NIH developed a second protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring a social or behavioral outcome or testing a behavioral or social science-based intervention. The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.īehavioral and Social Science Research (BSSR) Involving Humans This protocol template aims to facilitate the development of two types of clinical trials involving human participants. Phase 2 and 3 Clinical Trials that Require FDA-IND or IDE Application The following templates provide a common protocol structure and organization which can facilitate protocol review by oversight entities. Word versions of the protocol templates can also be downloaded for use outside of the e-protocol Writing Tool. The use of these templates is recommended, but not required. tracks progress and ensure document version control.allows assignments for writers and collaborators.enables participation for multiple writers and reviewers.Responsible Conduct of Research (RCR) - HHS ORI Resourcesīenefits of the e-Protocol Writing Tool include:.PHS Administrative Action Bulletin Board.What should you do if you Suspect Research Misconduct?.The substance and findings of the work are dedicated to the public. Department of Housing and Urban Development. What Happens if there is a Finding of Research Misconduct? Note: This material is based upon work supported by funding under an award with the U.S.NIH Process for Handling Research Misconduct Allegations.Requirements for Making a Finding of Research Misconduct.Resources to Evaluate Workplace Climate.NIH Expectations, Policies, and Requirements.Supporting a Safe and Respectful Workplace.Resources for Preparing Your Application.Guidance: Rigor and Reproducibility in Grant Applications.Principles and Guidelines for Publishing Preclinical Research.Glossary: Professional Codes, Norms, Ethics Training.Integrity and Confidentiality in NIH Peer Review.Promoting Research Integrity - NIH Initiatives.What can be done to Promote Research Integrity?.Consolidated List of Reviewer Documents.Recommendations for Improving NRSA Fellowship Review.Simplifying Review of Research Project Grant Applications.Applicant/Recipient COVID-19 Update History.Coronavirus Disease 2019 (COVID-19): Information for NIH.Lobbying Guidance for Recipient Activities.Process for Handling Allegations Related to Foreign.Format Pages, Instructions, and Samples.Requirements for Disclosure of Other Support, Foreign Components.Related Notices, Laws, Statements and Reports Communicating and Acknowledging Federal Funding.Human Subjects and Clinical Trial Information Form.Clinical Trial-Specific Review Criteria.Clinical Trial-Specific Funding Opportunities.Basic Experimental Studies Involving Humans (BESH).When Are Alternatives to Animals Used in Research?.How NIH Ensures the Care of Research Animals.Why Properly Designed Experiments Are Critical for Animal.How Animals Have Helped Improve Public Health.
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