbara Corpus
Yes, you read the title of this article correctly! As of April 16, 2018, the UIC OPRS is pleased to announce broadening of the institutional approval period to allow some research to be granted an extended approval period of up to 3-years. The goal of this article is to explain the nuances of this exciting new burden reducing initiative.
Please note that the requirement to include a separate protocol document has not changed.
What types of research are eligible for 3-year IRB approval periods?
- The research must not be federally funded (including no cost extensions);
- The research must not be under the oversight of FDA, Department of Justice, Department of Education, or other agencies that require continuing review at a minimum of once per year;
- The research must not involve greater than minimal risk;
- The research must be reviewed and approved via expedited IRB review procedures;
- The research cannot require a Certificate of Confidentiality;
- The research cannot be approved by the IRB for development only (45CFR46.118); or
- The IRB has NOT determined more frequent continuing review is required.
What are the key aspects of this new policy?
- The three-year approval period can only be granted at the time of Initial Review or Continuing Review for research approved on or after April 16, 2018.
- Since the IRB must determine the required review frequency on a protocol-by-protocol basis, research studies approved by the IRB prior to April 16, 2018 must abide by the current approval period specified by the IRB at time of initial review or the most recent continuing review. A Continuing Review application must be submitted in a timely fashion to avoid a lapse of IRB approval and to extend IRB approval beyond the period specified at time of initial review or the most recent continuing review.
- The IRB approval period cannot be extended via submission of an amendment.
- The approval period can, however, be decreased with an amendment if any of the items 1-7 above become applicable. In such cases, the approval period will be reduced to a one-year (or less) period with the approval period beginning on the amendment approval date. Approved documents will need to be stamped with the new (reduced) approval period. If at the time of Initial Review it is reasonably anticipated that any of these conditions will apply in the future (e.g., federal funding is pending), it is recommended that this be specified in the submission.
- Recruitment materials approved on or after April 16, 2018 will be stamped with the approval date only. This change will take effect regardless of whether the recruitment materials are approved with the Initial Review, Continuing Review, or Amendment.
- Informed consents/assents/parental permissions will continue to be stamped with the approval date and expiration date. Previously stamped documents are no longer required to be submitted with the Continuing Review application.
- Clean documents that are not submitted at the time of Continuing Review will be inactivated as it will be assumed they are no longer in use.
Are there any caveats?
- It is possible - but not currently anticipated - that the revised Common Rule when finally released (see “Message form the Director”) will require continuing review for all IRB-approved research on no more than an annual basis (i.e., at least once per year). In the unlikely event that this occurs, 3-year approval periods granted by the IRB will need to be reduced.
- As always, Principal Investigators are responsible for maintaining current IRB approval of their research. OPRS will send investigators annual notices for studies granted a three-year approval period, reminding them of the need to prospectively submit Amendments (particularly important when funding is being added, or there are any other changes requiring alteration of the three-year approval period), Continuing Review in a timely fashion to avoid a lapse of IRB approval at the end of the approval period, Prompt Reports as required, and a Final Report when the research has been completed.
- The IRB has the ability to administratively close research that has never enrolled any subjects and/or has not enrolled subjects in three (3) consecutive years and has indicated that subjects will continue to be enrolled. The investigator may provide a rationale on the Continuing Review form as to why the research should remain open.
Case studies involving this new policy:
Case Study 1: On January 15, 2018, the IRB approved a non-federally funded minimal risk study for one year via expedited IRB review. On April 24, 2018, the PI submitted an amendment adding an additional co-investigator. The IRB reviewer approved the amendment and noted that the research appears to be eligible for the 3-year IRB approval period. Can the reviewer grant a 3-year approval period via this amendment?
No. The 3-year IRB approval period can only be granted at time of initial review or continuing review.
Case Study 2: The IRB has granted a research study a 3-year approval period. The PI has submitted an amendment adding federal funding. Is the study still eligible for a 3-year approval period?
No. Because the research will now be federally funded, the IRB must reduce the approval period to no more than one year, with the approval period beginning on the amendment approval date. Approved documents will need to be stamped with the new (reduced) approval period.
Case Study 3: An investigator at UIC plans to partner with an investigator at a non-UIC site. The non-UIC site will receive direct federal funding and there will be a sub-contract in place with UIC. Since UIC will not receive direct federal funding, is the study eligible for a 3-year approval period at UIC?
No. The research must not be directly or indirectly federally funded (including no cost extensions). The research in this scenario is limited to an approval period of no more than 365 days.
Case Study 4: At time of initial review, the IRB granted a study a one-year approval period and approved the enrollment of 25 subjects. At time of continuing review, the PI reports zero subjects have been enrolled, but wants to keep the study open, “just in case.” What course of action can the IRB take?
The IRB has the option to administratively close this research because no subjects were enrolled during the one-year approval period. The investigator, however, may provide a compelling rationale on the Continuing Review form as to why the research should remain open.
This article includes information regarding a new policy allowing the IRB to grant some studies a 3-year approval period. One compelling reason for this change in policy is to allow the IRB to shift oversight responsibility slightly away from certain minimal risk studies and toward higher risk studies while still upholding all ethical, regulatory, legal and institutional responsibilities for the conduct of all human subject research. This common sense approach is intended to enhance the UIC Human Subject Protection Program.
As always, if you have any questions regarding the UIC Human Subjects Protection Program – including revisions of the Initial Review Health and Biological Sciences application – please contact OPRS at 312-996-1711 or firstname.lastname@example.org.
Contributed by Charles Hoehne
OPRS frequently receives questions about obtaining informed consent for participation in exempt research. The discussions seem to run a wide spectrum. Sometimes, investigators indicate informed consent is never required for participation in exempt research. Other times, investigators plan to submit multi-page consent documents for participation in a 10-minute innocuous survey. Both extremes are problematic.
To address this problem, OPRS provides the following guidance related to obtaining informed consent for participation in exempt research to UIC investigators:
Although exempt research is not subject to the federal regulations at 45CFR46 (or 38CFR16), UIC policy requires all research involving human subjects, including exempt research, to be performed responsibly and in accordance with the ethical guidelines of the Belmont Report. If interactions, intervention or other contact will occur with participants, the IRB/OPRS expects investigators to provide the participants with information about the research protocol and to obtain their voluntary informed consent to participate in the research. Obtaining informed consent is not expected with the use of existing materials or other activities where no contact with the participants will occur.
An appropriate consent document may include an information sheet, oral informed consent script, survey cover letter or a letter to subjects. The following information should be provided, when possible, to potential research subjects participating in exempt studies:
- That the activity involves research;
- Name, affiliation and contact information for investigator,
- The purpose of the research;
- A description of the procedures;
- Measures to protect the privacy of subjects and the confidentiality of the research information;
- Description of any reasonable foreseeable risks, as well as anticipated benefits;
- Statement that participation is voluntary;
- Statement that the researcher is available to answer any questions; and
- If the research involves an online survey, include the following information: “Confidentiality will be maintained to the degree permitted by the technology used. Your participation in this online survey involves risks similar to a person’s everyday use of the Internet.”
Because exempt research is minimal risk and when the primary risks involve privacy and confidentiality, written documentation of informed consent (i.e., participant’s signature) is generally not required by the IRB/OPRS unless signed consent is required by other applicable regulations, laws or institutional policy (e.g., FERPA).
Finally, as noted elsewhere in this newsletter (see “New Three-Year Approval Periods for Some Human Subject Research”), the way OPRS stamps IRB-approved recruitment and informed consent documents is changing. What is NOT changing is the fact that OPRS does not stamp exempt research documents. By definition, exempt research is exempt from the Common Rule and thus the need for IRB approval. If your research is granted an exemption, recruitment and consent documents will NOT be stamped as being IRB approved.
If you have any questions about this guidance, please feel free to contact me, Charles Hoehne, at 312-355-2908 or email@example.com.
Contributed by Charles Hoehne
In the era of big data, multisite studies and increased portability, the way research is being conducted is rapidly changing. In response to these changes, the way research is reviewed is also changing. To meet these new challenges, the UIC Office for the Protection of Research Subjects has been completely remodeled.
The massive file cabinets, overloaded shelves and gigantic copy machines are gone. In their place are streamlined offices with enhanced technology and multi-media conference rooms. There’s even a work station available to investigators who are having difficulty completing online investigator training and/or submitting applications electronically through OPRS Live.
The OPRS staff invites you to stop by the office (1737 W. Polk Street, Administrative Office Building, 2nd Floor) and take a tour!
|OPRS Large Multi-Media Conference Room||OPRS Small Multi-Media Conference Room|
|OPRS Office Suite||OPRS Education and Training Office|
Contributed by Charles Hoehne
Editor’s note: This is the first article in a series designed to introduce the OPRS staff to the UIC research community.
Teresa Johnston is a familiar name, face and voice around the UIC campus. She recently accepted the position of Senior Associate Director for Operations in OPRS. It has been a remarkable climb for Teresa. Let’s look at her story.
Teresa began working as clerical help in OPRS in 2000, about a year after graduating from the University of Illinois (“ILL! INI!”). Individuals who have been around UIC for a while may remember that time as the dark days following the fed’s (OHRP) restriction of UIC’s Federalwide Assurance. All research was ground to an immediate halt until such time that the UIC Human Subject Protection Program (HSPP) could be completely revamped and all research re-reviewed following a new, and much different, process.
Long-time OPRS staff members refer to those dark days as the “Basement Years.” OPRS staff and IRB members worked long hours, frequently 6-7 days per week. They came in before sunrise and usually left well after dark. Teresa entered this stressful environment and quickly proved capable of handling complex, sensitive tasks seamlessly.
Over time, Teresa moved from clerical help, to IRB Coordinator, to Assistant Director, and to Interim Associate Director before being named Senior Associate Director for Operations. During this time, she helped the UIC HSPP move quite literally from the dark ages into a nationally recognized and three-time AAHRPP accredited institution of distinction.
It is this background and wealth of experience that makes Teresa so valuable to UIC. She has been involved in innumerable wide-ranging aspects of the UIC HSPP. She can therefore relate to almost everyone, regardless of their role in the HSPP. Simply put, she’s been here, done that, and continues to do it very well.
Five questions for Teresa:
- Looking back, what do you see as the greatest institutional challenge and greatest institutional accomplishment during your time at UIC?
Even though I joined OPRS at the tail-end of the OHRP restrictions, I did get to experience some of the fallout. I know how much work and dedication it took to turn the program around and obtain initial AAHRPP accreditation in 2010. This was a huge achievement, not just for OPRS and the IRBs, but for all of the units that comprise the UIC HSPP and the research community as a whole. I have also been involved the development of the OPRS Live system, which has simplified and streamlined the protocol submission, review, and management processes in many ways. OPRS Live has certainly posed its own challenges, but I continue to work closely with the development team to identify ways to further improve the system for all users.
- Looking forward, in what ways do you see the UIC HSPP evolving?
We are already working on evaluating our policies and procedures to identify ways to make everyone’s lives a little easier. For example, note our recent update to the Continuing Review policy, which allows the IRB to extend the review period for certain protocols. If the proposed changes to the Common Rule are implemented as expected next year, I think the resulting burden-reducing measures would allow us even more time to focus on improving the HSPP through means such as education efforts, more pre-review options, and developing stronger working relationships with investigators.
In addition, we must continue to adapt to the use of new and emerging technologies in research. Even in the last few years, we have seen a huge increase in the research uses of technologies like smart phone apps, virtual reality environments, and global communications. I am really excited to see what’s in store for the future.
- What words of advice would you share with someone just beginning their research career at UIC?
Please contact OPRS with any questions! We are here to help investigators identify and address ethical and regulatory concerns, and we are more than happy to talk through a proposal or provide a pre-review before it is submitted to the IRB. Use us as a resource!
The IRB review process can be very stressful- I believe that in most cases a simple conversation can save everyone a lot of frustration.
- Outside of work, what do you do for fun?
In my downtime I will do some knitting while watching (just about) anything sci-fi, fantasy, or horror. I like to read and travel. In the summer I play in an adult kickball league, and I try to make it out to as many city neighborhood festivals and farmer’s markets as possible.
- Cubs or Sox?
Blackhawks! (Sorry, not much of a baseball fan)
Contributed by Charles Hoehne
- Enhancements of the OPRS electronic submission program, OPRS Live, are ongoing. For example:
- OPRS encourages investigators to consider, when appropriate, submitting Final Reports closing out their studies rather than submitting a Continuing Review application. In response to feedback from investigators who are unsure when to submit a Final Report, OPRS Live has been enhanced to include a True/False checklist to help investigators determine whether or not a Final Report can be submitted in place of a Continuing Review application.
- Additionally, based on feedback OPRS has received from investigators, the OPRS Live user interface and dashboards are being updated by the OPRS Live Tech Team to enhance usability and to make the system more streamlined and intuitive.
When faculty, staff and students submit Determination of Whether an Activity Represents Human Subject Research applications to OPRS via OPRS Live, they do so because they believe their activities do not represent human subject research. Conversely, when OPRS staff and/or members of the IRB determine the activity does not represent human subject research, they are not granting the activity an exemption. Exemptions can only be granted for specified categories of human subject research. Investigators who think their human subject research qualifies for an exemption must submit a Claim of Exemption Application.
Individuals conducting research as UIC faculty, staff or students at non-UIC sites must address institutional approval requirements at both the non-UIC site and at UIC. While entering into reciprocal agreements may be possible, such agreements are not automatically in place. Unfortunately, failure to prospectively address this issue may inadvertently result in serious non-compliance. If you find yourself in this situation, please contact OPRS for further advice prior to becoming engaged in the research. Hoping a situation doesn’t become a problem is never a good idea in research: 312-996-1711 or firstname.lastname@example.org.