Research involving minors may
require their assent, i.e., the minor's agreement or willingness to
participate in the study. This is in addition to parental or
guardian permission. Assent may only come from children
capable of making this decision. Parental permission may suffice
when a child is not capable of making this decision. Regardless of the situation, investigators are required to provide
a method of assent with their IRB proposals involving minors. This may include, but not limited to the following: 1) letter of
assent signed by the minor; 2) statement of assent read or
communicated to the minor; 3) a procedure whereby assent is implied
by the child's active participation; and 4) a statement explaining
why assent is not necessary. In the latter case, a minor's
assent may not be required, e.g., minors involved in classroom
activities that are part of their required curriculum and
Regardless of the method of assent
used by the investigator, minors may not be coerced, actively or
passively, into participating in a study. Furthermore, any
statement, written or expressed verbally, must be communicated in
ways that the minor will understand.
Investigators may request exception
to or waiver of assent procedures in their particular study. However, their request must come before the entire IRB for
approval, and may not be handled through exempt status or expedited
review proposals. In order to do this, investigators must
submit to the IRB 10 copies of a written proposal along with any
supporting documentation explaining their reasons for exception or
waiver. Federal regulations provides for exceptions and
Answers to Frequently Asked
Questions (FAQ) regarding the treatment of minors by the U.S.
Department of Health and Human Services, Office of Human Research
Projections may be found at the following link: http://www.hhs.gov/ohrp/researchfaq.html.
In order to involve a human subject in research, a researcher must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. Special care should be exercised when the subjects are legal minors or adults legally incapable of giving consent. Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. By federal law, researchers are to keep signed informed consent forms for three years. 45 CFR 46.116
Information conveyed in the informed consent procedure shall:
There are three types of research proposals:
A description of each type of research proposal and instructions for completing the application process is presented below. Please refer to the Research Proposal Checklist prior to completing any of the IRB forms. The checklist is provided for your convenience in order to ensure that you submit all the necessary materials.
Office for Human Research Protections (OHRP) approved on-line
training is required of principal investigators (PI) and
co-investigators (CI) prior to submitting proposals for full review
and expedited review. Only the PI is required to complete IRB
training prior to submitting proposals for exempt status reviews,
except when children are involved in the study. In this case,
both the PI and CI are required to complete basic IRB training.
The on-line training program is available at NIH Office
of Extramural Research.
A copy of the training certificate is to be submitted to the IRB
Chair prior to completing an initial proposal. This should be
accompanied by the person's Dragon ID number and name of their
department. A record of the training will be kept on file, as well
as in a database for future reference. Investigators may
obtain IRB forms upon completion of their training.
A full review by the IRB will be conducted for research that involves greater than minimal risk. A full review must be conducted at a meeting of the IRB under the procedures established below. In order to approve research under a full review, the IRB will consider the following:
Proposals for full review must include:
Full Reviews take place once a month during the academic year. A current meeting schedule is available on the IRB website.
An expedited review by the IRB will be conducted for research
that involves no more than minimal risk or to review minor changes
in previously approved research. An expedited review may be
conducted by the IRB Chair and by one or more reviewers designated
by the Chair from among IRB members. In order to insure that
all members have involvement in the expedited review process, the
Chair will designate reviewers on a rotating basis. Care will
be taken in the selection of expedited reviewers to avoid a
conflict of interest.
The IRB expedited reviewer will make one of five
recommendations: 1) proposal qualifies for exempt status, 2)
proposal is approved as submitted, 3) proposal is approved with
required revisions, 4) proposal should be revised and resubmitted,
and 5) proposal should receive full review.
The Chair of the IRB will make the final decision regarding
approval of proposals that were revised and resubmitted for
Expedited Review. When an expedited review procedure is used,
all IRB members will be advised of research proposals that have
been approved under the procedure. If issues of concern arise
in the process of full or expedited review, the
investigator will be provided the opportunity to respond to
those concerns prior to any action on that review.
Proposals for expedited review must include the same materials
required for full review. The only difference is in the
number of copies to be submitted to the IRB. Expedited reviews
require the original and one copy of the entire proposal.
Exemptions from IRB Review pertain to research where the
subjects are at no more than minimal risk, the subjects'
confidentiality is maintained, and the research meets at least one
of the six criteria for exemption. Research proposals that
meet the criteria for exempt status must still be processed through
the IRB, either directly or through a departmental review
committee. The Chair of the IRB will make the decision
regarding exemption approval when proposals contain a Request for
Exempt Status. Proposals may be returned to the principal
investigator if it does not provide sufficient information to make
a determination about exemption. In this case, the PI may be asked
to submit the proposal for expedited review.
Although a research project may meet the criteria for exempt
status, it does not mean the study is exempt from meeting federal
regulations regarding informed consent and storage of confidential
materials. Proposals approved for Exempt Status are not required to
submit a Continuing Review or Project Completion form. In the case
of minors, only research conducted in established or commonly
accepted educational settings may be considered for exempt
status. In this situation, the research must be conducted in
the minor's classroom or school by his/her teacher, instructor, or
therapist. This does not apply to student teachers in
locations outside of the MSUM campus. Proposals requesting exempt
status must include (1) Human Research Approval Form; (2) Request
for Exempt Status form; (3) letter of permission from
institution(s) other than MSUM (if applicable); (4) copy of
Informed Consent form or implied consent letter for surveys; and
(5) 100-150 word abstract or summary of the proposed study. The
abstract should contain information about the purpose and mechanics
of the study, to include information about the subjects, the
procedures and methods, data collection, etc. [See samples ofabstracts by following this link.]
The following types of research are exempt from the required review (45 CFR 46.101b):
Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefits or services programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. Taste and food quality evaluation and consumer acceptance studies, (1) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use founds to be safe, or agricultural chemical or environment contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Department Review Committees (DRCs) may be formed to handle the review of class projects and faculty or student research proposals within the department. Applications for the formation of a departmental review committee should be sent to the IRB c/o the Graduate Studies Office (Owens 215). The applications should include a letter of intent to form a committee along with the names of the DRC chair and members. DRCs are required to meet the following conditions:
All research conducted by students involving human subjects must be reviewed by the IRB or Departmental Review Committee (see Department Review Committees for details regarding their responsibilities). Students are expected to submit their research proposals through their faculty advisor who will serve as the principal investigator (PI) of the study. Students are to be listed as co-investigators (CI). Refer to Summary of Review Process frodtails. PIs and CIs must complete an on-line training program before proposals will be processed by the IRB or DRC. Refer to Training Requirements for details.
Researchers must take added precautions to protect the identities of their research participants when using electronic methods for obtaining and/or storing information and data. A MSUM (mnstate) account designated as a secure site must be used for any research:
Violations to the policies and procedures that are brought to the attention of the IRB will be handled on a case-by-case basis. As a general rule, the principal investigator of the alleged violation will be asked to meet with the IRB to discuss the situation. the IRB will make every effort to assist the principal investigator in finding a remedy to the violation. Failure on behalf of the principal investigator to comply with the decision of the IRB may result in one of the following:
In the instance of IRB disapproval of a project, or of a contingency approval, a project director/researcher may request an appeal hearing before the IRB in full. Records and notice of action will be provided.No other University approval may be provided in opposition to IRB disapproval. However, IRB approved projects may be disapproved by other offices of the University.
All researchers must complete a Project Completion or Continuing Review Form at the end of each academic year. Forms will be sent by the Graduate Studies Office to the Principal Investigator. Once a research project is determined to be complete, all associated documents will be sent to the Office of Academic Affairs to hold for three years. It is the principal investigator's responsibility to provide secure storage of the Informed Consent forms and any audio/video tapes or photographs. These items must also be maintained for three years.