BRYN MAWR COLLEGE IRB (Leslie Alexander)

BACKGROUND

• Pre-1997 
       What was reviewed
       Volume of research reviewed annually
• Post-1997 

What is research ?

"Research" is defined as "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge" (45 CFR 46.102d).

How is "research" operationalized at BMC?

All research, whether funded or not, involving human subjects, conducted under the auspices of Bryn Mawr College by its faculty, students, or staff, as well as research by outside investigators using Bryn Mawr College students, personnel, or facilities, must be reviewed. Research subject to review thus includes, but is not limited to, pilot studies; class projects aimed for publication; Master's theses; Ph.D. dissertations; co-supervised work; independent research; and senior theses, whether such research takes place on or off the Bryn Mawr campus, including work done outside of the United States. Class-based or lab projects should be reviewed on a biannual basis with the departmental reviewer to determine whether these projects are exempt or not". (Policies and Procedures for Reviewing Research Involving Human Subjects,p 1. http://www.brynmawr.edu/grants/IRBPol.html

How is research reviewed ?

      Membership of IRB
      Volume of research reviewed annually 

GENERAL ISSUES

• High institutional expectations for research and publication
• High ethical standards vs. undue scrutiny
• Staffing issues
• New frontiers - secondary analysis of audio and video-tapes, web-based research, service-learning courses, research on teaching

EDUCATION & RESEARCH (Kenneth Richman)

General points:

• Power relationships and total institutions make students a vulnerable population.
• Some research should not be done unless the PI can be sure that it will be done well.
• The Common Rule exempts some research in educational settings from review.

Undergraduate Research Assistants:

• Mentor-trainee responsibilities must be understood and fulfilled.
• The nature of collaborations raises authorship issues.
• Students may not be qualified to perform some human subjects research.

Service-learning courses:

• Service learning is being promoted to departments where faculty have no training in empirical research.
• Service placements are often made through a separate office rather than through the faculty supervisor.
• Students collect data on vulnerable populations.
• Material collected for education might later be attractive for research use.

Research on Teaching:

• Research on teaching is increasingly recognized as an area of specialization in some disciplines (esp. physics and modern languages).
• The human subjects involved are the PI's students.
• What counts as "commonly accepted educational settings"? and "normal educational practices"?
• Do the faculty engaged in research on teaching have appropriate training to do this kind of research?

A CASE STUDY (Celeste Johnson)

Bryn Mawr College Full IRB Review On A Qualitative Dissertation Research Project
Dissertation title: When friends are murdered: a qualitative study of the experience, meaning and impact on identity development of older african-american female adolescents.

Ethical dilemma: Protection of human subjects, vulnerable populations, risk disclosures, legal implications and management.

Informed Consent/Assent
Issues that must be considered when designing informed consent/assent for a vulnerable population.

Ethical Considerations
Special considerations regarding ethical issues in a case where knowledge about criminal actions may affect the interviewer and the study participant.

Pre and Post IRB Review
Considerations

• Voluntariness
• Parental permission required for participants under 18 years of age
• Intended use of findings
• Measures to protect confidentiality 
• Limits of confidentiality - 
•            Risk Disclosures
•            Child abuse
•            Expressed plans to act on threats of harm to self or others
•            Related Criminal Matters
• Emotional Risk management
• Signature Authorizations
• Research Contact Information
• Use of Understandable language

Informed Consent/Assent Post IRB Limitation Language 

The only limits to confidentiality will be if -

• you threaten to act to harm yourself or others. Your parents/guardians or implicated persons must be notified. A complete risk assessment will be pursued.
• there is suspicion that you are being abused. Appropriate authorities must be informed. 
• you disclose information relating to criminal activity not previously disclosed to law enforcement which could have a material effect on guilt or innocence determinations relevant to the murder of your friend. 

Informed Consent/Assent Post IRB Contact Language

If you have any further questions about the study you can contact Celeste Johnson , MSS [telephone] or her faculty director, [Dr.Name] at Bryn Mawr College Graduate School of Social Work and Social Research [telephone]. If you have any questions regarding your rights as a research subject, you can contact [Dr. Name], Chair of the Institutional Review Board, Bryn Mawr College and Professor at Bryn Mawr Graduate School of Social Work and Social Research .