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November 1, 2001

Q & A with Susan Sonnenschein, Chair, Institutional Review Board

Susan Sonnenschein has been the chair of the Institutional Review Board (IRB) since August, 1999. She is an associate professor in UMBC's Applied Developmental Psychology program. She has a background in developmental psychology, educational psychology and school psychology. Her recent research interests have focused primarily on aspects of language and literacy and the socialization of children's skills in these areas. She (along with colleagues Linda Baker and Robert Serpell) has recently completed a five-year longitudinal study of literacy development in young children from different sociocultural groups. A large focus of that study was a consideration of parental beliefs and practices and their impact on children's literacy appropriation.

1. What is the IRB and how long has it been in place at UMBC?

The function of the Institutional Review Board, more commonly referred to as the IRB, is to protect the well-being of participants in research by ensuring that the research conforms with a set of regulations established by the Department of Health and Human Services. The IRB is empowered by federal regulations to review and approve, require modifications in, or disapprove any research activities involving human participants. In addition to federal rules, our IRB is bound by state and institutional rules. The establishment of the IRB dates back to the 1970s, however, the acknowledgment of some need for such monitoring goes back to at least World War II.

2. Who is on the board? What kind of training must board members have?

According to federal guidelines, all IRBs must have a minimum of five members, including a scientist, a nonscientist and a community member who has no ties to the institution. This is to ensure that the IRB has sufficient expertise to evaluate the scientific merits of a proposal as well as sufficient diversity of backgrounds and experiences to be sensitive to the needs of the community. In addition to myself, current members of our IRB are Lowell Groninger, Psychology; Christoph Irmscher, English; Laidiily McBride, (community member); Thomas Robinson, Africana studies; Phillip Sokolove, biological sciences; J.R. Swancar (retired faculty member at UM,B dental school).

Several other people play key roles in ensuring that UMBC complies with federal laws and policy, although they do not serve on the IRB. Scott Bass, vice provost for research, and Elaine Young, assistant vice provost for research, serve as our institutional officials responsible for establishing a climate conducive to conducting research consistent with federal guidelines. Tim Sparklin, research services administrator for the College of Arts and Sciences, provides ongoing administrative support to the IRB. He assists researchers with applications, answers their questions, compiles and distributes educational materials to IRB members and manages the distribution and flow of submitted protocols.

University policy requires that all investigators engaged in research involving human participants complete a self-paced instructional program, designed to enhance the investigator's awareness of pertinent ethical principles and federal regulations. IRB members complete this training as well as web-based training programs available from the National Institutes of Health and the Office of Human Research Protection. IRB members also benefit from periodically receiving educational materials addressing pertinent issues within the field.

3. What research issues does the board oversee?

We oversee any and all research involving human participants. Most of the research conducted by investigators at UMBC falls within the behavioral and social sciences. Typical examples include studies validating psychological tests, parental beliefs about children's development, comparison of the efficacy of different educational programs, ethnographic interviews with senior citizens in nursing homes. Although most studies at UMBC are of minimal risk to participants, some are not. Examples of projects that are more than minimal risk include a study of a program to treat self-injurious behaviors in children, an investigation of the characteristics of people involved in abusive dating relationships, a trial of the efficacy of a vaccine for protection against HIV.

Regardless of the specifics of the project, we consider whether the potential benefits to society outweigh the risks to the participants, are risks minimized as much as possible, are participants freely volunteering or are they coerced, and, are participants adequately informed about the project. For example, should research participants receive compensation; and, if so, how much? If payment is too high, the decision to participate may be made for the wrong reasons. We also consider whether a participant's anonymity is adequately protected, in cases where it seems necessary. For example, if a participant is asked about illegal behaviors, what safeguards are in place to protect the identity of the person and does the participant understand the potential risks?

4. How do researchers work with the IRB during the course of a research project?

Researchers are required to submit a proposal to the IRB before they actually begin their research. Prior to preparing their application, researchers are encouraged to review the list of Frequently Asked Questions on our web-site, which contains pertinent information on which forms to use and how to complete them. This and other relevant information can be accessed through a link to the IRB from the Office for Sponsored Program's website, www.umbc.edu/ospa. Researchers can also contact Tim Sparklin with their questions.

The first issue for the researcher to consider when preparing a protocol is the amount of risk the project entails. Submitted protocols fall within one of three categories (exempt, expedited, full board review) according to the amount of risk to participants. Depending upon whether the project is classified as minimal or more than minimal risk, several or all the board will review the proposal. If questions or concerns are raised, the reviewer needs to address these before receiving approval to carry out the project. After the IRB has approved the project, the researcher can begin recruiting participants. Throughout the life of the approved protocol, the researcher must provide us with a progress report at least once a year. Once the project is completed, the researcher must submit what is called a closure report (a brief summary of what was done and found). Submission of a closure report means that the researcher cannot recontact participants without submitting a new proposal.

Researchers are required to contact the IRB if any adverse events occur (e.g., a participant was injured during a study). However, because of the nature of the research typically conducted at UMBC, adverse effects are infrequent.

Posted by dwinds1 at November 1, 2001 12:00 AM