Institutional Review Board

Student Handbook on Human Subject Research

August 2006

Frequently Asked Questions about Student Human Subject Research

What does it mean to conduct human subject research at USM?

Research with human subjects is defined by federal law as any kind of activity that involves “a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge.”¹ Though "generalizable knowledge" is the most commonly used criterion, many forms of scholarly work are recognized and regulated as "research". Examples include case studies, ethnographies, oral histories, and other qualitative data collection. Students can get research experience through data collection exercises, independent study, and collaboration with faculty mentors. No matter how research is defined, students at USM have opportunities to get experience conducting research and thereby enter a level of inquiry and learning that goes deeper than classroom participation and textbook reading. Being engaged in such research involves higher than average maturity and commitment and can fundamentally shape a student's life-long interests. Research allows the student to directly participate in the discovery of new information within the arts or sciences, leading to a deeper appreciation of how knowledge is acquired and utilized.

Who is allowed to conduct human subject research at USM?

All undergraduate and graduate students at USM are encouraged to participate in research. However, participation in research is determined by the prospective faculty mentor and is generally influenced by a combination of timing, student maturity, and demonstrated capability. There are three major types of research in which students may participate:

Student Classroom Projects

Student classroom projects are designed and supervised directly by the faculty mentor teaching a class. The criteria for IRB review of student classroom projects are not covered in this handbook because they are the instructor’s responsibility. Faculty can obtain information about the IRB review of student classroom projects directly from the ORC.

Existing faculty research programs

Though research programs vary dramatically by college, department, and faculty mentors, a common theme that links all student research involvement can be summarized in the following ways:

• Students are expected to demonstrate above average maturity and the ability to handle responsibility.
• Students are usually in good to excellent academic standing, primarily because research work can be extensive and require a significant time commitment. Students are generally advised to establish a strong academic record before becoming involved in research.

Student-initiated research

Students often have shown a flair or special interest for a particular area of research through coursework, independent study, or service learning. Students may decide to further their interest through engagement in additional research efforts (e.g., capstone projects, clinical projects, theses, dissertations).

Other more specific requirements for student researchers may be sought by individual departments or faculty mentors. For some human subject research (e.g., direct involvement with children; state/federal contexts) there may be other legal requirements or restrictions.

Why get involved in human subject research at USM?

Research participation can be one of the most gratifying university experiences. Often students discover areas of interest that shape their future post-graduation plans (e.g. graduate school) and careers. Successfully completing a research project of any kind is the culmination of great effort, focus, and creativity. Most students report great pride in their projects or contributions to a research program. However, there are also some very practical, concrete benefits to research participation:

• Getting into a graduate program: Admission to good graduate and post-graduate programs is becoming more competitive every year, especially in research oriented programs (e.g., Ph.D, Ed.D.). As an example, if two psychology majors with equal board exams and GPAs are going for the same slot, the one with some research experience (especially with presentations and/or publications) will likely win out.
• Getting a job: USM has an excellent record for undergraduate and graduate students with research backgrounds acquiring positions directly related to their research experience. These opportunities come in the form of internships, excellent volunteer opportunities, and career-track positions. Why? Primarily because research (though often academic and intellectual) often involves very marketable organizational skills, database management, and communication skills (i.e., oral, written, and technological).
• Career development: Research at USM can provide experience (as described above) that often helps students, already in part-time or full-time work, clarify strengths and goals for the future, and can directly impact pay and promotion.

What forms of human subject research are available?

The range of research at USM is extremely broad, and is characterized by the diversity of individual faculty. For example, psychological research will tend to be quantitative and statistically based, focusing on behavioral measures, ranging from human development to social processes. Whereas sociological research might have a macro-social approach and involve demographics, social policy, and government or a micro-social approach and involve observations of interactions or interviews with individuals or focus groups. Research goals should be driven by each student's individual interests and aptitudes, especially as they pertain to future graduate school or career plans. Often research assistant positions will be advertised within departments and on USM-wide lists. (See getting paid below).

How do I get involved in human subject research at USM?

Students engaged in research at USM are not part of an exclusive, secretive club! For many, student research may even be part of required course work. However, participation in independent study or faculty research programs usually happens in two ways:

• Joining an existing research program: This type of involvement can occur either by invitation of a faculty member, or by a student approaching a faculty member to explore the possibility of working as a research assistant. In the former case, it would usually occur when a faculty member individually recruits students with high academic standing from a class. Typically, when a student joins an existing research project, the ORC or IRB approval will have already been obtained, thus the student may not be directly involved in the initial review. However, if the faculty member’s research extends beyond the initial approval period or undergoes a change in design the student may be involved in preparing the necessary IRB application packet for continuing review or for revision/amendment.
• Student-initiated research: This process is fully described in steps 1 through 10 of the next section of this handbook. This may be a project that a student wishes to pursue for his or her own interest, but may also be for academic credit within the Independent Study program (e.g., PSY400 – Independent Study) or Honors Program. It is a good idea to set up a meeting with a faculty mentor under whose supervision you would like to work. Informal "brain-storming" sessions are great for generating research ideas and getting a good sense of appropriate scope and duration of a research project. Once a research proposal is fully articulated and approved (first by the faculty mentor, then eventually by the USM IRB), it can commence.

Can I get paid for research activity?

Often, yes. Some faculty members have grants that fund research projects and allow students to be paid for lab work, data collection/input, and occasionally for higher responsibility roles such as research design and even manuscript co-authoring. Some research positions are funded with work-study; however, one must not assume paid research positions at the undergraduate level.

What should I expect from the student-faculty relationship?

This is one of the most important considerations in student research, but also the most ambiguous. When students are participating in research as part of a course requirement, then the role of the faculty member is to very clearly define the activity and assessment criteria, and take responsibility for protection of human subjects. Usually in these cases, a joint or group IRB proposal is drafted for the purpose of class data collection. Students become more proficient with research design and more familiar with the literature in their area of interest, as they reach their junior and senior years, and certainly within the first year of a graduate program. As a result, the relationship with the faculty mentor tends to naturally become more collaborative, with more responsibilities shared with the student. As with other aspects of research, departments differ greatly on the extent to which students become more closely affiliated with the work of faculty. At USM, student-faculty relationships range from students working in a lab or research setting as an assistant with clerical or administrative duties, all the way to co-principal investigator, with responsibilities for research design and manuscript preparation. No matter what level of involvement a student has with a faculty mentor, a few key commonalities apply:

• Independence: Students should expect to work gradually toward independent research (either for academic credit or to take on part of a faculty mentor's research program) in a way that is consistent with their maturity level and proficiency.
• Expectations: Students should expect a clear division between coursework they may currently have with a faculty mentor, and the actual research responsibilities. It would be inappropriate for a faculty mentor to allow performance in one context to bias his/her evaluation of the student in another. Similarly, a faculty mentor should be sensitive to the academic needs of a student and not overload him or her with work in the research setting.
• Boundaries: Another issue that pertains to the research setting as much as to any other student-faculty interaction is the setting of boundaries. Students must feel secure that they will not be asked to take on responsibilities that are inappropriate, or are out of the scope of their research role (e.g., a student should not be expected to run personal errands for a researcher).
• Recognition: Students often contribute enough to the research program that they expect to be included as a co-author on publications or conference presentations. This can be a tricky, potentially problematic issue. The key to avoiding disappointment or resentment is to always establish, in advance, a transparent, predictable set of criteria for being included on published work. Below are direct questions that any research student should feel comfortable asking a faculty mentor:
  • "If I design and implement a study, collect the data and write up the results, can I be first author? And if so, do you expect to be added as a second author?"
  • "If I have worked in your lab managing databases, running subjects, etc. will I be added as a junior author (i.e., second author)?"
  • "What level of involvement in the current research will allow me to be considered as an author for future publications/presentations?"
• Equity and fair practice: As with any other university setting, students should always feel secure that they will receive fair pay or recognition for work, commensurate with their effort and level of ability. There should never be any bias on grounds of sex, sexual orientation, race, or ethnicity. Students should expect to be treated with respect, without fear of sexual harassment or inappropriate pressure within the student-faculty relationship. If questions arise on these issues, the student should address concerns with the faculty mentor. If he or she does not respond, or if the problem becomes worse, then the student should immediately seek help from a department chair or other University official.

How is research defined?

Although USM welcomes many different forms of inquiry by students, other organizations have developed specific definitions of research and related terms. Under federal regulations that govern research compliance, definitions of research and related terms have been developed to help researchers know when their activities need to be reviewed. Specifically, the terms research, research subject to regulation, human subject, and intervention are defined in federal statutes.². These definitions are as follows:

Research:

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Research subject to regulation:

Similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (e.g., Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (e.g., Wage and Hour requirements administered by the Department of Labor).

Human subject:

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

Intervention:

This process includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

USM does not restrict students from engaging in research, however the intent is to support high-quality and ethically sound student research. USM undergraduate and graduate students must be aware that all proposed research activities, including student classroom projects, that include animals or humans as subjects, biologically sensitive materials, or radiation must be reviewed by USM’s ORC. In the case of research that includes human subjects, all student research plans need to follow a ten step process for IRB review. Importantly, these steps must be followed prior to the start of any research activities by students that include human subjects. The steps are outlined in the next section of the handbook.

1. See The Common Rule, 45 Part C.F.R. §46.102 (2005)
2. See 45 C.F.R. § 46.102