Protocol/Consent Development

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.