Provost

IRB Frequently Asked Questions


Do my students' class projects need review by the IRB?
Where do I find the forms and guidelines for submitting proposals to the IRB?
Can departments oversee the ethical review of research projects?
How long does the IRB review process take?
Do certain groups of potential research participants require special considerations in the ethical review process?
What kinds of research projects are exempt from IRB review?  
Why does the IRB exist?


1.  Do my students' class projects need review by the IRB?

Depending on the nature of the student project, IRB review may be required.  The faculty member is responsible for determining whether the project requires IRB review.   Faculty members who plan class assignments that involve human subjects are responsible for discussing research ethics with students prior to beginning their projects.

If a student project involves human subjects and minimal risk, but data collected are shared only within the class context with only the instructor and other students in the course, IRB approval is not required.

If student projects involve communicating the collected data beyond the class (in a poster, paper, oral or written presentation, etc.), to any audience beyond the class, IRB approval is required.

If a student class project does not originally involve intent to disseminate data but develops into a research project to be communicated beyond the instructor and students in the course, immediate IRB approval is required.  IRB cannot grant retroactive approval.

 

If the faculty plans to disseminate data from student projects to an audience beyond the course (e.g., conference presentation or publication), IRB approval is required and should be obtained before the projects are undertaken.

 

2.  Where do I find the forms and guidelines for submitting proposals to the IRB?

A copy of the College’s policies and procedures for research involving human participants as well as the form for submitting proposals to the IRB are located at http://www.muhlenberg.edu/main/aboutus/provost/committees/irb/forms.html.  This page can also be accessed through the IRB link on the Committees list on the Provost’s web page. 

 

3.  Can departments oversee the ethical review of research projects?

Yes. Currently the policies and procedures approved by the College allow for ethical review to take place at the departmental level (see pg. 4 of Polices and Procedures….).  A faculty member serves as the Departmental Coordinator and is accountable to the college IRB. Ethical reviews at the departmental level follow the same substantive procedures and policies for record-keeping.  Departments interested in setting up a departmental review option should contact the chair of the IRB and develop procedures and forms in consultation with the IRB.

 

4.  Under what conditions do service-learning or community-based learning projects need to be reviewed by the IRB?

Generally, service-learning and community-based learning projects do not need to be reviewed by the IRB.  All students enrolled in service-learning courses are required to complete a Service Learning Agreement form, overseen by the course instructor and Valerie Lane, the director of Community Services.  Faculty planning service-learning or community-based learning projects should contact Lisa Perfetti, Kathy Harring, or Valerie Lane for further information on planning and implementing their courses in accordance with the ethical and legal responsibilities of the College to protect the individuals participating in such activities.

IRB Policy states:

"Instructional activities that do not constitute research [defined here as the 'systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge'] do not fall within the purview of [IRB] policy." p. 2

However, departmental or IRB review is required in the following cases:

If service- or community-based learning involves conducting formal research.

"Informal collection of information by students from respondents.does not require IRB review.  IRB or departmental review is required only where there is the intent to undertake systematic investigation, produce a design or protocol for the research, a sampling of a population, reportable findings, etc." (p. 4)

If data collected within service- or community-based learning experiences will be disseminated to any audience beyond the course through formal presentation (e.g. poster, oral or written, seminar).  If data collection and analysis are for instructional purposes only within the context of the course, without the intent of communicating it beyond the instructor and students of the course, IRB review is not required.

If the faculty member plans to use data from service-learning or community-based learning courses for disseminated research, IRB approval is required.

If a student research project intended only for class purposes develops into disseminated research, IRB approval must be obtained immediately.  IRB cannot grant retroactive approval.

While IRB approval is not required for service-learning and community-based learning course projects except in the cases described above, such activity must still be planned and carried out in consideration of the College's ethical and legal responsibilities to protect the individuals participating in these activities.  This process is currently overseen by the Community Services office.  Projects involving special populations as subjects (e.g., youth under age 18; prisoners, individuals with physical or mental disabilities; economically or educationally disadvantaged; institutionalized individuals; pregnant women) require additional safeguards.  In these cases, faculty should contact the Chair of IRB to determine whether IRB approval is required.

 

5.   How long does the IRB review process take?

In general, the IRB meets as frequently as necessary to ensure a timely review for all projects. In most cases, proposals will be reviewed by the board within 1 or 2 weeks of receipt. At that point, the IRB would provide approval or suggestion/requirements for revision.  In some cases (e.g., when involvement of a community member is required or for particularly complex studies) the review process may take longer.

 

6.  Do certain groups of potential research participants require special considerations in the ethical review process?

Yes. According to the Federal regulations, IRBs should give special consideration to “protecting the welfare of particularly vulnerable subjects” ( http://www.hhs.gov/ohrp/irb/irb_chapter6.htm). For these groups of participants, the IRB takes special care to ensure that risks are minimal and that there is clear potential benefit to the participant. Consequently, it is likely that a limited review will not be sufficient for research projects involving these groups of participants.  In accordance with the Department of Health and Human Services regulations, the Muhlenberg College IRB policies and procedures specifically give special consideration to research involving children, prisoners, fetuses, pregnant women, human in vitro fertilization, or testing for HIV serostatus (see pp. 8-9 of Polices and Procedures….).

 

7.  What kinds of research projects are exempt from IRB review?  

Research in which there is no risk .  This may include research involving only anonymous questionnaires, surveys, and educational tests, naturalistic observation in public places when there is no threat to anonymity, or archival research based on publicly available data. This type of research requires no informed consent but should be reviewed to determine that it is in fact exempt. The researcher themselves cannot determine that the research is exempt, they must apply for exempt status.

Research done for a class project when the results will not be disseminated beyond the scope of the class is exempt. If you think you or the student may someday want to publicly present or publish the results then IRB approval is required.

Institutional research for the purpose of internal (Muhlenberg) information or required data collection does not require a review, except in instances where the information deals with sensitive aspects of the individual’s behavior (such as drug and alcohol abuse).

All research with outside funding must go to an IRB review.

 

8.  Why does the IRB exist?

The actual rules and regulations for the protection of human research participants were issued by the U.S. Department of Health and Human Services (2001).  Consequently, under these regulations every institution that receives federal funds must have an IRB that is responsible for the review of research conducted within the institution.

On a broader level, the IRB exists to help the institution fulfill its responsibility to protect the welfare of participants in human research. The IRB serves as the College’s formal mechanism for evaluating ethical considerations in human research. In this role, the IRB serves as an important safeguard to ensure that all research with human participants is (a) conducted with respect for the participatingindividuals, (b) likely to produce benefit to the participant and society, and (c) minimize risks, particularly to “already burdened or vulnerable groups” (e.g., prisoners, children, mentally ill) (see Policies and Procedures…, pg. 2)