Index

New Faculty/Staff Orientation to the IRB

 

Mass Email for Research Recruitment

 

Livestream Webcast: Meeting New Challenges

 

IRB Member Recruitment: Seeking IRB Community Members

 

Protocol Changes or New Information: Remember to Re-Consent Subjects

 

The Role of Risk Management in Reviewing Human Subjects Research

 

IRB Advisor, July 2018

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New Faculty/Staff Orientation to the IRB

By Kelly O’Berry

Do you have new faculty researchers, research scientists and/or study coordinators in your department or college? Please consider sharing this survey link with them to facilitate a researcher onboarding initiative: New UI Faculty\Staff Researcher Survey.  If they are conducting human subjects research, the IRB Education & Outreach Group also offers one-on-one or small group IRB orientations to help new faculty and staff researchers find the resources and support they need to get started with their research at the University of Iowa. (Read more)

Every year, the UI hires 250-300 new faculty and approximately 28% of them will be involved in research of any kind (not all human subjects research). Many of the new faculty positions begin in conjunction with the academic year, which is coming soon! A one-on-one or small group IRB orientation session provides an overview of the entire UI Human Research Protection Program. During these sessions we tell researchers about the IRB review process and the additional approvals that might be required for their area research. Even researchers with experience conducting human subjects research can benefit from an overview and orientation to the following:

• UI Human Research Protection Program (HRPP) and IRB structure, resources and contact information
• IRB review process and requirements for submission
• Other committees and entities that review and approve research applications
• CITI training – especially if they completed this training requirement at another institution
• Principal Investigator oversight responsibilities
• HawkIRB application system – New Project and Human Subjects Research Determination (HSRD) forms and the Delegate Permission System

This new faculty/staff orientation does not take the place of existing educational opportunities, such as HawkIRB Training Sessions or the Institute for Clinical and Translational Science (ICTS) Academy for Research Professionals. New faculty and staff researchers are strongly encouraged to take advantage of the educational resources that are available through the Human Subjects Office and other offices in the Human Research Protection Program (HRPP) and across campus. More information on the HRPP resources can be found here.  If you are a new researcher, research scientist or study coordinator who would like to schedule an orientation (or know of someone who could benefit from this service), contact Kelly O’Berry, IRB Education & Outreach Manager at Kelly-oberry@uiowa.edu or 319-335-8477.

 

Mass Email for Research Recruitment

By Kelly O’Berry

Sending a Mass email to UI faculty, staff and students is a popular recruitment strategy. Researchers must describe this recruitment method in Section VII.D of the HawkIRB application and have IRB approval for the subject line and the content of the message.

@uiowa.edu Email Address Required

According to ITS policy, all mass email messages must have an email address with @uiowa.edu in the “From” and the “Reply to” fields. Researchers may not use a personal email account for UI mass email messages. The “Requester email” field can be @healthcare.uiowa.edu, if necessary, but ITS prefers @uiowa.edu addresses in all three of these fields of the request form.

There is a way to request an @uiowa.edu alias address for an existing departmental account. Follow this link to learn more about that process. All new shared/departmental account email aliases must include a hyphen (i.e. irb-outreach@uiowa.edu). According to Lisa Schintler in the ITS Enterprise Communications & Collaboration Team, there are some old accounts that do not have a hyphen, but all new shared/departmental account email addresses must use the format with a hyphen.

Time for Approval

As a reminder, the Human Subjects Office typically processes mass email requests within 2 business days. But according to the step by step process for requesting a mass email posted on the ITS website, the entire timeframe for a mass email request can be up to 7 business days. Please plan ahead to leave enough time for the approval process before you need to distribute your mass email for recruitment purposes.

If you have any questions about this, contact ITS at its-email@uiowa.edu.

 

Livestream Webcast: Meeting New Challenges in Informed Consent in Clinical Research

By Kelly O’Berry

On Friday, September 7, 2018 from 8:00 am-5:00 pm, the Office of Human Research Protections (OHRP) will offer a livestream webcast of an Exploratory Workshop entitled “Meeting New Challenges in Informed Consent in Clinical Research” that will focus on four topic areas:

• Laying the groundwork for meaningful informed consent
• Effectively presenting information to facilitate high-quality decision-making
• Pragmatic Clinical Trials (PCT) – challenges and innovations in getting informed consent
• Delivery room research and the challenges for informed consent

The tentative agenda lists the moderators and panelists for each of these sessions. Registration is not required. Viewers can tune in to sessions of interest as their schedule allows. Check the OHRP website for viewing information that will be coming soon.

 

IRB Member Recruitment: Seeking IRB Community Members

By Kelly O’Berry

Have you ever wondered about the people who review research applications submitted to the University of Iowa Institutional Review Board (IRB)? There are current openings for Community Members, Other Scientist and Non-Scientist members of the University of Iowa IRBs.  IRB members have a front-row seat to learn about the wide variety of research conducted at the university, from Alzheimer’s and diabetes to early childhood development and driver safety. [Read more]

 

 

Board members support the University of Iowa Human Research Protection Program, and by extension society, by reviewing proposals for such research.  IRB members are asked to attend one to three meetings per month based on their availability.  This volunteer opportunity may be of interest to someone who cares about protecting the rights, safety and welfare of individuals who volunteer to participate in research.  This is also an ideal position for someone who is interested in learning about research conducted by UI faculty, staff and students and VA researchers.

 

 

The UI currently has about 55 board members on the three separate IRBs:

• IRB-01 – reviews biomedical research
• IRB-02 – reviews social, behavioral and educational research
• IRB-03 – reviews research conducted at the VA Health Care System or using VA resources
• IRB-04  - will review Department of Defense research (This is a new IRB the University of Iowa Human Research Protection Program is hoping to launch once the IRB membership requirements are met.)

 

IRB Membership

The Human Subjects Office seeks balanced IRBs made up of UI faculty and staff as well as members of the Iowa City and surrounding area.  We also strive for balance in terms of gender, race and ethnicity. IRB members include people with scientific and non-scientific backgrounds. Unaffiliated members, scientists with a non-medical background and non-scientists play a crucial role in reviewing human subjects research and can bring fresh insight and perspective to the review process. No previous experience is necessary.  Community Members may include clergy, public servants (police officers, fire fighters), research participants, and others. 

 

 

As you can imagine, it’s difficult to find people in Iowa City and the surrounding area who are not employed by the University of Iowa themselves and do not have a connection with the institution through the employment of someone in their immediate family.  A Community Member may or may not have a scientific or medical background, but they must not have an affiliation with the UI. A former UI faculty or staff member who retires or is no longer employed by the UI would be considered unaffiliated after two years. Anyone who does not have a medical degree can serve as an Other Scientist member and those without training in a scientific field could be a Non-Scientist member of the IRB. 

 

 

The IRB relies on Community Members and Non-Scientist Members to serve as a “voice” for potential subjects who may be approached to participate in research.  Within that role, during the IRB meetings, these members are asked to:

 

• Raise questions (or concerns) they may have with the proposed research
• Make recommendations on how to present the research to subjects in terms that potential subjects can understand.

Testimonial “I see my role as being an advocate for the potential subject, making sure that what they are asked to do is reasonable and that the explanation of the research is understandable. While I rely on my medical and scientific colleagues to determine if the project is ‘good science,’ I have never been made to feel that my opinion is any less valuable.” Nancy Goldsmith Non-Scientist IRB Member

 

Qualifications to be a Community Member or Non-Scientist IRB Members

• Applicants and their immediate family must not be employed by (or volunteer at) the UI or VA hospital
• Applicants should have a non-scientific or non-medical background or training (preferred)
• UI or VA Retirees may qualify as community members two years post-retirement.
• Applicants must be able to attend regular review meetings (one to three times a month)
  • Meetings are generally held during business hours on Monday and Thursday afternoons or Wednesday mornings.
• Applicants should have interest in and general aptitude for reviewing research proposals prior to IRB meetings
• Applicants must complete IRB member training prior to participation

Testimonial “As a community member my primary task has been to help determine that the information and consents given to participants in clinical trials are accurate and understandable to persons who do not have medical training.  As a bonus, I have learned a great deal about human research and new medical advances.” Dave Schuldt, Former IRB Community Member

 

We appreciate assistance from the UI research community to spread the word to anyone who might be eligible and interested to serve as a Community Member.

 

Additional information is available on the Human Subjects Office web site.  To apply, contact Kelly O’Berry, IRB Education & Outreach Manager, by Phone: 319-335-8477 or Email: kelly-oberry@uiowa.edu

 

 

Protocol Changes or New Information: Remember to Reconsent Subjects

By Kelly O’Berry

There are regulatory requirements that researchers provide subjects with complete information about the study design and procedures at the time of enrollment (unless the IRB waives this requirement). But what if the study design changes after subjects are enrolled? What if the researcher receives new information that could affect enrolled subjects’ willingness to continue participation? There are several circumstances in which the research team should share this information with subjects and document their agreement to continue participation in the study.

The federal regulations for the protection of human subjects (45 CFR 46.116(a)) includes a list of the standard information, called ‘elements of consent,’ that need to be provided to each subject in the consent document and/or during the consent process. There is another list of ‘additional elements of consent’ that may be required depending on the study design. The UI IRB Informed Consent Document (ICD) Template document includes all of these required and additional elements of consent and the IRB ensures that all of this information is included in the study ICD before approving the HawkIRB application. Unless the IRB grants a waiver of one or more elements of consent, researchers must provide all of this information to subjects during the consent process.

According to federal regulatory guidance, if anything changes with the study design or procedures, the researcher should obtain IRB approval prior to implementing the change except where necessary to eliminate apparent immediate hazards to the human subjects. When these changes could affect the enrolled subjects safety, increase risk, or their willingness to continue to participate in the research, the researcher should inform the subjects affected by the change. This is called “reconsent” and is typically documented on an IRB-approved Informed Consent Document. The decision about whether to reconsent subjects depends on the nature of the change and the ongoing involvement of the subject. The following scenarios illustrate when a researcher might need to obtain and document the reconsent of enrolled subjects.

Example #1: Adding a study visit and study procedures

In a 2-year study about teaching methods for English as a second language, a new group of subjects are enrolled every semester. The researcher decides to add another study visit to collect data in the middle of the semester in addition to the previously described study visits at the beginning and end of the semester. The semester just began and all enrolled subjects have completed the first study visit.

Reconsent = Yes

Subjects agreed to participate in a study with two visits and now there will be three study visits and additional study procedures. This is a significant change from the study procedures described in the Informed Consent Document that subjects signed. The researcher needs to submit a HawkIRB Modification form to describe the reconsent process in Section VII.D.29 and/or VII.D.30 and use the Edit function to modify the Informed Consent Document. Once that Modification form is approved by the IRB, the research team can contact subjects to conduct the reconsent process.

If the timing of the change in study design was after the previously enrolled subjects had completed all study activities and before new subjects were enrolled at the beginning of the next semester, reconsent of previously enrolled subjects would not be necessary since the change would not affect them. Changes could be incorporated into the HawkIRB application and the Informed Consent Document, approved by the IRB, and presented to new subjects at the time of enrollment.

Example #2: Minor subjects reach the age of majority

A longitudinal study in the College of Dentistry is collecting information about dental health and access to dental care for 5-25 year olds. Subjects are enrolled when they are in Kindergarten and their parents complete annual questionnaires throughout the study.  In this scenario, there is no change in the study design, but subjects who are enrolled as young children will be asked to continue participation after their 18^th birthday when they reach the age of majority.

Reconsent = Yes

If children younger than 18 years of age enroll in a study with parent/guardian permission and the research study lasts beyond when they turn 18, when they reach the age of majority according to State of Iowa law, the subject’s participation is no longer covered by parent/guardian permission. There are two options if the researcher wants to continue to collect data from the now-adult subjects or to work with identified data for research purposes.  

1. Reconsent subjects following an IRB-approved consent process. This is the standard option if the subject will continue to attend study visits and/or provide data directly for the research study.
2. Obtain a waiver of consent for these subjects. If the research team will just continue to work with identified data that was previously collected or the study just involves the collection of existing data from the medical record, the IRB can grant a obtain a waiver of consent.

The plans for subjects who “age up” during the study may be described in the HawkIRB application from the very beginning or they can be added in a Modification form prior to the time any subjects turn 18 years of age.

Example #3: New information about risks from a study medication

After all study subjects have completed all study procedures for a 5-year clinical trial about an investigational drug, the Principal Investigator receives information about additional long term risks from the study drug that were not described in the HawkIRB application or in the Informed Consent Document that subjects signed.

Reconsent = No

This information should definitely be shared with subjects via an IRB approved letter. However, since all subjects are done with the study activities the researcher would not update the Informed Consent Document and reconsent subjects. The Principal Investigator should submit a HawkIRB Reportable Event Form (REF) for new information and a Modification form to describe sending the letter and to attach the letter for IRB approval.

If this new information had been received while subjects were still being enrolled or still participating in the study activities, this information would be shared with enrolled subjects through a reconsent process. It could be shared in a letter to subjects who have completed all study activities.

Usually reconsent is not necessary when the PI submits a Reportable Event Form (REF) about an adverse drug event, adverse device effect, unanticipated problem involving risks to subjects or others or noncompliance. It is possible that a REF for new information could reveal something that should be shared with enrolled subjects. Any of the five types of reportable events could lead to a change in the study design or procedures that would need to be reported to the subject in the reconsent process.

Example #4: Adding a research team member OR revising a recruitment message OR correcting a typo in an Informed Consent Document OR an adverse event in a single subject, etc.

No matter what the study is about, there are many changes in a research study application that do not need to be reported to subjects through the reconsent process. The IRB must review and approve all changes to the study design and procedures; including any change to a document that was previously approved by the IRB. Subjects only need to be reconsented if the change affects their participation in the study or their willingness to continue participation.

Reconsent = No

Adding or removing a team member does not usually require reconsent. However, reconsent may be necessary if a new PI will take over the study and this change affects the contact information that is included in the Informed Consent Document.

If the researcher is adding a new recruitment message, revising an existing recruitment message or correcting a typo in the IRB-approved Informed Consent Document, these changes typically do not require the reconsent of subjects. However, reconsent would be required if the revision to the Informed Consent Document is about a new or revised study procedure that will affect the previously enrolled subjects.

Summary

Whenever a researcher changes the study design or procedures or obtains new information about the study, they should ask themselves, “Does this change affect currently enrolled subjects?” If so, go ahead and plan the reconsent process and describe it in the HawkIRB Modification form seeking IRB approval for the change (in Section VII.D.29, for adult subjects, and/or Section VII.D.30, for child subjects). When in doubt, it’s always best to ask the IRB whether reconsent is necessary.

 

The Role of Risk Management in Reviewing Human Subjects Research

By Kelly O’Berry (Special thanks to Josey Bathke, Chief Risk Officer, for input on this article.)

The Institutional Review Board (IRB) reviews research from the standpoint of protecting the rights, safety and welfare of human subjects. The Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) and UI IRB policies all focus on oversight of the ethical conduct of research. Occasionally, a research study involves unusual circumstances with non-typical or uncertain levels of risk to subjects, to the research team or to the institution. For those studies, the IRB involves the UI Risk Management in the review of the study.

Risk Management Issues

The UI Department of Risk Management, Insurance and Loss Prevention, also known as “Risk Management”, is responsible for minimizing the risk of financial loss to the University through identification and analysis of risk. They are available to consult with the IRB and/or the researcher to recommend and develop strategies to reduce risk while still achieving research objectives. In this article, we will explore some frequent examples of study activities that can involve risks to subjects or others:

• Transportation of subjects
• Incidental recording of illegal behavior
• Data collection in an unsafe locations/environments
• Research involving minors

Transportation of Subjects

There are several examples of potential transportation or injury concerns in research that Risk Management would have strategies to help mitigate risk. Here are some examples of what may require review by risk management:

• Transportation of adult or minor subjects to and/or from their research related visits.
• Research related activities physically occurring in a vehicle or on the roadways.  

In these instances, there may be concerns related to auto insurance, safety issues, or injury.  A review may be required by the IRB regardless of whether the researcher or subject may be driving. For example, Risk Management may have recommendations for the researcher that include making other arrangements for transportation of subjects rather than using the researchers own personal vehicle.  In fact, it is generally recommended that the research does not use their personal vehicle.  Instead, Risk Management recommends using a cab/livery service, public transportation or an institutional fleet services vehicle or other rental vehicle.

There may also be concerns about whose insurance coverage applies when a researcher uses a personal vehicle or University vehicle.  That is why, in some cases, it is best for the subject to arrange for their own transportation and the researcher reimburses that expense rather than actually providing the transportation and assuming that additional risk on behalf of the study and the University.  If a researcher does not want to reimburse for transportation expenses then consultation with Risk Management can be helpful to identify if an additional insurance policy needs to be purchased for the study.

Incidental recording of Illegal Behavior

Some studies could involve audiotaping and/or videotaping in the subjects’ environment, such as a car or in their home. There is a risk that the researcher could record underage drinking, drunk driving or other illegal behavior. It is also possible not all individuals in the vehicle were subjects enrolled in the research.  It is important for all individuals to be informed of the recording.   Risk Management made suggestions for including appropriate notifications in the car (a sticker or sign on the dash) or other locations and can provide advice on what to do with records (audio or video) that may capture questionable/illegal activity.

Data Collection in Unsafe Locations/Environments

When researchers propose to collect data in a potentially unsafe neighborhood or other setting, such as a refugee camp, there are unusual risks to the researcher themselves and potentially to the subjects. Several years ago, a researcher proposed to interview refugees about physical and sexual violence from the guards in the refugee camp. Ultimately, this research study was not conducted because the PI was not able to propose adequate plans to protect subject privacy and data confidentiality. If Risk Management had been consulted, they would have had concerns about the safety of the researchers in a setting or environment that might be unsafe.

In other studies, researchers may plan to go into people’s homes, putting themselves at risk if the setting or neighborhood may be unsafe. Risk Management may recommend some options for collecting data in a way that would reduce the risk for the researcher while still allowing the researcher to collect the necessary data.  Recommendations could include researchers traveling with a partner or escort or meeting the research subject at nearby coffee shop or grocery store.

Research Involving Minors

Research involving minors would not always require review by Risk Management.  There may be scenarios where minors participating in research could intersect with other institutional policies or state law requirements.  Several examples could include situations where research may propose to provide childcare options to allow their parents to participate in research or where minors may be the subject of the research. 

• Providing Childcare - For research involving the parents of small children, it can be a challenge for researchers to find a time/setting to conduct study visits. However, in accordance with Risk Management recommendations, researchers/departments should not provide childcare unless they are an approved licensed childcare center. It is not acceptable to provide childcare even if the parents are in the next room. Researchers could offer childcare for the children in the same room as the parents, which may not be possible for most research projects. Researcher could also offer to compensate the subject for childcare or provide referrals to state licensed childcare centers in the area.
• Transportation of minors Researchers may elect to offer to transport minors to and from research related activities as an incentive to increase enrollment or reach a subject population outside Iowa City.  As noted before, Risk Management advises against transporting subjects in a researcher’s personal vehicle and instead encourages the compensation for transportation arranged by the minor’s guardian.  As a reminder, all research team members interacting with minors must have a background check.  Additionally, there should also be two research team members present at all times when interacting with minors.

The Risk Management Approach

The IRB may consult with representatives from Risk Management in addition to referring a researcher for a Risk Management consultation. Risk Management representatives prefer to meet with researchers one-on-one and discuss the study design, researcher goals and safety procedures. They may also consult directly with IRB Chairs and/or attend an IRB meeting as a consultant. They may provide suggestions about how to adjust the study procedures to minimize the risks to the institution, researchers and subjects while obtaining the research objectives. Ultimately it is up to the researcher to establish the study procedures that are scientifically sound and establish the highest possible level of protections from risk.

The IRB typically consults with Risk Management for situations that are novel or appear to involve higher levels of risk, or risks that have not previously been assessed or managed.  Once a particular situation has been assessed by Risk Management, the IRB can help researchers manage the risk for future studies with similar risks. For example, since Risk Management has already provided guidance about not providing childcare for research subjects, an IRB application reviewer in the Human Subjects Office (HSO) and/or the IRB Chair or Board will make recommendations to researchers based on our knowledge of these requirements.  The IRB highly recommends consulting directly with Risk Management prior to submitting a HawkIRB application proposing an unusual or high-risk study procedure to promote a streamlined IRB review.

Risk Management Contact Information:

430 Plaza Centre One

319-335-0010

risk-management@uiowa.edu  

https://uiowa.edu/riskmanagement/

 

IRB Advisor, July 2018

Right to Try Law Raises Questions about FDA, IRB Oversight

By Brent Collinsworth

Right to try laws have become more popular since 2014, when Colorado passed the first law addressing the issue. These laws open a path for patients suffering from a terminal illness not otherwise successfully treated by any other available options to try treatments that are still under review by the FDA. Congress recently passed a federal Right to Try law that extends this option in states that have not yet passed such laws. However, there is some overlap between these Right to Try requests and the FDA’s expanded access (or “compassionate use”) program. Some people are curious as to whether the new, more relaxed regulations would bypass the expanded access program altogether. Scott Gottlieb emphasized in a recent annual meeting of the American Society of Clinical Oncology that the expanded access program would work side-by-side with Right to Try law, and that both would still exist. However, this perspective appears to be at odds with that of one of the bill’s sponsors. Sen. Ron Johnson (R-WI) wrote a letter to Gottlieb once the bill was passed that the goal of the bill was to reduce the level of FDA oversight altogether, and that the bill was designed “to diminish the FDA’s power over people’s lives, not increase it.”

Much of the impact of the new regulations have not been felt, as institutions and the FDA come to terms with the bill’s impact on both the compassionate use program and IRB review for investigational drugs or devices as a whole. Many institutions do not have specific policies in place yet about whether use of a drug or device under Right to Try would need to be reviewed by an IRB. The law appears to state that “eligible patients” can have “eligible investigational drugs” made available to them as long as they sign a written informed consent, but the regulations do not specify  what makes drugs and patients eligible and how researchers should conduct the consent process.

Other articles in the May issue of IRB Advisor include:

•            “Prepare Contingency Plans for Transferring Oversight”

•             “FDA Explains IRB Written Procedures Policy”

•             “IRBs and IBCs: Critical Partners in Gene Research”

•             “IRBs Can Learn to Make the Most of Central IRB Partnerships”

•             “FDA Proposes Including Children in Adult Cancer Trials”

Current and Past Issues

IRB Advisor (a publication of Relias) is a monthly newsletter with articles about issues facing IRBs and individuals involved with human subjects research. The University of Iowa subscribes to this publication as a resource to UI faculty, staff and student researchers as well as for IRB members and Human Subjects Office staff.

Current and past issues of IRB Advisor are posted in the “IRB ICON Course for Researchers” which is accessible to anyone with a UI HawkID and password. You must access this ICON Course from the Education and Training page of the Human Subjects Office web site. Due to our licensing agreement, we are no longer able to post a link to this publication on the Human Subjects Office website.