- Institutional Review Board
- Submission Guidelines For All New Studies
Submission Guidelines For All New Studies
The principal investigator is responsible for preparing a proposal for Institutional Review Board review prior to initiation of research, and is advised to allow adequate lead time for the Institutional Review Board process, since it is not uncommon to be required to amend some aspects of the proposal to bring it in line with federal regulations prior to approval.
- The principal investigator (PI) and all co-investigators must review the educational material on the Web and satisfactorily complete the research with human subjects test. A copy (ies) of the verification of a passing test score will be required prior to Institutional Review Board approval. Doing this and forwarding verification along with other materials FIRST will alert the PI to issues that will need to be addressed in the proposal. See the sidebar for a web link.
- The principal investigator should carefully assess the proposed research with regard to whether it best fits as exempt, expedited, or full committee review. (Refer to the Web address listed above for educational material.) The Institutional Review Board will make the final determination about the appropriate level of review. In cases where the level of review is in question, the higher level of review will be required by the IU Kokomo Institutional Review Board.
- The PI should prepare the following materials which are available on the Web at the following address: http://www.iuk.edu/~koirb/forms.shtml for consideration of the Institutional Review Board:
- Verification of Passing the Research With Human Subjects Test
- Documentation of Review and Approval (DRA)
- Checklist for Appropriate Level of Review (exempt, expedited, or full)
- Summary Safeguard Statement (or Exempt Research Statement)
- Informed Consent(s)
- Copies of instruments, questionnaires, letters
- Other as appropriate: package insert, letters of cooperation, HIPAA checklist, assent document
Determining What Level of Review to Apply for:Exempt Studies: These are studies that are exempt from Institutional Review Board review. The application must demonstrate:
1. The research is minimal risk, and
2. Fits into one of the exempt categories:
a. Research on instructional strategies that is conducted in established or commonly accepted educational settings;
b. Research (except research with minors) including the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior;
c. Research involving the collection or use of existing data, if these sources are publicly available, or the information is recorded by an investigator in such a manner that subjects cannot be identified;
d. Research and demonstration projects, which are conducted by or subject to the approval of Department or Agency heads;
e. Taste and food quality evaluation and consumer acceptance studies, if
- Wholesome food without additives, or
- If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA, or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Expedited Studies: These studies may be reviewed by the Institutional Review Board through expedited review procedures. The application form must demonstrate:
1. No more than minimal risk to subjects, and
2. Involve only procedures listed in one or more of the following categories:
a. Collection of hair and nail samples
b. Collection of excreta and external secretion
c. Recording of data from subject 18 years of age or older using non-invasive procedures
d. Collection of blood samples in minimal amounts
e. Collection of dental plaque and calculus
f. Voice recording
g. Moderate exercise by healthy volunteers
h. Study of existing data
i. Research on an individual or group behavior that involves no manipulation of the subjects and is not stressful; and
j. Certain kinds of research on drugs and devices
Note: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research setting is not greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological tests.
Full Review Studies: These studies either involve more than minimal risk and/or are being conducted with vulnerable populations.
1. More than minimal risk to subjects, and/or
2. Research conducted with certain vulnerable populations
a. Certain types of research with children, pregnant women, fetuses, and other vulnerable populations
b. Research involving prisoners
c. Research that involves experimental drugs or devises
d. Research that involves invasive procedures
e. Survey research that involves sensitive questions or is likely to be stressful for the subject.
Note: More detail regarding categorization is available on the web at the OHRP web site on the sidebar.
Informed Consent Guidelines
The Informed Consent is one of the primary ethical responsibilities of the researcher, and it protects both the research subject and the researcher. The Informed Consent should be written in language that is understandable to the subjects. When research involves individuals who are not able to provide an informed consent (such as minors), informed consent from a legally responsible party should be obtained. In such situations, the best practice is to also use an assent document. If an investigator believes that one or more elements of the Informed Consent does not apply, the PI must indicate rationale for this in writing and request a waiver.
ALL IU Kokomo investigators must submit an application detailing the involvement of human subjects in the research project. All documents must be typed (10-12 point font) on a current edition of the forms and personally signed by the principal investigator and the faculty sponsor, when required, or the application will be returned to the investigator.
Requests for approval to use human subjects should be submitted to the IU Kokomo Institutional Review Board in the Office of Research and Sponsored Programs. The forms must be completed according to the instructions provided. Downloadable forms are available on the IU Kokomo Institutional Review Board Website. For Exempt studies, two copies are required. For Expedited Studies, three copies are required.
For Full Review Studies, ten copies are required.
Starting Your Research
Research may not begin until and unless final written approval or acceptance has been received from the IU Kokomo Institutional Review Board. This includes any and all contacts with human subjects (or work with documents on, or from, human subjects) and all categories of research. This restriction applies not only to the initial application, but also to any amendments or continuations.
Investigators may not institute changes to their research prior to receipt of written final approval for the change. The regulations governing research involving human subjects and our Letter of Assurance with the federal government preclude the granting of retroactive approval.
Subjects should not be recruited in any manner before Institutional Review Board final approval is received. Any documents recruiting subjects must be submitted to the Board with the application. This includes: fliers, e-mails, letters, newspaper and other media advertisements. Offers of compensation must not be in print larger than that used in the document generally. Other benefits cannot be over-emphasized.
Reports to the Institutional Review Board
The principal investigator is required to provide written documentation of:
Any changes to the study protocol
Any changes to the informed consent
Termination of the study (if the study is prematurely halted)
Continuation of the study (at designated intervals)
Completion of the study
Changes in protocol or consent must be approved before being implemented. Forms for reporting to the Institutional Review Board are available on the website or through the Office of Research and Sponsored Programs (455-9205).
Researcher Responsibilities Regarding Studies Once Begun
Investigators are required to report any proposed changes to their research study via a Study Amendment Form. Investigators must report any changes, regardless of the level of the original review and the significance of the change.
Reference the original title of the study, the principal investigator, and the proposal identification number. Any changes to the title, project beginning or ending dates, or the investigator should be described in section 1. If the investigator's appointment does not carry an approved rank code, then both the investigator and the sponsor must sign the form.
Amendments involving minor changes that pose no more than minimal risk to subjects will be reviewed on a weekly basis according to the weekly review schedule. Amendments involving more than minor changes or more than minimal risk will be reviewed by the full IU Kokomo IRB, according to the full committee review schedule.
Changes may not be implemented until final written approval is received from the IU Kokomo IRB.
A Study Amendment Form is available on the Website or through the Office of Research and Sponsored Programs (455-9205).
Study Continuing Review
Studies are approved for a designated period of time that will not exceed one year. For studies that will continue beyond one year or beyond the designated study period, a Continuing Study or Study Termination Report must be completed by the PI and approved by the IU Kokomo Institutional Review Board prior to the end of the designated time.
Studies involving greater risk may be reviewed at a shorter time interval, as designated by the Institutional Review Board and specified on the Institutional Review Board approval.
Exempt studies do not require continuing review.
The IU Kokomo Institutional Review Board will send out a call for continuing review or completion with a copy of the Continuing Study or Study Termination Report form with a copy of the Approved Consent Form(s) approximately one month before it is due in the IU Kokomo IRB office.
Principal Investigators who disregard the call for continuing review should recognize that the Institutional Review Board approval is only valid for the specified period of time, and the Institutional Review Board has the authority to halt research that does not comply with the guidelines.
When the study is completed or terminated the Principal Investigator must complete and submit the Continuing Study or Study Termination Report Form. The IU Kokomo Institutional Review Board will send out a call for this approximately one month prior to the anticipated completion date.
Principal Investigators who are completing studies at all levels are required to comply (exempt, expedited, and full reviews).
The IU Kokomo Institutional Review Board considers a study complete when data analysis is completed, or when all data have been collected and all the data have been de-identified so that there is no link whatsoever between the data and any subjects.
Reporting Adverse Events
Any adverse experience associated with a study must be reported to the IU Kokomo Institutional Review Board within 3 working days after the incident. The report should be in letter format containing the following:
- Study number and title to which the incident relates
- Description of the incident
- Principal investigator's assessment of the incident, outlining any changes and the significance/relevance to the study, e.g., changes in risk/benefit ratio.
- Any changes that need to be made to the consent statement, plus the revised form.
- Identification of the principal investigator and the principal investigator's signature
Guidelines for Transnational Research
Here are the guidelines for Transnational Research.