A.  It is a compliance committee responsible for the protection of the rights and welfare of individuals who participate as subjects in research conducted under the auspices of the Ball State University.  The IRB is responsible for the review and approval of research if it involves human subjects.

Q.  What constitutes research with human subjects?

A.  As defined by the federal regulations, research is the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

• systematic investigation – a plan for collecting data consistently and reliably        
• designed – is the intent of the investigation to examine hypothesis or to support a research claim
• generalizable – the impact of the research reaches beyond the research population, adds to a body of knowledge; a common test is whether the researcher plans to present or publish the data in a professional platform

A human subject is defined as a living individual about whom an investigator (whether faculty or student) obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information.

• living individual – dead people do not usually count; they do count if information about a dead person can identify a living person and put the living person at risk
• intervention – physical procedures by which data are gathered (e.g., blood or tissue samples) or  a manipulation of the subject or the subject's environment preformed for research purposes
• identifiable private information – may include secondary subjects if the identifiable private information can identify a family member or some other person close to the subject
  

The Office for Protection from Research Risks (OPRR) provides a graphic aid (http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm) to clarify portions of the Department of Health and Human Services (DHHS) human subject regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46).

Q.  Are there different categories of review?

A.  There are three categories of review depending on the amount of risk to the subject:

• Exempt review – (Exempt review is a category of review, it does not mean exempt from review.) there is essentially no risk to the subject and the research falls into one of six categories of research, see Exempt Review
• Expedited review – there is minimal risk to the subject and the research falls into one of the categories of research that may be reviewed through an expedited review procedure, see Expedited review
• Full review – there is more than minimal risk to the subject

Q.  What is minimal risk?

A.  According to the federal regulations, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Q.  How often does the IRB meet?

A.  During the academic year when classes are in session, a subcommittee of the IRB meets every week to review exempt and expedited review protocols.  The IRB does not meet during semester breaks or spring break.  Protocols must be received in the Office of Academic Research and Sponsored Programs by noon on Monday to be on the agenda for that week's meeting.  The full IRB meets the first week of the month to review full review protocols.  Protocols for full review must be received in the Office of Academic Research and Sponsored Programs by the 15^th of the month preceding the full IRB meeting date.

During the summer, the IRB meets at least twice a month to review exempt and expedited review protocols and as needed for full review protocols.

Q.  How long does it take to be notified of the findings of the IRB review?

A.  A researcher will be notified by mail of the results of the review within two weeks, usually sooner.

Q.  What do I submit for the review process?

A.  A researcher must provide five copies plus the original copy of all of the appropriate following materials for either the exempt or expedited review process::

1. the application form
2. the written protocol

If appropriate:

1. the consent form
2. all non-standardized instruments (surveys, questionnaires, test instruments, etc.)
3. a list of interview questions
4. letters of permission to conduct the research
5. any other documents relevant to the research project

For the full review process, the researcher must submit eleven copies plus the original copy of the relevant materials listed above and any additional materials.

For research that requires a full review, the principal researcher is invited to present his or her research at the meeting of the full committee.

The researcher and all key personnel (the faculty mentor, any person who interacts with the research subject or the data) must have on file with the IRB a copy of the completion certificate for the online tutorial (http://cme.nci.nih.gov) before the IRB can approve an application to conduct research.

Q.  What should the project begin and end dates be? 

A.  The begin date of the project is the anticipated date that the research will begin AFTER IT HAS RECEIVED IRB APPROVAL.  The begin date should not be a date prior to the approval of the research project by the IRB.  A suggestion for the begin date is that you use "Upon approval of the IRB".

The end date is the date that the investigator anticipates completing the research AND the analysis of the data.  Because the privacy issues remain until the data analysis is complete or the data have been de-identified, the investigator must maintain the approval of the project until the analysis is complete.  If the data collection and analysis will exceed the original approval period, the researcher will request a Continuing Review of the project for an additional period not to exceed twelve months.  To maintain the continuous approval of the project, the Continuing Review must be submitted to the IRB in sufficient time (usually one month prior to the expiration date) to allow for the review and approval by the IRB of the Continuing Review.

Q.  What may delay the approval of a research protocol?

A.  Frequently protocols are approved during the initial IRB review.  When protocols do not receive approval, however, it is usually because the IRB needs clarification and/or additional information.  Some of the more common omissions are listed below.

Not following the guidelines for writing the protocol – The guidelines provide guidance as to the basic information required in the protocol.  Bear in mind that some of the members of the IRB may not be familiar with the area of your research.  Therefore, the protocol should be written with sufficient clarity and detail that a person with no background in your field would understand the research.  Do not assume that "everyone knows that …."

Not proofreading the protocol – The  majority of  problems in a protocol can be detected by  proofreading.

Not providing the questionnaire – If you have developed a questionnaire or a survey (this includes the demographic sheet), you must include this instrument in the protocol for review.  If you are using a standardized instrument that is not well known or if there is a possibility that the IRB may not be familiar with the instrument, you should include the instrument with the protocol.

Not providing the recruitment materials – Any document used to recruit participants for the research must be reviewed by the IRB.  This includes recruitment flyers, posters, advertisements (e.g., for newspapers, radio, television, etc.), emails or letters, etc.

Not providing the general questions used in an interview or focus group – When the research involves interviews with the participants, a list of the general questions that will be used must be included as a part of the protocol.  The list of questions is to provide a feel for the direction the interview or focus group will follow.  It is understood that follow up questions on the topic are often necessary.  Such questions, so long as they remain within the scope of the general topic, often cannot be anticipated and therefore do not need to be included in the list of general questions.

Not providing the introductory script – An introductory script (whether read or written) or an introductory letter used to introduce the study and its purpose must be reviewed by the IRB.

Not providing a letter of permission to conduct the research for an institution outside of Ball State – When conducting research at institution or organization other than Ball State, the investigator must obtain the written permission of the appropriately authorized official from the institution or organization.  The permission letter must be on the letterhead of the institution or organization and have the original signature of the authorized official.

If the research is to be conducted at another university or at an institution such as a hospital, the researcher must contact the institution's IRB to determine whether that IRB must review and approve the research.

Q.  Can I get retrospective approval for data collection I have already carried out?

A.  The IRB cannot give retrospective approval for research conducted in the past.  IRB approval to conduct research must be obtained prior to any interaction with research subjects; this includes the recruitment of subjects to participate in the research.

Q.  What is archival data?

A.  Archival data are data that were collected in the past, usually for a purpose other than research.  The complete data set must exist prior to the initiation of a research project using the data.