Resources
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These resources have been provided to help you write protocols that meet IRB and regulatory standards.
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- Brief Summary of the Revised Common Rule and its Impact on Protocol Design, Informed Consent and IRB Review
- Potential IRB Review Category
Under the revised common rule some of the categories of exempt research that address observational or behavioral studies have changed, while a few new ones have been added. In some cases a study that was expedited under the old common rule may now be eligible for determination of exempt status.
The criteria for exempt status has been expanded and many observational or survey studies will now be eligible for determination of exempt status. If the study is not eligible for exempt status, then as long as the study represents minimal risk it would likely be reviewed via the expedited or designated IRB reviewer function.
Investigators should consider these changes when designing their protocols, paying particular attention to whether the study needs to collect identifiers, whether the data being analyzed in a review of data collected for another purpose would otherwise already be protected by HIPAA and whether the study only involves a benign behavioral intervention.
Why does this matter?
When research is exempt, many of the requirements of 45 CFR 46, including in some cases the requirement for informed consent or a waiver of informed consent, will not apply.
- Exempt Research
Some of the categories of exempt research that address observational studies have changed, while a few new ones have been added. For more information download the Exemption Categories Summary Table.
- General Requirements for Informed Consent
There are several major changes to the general requirements for informed consent in the revised Common Rule. They include the following:
- Informed consent must give prospective subjects the information that a reasonable person would want to have in order to make an informed decision about whether to participate.
- The information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate.
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Key information about the study must be provided at the beginning of the document. This will likely include information about the purpose, the risks, the benefits, and alternatives, and it will explain to the person how to think about these pieces of information in terms of making a decision. It should be presented in a concise and focused manner. – sample Key Information Summary
Note: Do not duplicate information in the consent form. The Key summary is part of the informed consent. Information included in the key information section also satisfies the elements of informed consent and this information need not be repeated later in the body of the informed consent.
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Basic Elements of Informed Consent – 45 CFR 46.116(B) - the addition of a new required basic element:
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
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Additional Elements of Informed Consent – 45 CFR 46.116(C) – three (3) new additional elements that are required when appropriate:
- A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; and
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)
Why does this matter?
This is a change in informed consent form format. There is recognition that consent is a process, the hope is that this change will improve comprehension and readability in consent form documents by providing a concise summary up front. In addition, for many observational or retrospective studies requiring a consent process, a concise summary may be sufficient.
- Informed Consent Key Information Summary
- Where can I find more information?
- For more information about Revised Common Rule categories for exempt determination at 45 CFR §46.104 (d) 1-8 Exempt research.
- For more information about the Revised Common Rule and its potential implications for study design, informed consent and IRB review see OHRP’s website Revised Common Rule Q&As
- Potential IRB Review Category
- NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
The National Institutes of Health (NIH) released in March 2019 a clinical trial protocol template with instructional and example text for NIH-funded investigators to use in writing protocols for behavioral and social sciences clinical trials. This template was developed in response to changes in NIH policies that expanded the requirements associated with clinical trials beyond FDA-regulated clinical trials to those studies including behavioral or social interventions. Use of the template is recommended, but not required.
- NIH and FDA Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
The National Institutes of Health (NIH) and Food and Drug Administration (FDA) developed a clinical trial protocol template with instructional and example text for NIH-funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. The agencies’ goal is to encourage and make it easier for investigators to prepare clinical trial protocols that are organized consistently and that contain all of the information necessary for the review of the protocol. The template follows the International Conference on Harmonisation (ICH) E6 (R2) Good Clinical Practice.
- New Protocol Builder Templates
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- Chart Review (replaces Retrospective Chart Review)
- Observational study of individual or group characteristics or behavior, or human factor evaluation (replaces Observational Retrospective)
- Observational study of an FDA regulated product (replaces Observational Prospective)
- Social Behavioral (revised) (replaces Social Behavioral)
- Behavioral Intervention (incl. benign behavioral intervention)(replaces Interventional Behavioral)
- Repository with use of Broad Consent (replaces Repository)
- Repository without Broad Consent (replaces Repository)
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- Residency & New Investigator Resources
- Chart Review Protocol Template
- A simplified protocol template specifically designed to write retrospective chart review protocols, the most commonly used for resident projects.
- Enhanced with deeper instruction and sample or standard text in the sections where it would be most helpful.
- Encourage best practices like starting the protocol writing process with the synopsis.
- Prepares protocol for later publication with properly defined sections and references.
- Observational Research Design TrainingHelp residents and new investigators to get up to speed on the different observational research design methodologies in a live 45-minute webinar with BRANY’s Training Expert.
- Useful Articles
Protocol Builder is here to help with thoughts and insights about protocol writing and clinical research.
Conducting a Successful Residency Research Project
6 key elements to writing a strong clinical trial protocol synopsis
- Mentoring Support
Protocol Builder makes it easier for faculty to mentor residents or new investigators. Standard templates incorporating protocol-writing best practices provide a great foundation for faculty to teach students about protocol writing. The mentoring process is supported with collaboration features that make the back and forth of the protocol writing assignment much easier to handle:
- Share and Clone: Faculty can create a sample protocol in Protocol Builder to share with students. Students can then clone that protocol and make the appropriate changes to it for faculty to review. View the tutorial video
- Update notifications and the Needs Review List: Protocol Builder include alerts and notifications for changes as well as a convenient list of all changes that need to be reviewed. View the tutorial video
- Commenting Tool: Protocol Builder provides the option to comment on sections without the need to change the section contents.
- Tips & TutorialsVisit the updated Help Center to see the tutorial videos and user training webinar recordings.
- Chart Review Protocol Template
- NIH IND/IDE Clinical Protocol Template Resources
Protocol Builder includes the recently updated template (May 2017) that provides a suggested protocol format for Phase 2 or 3 clinical trials supported by the National Institutes of Health (NIH) that are being conducted under a Food and Drug Administration (FDA) Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).
In addition to the template, the following instructional materials and forms are available for your reference to help facilitate the development of these protocols:
Word Template and Template Instructions
Table and Diagram Examples
Schematics of Study DesignSchedule of Activities (SOA) Table
Objectives and Endpoints Table
Abbreviations Table
Protocol Amendment History - Forms
- FDA
Below are the links to the required FDA regulatory forms and samples of commonly used forms and appendix charts. Once you download a PDF version of the form, you can fill them out and attach to your protocol using the Appendix Attachment feature that appears at the bottom of each protocol section.
IND Forms and Instructions
[https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/default.htm]Investigational New Drug (IND) Application
[https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm]Investigator-Initiated Investigational New Drug (IND) Applications
[https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm343349.htm]IDE Application
[https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046706.htm] - Sample Forms
- FDA
- Glossaries
Look up key terms by visiting the ClinicalTrials.gov and Patient Reference Guide Glossary links below.
- External Links
- FDA
21 CFR Part 50 Protection of Human Subjects
Describes FDA regulations for the protection of human subjects, including details on informed consent and additional safeguards for children.21 CFR Part 56 Institutional Review Boards
Describes FDA regulations for Institutional Review Boards (IRB), including organization and personnel, functions and operations, records and reports, and administrative actions for non-compliance.21 CFR Part 312 Investigational New Drug Application
Describes FDA regulations for Investigational New Drug (IND) applications, including general provisions, requirements, administrative actions and responsibilities of sponsors and investigators.21 CRF Part 812 Investigational Device Exemptions
Describes FDA regulations for Investigational Device Exemptions (IDE), including general provisions, requirements, administrative actions, IRB review and approval, responsibilities of sponsors and investigators, and records and reports.Guidance for IRBs, Clinical Investigators and Sponsors
FAQ and Statement of Investigator (Form 1572)
Investigator-Initiated Investigational New Drug (IND) Applications
Includes a table that provides links to information for investigators about submitting Investigational New Drug (IND) applications to the FDA. The resources for application reporting and applications procedures apply to IND applications for both clinical research and clinical treatment.IND Applications
Provides information on determining whether research studies can be conducted without an IND.IDE Approval Process
The IDE regulation distinguishes between significant and nonsignificant risk device studies and the procedures for obtaining approval to begin the study differ accordingly. Also, some types of studies are exempt from the IDE regulationsDevice Advice: Investigational Device Exemption (IDE)
Significant Risk and Non-significant Risk Medical Device Studies
Includes a comprehensive list of examples of medical devices and classification.FDA Guidance on Financial Disclosure of Clinical Investigators
Provides guidance on interpreting and complying with regulations governing financial disclosures by clinical investigators 21 CFR part 54.FDA Clinical Trials Guidance
Guidance documents that explain the FDA’s thinking on good clinical practice (GCP) and the conduct of clinical trials.Combination Products
Definition and detailed information on combination products from the FDA.How to Write a Request for Designation (RFD) (combination products)
Includes details on how to submit a Request for Designation (RFD) to determine the designation of a combination product. - ClinicalTrials.gov
ClinicalTrials.gov Home Page
A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. This is a useful site to search for other studies that have been or are being conducted.Registration
Why Should I Register and Submit Results?
All Applicable Clinical Trials need to be registered with ClinicalTrials.gov. Visit this link to determine if a study is an Applicable Clinical Trial.Glossary
Glossary of terms related to clinical trials.
- NIH
NIH Home Page
Includes links to clinical trial resources such as online training and searchable database for ongoing NIH clinical trials.Financial Conflict of Interest (FCOI)
Provides the NIH guidelines on managing financial conflicts of interest. - OHRP
OHRP Home Page
Includes information about the OHRP, regulations, policy and guidelines. The OHRP provides leadership in the protection of the rights, welfare and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).Protection of Human Subjects 45 CFR Part 46
OHRP’s Frequently Asked Questions About Human Subject Research
The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of ResearchThe Nuremberg Code (1947). In Mitscherlich, A. & Mielke, F. Doctors of infamy: The story of the Nazi medical crimes.
Describes the standard of ethical medical behavior for the post World War II human rights era.Declaration of Helsinki
A statement of ethical principles and guidelines for the protection of human subjects of research. - ORI
ORI – Home Page
The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration. - Pubmed
PubMed
Includes more than 23 million citations for biomedical literature from MEDLINE, life science journals and online books. Citations may include links to full-text content from PubMed Central and publisher sites. - HIPAA
HIPAA Privacy Rule
Establishes national standards to protect individuals’ medical records and other personal health information.Understanding Health Information Privacy
Guidance Regarding Methods for De-identification of Protected Health Information
- FDA