Research

Compliance Guidance & Resources

Adverse Event Reporting

Biosafety

Biosafety in Microbiological and Biomedical Laboratories

Belmont Report

Budget Tools to Help Investigative Sites Calculate Costs

Coordinator's Time for Outpatinet Study, Part I

Coordinator's Time for Outpatient Study, Part 2

Certificates of Confidentiality

NIH Kiosk (including background information, FAQ, link to instructions for application)

Comparison of FDA and HHS Human Subject Protection Regulations

Decision Charts

Chart 1	Is an activity research involving human subjects?
Chart 2	Is the human subjects research eligible for exemption?
Chart 3	Does exemption 45 CFR 46.101(b)(1)(for educational settings) apply?
Chart 4	Does exemption 45 CFR 46.101(b)(2) or (b)(3)(for tests, surveys, interviews, public behavior observation) apply?
Chart 5	Does exemption 45 CFR 46.101(b)(4)(for existing data, documents, records and specimens) apply?
Chart 6	Does exemption 45 CFR 46.101(b)(5)(for public benefit or service programs) apply?
Chart 7	Does exemption 45 CFR 46.101(b)(6)(for food taste and acceptance studies) apply?
Chart 8	May the IRB review be done by expedited procedures?
Chart 9	May the IRB continuing review be done by expedited procedures?
Chart 10	May informed consent be waived or consent elements be altered under 45 CFR 46.116(d)?
Chart 11	May documentation of informed consent be waived under 45 CFR 46.117(c)?

Disqualified/Restricted/Assurance List for Clinical Investigators

FDA Device Advice

FDA-GCP	Frequently asked questions about medical devices
FDA	Significant risk and non significant risk medical device studies
FDA	Device Advice
FDA	Investigational Device Exemption (IDE) for clinical studies
FDA	Humanitarian Device Exemption (HDE)
FDA	Overview of device regulations

FDA Guidances (Center for Drug Evaluation and Research)

Federal Regulations

45 CFR 46	Protection of Human Subjects (OHRP)
21CFR11	Electronic Records and Electronic Signatures (FDA)
21 CFR 50	Protection of Human Subjects (FDA)
21 CFR 54	Financial Disclosure by Clinical Investigators
21 CFR 56	Institutional Review Boards (FDA)
21 CFR 312	Investigational New Drug Application (FDA)
21 CFR 812	Investigational Device Exemptions

Glossaries

Agency for Healthcare Research and Quality, Web-based glossary

FDA Acronyms and Abbreviations

MedlinePlus Medical Dictionary

HHS Reference Collections (Dictionaries, Glossaries, Indices, Reports, Statistics)

Good Clinical Practice

Running Clinical Trials (FDA)

HIPAA

UT COMC HIPAA GUIDANCE PROCEDURES

UTCOMC HIPAA Waiver of Authorization Form H

Multi-site Research Toolkit

Building collaborations

Developing proposals

Starting up a study

Conducting and managing projects

Disseminating and closing research

Resources for training

NIH Regulations and Ethical Guidelines

45 CFR 46 Protections of Human Subjects

Guidelines for Condcut of Research Involving Human Subjects at NIH

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects

Nuremberg Code

World Medical Association Declaration of Helsinki

List of all institutions holding assurances

Office of Civil Rights--HIPAA

OHRP Guidances

Protecting Personal Health Information in Research (NIH HIPAA publication)

Research Resources 2011/2012

Standard Operating Procedures, UTCOMC Office of Human Subject Protections

Frequently Asked Questions

FDA	Access to investigational drugs for treatment use and charging for drugs
FDA	Adverse events (devices)
FDA	Clinical investigator (Form 1572 in devices)
FDA	Confidentiality (devices)
FDA	Early collaboration (devices)
OHRP	Exempt research determination
FDA	Guide to Informed Consent
FDA	Guidance for IRBs, Clinical Investigators, Sponsors
FDA	Guidance for Investigator Responsibilities
FDA	HDE (Humanitarian device exemption)
OCR	HIPAA FAQ
OHRP	Informed consent
FDA	Institutional Review Board (re device studies)
OHRP	Investigator responsibility
FDA	New indication for marketed device
OHRP	Prisoner research
FDA	Promotion of investigational devices
OHRP	Research with children
FDA	Significant/Nonsignificant Risk of devices
UTHSC	UTHSC Research Administration FAQ's
TN Code	Emancipated_minor_definition_2010
TN	TN Dept. Children's Services Informed Consent Policy
TN	TN Health Care Decisions Act