Clinical and Translational Science Institute
Advancing today’s discoveries to improve health for all.

Ethical Considerations

Ethical Considerations from a Regulatory Perspective

Important ethical considerations with regulatory support.

Ethical Support we provide:

  • Research Subject Advocate
  • Ethical guidance for protocol, research planning and consent development
  • Training and Educational Opportunities

Request support for ethical considerations from a regulatory perspective by contacting the CTSI-Regulatory Team.

What is a research subject advocate (RSA)?

A research subject advocate is independent of the research team who acts on behalf of a research participant. 

An RSA can:

  • Address concerns regarding a subject’s experience in a research protocol, and can direct any questions, complaints or ideas for improvement of research practices.
  • Be present during the process of consent for high-risk studies, as advised by the Senate Advisory Committee for Human Research Protection.
  • Provide a research participant perspective while planning study protocols.

What Ethical Considerations should be Addressed During Research Planning and Protocol Development

Researchers should approach ethical considerations from a multi-pronged approach and should base their ethical considerations off the Belmont Report, respect for persons, beneficence and justice.

Researchers should consider ethical standards when developing their recruitment plan, identifying their target population, determining inclusion/exclusion criteria, obtaining informed consent, protecting subject confidentiality, identifying risk of harm and evaluating the risk/benefit ratio, and communication of the study results. Research should be based on scientific validity and social and clinical value. 

Human subject research is required to undergo an independent review by an independent ethics committee, such as the Institutional Review Board (IRB).

ClinicalTrials.gov

ClinicalTrials.gov

Support to get your study registered on ClinicalTrials.gov.

Support we provide: 

  • Determining if your study should be registered.
  • Identifying required consent language address the CT.gov registration
  • Guidance for protocol registration and result reporting
  • Troubleshooting for registration and result reporting errors
  • Providing quarterly communication reports to Department Chairs and Associate Deans of Research regarding problem records. 

Request support with ClinicalTrials.gov registration, results reporting, or addressing problem records. 

Additional Tools, Templates and Resources

FAQs

IRB Submission

IRB Submission

Find numerous resources to help navigate the IRB.

IRB Submission Support we provide: 

  • Addressing general IRB questions
  • Regulatory and ethical guidance for how to address or IRB modifications, for initial submissions, amendments, continuing reviews and event reports
  • Regulatory Training and Guidance for Regulatory Compliance Officers outside of the CCRM and CTO

Request support for Essential Documents by contacting the CTSI-Regulatory Team. 

How do I utilize the Multicenter IRB Review?

The Ohio State University is committed to accelerating the IRB approval process for clinical research. This is illustrated through the establishment of:

  • IRB Authorization Agreements
  • IRB Reciprocity Agreements
  • Individual Investigator Agreements (IIAs)
  • Institutional Authorization Agreements (IAAs)

Ohio State has established IRB Authorization agreements to cede IRB review to the following external IRBs:

  • Advarra IRB - for review of some industry sponsored clinical trials
  • National Marrow Donor Program (NMDP IRB) - for review of studies sponsored by the Bone Marrow Transplant Clinical Trials Network (BMT CNT)
  • NCI CIRB – for review of select NCI-sponsored clinical trials
  • WIRB Copernicus Group IRB (WCG IRB) - for review of most industry initiated and sponsored clinical trials

Ohio State has an established IRB Reciprocity Agreement with Nationwide Children’s Hospital that permits Ohio State and Nationwide Children's Hospital to collaborate in the review and oversight of human subjects research that would otherwise require review by both organizations. This agreement applies when an:

  • Ohio State Investigator performs or is engaged in a study at Nationwide Children's Hospital
  • Nationwide Children's Hospital investigator performs or is engaged in a study at Ohio State

The CTSI has an established agreement between Ohio State’s Office of Responsible Research Practices and the eight institutions that compose the three CTSA sites in Ohio, to allow for one IRB to serve as the IRB of record for multi-center clinical research studies involving these CTSA-affiliated institutions which include:

  • The Ohio State University
  • Nationwide Children’s Hospital
  • University of Cincinnati
  • Cincinnati Children’s Hospital Medical Center
  • Case Western Reserve University
  • University Hospitals – Cleveland
  • MetroHealth
  • Cleveland Clinic Foundation


Read Ohio State’s IRB Guide to Establish Ohio State as Your Central IRB


Ohio State has also joined SMART IRB in support of the NIH Single IRB Review policy. SMART IRB is a platform designed to streamline and harmonize the IRB review process for multisite research. This effort was led by our CTSA consortium partner Harvard Catalyst, in collaboration with Dartmouth Synergy and University of Wisconsin-Madison. SMART IRB is intended to serve as a roadmap for institutions to implement the NIH policy on the Use of Single Institutional Review Board for Multisite Research.

SMART IRB

SMART IRB is a platform designed to ease common challenges and burdens associated with initiating multisite research and provide a roadmap for institutions to implement the NIH Single IRB Review policy. Through a flexible master IRB reliance agreement, standard operating procedures and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

The CTSI aims to apply this “Reliant IRB” model to other collaborative research networks, with a goal to improve efficiencies in the IRB review and study implementation processes without compromising the regulatory and ethical environments that exist within any institution.

Protocol/Consent Development

Protocol/Consent Development

Plan and develop your protocols and your consent documents.

Comparative Effectiveness Research

Comparative Effectiveness Research (CER) is a field of study that utilizes data generation (new studies) and synthesis (comparisons of existing studies) to provide evidence identifying best practices and policies related to improving health care. CER studies are generally conducted after randomized controlled trials (RCTs). RCTs determine efficacy or how well a treatment works under ideal conditions. CER studies examine effectiveness by comparing one or more treatments, procedures or medications to determine what works best for which patients under real world conditions.

Protocol Development

Protocol Support we provide: 

  • Consultation for Required Protocol Elements
  • Development of Data Monitoring Plan, Event Reporting and Protocol Stopping Criteria
  • Detailed Review and Feedback of Study Protocol Formatting from a regulatory and ethical lens
  • Detailed Review and Feedback for consistency between Study Protocol and Consent Form
  • Assistance with addressing FDA, IRB and/or DSMB protocol modifications

Request support for Protocol Development by contacting the CTSI-Regulatory Team.

Protocol development is a collaborative effort between the Study Sponsor, Site Investigator, Biostatistician, the IRB, the FDA and others. The Regulatory Knowledge and Support team can help serve protocol development from a regulatory and ethical perspective. In addition, this team can help ensure consistency with the protocol and consent form and identify logistical barriers to clinical care standard processes. Protocols should be written in a manner that ensures scientific validity and feasibility.  

Consent Development

Informed Consent Form Support we provide: 

  • Consent Form Development
  • Consent Form Review and Feedback
  • Consent Process Guidance
  • Consent Process Witness

Request support for DSMB by contacting the CTSI-Regulatory Team.

In addition to these services, the RKS has consent form boilerplate language for standard medical procedure risks available in the CTSI Research Resources Toolkit.

What is Informed Consent?

Informed consent is an entire process designed to give potential study participants all the information needed so they can make an autonomous decision about participating in a research study.  

It starts with the initial introduction of the study and doesn’t end until the participant completes their study participation or declines their study participation. Informed consent is an ongoing process.

Informed consent typically includes obtaining a signed informed consent form, although in some rare cases, consent may be provided through other means. The process in which informed consent is obtained must be IRB approved prior to implementation of that informed consent process. 

What is Required to be included in the Informed Consent Discussion and Consent Form?

Federal Laws (45 CFR 46 – Common Rule and 21 CFR 50 – Protection of Human Subjects) indicate the required basic elements of informed consent and when appropriate, the additional elements of informed consent. The basic elements must be included in the consent form and discussed during the consent process and the additional elements should be included when appropriate.  

Researchers should refer to the Ohio State Office of Responsible Research Practices Informed Consent Process and the Elements of Informed Consent policy for additional information regarding the informed consent discussion and consent form requirements.

Which Informed Consent Template should be used?

Researchers should use the IRB of Records Informed Consent form template, while ensuring all elements of informed consent and any institutional required language are included.  

If Ohio State IRB is the IRB of Record, researchers should use the Ohio State IRB ICF Templates and Guidance.

IND/IDE Support

IND/IDE Support

Helping research teams navigate the investigational new drug approval process.

Regulatory Guidance for Academic Research of Drugs and Devices

Clinical Trials for drugs being developed for initial use in humans as well as for FDA approved drugs but being investigated for additional use(s) require an Investigational New Drug Approval (IND) from the FDA prior to commencing.

For clinical trials involving marketed drug(s) for alternative use an IND Exemption (PDF) may be an acceptable alternative. The CTSI, in collaboration with the Ohio State Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.

IND/IDE Support we provide:

  • Meetings with the FDA (INTERACT, Pre-IND, Q-sub: Pre-Sub)
  • IND Submission Packet Templates
  • IDE Submission Packet Templates
  • Expanded Access “Compassionate Use” submissions
  • Clinical Hold Responses
  • Guidance and training for preparing IND/IDE initial submissions, amendments/supplements, annual reports, and withdrawals/terminations
  • Full preparation of IND/IDE submission packets
  • Guidance with determining device risk level and classification (Note: The study sponsor maintains overall responsibility for making the final determination in collaboration with the FDA and IRB)

Request support for IND/IDE submissions and FDA meetings by contacting the CTSI-Regulatory Team

When conducting human research with an investigational drug or device (drugs or devices that have not been approved or cleared by the FDA for marketing) researchers need to obtain an exemption from the pre-marketing approval requirements in the Food Drug and Cosmetic Act, prior to starting the research. This is obtained through the Food and Drug Administration (FDA) by submitting an Investigational New Drug (IND) Application or an Investigational Device Exemption (IDE). 

Once an IND is submitted to the FDA the sponsor must wait 30 days to begin the research, or until they receive a study may proceed letter.  Within that 30 days the FDA may issue a clinical hold until specific items are addressed.

Once an IDE is submitted to the FDA the sponsor must wait 30 days to begin the research, or until they receive an approved or approved with conditions notification from the FDA.  Within that 30 days the FDA may issue a disapproval of the research or require specific conditions be met in order to conduct the research. 

IND/IDEs need to be maintained throughout the protocol lifecycle through the submission of amendments/supplements, annual reports/progress reports, safety reports and IND/IDE termination or withdrawal.

FAQs

NIH Requirements

NIH Requirements

Support in navigating NIH requirements.

NIH Requirement support we provide:

  • Regulatory Consultations for CTSI Funded proposals (Pilot, Element E, KL2, T32)
  • Submission of CTSI Funded proposals to NCATS for Prior Approval
  • Guidance and Consultation regarding other NIH requirements

Request support for NIH requirements by contacting the CTSI-Regulatory Team

What is included in a Regulatory Consultation for CTSI Funded Proposals?

During your regulatory consultation a regulatory professional will obtain a brief description of the study from you and ask you questions about your proposed project. They will help identify the regulatory needs of your project and help link you to other resources, such as community engagement and recruitment and retention.

Additionally, the regulatory professional will help provide guidance for any required submissions, approvals, or authorizations needed for your project, including the IRB, NCATS, FDA, Research Stakeholders, IBC and IACUC.

Do all CTSI Funded Projects Require NCATS Prior Approval?

All human subject research and vertebrate animal research projects require submission to NCATS.  Any human subject research that fits under Category 1 will require prior approval from NCATS before the project can begin. Your regulatory professional will help you identify what is required for your CTSI funded project.

What other NIH Requirements Support can CTSI Provide?

Regulatory professionals can help provide guidance for researchers to meet the NIH Policies, for their NIH funded project. NIH has general policies and announcements, but important to note that each NIH Institute may have their own individual policies and requirements, such is the case for Data Safety Monitoring. 

Collaboration

Collaboration

The CTSI has a couple of great relationships already established with outside clinical options to aid in your multisite clinical research initiative.

CATALYST does not focus on Clinical Trials per say but is instrumental in the areas of health services research and implementation science. Health services research is a multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies and personal behaviors affect access to health care, the quality and cost of health care and ultimately, our health and well-being. Implementation science is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice and to improve the quality and effectiveness of health services and care.

Healthy State Alliance is a strategic initiative between The Ohio State University Wexner Medical Center and Bon Secours Mercy Health (top 20 health system in the United States). Offers 500 care facilities, 23 hospitals and 26 post-acute care facilities spanning five states.   

Ohio Primary Care Innovation Network (OPCIN) is with Ohio Association of Health Centers (OACHC) they are available to partner on projects focusing on general health needs of the community and offer availability of over 511 locations and 76 counties in Ohio.   

Trial Innovation Network (TIN)

Trial Innovation Network (TIN)

The vision of the TIN is to innovatively address critical roadblocks in multisite clinical research and accelerate the translation of novel interventions into life-saving therapies.

Ohio State/Nationwide Children's Hospital is a member of the Trial Innovation Network (TIN), a collaborative partnership with investigators at the 60+ hubs in the national CTSA network.

The Trial Innovation Network can help investigators planning multi-center clinical research with the following:

  • Protocol development
  • Study operations enhancement
  • Trial budgeting guidance
  • Regulatory agreements
  • Data coordination and management
  • Clinical coordination and management
  • Data safety and monitoring
  • Site identification
  • Recruitment planning and feasibility

“The TIN was a great FREE review of our grant prior to submitting it to NIH. The TIN addressed areas of concern and potential holes in our proposal allowing us to be successful in securing funding from NIH on initial submission.”

Ohio State Investigator

There are two ways to participate in the Trial Innovation Network:

  • Inbound studies:  Researchers can participate in multisite clinical trials initiated by other network sites. These study requests are sent to the Ohio State TIN liaison team and then disseminated to investigators within the broader Ohio State/Nationwide Children's Hospital research community.
  • Outbound studies: Any researcher can submit projects of their own to be conducted using TIN network resources. Before submitting a proposal, investigators should reach out to the Ohio State TIN liaison team to learn more about which study resources available through the TIN they may want to utilize.

For more information on how the TIN can help with your research ideas, view visit the TIN website or contact CTSI-info@osumc.edu.

Trial-CORE

Trial-CORE

Trial-CORE is a service from the Clinical and Translational Science Institute (CTSI). We can provide specialized expertise and trial implementation support to faculty who seek to conduct investigator-initiated clinical trials, with a focus on multi-center clinical studies or those trials with more complex elements.

To meet the needs of study teams, Trial-CORE provides multiple tiers of service. In addition to providing initial consultations and focused guidance on study organization, regulatory pathways, budget development, sponsor interaction and recruitment strategies, Trial-CORE also offers a full suite of management services to execute trials in partnership with the department of Biomedical Informatics, Research Information and Technology and your department-based study teams and investigators.

As needed, investigators will also be connected with resources at the other departments in the College of Medicine and the university to facilitate the success of their studies.

Services Include:

  • Protocol Development
    • Assist with protocol development with key considerations for multicenter trials in collaboration with study team and statistician
  • Recruitment Guidance and Plans
    • Develop a robust subject recruitment plan focusing on engaging voices from across the community, including online and tangible materials
    • Cohort identification with EMR
  • Community Engagement Initiatives
  • Study Oversight and Monitoring
    • Guidance and or Management of Data Safety Monitoring Board (DSMB) 
    • Independent Quality Checks/Audits
    • Independent Safety Medical Monitoring
    • Clinical Trial Monitoring
    • Tools for Investigative Drug Management and Accountability
    • Quality Management Plan development and implementation
    • Guidance on best practices for study monitoring and monitoring services
  • Regulatory Guidance
    • Guidance and support for investigators conducting FDA- regulated research (ex. IND,IDE)
    • Guidance and planning and implementing multi-center trials that involve a Single IRB
  • Template Documents and Databases
    • Templates for protocols, databases and operating manuals for clinical trials
    • Templates for standard operating procedures documents for study management functions, data/safety monitoring function and ongoing quality monitoring and management

Trial-CORE consultations and many pre-award activities are subsidized by the Clinical and Translational Science Award (CTSA). Post-award study management services require substantial ongoing effort and collaboration of the Trial-CORE team so would be budgeted into your clinical study grant. The Trial-CORE service model is designed to be flexible. Investigators must meet with the Trial-CORE team directly to discuss the specific need of the study and associated costs.  

Free Consultation

The initial consultation includes an interactive discussion with experienced Trial-CORE professionals about your study. After each initial consultation, faculty members receive written recommendations from our expert support team on key steps that can be taken to move their project forward efficiently. During the Trial-CORE consultation process, we will work with you to determine the Trial-CORE Support Services of best fit for your study. Additional consultation meetings can be scheduled as needed to support the study leading up to implementation of Trial-CORE Support Service.

After the consultation the budget and scope of work will be provided outlining the terms the trial team will assist. 

Any questions can be directed to CTSI-info@osumc.edu.

Request a consultation

History

The Ohio State University Clinical and Translational Science Institute: Then and Now

The present, past and future of the CTSI.

1 2006

The Ohio State University Board of Trustees voted to create a new entity, The Ohio State University Center for Clinical and Translational Science (later to be renamed The Ohio State University Clinical and Translational Science Institute or CTSI), to speed the translation of scientific discoveries into clinical therapies to improve human health for all. The late Dr. Rebecca Jackson, was named to lead the new enterprise based on her international recognition and outstanding leadership of numerous multi-center research collaborations. Her first task was to develop the application for a National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) grant to fund the new endeavor.

2 2008

The NIH awarded a $34-million, five-year CTSA grant to The Ohio State University and Nationwide Children’s Hospital to fund the CTSI. Among the largest research grants in the university’s history, the CTSA award was a team effort based on the clinical and translational research enterprise, training programs, informatics capabilities, trans-disciplinary collaborations and partnerships with private and public organizations.

3 2013

The NIH renewed the CTSA grant to The Ohio State University for a second five-year funding cycle with Nationwide Children’s Hospital continuing as the pediatric institutional partner. CTSA funding via a U54 specialized center, TL1 trainee program and KL2 scholar program is combined with significant local resources to provide core resources, essential mentoring and training and opportunities to develop innovative approaches and technologies designed to re-engineer existing capabilities. Program support also fosters collaborations to improve the quality, safety, efficiency and speed of clinical and translational research.

4 2018

The NIH awarded $25M to the CTSI to continue its work for an additional five years in clinical and translational science. This UL1 grant supported team science initiatives, workforce development and partnerships with private and public organizations. The CTSI also continued to partner with local communities to improve health outcomes in areas such as substance abuse, infant mortality and obesity.

5 2022

The NIH awarded a new, seven-year $37.9 million UM1 award to continue to fund the center’s work. With a "health for all" lens, this new grant will focus on the development of innovative methods and approaches to address roadblocks in clinical and translational research, support workforce development, increase collaboration across academic and scientific disciplines and expand access to research technologies. The grant supports collaborative research across The Ohio State University, The Ohio State Wexner Medical Center, Nationwide Children's Hospital and new partners, the Ohio Primary Care Innovation Network (OPCIN) and Bon Secours Mercy Health. The (OPCIN) is a partnership between the Ohio Association of Community Health Centers (OACHC) and the Ohio State CTSI to help advance health for all by placing established clinical trials infrastructure in FQHC primary care settings to serve all patients across Ohio. Healthy State Alliance is a collaboration between The Ohio State University Wexner Medical Center, the CTSI and Bon Secours Mercy Health to improve the health of communities by tackling Ohio’s most critical health needs.

6 2024

In autumn 2023, Dr. Julie Johnson was hired as director of the CTSI and contact PI of the most recent CTSA grant. To elevate the status across campus, and better align with strategic goals and Ohio State’s definition of center versus institute, the CTSI made a formal application to the university to be recognized as an Enterprise for Research Innovation and Knowledge (ERIK) institute and a formal name change to The Ohio State University Clinical and Translational Science Institute. The change was approved by Ohio State’s faculty senate in April 2024.

Dr. Rebecca Jackson

Founding Director and PI, Dr. Rebecca Jackson, 1955 – 2022

Dr. Jackson was a visionary and nationally recognized leader in the world of translational science and research. She helped establish the CTSI in 2006 as its founding director and served through 2022. While her clinical work specialized in understanding and improving women’s health, she built a legacy that lives on through her impact as a leader. She supported the education and training of translational scientists and physicians and served as a mentor to many. Dr. Jackson’s work will forever leave a profound impact for the future of medicine.

Read more about Dr. Jackson on Ohio State News
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