February 2021 IRB Connection Newsletter

Index

 

IRB Membership: Regulatory Requirements and Rosters

What’s the Difference Between Human Subjects Protection and Good Clinical Practice Trainings?

External and Commercial IRB Q & A: What is the order of workflow for other committees when using a commercial external IRB?

Herky Hints: Selecting the Status of Your Funding in Section III

IRB Advisor Newsletter, January 2021

In the News

 

 

IRB Membership: Regulatory Requirements and Rosters

By Kelly O’Berry, BS, CIP


In order for the institution to receive federal funding for research, it must have an Institutional Review Board (IRB) that follows the federal regulatory requirements for operations and membership. IRB members are faculty, staff (and sometimes a student!) in biomedical and social/behavioral departments across the UI campus and at the VA Health Care System (VAHCS). IRB members are your colleagues, your peers and your friends. This article reviews the regulatory requirements for types of IRB members, meeting attendance and instructions for accessing current and past versions of the IRB roster.

Types of IRB Members

The Federal Regulations for the Protection of Human Subjects (45 CFR 46.107) require members of varying backgrounds to have the expertise to review the types of research applications submitted to the board. The IRB must also include members who are knowledgeable about certain vulnerable subject populations that might be recruited for studies conducted by UI researchers. We typically refer to the following categories of IRB members:

  • Scientist Members – These members have education and training in a scientific field. On the biomedical board (IRB-01) and the VA Health Care System board (IRB-03), we have members with medical training and members with a background in other scientific areas.
  • Non-Scientist Members – These members have training or experience in a non-scientific field. They could be clergy, attorneys or business professionals.
  • Unaffiliated (Community) Members – To qualify for this category of membership, these members, and anyone in their immediate family, cannot be affiliated with the UI, UIHC, or the VA Health Care System.

    [A Request to the UI Research Community: It is challenging to find people who satisfy the requirements to serve as a Community Member. If you know someone who might be interested, feel free to share the information on the Become an IRB Member page of the Human Subjects Office (HSO) website. They can contact us at irb@uiowa.edu to explore the option of serving on the IRB. We are always recruiting Community Members!]
  • Prisoner Advocate – This category is specified in the federal regulations under 45 CFR 46.304(b).  It requires either a prisoner or a representative with knowledge of the experiences for incarcerated persons whenever the research involves prisoners as subjects. Prisoner Advocates participate in the review of any studies that involve prisoners, including research that qualifies for Expedited Review or Exempt Status.
  • Consultants – Since it is not feasible to have enough IRB members to represent every possible area of expertise, the board uses non-member consultants to provide information and assist the board in reviewing research for which there are no members with expertise in that field of research, such as Dentistry and Exercise Physiology. In the past, the board also consulted with a bioethicist for planned emergency use research (21 CFR 50.24). Although they are not members of the IRB and may not cast a vote, they help to fill expertise gaps among the IRB membership to make sure the board can review all types of research applications submitted for IRB review and approval.

IRB Meeting Attendance

IRB members commit to attend a certain number of meetings per year, ranging from 12-33 meetings. Members typically commit to serving on the board for a minimum of two years, but we have had members serve for much longer, even decades. According to federal regulation (45 CFR 46.108(b)), a non-scientist member must be present to convene an IRB meeting.

Although it is not a regulatory requirement, we also strive to have a community member in attendance at all IRB meetings. And if a study on the agenda will enroll prisoners as subject, the Prisoner Advocate must also attend the meeting.

For IRB meetings, all members attending the meeting receive all the application materials for each item on the agenda. Additionally, members are selected to serve as the Primary or Secondary Reviewers for items on the agenda based on their background or expertise. The Primary Reviewer for a study presents the form at the meeting.

An IRB must have a minimum of 5 members identified on the institutional roster. IRB meetings are required to maintain a certain number of voting members at any given convened meeting (known as quorum). Quorum is met when half plus one of the primary members are present.  Primary IRB members are all identified in the first section of the roster. The primary membership roster is used to determine how quorum is calculated.  Alternate members, identified in the second section of the roster, can serve in place of any primary member that matches their expertise. (e.g., Physician Scientist, Other Scientist, Non-Scientist, Community member)   

The IRB Roster

There are approximately 75 members across the four UI IRBs. Some members serve on more than one IRB and there are some HSO staff, serving as IRB Chair Designees, who are also IRB members. Each UI IRB has a different number of primary members and all the boards have additional alternate members. Here is the UI IRB makeup as of January 2021:

IRB

Primary Members

Alternate Members

Primary Prisoner Advocate

Alternate Prisoner Advocate

Quorum

IRB-01 (Biomedical)

13

34

1

2

7

IRB-02 (Social Behavioral)

8

12

1

2

5

IRB-03 (VAHCS)

6

10

1

0

4

IRB-04 (Department of Defense) *

8

7

0

0

5

*(Not a currently an active UI IRB)

Accessing the IRB Roster

Researchers may need to provide a copy of the IRB roster to a study sponsor for a meeting at which a form related to the project was reviewed. On the Federalwide Assurance Document page of the HSO website, there is a link to where the IRB meeting rosters are posted in Sharepoint. A HawkID is required to access the IRB rosters, and you must login with HawkID@uiowa.edu and your HawkID password.

We currently provide all versions of the roster from 2019 and 2020. Send an email to irb@uiowa.edu if you need an older version of the roster. 

The Office of Human Research Protections, the federal regulatory agency that oversees and provides guidance on human subjects research, reviews all IRB members identified on an institutional IRB roster via an electronic submission process. This review fulfills the Food and Drug Administration (FDA) requirement for regulatory approval of all IRB member rosters.  The roster changes periodically as we add or remove IRB members. There is no regular schedule for roster updates, and we do not announce when the roster is revised. When a study is reviewed at an IRB meeting, researchers should follow the link on the HSO website to make sure they have the most current version of the roster in their regulatory binder.

 

What’s the Difference Between Human Subjects Protection and Good Clinical Practice Trainings?

By Joanie Hoefer, BS, CIP


All investigators conducting human subjects research at the University of Iowa or at the Iowa City Veteran Affairs Health Care System (VAHCS) are required to complete an education program and become "certified" in human subject protections (HSP) prior to conducting the research.  Some researchers may also need to complete Good Clinical Practice (GCP) training as a requirement for an NIH-funded grant or a sponsor contract. To clarify confusion around these two types of training, this article will explain the differences between HSP training and GCP training and who needs to complete each one.

HSP Training

Per the UI IRB Standard Operating Procedure\Researcher Guide (Section 2, Part 1.B) anyone at the UI or the Iowa City VAHCS who is involved in human subjects research must complete HSP training before they can submit an application as the Principal Investigator (PI) or be added to the research team in the eResearch (HawkIRB) system. This includes the PI and all individuals (faculty, staff, or student) who have contact or interactions with research subjects or access to their private, identifiable information. Faculty advisors and supervisors of student research projects that require IRB review must be listed on the research team in HawkIRB and therefore must complete the HSP training as well.

HSP training covers the history and ethics of human subjects research, basic institutional review board (IRB) regulations and the review process, informed consent and other basic topics about human subjects research. For UI researchers, this is a one-time training requirement, no refresher required. The HSO/IRB tracks completion of this training requirement in the Certified Investigator Database.

The VAHCS, many funding agencies, other academic institutions, and some industry sponsors may require renewal of HSP training every few years. As a courtesy, the UI provides refresher courses for Group 1 - Biomedical - IRB-01 and Group 2 - Social & Behavioral - IRB-02 on the CITI Program platform for UI researchers who may have to renew their HSP training as a requirement for the funding agency or sponsor. Unlike completion of the UI-required basic courses in HSP, refresher course completion is NOT recorded in the Certified Investigator Database. The individual learner has the responsibility of maintaining records of their HSP training refresher course completions.

GCP Training

GCP training concentrates on topics specifically related to clinical trials with drugs and devices with a focus on US FDA regulations. The requirement to complete this training is usually determined by the funding source. GCP training is required for all investigators and staff who are involved in the conduct, oversight or management of NIH-funded clinical trials and applies to all active NIH grants and contracts. This training is consistent with Food and Drug Administration (FDA) Good Clinical Practice regulations and must be renewed every 3 years. In addition to the NIH, other clinical trial sponsors may require that researchers complete GCP training. You will need to check with your sponsor to see if they have this requirement.

Not everyone needs to complete GCP training at the UI even though they may have contact or interactions with research subjects or with their private, identifiable information and/or biospecimens. But if it is required by the sponsor or funding agency, this training must be completed in addition to HSP training.

GCP training is not required by the UI IRB. As a courtesy, completion of the basic course is recorded in the Certified Investigators Database within HawkIRB, however, refresher course completion is NOT recorded. The individual learner has the responsibility of maintaining records of their GCP training completions.

The training requirements for both HSP and GCP are fulfilled by completing the applicable courses on the Collaborative Institutional Training Initiative Program (CITI Program) platform. The HSO website provides FAQ pages for HSP and GCP training that includes instructions on how to register and complete these trainings.

 

External and Commercial IRB Q & A: What is the order of workflow for other committees when using a commercial external IRB?

By Jarrod Feld, BA


For studies using an external or commercial IRB, the HawkIRB application is used as a means of documenting research occurring at the University of Iowa, regardless of the IRB of record.  Per the assurances, as defined in the Federalwide Assurance (FWA) on file with the Office of Human Research Protections, the institution remains ultimately responsible for the conduct of the research regardless of the IRB of record.  HawkIRB serves as a centralized system to track all such research.  HawkIRB also serves as a data management repository collecting key study information such as approved versions of the Informed Consent Documents, key recruitment materials, a copy of the external IRB application, protocol (as applicable), and IRB approval memo. It is also a tool to activate other Human Research Protection Program (HRPP) committee reviews, depending on the study procedures.

When using an external or commercial IRB of record, there is a different order for other committee reviews and workflow processing than the processing for IRB 01 applications, depending on which IRB of record is used. In most cases, the HSO requires sign off from all other HRPP committees prior to approval to submit to the external/commercial IRB of record.

When submitting a HawkIRB New Project form for initial review, Section V captures study processes/procedures that may require review by other HRPP committees. The following committees’ reviews will be activated when an affirmative response is given in their respective section:

  • Pharmacy and Therapeutics Committee and Investigational Drug Service

Sections V.1 – V.8 ask about the testing of any investigational drugs or devices (being tested outside the FDA-approved population, dose, route of administration, or disease/condition).

  • Medical Radiation Protection Committee

Sections VI.9-V.19 ask if the study involves any diagnostic or therapeutic radiation procedures that will take place outside of standard of care procedures or timepoints. If so, the study requires approval from the Medical Radiation Protection Committee (MRPC).

  • Institutional Biosafety Committee

If Section V.20 indicates whether the study will involve transfer of recombinant or synthetic DNA or RNA, Institutional Biosafety Committee (IBC) review and approval will be required.

  • Holden Comprehensive Cancer Center (HCCC) Protocol Review and Monitoring Committee

If a study will involve any resource or patients/subjects from the Holden Comprehensive Cancer Center, or involve treatment, detection, or care related to cancer, Section V.22 will activate Holden Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) review and approval.

  • Nursing Research Committee

If a study will involve Department of Nursing Services and Patient Care nursing, nursing resources, or evaluation of nursing practices at UI Health Care, Nursing Research Committee (NRC) review will be activated via Section V.26.

Additional committee reviews may be indicated in HawkIRB, but communication and approval will take place outside the HawkIRB system. For example, if a study will utilize the Clinical Research Unit (CRU) in any capacity (indicated via question V.21), a separate review and approval process will be activated and completed outside of HawkIRB. It is the responsibility of the research team to complete the review processes per the respective committees’ review processes. For instance, if a study intends to utilize Pathology or Institute for Clinical Translational Science department resources, it is the study team’s responsibility to inquire and initiate review processes directly with the respective departments, depending on the study protocol and procedures. For more information about other committee reviews in HawkIRB, please refer to the HSO ‘Other Research Review’ website.

In addition to the committee approvals described above, when using any external or commercial IRB other than WCG (WIRB Copernicus Group), a study’s contract and research billing plan must be in place and fully executed prior to approval to submit the study externally. These are indicated in HawkIRB via the Division of Sponsored Programs (DSP) and Research Billing Compliance (RBC) committee approval status.

Since the UI IRB has a master service agreement and workflow processing agreement in place with WCG, research teams may be approved to submit their study to the external IRB prior to a contract or research billing plan being in place. The study will remain on hold, however, after WCG approval is received if DSP, RBC or any other committee approvals are still outstanding (via the ‘other committee review’ section in HawkIRB).

Finally, in some special cases, a study may need review and approval by other UI or UIHC groups that are not captured in HawkIRB. For example, new technology may require IT approval (via a security or a technology review) or the use of UIHC billing or insurance information may require Financial and Accounting Services review. Depending on the circumstances of the study, other local entities may need to review a study as well.

Because each study is different, and with variability in workflow processes, we recommend you reach out to the HSO for guidance. The HSO’s commercial and external IRB coordinators can be reached at UIWIRB@UIowa.edu (for WCG studies) or UIRB-External@UIowa.edu (for all other external and/or commercial IRBs). Additionally, Jarrod Feld, Human Subjects Office External/Commercial IRB Coordinator, can be reached at jarrod.feld@uiowa.edu or 319-467-1806, or via the HSO main line at 319-335-6564. Guidance is also available on the HSO website under the Central & External IRBs (Single IRB of Record) menu option.

 

Herky Hints: Selecting the Status of Your Funding in Section III

By Joanie Hoefer, BS, CIP


Once you have listed the original source of funding for your study in Section III.1 of the HawkIRB application and linked it to the correct record in the Division of Sponsored Programs/University of Iowa Research Information System (if applicable), you must then provide the status of that funding source in Section III.5.

For each internal or external funding source listed in Section III.1, the PI must select one of four options for the status of the funding in Section III.5 (listed below). The only exceptions are when departmental, PI discretionary, or the PI using their own personal money to fund the research. In these situations, the PI is not asked to provide the status of the funding.

Awarded

Awarded means that the contract or subcontracts have been finalized, the master file key (MFK) has been set up and the money has been deposited in the account.

Just in Time

‘Just in Time’ (JIT) refers to the stage in federally funded projects in which the grant proposal has received a favorable score. This means that the proposal is under consideration to be funded and the PI has been notified to complete certain procedures, such as obtaining IRB approval, as a condition of receiving the award. It may be helpful to verify the grantee’s requirements for a JIT scenario.  Sometimes submission to the IRB, not full IRB approval, is appropriate documentation to fulfill a JIT review.

Not Submitted

This option should only be selected if the funding source requires proof of IRB approval before you can submit the funding proposal. This is not a common situation, but if it applies to your study, attach documentation of this requirement to the HawkIRB application. This could be the funding application form, a screen shot from the funding source web site, or a letter on their letterhead.

Other

If the none of the other options apply, select ‘Other’. The IRB will expect a complete description of the status of the funding in the text field for this option. If funding is pending or a grant has been submitted but not yet approved, let the IRB know if you plan on proceeding with the study, even if the grant is not awarded. The IRB recommends that researchers wait to submit the HawkIRB application until they have secured adequate funding to conduct the study especially when there are costly procedures involved or the subjects will be provided compensation. In some cases, PIs may have to use departmental or personal funds to finance the study until adequate funding is obtained. When or if grant funding is awarded, a modification can then be submitted to update Section III of the application.

 

IRB Advisor Newsletter, January 2021

By Joanie Hoefer, BS, CIP


IRB Advisor (a publication of Relias) is a monthly newsletter with articles about issues facing IRBs, Human Research Protection Programs (HRPPs) and researchers. Current and past issues of IRB Advisor are posted in the “IRB ICON Course for Researchers” which is accessible to anyone with an active UI HawkID. The portal to this ICON Course is on the Education and Training page of the Human Subjects Office website.

This month we are highlighting the January 2021 issue that includes articles that give kudos to Data Safety Monitoring Boards (DSMB) regarding their important work in vaccine and HIV research.

Data Safety Monitoring Boards Were Quietly Behind the Scenes, but No More

This article demonstrates that before 2020 and the COVID-19 pandemic, the general public was relatively unaware of Data Safety Monitoring Boards (DSMB) and their function. But when interim information about a few potential vaccines for SARS CoV-2 came out, DSMBs were catapulted into the spotlight. The media began talking about DSMBs and their role in looking for safety issues and potentially stopping clinical trials if there is a safety concern.

The article also provides a general overview of how a DSMB works and suggests that the attention DSMBs have received regarding the expediency with which they reviewed vaccine information could set a new standard of responsiveness for all DSMBs going forward.

DSMBs Have Helped Advance Safe, Effective HIV/AIDS Research

Even though the pandemic consumed much of the world’s focus in 2020, important research on HIV prevention advanced because of the work of DSMBs. In a pre-exposure prophylaxis (PrEP) trial, the DSMB determined that a bimonthly injectable had excellent efficacy and they recommended that randomization be stopped in large trials and everyone be told that the injectable worked better than the PrEP pill to which it was compared. This gave subjects in the trial a choice of which drug to choose—the twice a month injectable or the once daily pill—while safety data continued to be collected on the injectable.

DSMBs will stop a trial when the drug or other study product does not work as well as hoped. However, they can also stop trials if the interventions work better than anticipated. Such was the case in circumcision trials that were conducted in Africa about 15 years ago. Interim analysis of the data showed that men who were circumcised as part of the trial had significantly fewer infections with HIV. The DSMB said it was time to stop the trial because the data clearly showed that circumcision was an effective tool in reducing HIV infections, and to continue the trial would be unethical. The article goes on to describe additional instances where the DSMB called for a trial to end early due to the interim data analysis.

Additional articles in this issue:

  • COVID-19 Trial Protocol/Consent Issues Discussed on National Stage
  • 20 Years of Reports on Research Protection
  • OHRP [the Department of Health and Human Services, Office of Human Research Protections] Looks Back at its First 20 Years

 

In the News