HUMAN RESEARCH SUBJECTS PROTECTION

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UT DEPARTMENT FOR HUMAN RESEARCH PROTECTIONS

HUMAN SUBJECTS RESEARCH REGULATIONS DECISION CHARTS (via OHRP)

HIPAA-RESEARCH RELATED INFORMATION

TIPS ON WRITING INFORMED CONSENT DOCUMENTS

TIPS ON WRITING MUOT IRB APPLICATIONS

Law Suits Related to Human Subjects Research

MUOT IRB Forms

IRB Reviewer Checklist

MUOT IRB MEETING RESULTS

ACTIVE MUOT IRB PROTOCOLS [As of Date on Report]

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COMPUTER-BASED PRESENTATIONS AND TRAINING MODULES

FEDERAL POLICIES AND REGULATIONS GOVERNING RESEARCH WITH HUMAN SUBJECTS

FDA INFORMATION FOR CLINICAL INVESTIGATORS

FREQUENTLY ASKED QUESTIONS REGARDING RESEARCH WITH HUMAN SUBJECTS

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International Compilation of Human Subject Research Protections (via OHRP)

ETHICAL CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS (via Canadian Institutes of Health Research)

BIOETHICS RESOURCES ON THE WEB (via NIH)

HUMAN SUBJECTS PROTECTION AND FINANCIAL CONFLICTS OF INTEREST (via HHS)

Points to Consider When Planning a Genetic Study That Involves Members of Named Populations (via NIH)

Protection of Third Party Information in Research: Recommendations of the NIH (via NIH)

MUOT IRB POLICIES

MUOT Guidance for Removal of Individual Identifiers from information/Records/Samples

Provider-Recipient Agreement for Non-Disclosure of Identifying Information

MUOT Guidance for Establishing Databases of Human Subject Information or Banks of Human Biological Material

Incentives Paid by Sponsors of Clinical Trials

Required Departmental Review of Human Research Protocols PRIOR to IRB Submission

Personnel on MUOT IRB Application: Decision-Support Chart

Investigator Responsibilities in Research Involving Human Subjects

MUOT Policy on Use of Human Subjects in Research (MUOT Policy # 02-001)

MUOT Policy on Adverse Event Reporting & Required Reporting Forms

MUOT Policy on Payment for Injury to Study Subjects

MUOT Policy on Recruitment of Study Subjects

MUOT Policy on Acquisition of Fresh Human Tissue

MUOT Policy on Remuneration for Referral of Human Subjects for Research (MUOT Policy # 05-083

OTHER MUOT-SPECIFIC INFORMATION

MUOT Clinical Research Pledge

MUOT IRB Deadlines & Meeting Schedule

MUOT IRB Membership

MUOT IRB Forms

Charges for MUOT IRB Review

Checklist for Exempt and Expedited Review Protocol Applications

When is MUOT IRB Approval Necessary for an Activity?

INFORMED CONSENT

Required Elements of Informed Consent (via OHRP)

Simplification of Informed Consent Documents (via NCI)

Informed Consent in Gene Transfer Protocols (via NIH OBA)

Opportunities to Improve Informed Consent (Applied Clinical Trials - May, 2003)

Resources on Informed Consent (via U. MN.)

Informed Consent Tutorial

The Process of Informed Consent

FAQ - Informed Consent Issues

What Must Be Included in a Consent Form?

How To Avoid Problems with Consent Forms

Appropriate Language for Studies that Exclude Women

Common Language Dictionary

CDC Reference for Developing Consent Forms (via CDC)

Tips on Informed Consent (via OHRP)

Informed Consent Checklist (via OHRP)

Tips on Preparing Understandable informed Consent Documents (via U. Mich.)

Glossaries of Lay Terms for Use in Preparing Consent Forms

via Stanford Univ.

via Univ. California at Davis

via Univ. of Michigan

via Univ. of Minnesota

USE OF HUMAN TISSUES IN RESEARCH

OHRP Guidance on Research Involving Coded Private Information or Biological Specimens (8/19/2004)

Research Repositories, Databases, and the HIPAA Privacy Rule (via NIH)

Provider-Recipient Agreement for Non-Disclosure of Identifying Information

MUOT Guidance for Removal of Individual Identifiers from Information/Records/Samples

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (National Bioethics Advisory Commission)

Special Issues to Consider When Establishing a Database of Human Subject Information or a Sample Bank

Research on Human Specimens: Are You Conducting Research Using Human Subjects? (via NIH NCI)

Research Use of Stored Data or Tissues: Issues to Consider (via OHRP)

MUOT Policy on Acquisition of Fresh Human Tissue

Pathology Societies' Statement on Use of Human Tissue in Research (August, 1996)

Guidance on the Research Use of Stored Samples or Data (via NIH Office of Human Research)

 

GENERAL INFORMATION

NIH Primer: Research and Privacy

Research Involving Human Subjects (MSU Research Integrity Newsletter, Spring Issue, 2000)

Genetic Privacy Act and Commentary (via DOE - Human Genome Program)

Inclusion of Women, Minorities, & Children as Subjects in Clinical Research

Categories of Research Eligible for Expedited IRB Review (via NIH OHRP)

Human Research Educational Resources (via Univ. of Nebraska Medical Center)

IRB Forum (Formerly MCWIRB) (via Childrens' Hospital of Philadelphia)

LAW SUITS RELATED TO HUMAN SUBJECTS RESEARCH

Medical Research and Human Experimentation Law (via LSU School of Law)

Medical Research Cases (via LSU School of Law)

Clinical Trials Litigation (via Sherman, Silverstein, Kohl, Rose and Podolsky, Law Offices)

ADDITIONAL INFORMATION REGARDING USE OF HUMAN SUBJECTS IN RESEARCH (Including More Federal Regulations)

Page Updated: 2/9/2007

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research@meduohio.edu