April 2022 IRB Connection Newsletter

Index

 

Reminder: Pre-Grant Submission Survey for Single IRB Model

Annual Disclosure of Outside Activities Due Apr 30

The IRB Review Process—How Long is This Going to Take?

Going Abroad? Plan Ahead to Conduct Research Outside the U.S.

ClinicalTrials.gov Guidelines for Reporting Results – A Presentation to Simplify the Process

Presentation Overview: Single IRB of Record Review Model for Federally Funded, Multi-Site Research

Medical Ethics Advisor Newsletter, February 2022

In the News

 


 

Reminder: Pre-Grant Submission Survey for Single IRB Model

By Kelly O’Berry, BS, CIP


Federal agencies require the use of a single IRB (sIRB) for federally funded research conducted at multiple sites. This means one IRB oversees research conducted at some or all of the study sites. The budget must include the fees for this type of IRB review and this type of research may require some additional approvals and agreements. Researchers can access information about UI IRB fees for budget planning.

If you are planning to submit a grant proposal to the National Institutes of Health (NIH) or any other federal agency that requires the sIRB model, complete the Pre-Grant Submission Survey as soon as you become aware of the award notice. Plan ahead and complete this survey well in advance, especially if the Iowa IRB is either serving as a lead IRB or relying on an external IRB as an expectation of the grant!

If you have questions or need any assistance, contact the External IRB Team at uirb-external@uiowa.edu.

 

Annual Disclosure of Outside Activities Due Apr 30

By Martha Hedberg, MPA


eCOI Logo
All UI faculty and staff identified as key personnel that conduct human subjects research are required to complete an “Annual Disclosure of Outside Professional Activities and Interests” via the eCOI online disclosure portal by April 30, 2022. This article describes the disclosure requirements and highlights new questions that were added to the eCOI disclosure form in 2022.


The University of Iowa community is committed to the principle of free, open, and objective inquiry in the conduct of its teaching, research, and service missions. Further, the University of Iowa encourages its employees to engage in external activities that promote the University's mission, contribute to their professional fields, enhance their professional skills, and/or enhance the public good. To ensure that external activities are conducted in a manner consistent with institutional and public values, policies have been established to ensure that University employees avoid improper conflicts, and otherwise disclose activities for review and management.

Employees may monitor compliance with this annual disclosure requirement via the UI Compliance and Qualifications system accessible through UI Self-Service “My Compliances” tab.  Employees who have not completed the requirement will receive reminder emails on April 1,April 25,and April 30.  Supervisors and Compliance Administrators will be copied on the final two notifications. After April 30, employees may add new, review or edit previously-submitted reports directly using https://ecoi.uiowa.edu.

Implications of the Annual Disclosure Requirements with Human Subjects Research

If research team members identified as key personnel have not completed the 2022 annual disclosure by May 1, 2022, HawkIRB will flag them as noncompliant.  This flag will prevent the Principal Investigator (PI) from submitting any new projects, modifications or continuing reviews to the IRB until the annual disclosure of the research team member is complete.  An incomplete annual disclosure could result in removal of the team member from the IRB application and thus, participation in the conduct of any research related activities. 

Who Should Disclose

Under this policy, “key personnel” means anyone involved in the design, the conduct and/or the reporting of the research. These roles are specified because they provide opportunities for the introduction of bias into the research. If you are unsure if this applies to you, check with the PI of any studies in which you are a research team member. HawkIRB automatically defines the PI and any research team members with a faculty appointment as key personnel. 

What to Disclose

Disclosures should be submitted to the University for any outside activities and interests that are related to an employee’s role or area of expertise at the University. For more detail about what types of activities to disclose, see the Conflict of Interest in Research’s website.

International Engagement

The eCOI system continues to collect information about international engagement. NIH Grants Policy Statement defines a Foreign Component or engagement as “any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended" and includes “collaborations with investigators at a foreign site anticipated to result in co-authorship; use of facilities or instrumentation at a foreign site; or receipt of financial support or resources from a foreign entity.” 

International collaboration is often an important aspect of those activities. To ensure it is conducted in a manner consistent with institutional and public values, policies have been established to ensure that UI employees avoid improper conflicts by disclosing those relationships for review and management. Full and timely disclosure regarding research support and conflicts of interest is essential to ensure compliance with federal regulations and sponsor requirements.

Failure to disclose this information can have significant fiscal and regulatory consequences, impacting both the individual PI and the institution. This addition will assist with identifying possible risk to research integrity and security which may require conflict of interest management or adherence to other federal regulations. 

New for 2022Continuing Medical Education Requirements

In order to ensure adherence to Accreditation Council for Continuing Medical Education (ACCME) accreditation standards, additional definitions were added to the Definitions section of the eCOI Overview page. Two additional questions were also added to the individual disclosure reports. These include a question to report whether the relationship with the entity is ongoing or has ended, and a free text question to share the type of business they conduct.

Institutional Policies

The Annual Disclosure fulfills the reporting requirements of the following UI policies:

Thank you for your contributions to ensuring that UI academic, health care, business, research, and teaching endeavors may be free of potential or actual conflicts of interest.

 

The IRB Review Process—How Long is This Going to Take?

By Joanie Hoefer, BS, CIP


The length of time it takes for a HawkIRB form to go from submission to approval is a very important question for the research community, the Human Subjects Office (HSO), the UI Institutional Review Board (IRB) and the entire Human Research Protection Program (HRPP). This article is a follow-up to the description of the review process that appeared in the October 2021 IRB Connection newsletter and will describe review goals and variables affecting the amount of time it takes to receive IRB approval.

Institutional Goals for IRB Review

IRB/HRPP processing goals are based on national metrics issued by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and are calculated using a median time. IRB review goals vary by the type of review (Full Board, Expedited Review and Exempt Status). The review process time frame is calculated from the point the submitted form is complete enough to begin staff review to the time the project is released to the Principal Investigator (PI). Total review time includes not only IRB review, but also other HRPP committee reviews and the time a form is with the PI to respond to workflow questions. 

Institutional median goal by submission type

Project Type

IRB Review Type

Median Goal

Greater than minimal risk

Full Board Review

45 Working Days

Minimal risk

Expedited Review

21 Working Days

Little to no risk

Exempt Status

14 Working Days

 

Factors That Affect IRB Review Time

There are several factors affecting IRB review processing:

The type of form

A researcher can submit the following types of forms in the HawkIRB system: New Project, Modification, Continuing Review, Reportable Event Form (REF) or Project Close form. Generally, a New Project form takes longer to review than a simple modification form because it is longer and requires review of every aspect of the study design, procedures and documents. However, if a researcher makes extensive changes to an approved project, the review of that modification form will take longer than a modification form to update the research team.

hourglass
The type of review

Studies that pose more than minimal risk to participants must be reviewed and approved by a convened IRB board. Extra review time is needed for these types of studies to allow for scheduling the form on the agenda of an upcoming board meeting and the preparation of the minutes after the meeting has concluded. Studies that pose minimal to no risk to subjects can qualify for Expedited Review or Exempt status. These forms can be reviewed and approved by a single IRB Chair or Chair Designee and generally do not take as much time for approval as a full board study.

Requires other committee review

Several other committees conduct their review in the HawkIRB system. Any delays in their approval affect the total amount of time to approval and release of the project to the study team.

Which IRB reviews the project

The University of Iowa IRBs have different meeting schedules. The bio-medical research board (IRB-01) meets six times a month. The social/behavioral/educational research board (IRB-02) meets the once a month (as needed) and the Veterans Administration Healthcare System board (IRB-03) meets once a month. It’s important for researchers to factor in these meeting days when getting ready to submit a form that may need to be reviewed by the full board.

Number of forms in the queue

Typically, Application Analysts process forms in the order they are received. However, they give priority to pending forms based on the amount of time a form has been in staff review. That means they prioritize forms that have been returned after the PI addressed questions in Workflow.

Quality of the form submitted

This is the main factor over which the researcher has complete control. Review time will be longer if the form does not contain enough information for the IRB Chair or board to assess whether it satisfies the regulatory criteria for approval (45 CFR 46.111). The HawkIRB application should include sufficient details about study procedures to “stand alone,” independent from an attached protocol. The HawkIRB form should provide the complete picture of the study. The HawkIRB form should be provide a consistent description of study procedures. The researcher will need to resolve any inconsistencies between questions and/or attachments before the form can be passed on to the Chair or the board. Poorly written and incomplete or inconsistent forms slow down processing time for ALL forms being reviewed. Incomplete forms may be returned to the researcher without review.

Response to Workflow

The researcher also has complete control over how quickly they respond to questions and route the form back to the IRB. Active review of the form stops when the IRB routes a form to the PI through Workflow. When a form is with the PI, HawkIRB sends automated emails every two weeks to the principal investigator, their delegates and research team members who are listed as contacts for the project. The IRB hopes that these reminders will prompt the PI to address the questions and route the form back in a timely manner.

Staffing levels

Several full-time positions have been added in the HSO since 2018 to assist with the growing submission review workload.  However, similar to what many industries and other academic institutions are experiencing, filling open positions and retaining skilled staff has been challenging. Review processing goals can only be met when HSO positions are filled with well trained staff.  

For additional information about the IRB review process, review the Frequently Asked Questions topics What to Expect During the IRB Review Process  and the Status of a Submitted Application on the HSO website or Section I, Part 11.C in the University of Iowa IRB Standard Operating procedures (SOP) & Researcher Guide.

 

Going Abroad? Plan Ahead to Conduct Research Outside the U.S.

By Kelly O’Berry, BS, CIP


It is a wonderful opportunity to conduct research outside the U.S. Before you submit a HawkIRB application, you need to know, and plan ahead for, additional approvals and documentation required for international research.

Congratulations! You are doing research in another country. Below is guidance and best practices for designing and preparing for your project.

flag globe
Identify Laws/Rules for Research in the Country

You need to follow any local laws that govern the type of research you will conduct. That means you may need in-country ethics board approval, or approval from a Ministry of Health or a license from a government agency.

The Office of Human Research Protections (OHRP) in the U.S. Department of Health and Human Services, maintains an International Compilation of Human Research Standards that contains over 1,000 standards from 131 countries and international organizations. (You can also access the compilation by searching for “OHRP” in your browser and clicking on the “International” tab.) OHRP provides regional compilations of human research standards for Africa, Asia and the Pacific, Europe, International Organizations, Latin America and the Caribbean, Middle East/North Africa, and North America. To use this compilation, use CTRL-F to search the document for the country name. Review the laws to see if they apply to your type of research. You may need an interpreter if you cannot read the regulatory documents/materials.

Most countries only have laws related to biomedical research. OHRP used to have a separate, smaller compilation of countries that have laws about social/behavioral/educational research. However, that information is now rolled into the main international research compilation. Use CTRL-F to search for “Social-Behavioral Research.”

Design the Project

Plan the study to comply with local customs and cultural and religious norms. This applies to both the study documents and the study procedures. In some countries, it is not standard practice for subjects to sign an Informed Consent Document. The researcher can request a waiver of documentation of consent in Section VII.D.16 of the HawkIRB new project application. There are other aspects of the study that may need to be established based on the norms and standards for conducting research in that country. For example, in some cultures, the researcher obtains permission from a tribal leader or elder to conduct the research project and there is no consent process with individual subjects. In some cases, it may be necessary to have someone else present during study procedures.

During the design phase, the researcher should consult with someone who is knowledgeable about conducting research there.

If you are conducting research in a European Economic Area (EEA) country, you will need to comply with the General Data Protection Regulations (GDPR). See the UI Operations Manual, Chapter 46. Contact the Human Subjects Office (irb@uiowa.edu) for additional guidance.

If you are conducting research in China, there is a similar new law called the Personal Information Protection Law (PIPL) that was passed in November 2021 that may be applicable to the conduct of your research.  Contact the Office of the General Counsel (general-counsel@uiowa.edu) for additional guidance. 

Begin a Draft HawkIRB New Project Form

Generate a draft New Project form in HawkIRB. Fill it out to describe the study procedures, attach any documents that will be used to conduct the research, but DO NOT submit the form until you have in-country ethics board approval or a local context review. Drafting the New Project form up front can help you finalize the study design and procedures before you approach other entities that might need to review or approve the project.

Obtain In-Country Ethics Board Approval (if necessary)

If the country has laws that apply to the type of research you are doing, contact the in-country ethics board to initiate their application and review process. Other countries may not have an Institutional Review Board (IRB), but they might have an independent ethics committee (IEC), an ethical review board (ERB), a research ethics board (REB) or a research ethics committee (REC). Whatever they call it, you will need their approval before you submit your application for UI IRB approval.

You may need to consult with researchers in the country about how to obtain ethics board approval. The draft HawkIRB New Project form, with a thorough, detailed description of the study procedures, may help you prepare the application for the in-country ethics board.   

A few recommendations about in-country ethics board approval:

  • It can take a long time - Some ethics boards meet infrequently or only as needed. Submit the application to them far enough in advance to receive approval and then submit your HawkIRB application for UI IRB approval.
  • Translation may be required – If the application to the in-country ethics board is in a language other than English, unless you speak the local language, you will need a mechanism to prepare that submission. You will also need to translate the approved documents into English. You must provide the IRB with the original documents and the English translation.

Attach the in-country ethics board approval memo (and translation, if necessary) in the Miscellaneous Attachment category of the draft New Project form.

Obtain Local Context Review (if no in-country ethics board)

The local context review provides input and guidance for the IRB to make sure the project complies with norms, standards and any laws or regulations that apply to the conduct of the study. A local context reviewer is someone who has experience conducting a similar type of study (either biomedical or social/behavioral/educational) in the country where the researcher plans to conduct the project. They could be a researcher at the UI or another academic institution in the U.S. or they could be a researcher in another country.

Generate the Local Context Review form in the drop-down menu of the Miscellaneous Attachment category on the draft New Project form. Insert the location of the study activities on the first page and ask the local context reviewer to respond to the questions and provide their CV or resume to document their expertise. Attach the completed Local Context Review in the Miscellaneous Attachment category of the draft New Project form.

Letter of Agreement (if applicable)

Obtain a Letter of Agreement for each site for which approval is required to conduct research activities. When you indicate in Section VII.A.1 of the HawkIRB application that you are doing research outside the U.S., an attachment category for a Letter of Agreement will open. This documents the agreement between the researcher and the location where the research will be conducted, such as a school, business, clinic, social service agency, or NGO. It indicates that the researcher has permission to conduct research in that location. The IRB needs this documentation before approving a project. In some cases, a letter of agreement may not be an appropriate method to obtain permission to conduct research. This should be discussed with the local ethics board or local context reviewer.  Some cultures may require you to speak with an elder or seek some other verbal form of agreement to proceed.  Whatever the cultural context for agreement may be, it should be documented in the IRB application as part of the local context or ethics review.

  1. Figure out if you need a Letter of Agreement. If you are conducting research in a location where you would normally need permission to be there, then you need a Letter of Agreement. However, if you are doing research in a public place, such as a coffee shop or public park, you do not need permission to be there and a Letter of Agreement is not necessary. The HawkIRB system will let you submit your New Project form without a Letter of Agreement, but if it turns out you need one, it can delay IRB approval while you obtain the letter.
  2. Talk to the site to establish the agreements about what will happen during the research study and what the researcher and the site will do.
  3. Generate the Letter of Agreement template from the drop-down menu of the Letter of Agreement category on the Attachments Page of your draft New Project form. Use the instructions to make sure the letter includes all necessary information. The site can add any additional information or make any edits. Ask the local site to put the Letter of Agreement either on their letterhead OR send it from an email address associated with the site (preferably not a Yahoo or Gmail account).
  4. Attach the letter in the appropriate Attachment category of the draft New Project application.
  5. Repeat these steps for any additional locations that require permission to do research activities at that site.

Obtain UI IRB Approval

UI faculty, staff and student researchers need UI IRB approval to conduct research on campus, off-campus or outside the United States (UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 8.C. International Research). You will be ready to submit the New Project form once you provide a complete description of the project in the application and attach all necessary documents and approvals, including the in-country ethics board approval or Local Context Review and the Letter of Agreement (if applicable).

The IRB must review study materials in English and translations into any other languages. First attach documents in English. When they are ready to be approved, the IRB will route the form back to the researcher for translation.

It can take more time than you would expect to receive in-country ethics board approval OR identify a local context reviewer and have them review the study protocol and complete the review form. It is best to plan ahead to obtain all required documentation and submit the New Project form far enough in advance to obtain IRB approval before the proposed start date for the project.

University of Iowa Requirements for International Travel

UI faculty, staff, and students planning international travel to conduct human subjects research must adhere to institutional policies and procedures for international travel. Undergraduate, graduate, and professional students traveling for a university purpose may submit an international travel registration request to International Programs. Approved student travel is entered in the ProTrav system by International Programs. The University of Iowa mandates international health insurance for all UI students traveling abroad for educational purposes—studying abroad, interning, conducting research, performing a rotation, presenting at a conference, or any other educationally-related activity abroad. Health insurance is also available for faculty and staff traveling on university business.

Follow these links for additional information about these requirements:

Faculty and staff inquiries regarding international travel can be directed to safety-abroad@uiowa.edu

 

ClinicalTrials.gov Guidelines for Reporting Results – A Presentation to Simplify the Process

 By Fozia Ghafoor, MBBS


This article provides an overview of an IRB presentation in February of 2022 that demonstrated how to update the results section of a ClinicalTrials.gov (CT.gov) record to be in compliance with the FDA regulations. A recording of this presentation is available in the Additional Topics section of the IRB ICON Course for Researchers.

If a study fulfills the criteria of an “Applicable Clinical Trial” or “NIH Clinical Trial,” the responsible party (i.e. the principal investigator (PI)) must register the study with ClinicalTrials.gov (CT.gov) and are responsible for the submission of scientific and administrative information about the results of the trial as well.

For applicable clinical trials (ACTs) that are subject to 42 CFR 11.42 and NIH clinical trials, the standard submission deadline for results information is no later than one year after the study's primary completion date, as described in 42 CFR 11.44(a) of the Final Rule. The primary completion date is the date that the final participant was examined or received an intervention for the purposes of the final collection of data for the primary outcome. This applies if the study concluded according to the pre-specified protocol or was terminated. If a study has more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all primary outcomes. Once the primary completion date is reached, the responsible party must update the primary completion date to reflect the “actual” date rather than the “anticipated” date in the PRS record. The person submitting the results information to  CT.gov must be very familiar with the study design and data analysis to accurately summarize the results information in compliance with federal regulations (section 801 of the Food and Drug Administration Amendments Act, FDAA 801) and the CT.gov review criteria.

The February 2022 presentation given by the PRS Administrator covered the following topics:

  • CT.gov registration and results submission requirement
  • Deadline for submission of results
  • Purpose of results reporting
  • CT.gov results database
  • Steps for submitting results of a clinical trial
  • Editing and updating the record results
  • PRS support, training material, and assistance
  • CT.gov results information review process
  • Consequences of noncompliance

The University of Iowa policies regarding ClinicalTrials.gov registration and results reporting can be found in the ClinicalTrials.gov Investigator’s Guide on the ClinicalTrials.gov Requirements page found on the HSO website.

 

Presentation Overview: Single IRB of Record Review Model for Federally Funded, Multi-Site Research

By Jarrod Feld, BA


This article provides an overview of a presentation in March 2022 about utilizing a Single IRB of Record Review Model (sIRB) for NIH and other federally funded human research studies. A recording of this presentation is available in the Additional Topics section of the IRB ICON Course for Researchers.

Key take-aways:

As of January 2020, most multi-site human research studies funded by NIH and other federal agencies require all sites working under the same protocol to use a single IRB of record. Exceptions include:

  • Exempt research
  • Sites located outside the United States
  • Sites where sIRB review is prohibited by federal, tribal, or state regulations (including Veterans Affairs sites)
  • If the funding agency has made an exception due to a compelling reason (this is extremely rare)
  • Career development (K type), research training (T), or fellowship (F) grants, even if it is collaborative.

If you intend to apply for a grant that may require the University of Iowa to serve as the single IRB of record over other sites, please plan ahead and contact the Human Subjects Office (HSO) early in the process. The HSO requires the UI Principal Investigator (PI) to submit a pre-grant submission survey to gather information about the proposed study. This information helps the HSO determine whether the UI IRB can serve as the lead IRB for the study. Note: the HSO requires at least 14 days to review any sIRB requests.

There are several important considerations the PI should keep in mind when thinking about being the lead site for a study. These include:

  • The other sites’ platform for establishing reliance between institutions. The UI prefers using the SmartIRB platform, which nearly 1000 other institutions have also agreed to use. If a potential relying site does not use SmartIRB, there are other options for establishing reliance.
  • Understanding the UI’s role as the lead site/IRB. This can be a very time intensive endeavor for the UI PI and the research team.
  • The capacity and location of potential relying sites (e.g. Iowa cannot serve as lead IRB for any California sites).
  • Establishing a thorough communication plan between sites, their respective IRBs and Human Research Protection Offices, etc.

The HSO has specific requirements and expectations for proposed research with a single IRB, especially when the UI is the proposed IRB of record. The PI and study team will be expected to meet with HSO staff for an onboarding meeting after a grant award notice is made, and if requested, during the initial study review in HawkIRB or when adding relying sites to the study. Best practice is for the UI team to obtain IRB approval for their study activities first, then add relying sites, one at a time, via subsequent modifications to the study.

Conversely, another site may approach a UI researcher to potentially rely on their institutional IRB. There are important considerations for this type of reliance as well, including the lead IRB’s policies and expectations, how documents will be submitted to and received from the lead site/IRB, their detailed plan for communicating with the UI researchers during the study, etc.

The most important take-away of any study that uses sIRB review, is to contact the HSO early and often. Single IRB studies can quickly become very complex for a variety of reasons including the number of stakeholders involved across all sites, the complexity of procedures and local context considerations at sites in other states, and the amount of documentation that will need to be completed and submitted for review.

More information is available in this presentation and on the External and Central IRB Reliance Models page of the HSO website. Please contact the External IRB Coordinator, Jarrod Feld, or other HSO colleagues, via the shared UIRB-External@UIowa.edu email address, or via the HSO’s general phone line, 319-335-6564. 

 

Medical Ethics Advisor Newsletter, February 2022

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 February 2022 Medical Ethics Advisor Newsletter.
 

Incentives for Online Surveys Boost Research Participation, But Fraud Remains a Concern

Online surveys can easily be shared, and as such are easy targets for fraud.

Recommendations and considerations to prevent survey response fraud:

  • Consider fraud detection safeguards early on in study planning, allot time and resources to ongoing and rigorous data quality checks, invest in fraud detection technology
  • Some precautions could unintentionally dissuade eligible participants due to extra steps
  • Additional verification questions could require justification to IRBs for identifying information and geolocation
  • Gift cards, lotteries and other incentives create an incentive for individuals to respond more than once
  • Be mindful of signs of duplicate responses; email addresses and passwords that are similar, surveys with the same answers selected repeatedly or a response pattern, responses that don’t make sense or contradict previous responses, investigate if responses don’t match enrollment criteria
  • Develop a plan for the inevitable fraudulent response: do you check responses prior to payment? Withhold payment from responses that appear fraudulent?
  • To guard against fraud, avoid calling attention to compensation in advertisements, consider not offering compensation at all for surveys at higher risk for fraud (anonymous public-facing surveys), if offering compensation, mandate identify verification as a requirement for payment

IRBs Are Reviewing Artificial Intelligence Research, Outside Expertise Needed

Health-related artificial intelligence (AI) research poses unique and complex ethical issues. Some AI projects fall outside of what constitutes research and could bypass IRBs. Considerations and potential solutions:

  • Ask IRB to review agreements with outside entities (software vendors, biotech firms)
  • IRBs needing expertise to understand the potential bias and privacy risks associated with applications and research can utilize the academic computer science community to review study protocols
  • Additional processes and safeguards may be needed as the downstream ethical implications and consequences of technological and scientific discoveries are not within the scope of the IRB

IRBs Are Scrutinizing Digital Tools for Informed Consent

Multimedia digital tools can be easier to use, provide more people the ability to complete consent independently, and are sometimes perceived as taking less time to complete. While there are many benefits, there are considerations for IRBs:

  • Quality of subject and investigator interaction shouldn’t be dependent upon quality internet connection, type of computer, or familiarity with software.
  • Digital tools do not negate the need for discussion of risks and benefits between the researcher and the subject
  • Need for technical support; if something goes wrong, who will fix it?
  • Data security; is the technology compatible with the requirements of the institution?
  • Are the digital tools appropriate for the type of research or subject population?
  • What are the risks and benefits of using digital tools?
  • If the digital consent tool is required for all subjects, how will researchers handle subjects that are visually challenged, lack access to technology, or are non-English speakers?
  • Do the digital tools enhance the consent process as a whole?
  • What multimedia options will help the subject to best understand the research (video, interactive elements, attention-check questions)?
  • How will it be verified that the subject looked at or listened to the content instead of skipping past it?
  • How will participants be able to ask a question during the digital consent process?
  • Can a tool be created in a cost-efficient manner?

Articles in the February 2022 Issue:

  • Industry Payments to Surgeons Increased Despite Transparency Requirements
  • Expedited Approval of Medications Calls Evidence Standards into Question
  • Clinicians’ Confusion over Brain Death Criteria Persists
  • Access Problems with Pediatric Mental Healthcare Raise Ethical Worries
  • Hospitals Disproportionately Sue Low-Income, Rural, and Black Patients
  • Rural Patients Still Lack Palliative Care Access
  • Gene Editing Is Popular, But Controversial, Research Area
  • Orthopedic Surgeons Say ‘Open-Label’ Placebos Are Ethical, Yet Few Use Them
  • Study Shows Ethics Complaints in Psychiatry Could Be Declining
  • Physician Assistants in OB/GYN Field Want More Ethics Expertise

 

In the News, April 2022