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COUHES 101 Committee on the Use of Humans as Experimental …

WebDHHS defines a human subject as: A living individual about whom an investigator conducting research: (i) Obtains information or biospecimens through intervention or …

Actived: 5 days ago

URL: https://couhes.mit.edu/researchers/couhes-101

Guidance on Conducting Research Involving Mental Health Topics

WebIn human subjects research, many studies utilize questionnaires and assessments that address mental health, behavior or quality of life. These may include questions and …

Category:  Health Go Health

Frequently Asked Questions Committee on the Use of Humans as

WebALL types of human subjects research are reviewed by COUHES, including investigations of new drugs, and medical, radiological, engineering, physiological, behavioral, sociological …

Category:  Medical Go Health

Basic Elements of Informed Consent

WebInformed Consent must contain the basic elements of informed consent: A statement that the study involves research, an explanation of the purposes of the research and the …

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ClinicalTrials.gov Requirements Committee on the Use of …

WebNIH Posting Requirement (FDAAA 801 Requirement) Any NIH sponsored clinical trial requires that the investigator (s) register with ClinicalTrials.Gov, a publically accessible …

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Data Safety Monitoring Plan (DSMP) Committee on the …

WebA Data and Safety Monitoring Plan (DSMP) is required for all research, regardless of the risk level. Investigators must have adequate plans in place to protect human subjects …

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HIPAA Guidance Document Committee on the Use of …

WebIntroduction. MIT is committed to conducting research in compliance with all applicable laws and regulations. To ensure this result, the Committee on the Use of

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Single IRB Review Committee on the Use of Humans as …

[email protected]. (617) 253-6787. For institutions not participating in the SMARTIRB Reliance Agreement, single-IRB is still applicable. Investigators must complete the …

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About COUHES Committee on the Use of Humans as …

WebAs an institution engaged in non-exempt human subjects research conducted or supported with federal funds, MIT is required to submit a written assurance of compliance with the …

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Forms & Templates Committee on the Use of Humans as …

WebInstructions for Using Forms and Templates. Download the appropriate form or template from the list below. Save ("Save As") the document with a project-specific name. …

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AUTHORIZATION TO RELEASE PROTECTED HEALTH …

WebHIPAA requires me to sign an authorization in order for researchers to be able to use or disclose my protected health information (PHI) for research purposes in …

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Certificates of Confidentiality Committee on the Use of Humans …

WebCertificates of Confidentiality. NIH sponsored research that involves collecting or using identifiable, sensitive information is automatically issued a Certificate of Confidentiality …

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Guidance on Use of Protected Health Information for Research …

WebHIPAA defines a “covered entity” as including the following: (1) health plans; (2) health care clearinghouses, and (3) health care providers who electronically transmit …

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Health Insurance Portability and Accountability Act

WebMIT is not considered a covered entity. Therefore, research conducted outside of MIT Health or MIT Health Billing is not subject to Health Insurance Portability and …

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Adult Subjects with Cognitive Impairment and Reduced Decision …

WebIndividuals with reduced decision-making capacity require special protections. Investigators may decide to exclude or include them from their research.

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Guidance on NIH Genomic Data Sharing (GDS) Policy

WebApplicability Who does this policy apply to? All NIH-funded research that generates and uses large scale human or non-human genomic data, as well as the use of these data for …

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Additional Standard Language for Informed Consent

WebBelow is standard or canned language investigators can add when appropriate to their research. Each section includes a brief description of when the language would be …

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