November 2023 IRB Connection Newsletter

Index

 

Best Practices for Research Collaboration and Data Sharing
Herky Hint: Data Sharing and Security
Informed Consent Tips
eConsent Process and Checklists
Tabling a Form Submission
Medical Ethics Advisor Newsletter, October 2023
In the News

Best Practices for Research Collaboration and Data Sharing

By Kelly O’Berry, BS, CIP

Collaboration is an important aspect of the research process. UI researchers may collaborate across departments/colleges or with colleagues at other institutions, in the U.S. or outside the country. You should describe these collaborations and any plans for sharing data and/or specimens, in the HawkIRB application. In addition to Institutional Review Board (IRB) approval, other institutional approvals and agreements are necessary for data sharing. See the November 2023 Herky Hint article for how to describe plans for data sharing in the HawkIRB application.

Considerations for Collaboration

An online search yields many suggestions for research collaboration: a brief guide, five strategies, five tips, seven tips, and 13 steps to better collaboration.  The Research Development Office offers a variety of programming and opportunities for collaborating and networking with other researchers. See their Networking Surveys and directory of potential collaborators under each topic.

Here are the IRB-related considerations when entering a research collaboration relationship with non-UI researchers:

IRB oversight responsibility

If the project is federally funded, multi-site research, it will need to be overseen by a single IRB for all sites. The sites need to decide on the lead site to coordinate and oversee the research and the IRB of record. There are fees for use of the single IRB model. Please complete the pre-grant submission survey as soon as you know you will be using this model of IRB oversight.

If the project does not have federal funding, each researcher will need to obtain approval from their local IRB for their research activities. It is helpful to have a final study design/protocol prior to IRB submission so researchers submit IRB applications that are consistent with the planned study procedures.

Non-UI team members

If you collaborate with someone who is not affiliated with an academic institution that has an IRB, you will need to add them as non-UI team members if they are engaged in research activities. The External IRB Coordinator will help you establish the appropriate agreements to extend UI IRB oversight to an individual or institution/agency. 

IRB Approval for Data Sharing

The IRB reviews plans for data sharing just like it does all other study procedures. These activities must satisfy the Criteria for IRB Approval (45 CFR 46.111). In the case of data sharing, the IRB can only approve the plans if:

  • The data sharing procedure is described in the HawkIRB application.
  • The data sharing procedure is described in the Informed Consent Document, so that appropriate subject approval is obtained.
  • Adequate data security measures are in place.
  • The necessary agreements are in place between the UI and the receiving institution.

To facilitate the IRB review process, make thorough, detailed plans for data sharing before filling out the HawkIRB application

UI Health Care Approval for Data Sharing

You will likely need approval from the UI Health Care Data Governance Task Force to share UI Health Care data or protected health information outside the UI. They have separate REDCap surveys for:

Funding Agency Requirements for Data Management and Sharing

NIH and other funding agencies require detailed plans at the time of submission for making scientific data accessible to other researchers within a certain timeframe. Guidance, tools and educational resources are available on the NIH Data Management and Sharing page of the Division of Sponsored Programs website.

Where to Describe Data Sharing Plans

In the HawkIRB application, describe data sharing in the question about whether study data is only accessible to members of the UI research team (Section X.5). When you share data with a non-UI colleague, or if research team members leave the UI and want to take data with them, the appropriate answer to Section X.5 is “No.” This will open the question in the HawkIRB application to describe data sharing plans (Section X.6).

The requirements for data sharing include IRB approval, subject consent (if applicable) and a Data Use Agreement between the UI and the institution of the recipient (see below). For additional guidance on the UI IRB record storage requirements, see the UI IRB Standard Operating Procedures, Section II, Part 23.

The HawkIRB application must specify the individual(s) and institution(s) with whom you will share data (Section X.6). Either specify in Section X.6 that you will work with the Division of Sponsored Programs (DSP) to establish a Data Use Agreement (DUA) or go ahead and initiate the process with DSP and attach a copy of the initiated DUA in the Miscellaneous Attachment category. That demonstrates to the IRB that you know this is a necessary step in the process.

Data Security for Data Sharing

Researchers describe confidentiality protections or data security plans in Section X.4. The question asks about plans to protect paper records, electronic records and biospecimens. The plans typically describe storage on the UI campus or on UI-managed servers or drives. It could also describe plans to transport data from one location to another. The level of data security needs to be appropriate for the sensitivity level of study data. If you have more sensitive data, you need more security for data storage.

When you plan to share data outside the UI, the data security plan must also describe data transmission methods from UI to non-UI researchers/institutions.

If you need assistance establishing a data security plan:

Data Use and Material Transfer Agreements

Study data are not shared from researcher to researcher, they are shared from institution to institution. If data are shared with, or received from, an outside institution, you must have UI institutional approval. The Division of Sponsored Programs (DSP) is the signatory official for the University of Iowa. When sharing University of Iowa data with an individual or entity outside of the University, a DUA or Materials Transfer Agreement (MTA) is usually required as documentation. The Division of Sponsored Programs (DSP) provides guidance and a flow chart on data sharing and data use agreements to assist researchers in determining if the data sharing is permitted, and if a DUA or MTA is needed.

Typically, the sharing institution initiates the agreement process. The DSP website provides guidance for when the UI is the sharing or the receiving institution.

You should submit the HawkIRB application describing the data sharing before contacting DSP for help with establishing a DUA or MTA. They need to see that the UI IRB approved data sharing before they help you establish the agreement.

 

Herky Hint: What to do with all that Data? Data Sharing and Security Guidance

By Rachel Kinker, MPA

This article provides guidance for describing data management and sharing plans in a HawkIRB application. Data security protects the privacy of research subjects and confidentiality of study data. For additional information, see Best Practices for Research Collaboration and Data Sharing (November 2023).

Confidentiality Protections for Data Sharing

In HawkIRB, Section X refers to privacy protections and data security. The Data Security Guidance Tool on the Education and Training page of the HSO website offers helpful information and best practices for data security.

Question X.4 requests the confidentiality protections or data security plan. These are the measures taken to protect data after it is collected. Confidentiality protections include, but are not limited to, using an ID code number or links, locked offices, locked file cabinets, password protected computer files.

Confidentiality protection plans should be in place for each type of data and form of storage (specimens, hard copies, electronic records, etc.).

Paper and hard copy records include hard copy surveys, questionnaires, case report forms, pictures/photographs, and signed consent documents. Describe security measures for paper records; how they will be securely transported, transferred, and stored. Paper records could be transmitted via mail, certified mail, or hand delivered. You may need to encrypt emails with sensitive or protected health information (PHI). Common confidentiality protections for storage and transport include a locked file cabinet, locked office, transporting documents in a folder, envelope, or a locked briefcase.

Electronic records include computer files, electronic databases and web surveys. Describe the protections that will be in place for these records as well as indicating the person (possibly departmental IT personnel) that is responsible for security for the storage of the electronic records via either hard drive, shared drive or laptop. This person is responsible in the event of a breach of security with study data. Common confidentiality protections include password protected files, limited access to folders on a shared drive, and encryption. Record storage in a cloud environment (including electronic data capture platforms) may require a Security Review by UI Information Technology Services (ITS).

Biologic samples include blood draws, cheek swabs, saliva samples, tissue samples etc. Describe the protections in place for the secure storage of these samples and indicate the person responsible for storage and maintenance of these specimens.

If you plan to share data, it is important to provide a detailed description of your data sharing plan in your HawkIRB application to request IRB approval.

Data/Specimen Sharing

If you know up front that you will share data or specimens outside the UI, you can describe plans for that in the sections below in the New Project form. If you decide to share data/specimens outside the UI after you have IRB approval for the project, submit a modification form and edit the following questions. Keep in mind, this sharing includes when the Principal Investigator or a research team member leaves the UI and wants to take data/specimens with them.

If you will be sharing data outside of the UI, indicate ‘No’ on question X.5.

This response will trigger question X.6, in which you describe the individual and/or entity with whom you will share data/specimens with. Specify all individuals who are not members of the UI research team that may have access to data/specimens or with whom they will be shared. Describe how they will have access to the data/specimens and whether they will be identifiable, coded, or de-identified. After the UI IRB approves a data sharing plan, the research team may only share data/samples that were collected after the approval date. It is necessary to reconsent subjects before sharing data/samples collected prior to IRB approval of the data sharing plan.

 

Informed Consent Tips

By Kelly O'Berry, BS, CIP

In 1993, the Office of Protection from Research Risks (now called the Office of Human Research Protections or OHRP) posted guidance on informed consent that is still relevant today, 30 years later. The guidance document was intended to help researchers plan the consent process and the language to describe the study in the consent document. This article provides a summary of those tips.

Informed Consent is a Process (not just a form)

If you’ve attended an IRB lecture on informed consent, you’ve heard us say this. Planning the consent process is as important as crafting the consent document. These requirements are outlined in the federal regulations about the consent process (45 CFR 46.116) and the consent document (45 CFR 46.117).  Conducting a thorough, detailed consent process is the main way researchers satisfy the ethical principle of Respect for Persons as described in the Belmont Report. This requires providing enough information, in a language that potential subjects can understand, to allow them to make an informed decision about whether to participate in the study.

Using lay language is especially important, so the people you are inviting to participate can read and understand the description of the study. When you write a new consent document or evaluate an IRB-approved consent document, you should strive to use language that is accessible to your potential study subjects, avoiding jargon, acronyms and language that would be unfamiliar to people outside your area of study. The purpose of the Informed Consent Document is to communicate information about your study to potential subjects.

The guidance document suggests that researchers should revise the consent document when deficiencies are noted or to add information necessary to facilitate understanding during the consent process. The annual continuing review would be a great time to reassess consent documents and make any necessary updates, but researchers can submit a modification form as needed to make improvements to study documents.

Without Coercion or Undue Influence

The federal regulations (45 CFR 46.116(a)(2)) state,

An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.

Coercion is trying to make someone do something using force or a threat of harm. Most researchers know that is not acceptable in the consent process. The guidance document gives examples of what might be considered coercive. This can include asking subjects to sign off that they understand the information in the consent document. The consent document should be considered a teaching tool, that conveys detailed information about the study.

Undue influence is when someone uses their power or authority to force someone to do something to which they would not normally agree or that is not in their own best interest. Researchers should invite people to enroll in a study without excessively trying to influence them to participate. In some cases, the undue influence may come from someone outside the research team, such as friends or family members trying to get someone to participate in a study. Researchers should anticipate and try to minimize the possibility of communications or circumstances that would put undue pressure on individuals to enroll in the study.

Sections VII.D.29 (adult subjects) and VII.D.30 (minor subjects) of the HawkIRB application ask researchers to specifically state how they will minimize coercion or undue influence in the recruitment and consent process.

The Study Description

The consent document should describe the following aspects of the study:

  1. Overall experience – Inform subjects of what aspects of the research study are experimental. Tell them all reasonably foreseeable harms, discomforts, inconvenience, and risks. Specify what happens if additional risks are identified after subjects are enrolled in the study.
  2. Benefits – Although subjects themselves may not have direct benefits, they may have a sense of helping to answer the research question, which could be a benefit to society. The amount of compensation should cover time and effort and any costs incurred. It should not be such a large amount as to be considered coercive. And the method of distribution should also not be coercive (i.e., holding all payments until the end or only providing compensation if subjects complete the study).
  3. Alternatives – If they could receive treatment without enrolling in a research study, subjects need to be informed about that.
  4. Confidentiality Protections – State if information will be shared or disclosed outside the UI research team. That includes third parties who may transcribe audio or video recordings or enter data. Your departmental IT representative is the first place to start when creating a data security plan. See also the UI IRB’s Data Security Guidance Educational Tool.
  5. Research-Related Injury – It is a common misperception that this only refers to physical injuries. However, these could also be psychological, social, financial, or other types of injury.
  6. Waiving, or Appearing to Waive, Legal Rights is NOT Allowed – Sponsor legal departments sometimes add what is called “exculpatory language,” which waives or appears to waive the subject’s legal rights, to consent templates, which the IRB will not approve.
  7. Contact Persons – There will mostly likely be different contact people to answer questions about the research study, rights of research subjects and research-related injury. The consent document should have names and local phone numbers or other contact information for people who can answer these types of questions.
  8. Voluntary Participation – The informed consent document should explicitly state that there will be no penalty or loss of benefits if people choose not to participate or if they withdraw from the study at any time. Subjects also need to be informed of what will happen, or what they will be asked to do, if they decide to withdraw from the study. The guidance recommends using the statement about voluntary participation directly from the regulations (45 CFR 46.116(b)(8): A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The UI IRB Informed Consent Document Template provides template language for providing this information. The guidance document provides some background information about these requirements.

Additional Requirements for Informed Consent

Some additional provisions in the regulations regarding vulnerable subjects may affect the content of the consent document, and the IRB can impose additional requirements for the consent document beyond the regulatory requirements. We encourage researchers to educate themselves and consult with the Human Subjects Office prior to submitting the HawkIRB application to make sure the consent document contains all the required information.

 

Electronic Consent (eConsent) Process and Checklist

By Catherine Fruehling, MBA

This article provides an overview of an October 2023 presentation about the use of electronic consent (eConsent) and an introduction to the eConsent checklist. A recording of this presentation is available in the Additional Topics section of the IRB ICON Course for Researchers.

eConsent Process

Electronic consent refers to the method of obtaining informed consent to participate in a research study other than face-to-face or paper copies of informed consent documents. Platforms for eConsent include REDCap, DocuSign, Qualtrics, or other online platforms.  Electronic consent may also be obtained via email.  The IRB Educational Tools page of the HSO website offers several helpful resources related to eConsent and other alternatives to in-person informed consent.

Electronic consent processes must contain the Elements of Informed Consent (45 CFR 46.116) and comply with the regulatory requirements for Documentation of Informed Consent (45 CFR 46.117). For studies that are FDA regulated, the use of an eConsent process must also adhere to regulations for Electronic Signatures (21 CFR 11), Protection of Human Subjects (21 CFR 50), and Institutional Review Boards (21 CR 56).  In cases where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.

Currently, the University of Iowa does not support an eConsent platform that is compliant with 21 CFR 11.  A study sponsor might provide and support an eConsent platform that meets the regulatory requirements of the Food and Drug Administration (FDA).

eConsent Checklist     

The Human Subjects Office has developed an educational tool to assist UI researchers who wish to use eConsent procedures for their studies. The purpose of the eConsent checklist is to ensure the eConsent process is compliant with federal regulations and to assist UI researchers with the use of UI-supported eConsent tools, such as DocuSign. The eConsent Checklist and DocuSign Guidance can be found on the IRB Educational Tools page of the HSO website.

Each question in the eConsent checklist addresses a required element of informed consent that must be met by the proposed eConsent process. If the answer to any question is ‘No,’ the proposed process is noncompliant and should either be revised or not used. The checklist also includes links to regulatory guidelines and other resources.

Additionally, the eConsent process should include all the key features of an in-person consent process:

  • Conducted by a researcher listed in Section VII.D.12 of the HawkIRB application who is approved to conduct the consent process.
  • Provides the necessary information for potential subjects to make an informed decision about whether to participate in the research.

 

When using eConsent, the researcher must have a mechanism to assess whether potential subjects understand the procedures and risks of the study and to ensure that potential subjects are making a voluntary decision to participate in the study, free from coercion or undue influence, and awareness that they can choose to withdraw from the study at any time. The eConsent process must be described in detail in the HawkIRB application - Section VII.D.29 (adult subjects) and/or Section VII.D.30 (minor subjects).

We hope the new eConsent checklist and other educational tools are helpful in designing and implementing a compliant eConsent process that works well for your team and for your participants.

 

When and Why the IRB Tables a Form at an IRB Meeting

By Kelly O'Berry, BS, CIP

The IRB can only approve a HawkIRB New Project, Modification or Continuing Review form if it satisfies all of the Criteria for Approval as outlined in the federal regulations (45 CFR 46.111). This article outlines these criteria, describes the decision process for tabling a form and the actions a PI can take to avoid having a form tabled by the IRB.

Criteria for IRB Approval

The IRB uses the following Criteria for IRB approval (45 CFR 46.111) as the basis for the review of every form. The regulations state, “In order to approve research covered by this policy the IRB shall determine that the following requirements are satisfied:” When designing a study and creating the HawkIRB application, consent documents and other study materials, researchers can facilitate the IRB review process by ensuring the project satisfies these criteria:

Risks to subjects are minimized – After identifying all possible risks (physical, psychological, financial, social, legal, other), researchers must specify methods for minimizing risks wherever possible.

Risks to subjects are reasonable in relation to anticipated benefits – The IRB can approve a high-risk study if there is a good possibility of benefits to subjects or to society. That would have a favorable risk-benefit ratio. The IRB would have a harder time approving a low-risk study that has low (or no) potential for benefit.

Selection of subjects is equitable –The inclusion and exclusion criteria has a scientific basis.

Informed consent will be sought* – The requirements for seeking informed consent are outlined in the federal regulations (45 CFR 46.116).**

Informed consent will be appropriately documented* - The requirements for documenting informed consent are outlined in the federal regulations (45 CFR 46.117).**

Adequate provision for monitoring the data collected to ensure subject safety – Studies involving treatment or physical intervention must have an internal or external committee to review summary or aggregate on a regular basis throughout the study.  

Adequate provisions to protect subject privacy and to maintain the confidentiality of data – Privacy protections protect the person, from whom, or about whom, the researcher collects data. These protections allow subjects to keep private information to themselves. Confidentiality protections protect study data – paper and electronic records, biospecimens, audio and video recordings, etc.

Alternate determinations for Limited IRB Review – This only applies to research that qualifies for Exempt Status. It is not applicable for full board review.

Additional safeguards for subject likely to be vulnerable to coercion or undue influence – Such as children, prisoners, individuals with impaired decision-making capacity, economically or educationally disadvantaged persons, or other (possibly situational) vulnerabilities.

* Several types of Waivers of Consent provide an exception to the requirement to obtain and/or document informed consent.
** See Informed Consent Tips in November 2023 IRB Connection Newsletter.

Factors in Decision to Table

During the IRB review process, Human Subjects Office staff request clarification and make suggestions for changes to help researchers get their HawkIRB application and attached documents comply with the Criteria for IRB Approval. The Application Analysts provide this service to try to prevent from having the IRB table a form at a meeting.

There are four options for the IRB to make during an IRB meeting:

  • IRB approval are “as-is” (straight approval)
  • IRB approval “with conditions” (specific required actions can be outlined in the meeting minutes and, if addressed, the study can be approved)
  • Table the review of the form (The form does not meet the criteria for IRB approval, but the IRB cannot specify the actions required to modify the study design or procedures.)
  • Disapprove the form (The IRB would prefer to work with the PI to modify the study design, so it meets all Criteria for IRB Approval.)

Obtaining IRB approval is still possible when the IRB tables the review of a. When the IRB tables a form, the meeting minutes describe controverted issues and concerns so the PI and research team can address them. The PI has 21 days to respond to the required actions in the minutes; longer than the standard 14-day response deadline for approval with conditions.

The minutes should serve as a guide for the PI to makes the required changes to the HawkIRB application. Once that is done, the form goes through staff review and is scheduled for the next available IRB meeting. Sometimes the PI is invited to attend the second IRB meeting, in person or via Zoom, to answer questions from the board. The board will be able to approve the form if it satisfies the Criteria for IRB Approval.

At any point in the process, the PI can reach out to the Application Analyst or the IRB Chair for further guidance or clarification on the steps necessary to modify the form so it can be approved by the IRB.

 

Medical Ethics Advisor Newsletter, October 2023

By Rachel Kinker, MPA

Medical Ethics Advisor (a publication of Relias, LLC) is a monthly newsletter with articles about human subjects research and medical ethics. Current and past issues of Medical Ethics Advisor and IRB Advisor are posted in the “IRB ICON Course for Researchers.” The portal to this ICON Course is on the Education and Training page of the Human Subjects Office website. This month we are spotlighting some articles about human subjects research from the October 2023 Medical Ethics Advisor Newsletter.

To Pay or Not to Pay: Researchers Grapple with Implications of Reimbursing Study Participants

Payment to research participants is generally considered normal practice, however, there can be concerns regarding the amount. Researchers may have budgetary limitations and IRBs may be concerned with the potential undue influence caused by the payment amount. It could be viewed as paternalistic for researchers or the IRB to determine what amount is too high to affect a participants decision making capacity. There is currently no specific guidance regarding payment amounts, but researchers can review previous data on similar studies and what they have paid participants in the past and discuss with participants what they feel would be a fair payment amount to participate in the study.

The following are considerations for researchers when making payment decisions.

  • Are you paying the participants enough?
  • Does the payment amount show respect for the participants time?
  • Is the payment amount commensurate with people’s time and effort?
  • Is the payment method accessible to everyone? Often cash is preferred for this reason.
  • How will payment be discussed during the consent process? Researchers should specify the payment schedule and amounts.
  • Is there clear information regarding payment if the participant decides to drop out of the study? Generally, the voluntariness of the participant could be impacted if the study requires multiple visits with an end of study payout.
  • Is there clear information regarding payment if the study closes early?

Articles in the October 2023 Issue:

  • Does Current IRB System Ensure Ethical Research?
  • Growing Concerns About Health Data Use
  • Patients Say Researchers Are Ethically Obligated to Return Study Data
  • To Pay or Not to Pay: Researchers Grapple with Implications of Reimbursing Study Participants
  • Literature Review Reveals Gaps in Research on Assisted Reproductive Technologies
  • Clinicians Need Proactive Approach to Ensure Ethical Artificial Intelligence Use
  • Higher Mortality Rates Among ICU Patients with Alzheimer’s Disease
  • Ethics Consults Focus on the Criteria Used to Determine Death
  • Survey: Patient and Family Ethical Worries May Go Undetected
  • Compensation, Employment Models Vary Widely in Clinical Ethics Field
  • How Ethicists Can Make Business Case for Resources
  • Surgeons May Need Additional Ethical Guidance

In the News