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Institutional Review Board
Student Handbook on Human Subject Research
August 2006
Steps Required for Conducting Research with Humans
In order for students to develop strong research skills that will be useful in their future work endeavors,
training and support by faculty are essential. For this reason, all USM student research MUST be
supervised by a USM faculty mentor. Together, the student and faculty mentor co-develop and work through the steps
required for successful completion of the research. When the study includes human subjects, the research proposal
must be reviewed by the IRB. To help students and faculty prepare materials for IRB review, a 10-step process for
research proposal development and review has been developed. The steps in the IRB review process for student-based
human subject research are depicted in flow chart in Figure 1 (see Attachment C).
Training for protection of human subjects
Personnel who participate in collecting or handling data from human subjects in the study must complete approved
training. The National Institutes of Health (NIH) has an online training program that students and faculty must complete
to become aware of the historical, social, and legal components of human subjects protection. This training can be
accessed via the NIH
web site, as well as from the link on the USM IRB web site at
www.usm.maine.edu/orc/irb/. Once the training is completed, a certificate
verifying the training should be saved and printed. This certificate must be sent to the USM ORC with the submission forms.
Ten Step Process
Idea
The first step in student research is an idea. Students of all levels can generate ideas that may lead to research
activities. The idea and planning stage of the research process should be guided by prior research in the student’s
field of study. In order to move forward, student research ideas need to be organized into a research proposal. Student draft proposal
All student research needs to be outlined in a written proposal of the research. The research question(s), design,
subject(s), method, procedures, and time frame should be described in the proposal. Proposals can be written in the
format that is common for research in the discipline of study; however, certain information about the study is required
for all IRB reviews. Specifically, proposals must include descriptions of the research questions, study participants, and
materials and procedures to be used. The forms and required information that need to be included in the proposal can be
found on the ORC web site at www.usm.maine.edu/orc/irb/. All research
proposals must be submitted with a separate Research Proposal Summary that includes the required content and follows the
designated format indicated on the form being used (e.g., on the IRB Exempt form [see #9] and on the IRB Review form [see #5]).
Students and faculty should be aware that there are a number of different
forms that the ORC uses for research proposal submissions. These
forms help the ORC staff identify what type of research is being proposed and whether the proposal is for initial, amendment
or revisions, or continuing review. Below are the names of important ORC forms. These forms can be obtained directly from
the ORC web site.
If you are uncertain which form you need to submit or have any questions in general about the process, please contact
the ORC office at usmirm@usm.maine.edu or 780-4368. Please note that only
complete research proposals will be reviewed and the ORC will return incomplete, incorrect, or handwritten submissions
to the faculty mentor unread. Faculty mentor reviews proposal
Once the student has drafted the research proposal, it is reviewed by a faculty mentor. Students cannot submit research
proposals on their own. All student-initiated research must be sponsored by a USM faculty mentor. The faculty mentor is responsible
for reviewing and approving the research design as sound and appropriate for the proposed study. It is up to the faculty mentor to
review the proposal carefully and arrange for any changes in the research proposal and IRB submission forms before signing the
request for IRB review. Student and faculty mentor revise proposal
Since most successful research initiatives undergo multiple revisions before a final study is conducted, it is expected that
the initial student draft of a research proposal will require changes. The faculty mentor should communicate what design changes
are needed directly to the student and together with the student revise the written research proposal. Faculty mentor approves research proposal
Once the student and faculty mentor have agreed on the final version of the research proposal, the IRB review forms can be
completed and signed. The correct IRB review form must accompany all research proposals submitted for review. All IRB forms are
available on the ORC web site at www.usm.maine.edu/orc/irb/forms.htm.
The student and faculty mentor need to complete the correct form to match the research proposal. Submission of the research
proposal and completed ORC forms will help prevent delays in the review process. Both the student’s and faculty mentor’s
names should be listed on the research proposal and IRB forms as co-principal investigators. Both the faculty mentor and student sign
the IRB form that accompanies the research proposal submitted for review. Proposal is submitted to USM Office of Research Compliance
As soon as the research proposal has been approved by the faculty mentor, and the IRB forms have been completed and signed,
the total research application can be submitted to the IRB for review. The research proposal and IRB forms should be submitted
in both hard copy and electronic (e-mail) format. E-mailed research proposals and IRB forms may be submitted to
usmirb@usm.maine.edu. Hard copies can be sent via campus mail to the Office of Research
Compliance at:
178 Science Building, New Wing
5th Floor
Portland Campus
In situations where a student joins a research project after it has already been reviewed by the IRB, a Protocol Revision
and Amendment form will need to be submitted to the ORC, by the faculty mentor, in order to list the student as a new
associate and to assure the ORC that the student has an up-to-date NIH certificate. All researchers must complete appropriate NIH
human subjects training. Copies of the completed/updated NIH training certificates are required from the student and the faculty
mentor, as well as a copy of the faculty’s current curriculum vita (CV), with each to be sent to the ORC. A student
CV is not required. A faculty CV is required and is kept with individual research protocol applications, therefore a copy of a
faculty CV is requested with each new protocol submission. ORC determines IRB level of review
As soon as a research proposal is submitted to the ORC, it is assigned a protocol number. Each submission is
referred to as a “protocol” and the ORC staff will refer to the protocol number when communicating about
the submission. The protocol number helps the ORC keep track of submissions and communicate about them without revealing
confidential information during the review process. Once the protocol is assigned a number by the ORC, a determination
will be made as to the appropriate type of review to be conducted. Consistent with U.S. legal standards regarding IRB
reviews, the ORC will first determine if the proposed activities constitute research as defined by federal regulations.
If the proposed activities do not fit the criteria for research, the ORC will issue a formal letter to the faculty
mentor and student indicating that the proposal needs no additional review by the ORC. If the proposal fits the
criteria for research activities, there are three levels of review that can be conducted for an initial research proposal.
These are:
- Exempt
- Expedited
- Full Board Review
The ORC staff will read the submitted research proposal and determine which level of review is needed. The only legally
authorized entity at USM that can determine what is or is not research (as defined in 45 C.F.R. §46.102 (2005)), for
purposes of regulatory compliance and human subjects protection, is the ORC/IRB. No other person, group, department, or
entity has the legal authority to make such a determination.
Research that involves minimal risk to human subjects and meets certain regulatory guidelines may be exempt from
additional review and such exemptions are granted by the ORC. Other research that also includes minimal risk to the
subjects may, however, require an expedited review. Expedited reviews include review by both ORC staff and one or more
IRB members. Research that involves greater than minimal risk to the subjects and/or includes certain protected subjects
such as prisoners may require full review by the IRB. A summary of the levels of review for research proposals involving
human subjects can be found on the ORC web site at:
www.usm.maine.edu/orc/irb/process.htm. Once the IRB determines
what type of review is needed the proposal is sent on to the parties who will conduct the review. The faculty mentor will
be notified of the type of review to be conducted. Approximate time frames for completion of reviews, depending on the level,
are available on the IRB web site. Review conducted
The review is conducted according to the requirements set forth in relevant federal and state laws and USM Policies,
Procedures, and Guidance For Human Subjects Research. The reviewer, or the entire IRB if a full board review, will consider
the features of the proposed study and whether they meet the federal requirements. In some cases, a reviewer may request
additional information prior to completing the review. When necessary, the ORC will contact the faculty mentor and student
to request specific information about the research proposal; the faculty mentor is responsible for obtaining the requested
information and submitting it to the ORC in order for the review to be completed. Faculty mentor notified of review results
After the level of review has been determined (i.e., Not Human Subject Research, Exempt, Expedited, or Full Board) and
the review process has been completed, there are three types of decisions that can result. The ORC staff will notify the
faculty and student of the results of the review. The three potential decisions are:
- Approved as Written
- Approved with Conditions
- Not Approved
If a proposal is approved as written, then the faculty mentor can notify the student and the research can begin according
to the planned time frame. Approvals are given for no more than 12 month time periods. If a proposal is approved with conditions,
then the research can begin only after the stated conditions are met. If a proposal is not approved, then none of the research
can be conducted. In such cases, the faculty mentor should meet with the student and discuss revising the proposal to meet ORC
requirements. If the student and mentor decide to re-submit a proposal, the process would include the same 10 steps as the
initial research proposal. Research begins
Only after a proposal has been approved by the ORC can the student’s research begin. Research initiated prior to ORC
approval is subject to potential termination by the ORC. Any data collected before or after the time period approved by the ORC
is subject to potential confiscation by the ORC. Both the student and faculty mentor who engage in research activities not
approved by the ORC, are subject to any applicable USM and/or federal penalties.
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