Last updated 10/12/2007

Catalog of IRB and Human Research Reading and Viewing Materials

The below materials may be borrowed from the Human and Animal Research Protections Office for review, education and training purposes. New materials will be added to the collection periodically. To make a request, please contact Timothy Sparklin at 5-2737 or sparklin@umbc.edu

Books/Articles

Institutional Review Board Member Handbook, Jones and Barnett, 2004

UMBC IRB Researchers Guide (July 2005 Version)

Office of Human Research Protection (OHRP) Quality Improvement Program and Compliance Activity

Office for Protection from Research Risks (OPRR) (1993) Protecting Human Research Subjects: Institutional Review Board Guidebook

Protecting Participants and Facilitating Social and Behavioral Sciences Research, from The National Research Council

Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) Evaluation Instrument for Site Visitors

Multimedia

Investigator 101: Training for investigators in the responsible conduct of human subjects research (Office of Human Research Protections) (CD-Rom)

Public Responsibility in Medicine and Research (PRIM&R): 2003 Annual Institutional Review Board Conference, including the 18th Annual meeting of ARENA (CD-Rom)

Unforgotten: Twenty-Five years after Willowbrook (DVD)

Protecting Human Subjects, (National Institutes of Health and the Food and Drug Administration (VHS Video))

Articles from IRB Ethics and Human Research (The Hastings Center)

previous editions are available from HARPO

January/February, 2007 (Volume 29, Number 1)

· Developing Model Language for Disclosing Financial Interests to Potential Clinical Research Participants

· Conflicts of Interest in Research:  How IRBs Address Their Own Conflicts

· Evaluating the Risks and Benefits of Phase II and III Clinical Cancer Trials: A Look at Institutional Review Board Members in The Netherlands

· Cutting into the Spongy Belly of Surgical Innovation

March/April, 2007 (Volume 29, Number 2)

· Ethical Issues in Cancer Chemoprevention Trials:  Considerations for IRBs and Investigators

· Determining the Costs of Institutional Review Boards

· Deception in the Single-Blind Run-In Phase of Clinical Trials

· The Nuts and Bolts of IRBs

May/June, 2007 (Volume 29, Number 3)

· Third Party Risks in Research:  Should IRBs Address Them?

· The Many Ways of Saying Yes and No:  Reflections on the Research Coordinator’s Role in Recruiting Research Participants and Obtaining Informed Consent

· Monitoring Reportable Events and Unanticipated Problems:  The PHAROS and PREDICT Studies of Huntington Disease

· First Impressions:  The Experiences of a Community Member on a Research Ethics Committee

July/August, 2007 (Volume 29, Number 4)

· Who Should Go First in Trials with Scarce Agents?  The Views of Potential Participants

· Informed Consent for Dementia Research:  The Study Enrollment Encounter

· Does Size Matter?  Salience of Follow-up Payments in Drug Abuse Research

 

Articles from IRB Advisor (Thomson - American Health Consultants)

previous editions are available from HARPO

January, 2007 (Volume 7, Number 1)

· Improve SAE reporting via electronic submission

· When are public health researchers obligated to inform about outside threats?

· Virtual reality “subject” helps students learn informed consent questions faster

· IRB has well-organized process for reviewing unanticipated problems

· Review process in streamlined to improve IRB response time

February, 2007 (Volume 7, Number 2)

· Experts discuss various facets to conflicts of interest

· Hospitals—hospitals often involve IRBs in proposed agreements with commercial tissue repositories

· What to consider if your IRB is asked to weigh in on a tissue banking proposal

· Study finds blacks have concerns about biomedical research, but are willing to volunteer

· Research geared toward benefiting only one group raises ethical questions

· IRBs are adopting the component analysis model

March, 2007 (Volume 7, Number 3)

· Here are some of the comments OHRP received on its new AE/UP guidance

· Research ethics:  Study participant offers unique perspective on weighing risks and benefits

· Improve management by using practice strategies

· Washington University successfully combines IRBs from two campuses

· The ethics of placebo:  What IRBs should consider in reviewing a placebo-controlled trail

April 2007 (Volume 7, Number 4)

· IRB refusal forms basis of journal article

· Study raises issues of liability, informed consent, and potential entrapment

· Children’s hospital creates award-winning education for parents of subjects

· Herpes study criticized for use of placebo control

· See how one IRB re-invented itself

· Reorganized IRB has new policies and processes

· Expert offers advice on reviewing ethics of on-line research

May 2007 (Volume 7, Number 5)

· Institutions learn from experiences of the first SCRO committees

· Here are some pointers on establishing a new SCRO committee

· Create a how-to book to explain procedures when IRB director is absent

· HIPAA proves thorny issue for historical medical archives

· Some ides for IRBs dealing with historical documents

· Focus on risk, not incentives in surgery research review

June 2007 (Volume 7, Number 6)

· Research with illegal immigrants raises ethical, practical concerns

· What IRBs should consider in research with illegal immigrants

· OHRP director says new guidance on research definition could be public by year’s end

· Clinical trial registries are an idea whose time has arrived

· Compliance Corner:  Expert offers advice on dealing with investigator noncompliance issues

July 2007 (Volume 7, Number 7)

· Recipe for confusion:  FDA’s draft guidance plus OHRP’s final guidance

· Here’s the FDA’s draft guidance about AEs in a nutshell

· IRBs need to look at risks and benefits from cancer patients perspective

· Does your IRB need some help:  An expert gives tips

· Sexual abuse survey shows no risk of harm to subjects

· Physicians’ group coordinates research through network, internal IR

August 2007 (Volume 7, Number 8)

· IRBs still recovering from Hurricane Katrina

· Tips from the front lines:  Improving IRB disaster preparedness

· A novel idea for improving IRB ethics focus:  Recruit more nurses

· IRB director revises informed consent policy to include often excluded populations

· Expert discusses how IRBs interpret “minimal risk”

· Institution's best practices include quality improvements in adverse event reporting forms and obtaining feedback for IRB office