Protection of Human Subjects in Research Studies and Research Related Activities at Indiana University
The Federal Policy for the Protection of Human Subjects, published in the Federal Register on June 18, 1991, as a final ‘Common Rule’, became effective August 19, 1991. This policy was the result of many years of effort to have a government-wide policy governing the conduct of research with humans. The ‘Common Rule’ is based on and replaces subpart A of the 1983 Department of Health and Human Services regulations for the protection of human subjects at Title 45 CFR Part 46 and is quite similar to those regulations. The ‘Common Rule’ is observed by the following federal departments and agencies conducting or supporting research involving human subjects.
|Department of Agriculture
Department of Defense
Department of Energy
Department of Health & Human Services
Department of Housing & Urban Development
Central Intelligence Agency
Consumer Product Safety Commission
National Aeronautics and Space Administration
International Development Cooperation Agency (AID)
|Department of Commerce
Department of Education
Department of Justice
Department of Veterans Affairs
Department of Transportation
Environmental Protection Agency
National Science Foundation
In addition, the Food and Drug Administration (part of HHS) simultaneously published modifications to its regulations to adopt provisions of the ‘Common Rule’.
All campuses of Indiana University (IU) operate under a Federal Wide Assurance (FWA). The IU FWA is registered with the Department of Health and Human Services. The ‘Common Rule’ requires that the other federal agencies listed above recognize its guidance when using humans in research. Because of this reciprocity the ‘Common Rule’ allows IU to carry on many projects using human subjects without having to ask permission from the individual federal agencies listed above, for each research project. The FWA is a "Letter of Assurance" on file with the Department of Health and Human Services that assures IU's compliance with the federal relations governing the conduct of research with humans.
The ‘Common Rule’ applies to all of IU's seven campuses with the exception of research protocols from Ft. Wayne which are reviewed through Purdue University. Each of the IU campuses has its own Institutional Review Board (IRB). The Institutional Review Board on the IU Bloomington campus has members from, optometry, informatics, gender studies, sociology, psychology, education, business, HPER, university counsel, two physicians, a prisoner representative, a student representative, and a community representative.
Beyond the requirements the ‘Common Rule’ IU has indicated it will review all research using human subjects whether funded or not, whether conducted by faculty, students, or staff. Further, the IRB at IU-B reviews projects that would fall in the Exempt Category, which include existing data and pilot studies.
IU FWA number for Bloomington campus FWA 00003544 - IRB00000222.
Anytime an IU-B faculty member, student (both graduate and undergraduate), or staff member wants to engage human subjects in a research protocol, review and approval from the IRB is needed prior to gathering any data or information from the subjects. If a faculty member, student, or staff person is evaluating a department program, gathering information from people using a survey instrument, observing, or interacting on-line with subjects, drawing blood or other bodily fluids, video taping or audotaping human subjects, testing physical endurance, or engaging in any activity with humans (regardless or their age) under the auspices of a research project, then review and approval from the IRB is required. In addition, if results of the research project are to be published or disseminated beyond the university, review and approval from the IRB is required. Examples of disseminating results beyond the University include making presentations at conferences, writing a book, writing a journal article, or other publications.
Researchers not affiliated with IU-B, who wish to come onto the IU-B campus, or use IU-B records to identify potential subjects, must either provide the IRB with a previously approved application from an IRB at an institution with an FWA, or submit a new application to the IRB. The outside researchers must have approval from the IU-B IRB before they access IU-B records or IU-B personnel.
Infractions of the above referenced regulations could have very serious consequences placed on the researcher and the institution. If a research protocol is conducted without prior IRB review and approval the DHHS can withdraw all federal funding from the investigator and the University. Consequently, the University takes the protection of human subjects very seriously, not only for the sake of protecting human subjects in research and the obvious ethical ramifications, but for fiscal reasons as well.
It is the explicit policy of the IRB NOT to approve any project if the principal investigator has begun data collection prior to receiving IRB approval. This policy is needed to assure compliance with and carry out the purpose of the federal regulations: that is to protect human subjects involved in research and research related activities.
Investigators requesting approval for a project that has already collected data, and was not previously reviewed and approved by the IRB face the possibility that the IRB will disapprove their application and disallow any further use of the data collected. In the event of data collected without IRB approval, the IRB will require the investigator to show that he or she could not reasonably have foreseen having an interest in publishing the results of the "research." While the "existing data" exemption may be available for qualifying research, the IRB is reticent to approve such applications where it thinks that the investigator has attempted to circumvent human subjects’ policies by collecting data as non-research and then applying for use of existing data. It is therefore in the investigator's best interest to consider carefully the likelihood that he or she will want to use the data for research purposes in the future, and to err on the side of inclusion and seek human subjects approval prior to commencing the work.
In any instance in which IRB requirements are not being followed, the IRB shall inform the principal investigator that approval has been suspended and the project must immediately cease.
Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general 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.
Human Subject: a living individual (as well as human embryos, fetuses, and any human tissues or fluids) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subjects’ environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject (this includes interviews and surveys). 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 (for example, a medical, or academic 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.
The environment in which investigators conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate and responsible investigators provide the best possible protection for research subjects. In order to determine these responsibilities, there are eligibility guides. In addition to eligibility guides, there are other criteria that can assist in outlining the responsibilities. Please refer to researchcompliance.iu.edu/hso for more detailed information.
The IRB has established a list of academic and personnel ranks that are approved to submit, or sponsor, an application to the IRB. The approved ranks are:
FT2 Associate Professor
FT3 Assistant Professor
FT5 Lecturer convertible to tenure-track
FLS Senior Lecturer
ER1 Emeritus Professor, Assoc. & Asst.
FC1 Clinical Professor
FC2 Clinical Associate Professor
FC3 Clinical Assistant Professor
FC5 Clinical Lecturer
FCS Senior Clinical Lecturer
EC1-3 Emeritus Clinical Prof., Assoc. & Asst.
AAB Vice President
AAD Assistant Vice President
AAC Associate Vice President
AAF Vice Chancellor
AAG Associate Vice Chancellor
AAH Assistant Vice Chancellor
AAJ Associate Dean
AAK Assistant Dean
HAI-HAM Acting I-M
LT2 Associate Librarian
LT3 Assistant Librarian
EL1-3 Emeritus Librarian, Assoc. & Asst.
RS1 Senior Scholar/Scientist
RS2 Associate Scholar/Scientist
RS3 Assistant Scholar/Scientist
As of October 1, 2000, the National Institutes of Health (NIH) requires researchers with NIH funding to have institutional certification of educational training with respect to the use of human subjects in research. Indiana University has developed a web based educational module on the basic principles and procedures of human subjects.
In July of 2002, the Department of Health and Human Services set forth a policy specifying that all researchers (and faculty advisors and co-investigators) wanting to use human subjects in research and research related activities must first complete and pass the Protection of Human Subjects in Research test before any application will be reviewed by the IRB.
This test covers basic principles and procedures of human subject’s research and provides evidence of participation in an education program on the use of human subjects in research. Completion of the module or participation in a workshop will satisfy this requirement. Renewal of the certification will be required every three years. This is now a campus requirement, regardless of funding.
All protocols requiring Full Committee review items must be received by Friday at 5:00 p.m., four weeks before the next Full Committee meeting.
If it is determined your application requires full review and it has been submitted after the stated date, it will be held for the next month's meeting.
Exempt and expedited level projects and most amendments and continuing reviews are reviewed weekly by either the chair of the IRB or the director of the IUB Human Subjects Office, currently on Wednesdays. Applications must be received by 5:00 p.m. on Friday in order to be reviewed the following week.
Investigators should allow sufficient time for review prior to the beginning date of the project. While projects are reviewed frequently, the entire process can take up to 3 weeks. Projects that require a full board review may take at least 6 weeks from the time of submission.
There are some exceptions to these schedules and researchers are encouraged to contact the IUB Human Subjects Office by email or by phone with any questions about the deadlines.
Regulations require that approval be obtained before data collection begins.
The IRB application process and guidelines are available from their Web site. For those wanting more detailed information on the policies and procedures for the Bloomington campus. A list of helpful Web sites follows.
IU Human Subjects Web site
Office for Human Research Protections (OHRP)
The IRB office is open Monday - Friday 8:00 a.m. - 12:00 noon and 1:00 - 5:00 p.m.
Staff members are available during office hours to answer questions, help determine if review is needed and which type of review is required, and to help with completion of the IRB application forms. Staff can be reached at Carmichael Center, Suite 203, by phone at 812-856-4242 or by e-mail at .
INDIANA UNIVERSITY REQUIRES THAT ALL RESEARCH UTILIZING HUMAN SUBJECTS BE APPROVED PRIOR TO THE COMMENCEMENT OF ANY DATA COLLECTION OR RESEARCH.