IRB Protocol Review FAQs
What is an IRB?
An Institutional Review Board (IRB) is a committee within the University that reviews research proposals that use human subjects as participants in research. The Institutional Review Board reviews medically non-invasive proposals to determine if the research project follows the ethical principles for the protection of human subjects as required by federal and University regulations. The IRB has the authority to approve, disapprove, or require modifications of these projects.
How do I know if my project needs IRB review?
All proposed research that involves the use of human subjects requires review and approval by the IRB prior to the initiation of the research. Human subjects research is research that meets both the definition of research and involves human subjects as defined in the federal regulations. Research means a "systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.The definition of a human subject is "a living individual 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.If you have questions about whether your study needs to be reviewed e-mail or call the Office of Grants and Sponsored Research.
How do I submit my research for review by the IRB?
Complete the IRB review protocol form found on the "Forms" page of the CCU website, or from the Office of Research Services website under "Forms." Follow the instructions on the form and guidance document. Submit the form and appropriate attachments to the grants office. NOTE: You must submit a final version of all questionnaires, interview protocols, etc.
including the informed consent form(s).
If I know my project meets the exempt regulations, do I still have to submit an application for IRB review?
Yes! Only the IRB can determine whether a proposal is eligible for exempt status. EXEMPT DOES NOT MEAN THAT IRB REVIEW IS NOT REQUIRED.
How long will it take for my proposal to be reviewed?
It depends on the nature of the study and the level of risk to research participants. The times given below are averages for studies that are not given restrictions by the board or require additional information. Studies that are given restrictions or require additional information will take an additional amount of time depending on how fast these restrictions are met or additional information provided.
Exempt Review - 5 to 10 working days.
Expedited Review - two weeks.
Full-Board Review - 5 days following the monthly board meeting.
NOTE: The IRB does not meet during the summer.
How will I know if my project is approved?
Investigators will receive e-mail notification of approval followed by a letter sent by mail.
What do I do with the IRB date-stamped consent information?
Copies of the current, dated documents are the only versions that may be used by investigators when obtaining consent. Investigators should make copies of the stamped version returned to them by the IRB at the time of study approval or reapproval.
What do I do with the signed informed consent documents?
The principal investigator is required by University and federal regulations to maintain records of all correspondence, relating to the use of human subjects in research. Copies of the application, research progress reports, notices of approval and signed Informed Consent Documents must be maintained in the investigator's records. Copies of these research records must be retained for three years after the close of the study and are subject to inspection by federal authorities and the IRB.
Do I need to complete training on protections of human subjects before starting my work?
Yes. Investigators and all other key personnel are required to complete:
CITI TRAINING (click on the link to enter the site)
Online training will be required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects by the fall of 2009. These modules need only be completed once and you must provide a copy of the certification of completion to the IRB. When finished with the training, be sure to print out the certificate of completion.
What if I want to make a minor change in the study (add or remove a question from a survey, add a second focus group, or put an advertisement in the newspaper to recruit more participants) do I need to do anything?
All modifications to human subjects research must be reviewed and approved PRIOR TO IMPLEMENTATION. The investigator should request modifications by submitting a request to the Office of Research Services.
What if my funding changes?
Investigators are required to keep the IRB informed about any changes in funding.
Do I need to notify the IRB when my project is finished?
Yes. When your project is completed you will need to submit a final report.
HOW DO THE FEDERAL REGULATIONS DEFINE HUMAN SUBJECTS?
Human subject means 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 regardless of its source.(46.102(f))
HOW DO THE REGULATIONS DEFINE RESEARCH?
Research means a systematic investigation (i.e., the gathering and analysis of information; including research development, testing and evaluation) designed to develop or contribute to generalized knowledge.(46.102(d))
ARE THE FOLLOWING TYPES OF RESEARCH SUBJECT TO IRB REVIEW?
If the research/protocol is funded by an external funding agency, and it is unclear if it should be reviewed, submit an IRB application. The IRB will determine if review is necessary.
a. Political polls, public opinion polls and journalism:
In general, political polls, public opinion polls, and journalism do not meet the definition of research as defined by the Code of Federal Regulations. However, if poll results are intended to contribute to generalizable knowledge and/or if results are disseminated or used in news stories, then they would appear to meet the definition of research and should be reviewed by the IRB.
b. Oral Histories:
Oral histories in general, appear to be designed to create a record of specific historical events and therefore are not intended to contribute to generalizable knowledge. However, activities designed to contribute to generalizable knowledge (that is, designed to draw conclusions, inform policy, or generalize findings) would appear to be research as defined by the Code of Federal Regulations. Also, if archives are created for the purpose of providing a resource for others to do research, then the creation of that archive would appear to constitute research. Two questions can be used to determine if an oral history project is research as defined by federal regulations. 1) Are conclusions, generalizations going to be drawn? 2) Is there a record being produced that will potentially be available to the public?
c. Marketing Research:
Marketing research that requires IRB review includes research designed with a clear intent to disseminate or publish the results/data.
d. Program Evaluation
Program Evaluation is the inquiry into past, present, and potential programs to understand or clarify their need, working process or impact.
There are three major categories of program evaluation: Needs assessments (formative evaluations) establish whether or not a program is feasible or necessary; process evaluations determine whether or not a program's implementation is congruous with its conception; impact evaluations (summative or outcome evaluations) ascertain whether or not a program meets its goals. Some program evaluations constitute human subjects research and others do not. Generally, program evaluations not requiring human subjects review involve data internally collected and analyzed for the normal course of business. These evaluations' goals range from simple descriptive statistics to qualitative information, and examples include program enrollment data, constituent demographics, and outcome analyses. Therefore, irrespective of human subject involvement, these program evaluations remain internal and thus do not contribute to generalizable knowledge. However, if a program evaluation is research and uses human subjects, then it requires approval. Program evaluations that lead to publishing results in scholarly journals or making presentations outside your institution likely require approval. The assumption being that publishing/disseminating the findings generalizes the data. Moreover, evaluations connected to groups' or individuals' outcomes and affecting the development or implementation of other programs similar in nature, are generalizable human subjects research and require human subjects review. Furthermore, an evaluation building upon the replication of other programs or services and the population at large or public policy, should be reviewed and monitored.
e. Data sets
Public and/or published data sets include those that are accessible without restriction (e.g., password not needed*) and containing no readily identifiable, individual information. (Note only the IRB can determine if the research is exempt.)
- U.S. Bureau of the Census
- National Center for Health Statistic
- National Center for Education Statistics
- National Election Studies
- Public and/or published data sets, accessible without restriction (e.g., password not needed*), and containing readily identifiable information and where individuals can reasonably expect this information to be available to the public (examples include letters to the editor, blogs)
- Public and/or published data sets, with restrictions to access, that contain data that is presented in aggregate form only; thus, individuals cannot be identified.
* or in those cases where you must register with a site or organization to gain access, the registration for login and password must be without qualification - that is, anyone could register with this site.
WOULD PILOT STUDIES, WITH NO INTENTION TO PUBLISH THE RESULTS, NEED IRB REVIEW?
Yes, "Generalizable" knowledge means more then formal publications and presentations. In a pilot study, the outcome has predictive value so the concepts or principles elucidated by the research can be applied to other circumstances, thus building upon knowledge base.
WHAT ABOUT STUDENTS COLLECTING DATA FROM HUMANS? WHAT ABOUT FACULTY COLLECTING DATA FROM STUDENTS? IS IRB REVIEW NEEDED?
It depends? All academic units collect routine data about class or program effectiveness (e.g., FCQs, exit/senior interviews, student surveys assessing perceptions of a class or academic program). These activities are exempt from IRB review. However, assessment activities that address students' personal lives (e.g., dating behaviors, drug/alcohol use, mental health, social life, etc.) may involve some element of risk to subjects and/or investigators, and thus would require IRB review.
A. Classroom Activities Involving Data Collection
Courses sometimes require students to undertake small projects in which other people are interviewed, observed, or otherwise serve as human subjects. The purpose of these course projects is to provide students with a closer view of social, educational, or psychological processes, and/or with an opportunity to practice the same methods of observation customary to the various disciplines. Because such activities are not undertaken with the goal of developing or contributing to generalized knowledge, the IRB does not consider them to be research as such. Faculty are encouraged to discuss human subject protection issues with students involved in these classroom activities.
B. Student Research Projects
Any student-initiated and/or student-conducted data collection activities designed to develop or contribute to generalized knowledge, and which use human subjects, require review by the IRB. This includes graduate theses, dissertation research, and honors theses. Note that all students conducting research must have a faculty advisor.Responsibility for obtaining the IRB approval for student research resides equally with the student and the faculty advisor. The student and faculty advisor are both required to complete IRB training.
WHAT IF THE RESEARCH IS BEING CONDUCTED OFF CAMPUS? All research involving humans carried out by students, faculty, or staff, whether funded or unfunded, sponsored or unsponsored, on or off campus, is covered by the Institutional Review Board for the Protection of Human Subjects
WHAT ARE THE LEVEL OF REVIEWS?
When in doubt, ask the Administrator of the IRB. Otherwise, follow these general guidelines:
a. Exempt. The federal regulations provide for exemption from review for certain kinds of research (e.g., reviews of existing data, documents, records, if the information is recorded in such a manner that subjects cannot be identified).
b. Expedited. Research that poses only minimal risk to adult human subjects and does not deal with sensitive or personal aspects of the subjects behavior may be granted an expedited review.
c. Full. Research involving more than minimal risk and/or vulnerable subjects must undergo a full IRB review. Vulnerable subjects include children under 18 years, prisoners, pregnant women, mentally/cognitively impaired persons, economically/educationally disadvantaged persons, and any subjects likely to be vulnerable to coercion or undue influence.
WHAT CRITERIA ARE USED TO REVIEW PROPOSALS? ONCE THE IRB HAS REVIEWED AND APPROVED MY RESEARCH, HAVE I FULFILLED MY OBLIGATIONS?
Once human subject research has been approved, it is the Principal Investigator's (PI) responsibility to do the following:
a. Risks to subjects are minimized.
b. Risks to subjects are reasonable in relation to anticipated benefits.
c. Selection of subjects is equitable.
d. Informed consent will be sought from each prospective subject or the subjects legally authorized representative.
e. Required elements of informed consent are present.
f. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
g. Whenever appropriate, there are provisions to protect the privacy of subjects and to maintain the confidentiality of data.
h. When some or all of the subjects are vulnerable research subjects, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
What are some links where I might find guidance and training?
THE BELMONT REPORT
45 CFR 46 PROTECTION OF HUMAN SUBJECTS
PROTOCOL EXEMPT FROM IRB REVIEW
RESEARCH THAT MAY BE REVIEWED THROUGH AN EXPEDITED PROCEDURE
Protecting Human Subject Participants
(click on link to enter the site, register, and take the course)
Online training from OHRP is required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects. These modules need only be completed once.