Changes to the Oversight Process for Exempt Research Studies

Policy Change to the
Criteria for Reporting Major Changes to Previously Approved Exempt Studies

Purpose: The IRB is modifying its current policy for the reporting of changes to previously approved Exempt studies. The IRB will no longer require amendments to be filed for minor changes. Major changes to previously approved Exempt studies will still require that the Principal Investigator notify the IRB of these changes. Below we describe the differences between minor and major changes and provided several scenarios to illustrate the points. When in doubt, or if you have a question please do not hesitate to contact us at 812-855-3067 or at iub_hsc@indiana.edu. Researchers should keep a record of changes to exempt protocols that they judge to constitute a minor change not requiring official notification and approval by the IRB. It is the responsibility of the researcher to ensure that they follow the guidelines outlined below. Failure to file an amendment for a major change to an Exempt study constitutes non-compliance.

What is considered a major change to a previously approved Exempt protocol?

A major change is defined as any change to a previously approved Exempt protocol that increases the level of risk (psychological or physical harm) to participants or any change that is more than a minor modification in any of the following areas. For example:
Summary of Major Changes:

Any change that increases the risk to subjects or that places the subject at increased civil or criminal risk;
The addition of any vulnerable population(s) to the study;
Change to the protocol to begin collecting body fluid samples from subjects;
Any change to the protocol that substantially increases the length of time necessary to complete the study.
Any change to the protocol that could be construed as coercion such as an increase in compensation;
Asking additional questions outside parameters (purpose) of the approved research protocol (i.e., an approved survey designed to determine food preferences could not be revised to ask questions regarding sexual orientation without submission of a Protocol Amendment Form);
Any change to the protocol that alters participants’ confidentiality or anonymous status;
Inclusion of new questionnaires or surveys that are in addition to previously approved items;
Any change that would cause the research protocol to be reviewed under the criteria for Expedited of Full Committee Review (refer to http://research.indiana.edu/rschcomp/hmpg.html for review criteria);
Any change in recruitment that involves including subjects who are under the investigators authority (students, employees, patients, etc.) must be reported to the IRB; and
Any change in the method of securing date collected or a change that involves altering the security measures to protect the date will be considered a substantive change.

Scenario 1: An investigator wants to enroll a new vulnerable subject population in a previously approved Exempt research protocol (e.g., adding subject populations such as children, the use of minors under the age of 18, prisoners, pregnant women, economically or educationally disadvantaged persons, the use of deception, or cognitively impaired individuals). Because the addition of vulnerable populations increases risk to subjects and constitute a major modification to the protocol the principal investigator needs to inform the IRB of these changes by submitting an amendment prior to initiating the change.

Scenario 2: As part of a previously approved Exempt protocol a researcher wants to collect additional information/data or record behavior from currently enrolled subjects. The additional information is recorded in such a fashion that if known outside the research, it could reasonably place the subject at risk of civil or criminal liability, or damage the subjects’ financial standing, employability, insurability, reputation, or being stigmatized. The principal investigator needs to inform the IRB of these changes by submitting an amendment prior to initiating the change.

Scenario 3: As part of a previously approved Exempt study surveying subjects’ knowledge and use of vitamins, a graduate student conducting research for her master’s thesis decides to collect blood samples from the subjects. Adding a blood draw to the research increases the potential risk to subjects; because blood draws must be reviewed at the Expedited Review level. Because this scenario constitutes a major change in the protocol the IRB needs to be informed of the proposed changes. Protocol changes adding the collection of urine samples, saliva samples, collection of identifiable data, etc., require the principal investigator to notify the IRB using a Study Amendment Form.

Scenario 4: An investigator decides to increase the length of time subjects will need to complete a survey. The investigator is also having difficulty recruiting subjects to the study. As an incentive the investigator decides to double the monetary compensation for subjects. Taken individually, any one these changes would need to be reported to the IRB because they are substantive changes to the previously approved protocol.

What is considered a minor change to a previously approved Exempt protocol?

A minor change is defined as any change to a previously approved Exempt protocol that does not affect the level of risk to participants and does not involve a change to the aims, purpose, procedures, or design of the study. For example:

Extending the time of recruiting subjects for the study (e.g., adding an additional month, semester or year, etc.);
Any grammatical revisions to the survey script or informed consent statement;
The addition of low-risk subject populations;
The addition of co-investigator as long as the co-investigator meets established IU eligibility (click here for COI requirements) and training criteria (click here for educational requirements);
Any minor change in the manner in which subject will be contacted (i.e., phone vs. e-mail or letter) by the researcher that was not mentioned in the previously approved protocol application;
Addition or deletion of low-risk survey or interview questions to an approved survey, interview or questionnaire that doesn’t change the parameters of the approved research protocol.

Scenario 1: An investigator determines that the previously approved Exempt protocol will take a longer period of time for subject recruitment. As such the investigator decides to recruit subjects for an additional year. This is not considered a substantive change because under the Exempt review process studies do not need to report a change in end date. In this situation the researcher would not have to report this minor change to the IRB. At the termination of the study it remains incumbent upon the researcher to notify the IRB that the study has ended.

Scenario 2: A research center on campus determines that they need to send out one more follow-up e-mail to participants in an on-line survey for their previously approved Exempt study. The researchers may do this without notifying the IRB as long as they do not exceed the limit of 5 e-mails as additional contact beyond this is considered burdensome to the subjects. In this situation the researcher would not have to report this minor change to the IRB.

Scenario 3: In a previously approved Exempt study a researcher decides to audiotape subjects’ responses instead of videotaping responses. As long as confidentiality is maintained this change would not have to be reported to the IRB because data collection was previously approved.

Scenario 4: A researcher wants to change the method of recruiting subjects while maintaining the essential nature of the recruitment message. The researcher wants to change recruitment from a letter format to an e-mail, or visa versa. In this situation the researcher would not have to report this to the IRB because it is a minor change.

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Review Schedule

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.

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 OHRPP, currently on Wednesdays. Applications must be received by 5:00 p.m. on Friday in order to be reviewed the following week.

IRB meetings are held the third Thursday of each Month at 3:00-5:00 in the Carmichael Center LL003. (Note: The December meeting is held the second Thursday to accommodate the Winter Break schedule). 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. There are some exceptions to these schedules and researchers are encouraged to contact OHRPP by email (iub_hsc@indiana.edu) or by phone (812 / 855-3067) with any questions about the deadlines.

July 17, 2008 – IRB Meeting: Receipt Date for July IRB Review: June 20, 2008

August 21 - IRB Meeting: Receipt Date for August IRB Review: July 27

September 18 - IRB Meeting: Receipt Date for September IRB Review: August 22

October 16 - IRB Meeting: Receipt Date for October IRB Review: September 19

November 20 - IRB Meeting: Receipt Date for November IRB Review: October 17

December 11 - IRB Meeting: Receipt Date for December IRB Review: November 21

January 15, 2009 - IRB Meeting Receipt Date for January IRB Review: December 12

February 19 - IRB Meeting Receipt Date for February IRB Review: January 16

March 19 - IRB Meeting Receipt Date for March IRB Review: February 20

April 16 - IRB Meeting Receipt Date for April IRB Review: March 20

May 21 - IRB Meeting Receipt Date for May IRB Review: April 17

June 18 - IRB Meeting Receipt Date for June IRB Review: May 22

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.

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Commencement of Research

Investigators are reminded that research may not begin (i.e., data may not be collected) until they receive final written approval from the OHRPP . This includes any and all contacts / recruitment with human subjects (or work with documents on, or from, human subjects) and any and all categories of research. This restriction applies not only to the initial application, but also to any changes filed by an amendment. Investigators may not institute changes to their research prior to receipt of written 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 IRB approval is received. Any documents recruiting subjects must be submitted to OHRPP 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. Nor can any other benefits be over-emphasized. Refer to the Recruitment Policy .

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Information Mining from the Internet (including Facebook, MySpace and other social networking sites)

When mining information from any source—be it a purchased data set or an internet based source—the IRB at IUB requires all researchers to comply with terms of use for that source. In the case of Facebook and MySpace, both sites explicitly state that their site is not for research but for social networking only. Therefore, the IRB will not approve any study wishing to mine these sites without an independent statement from the site sent directly to the IRB prior to the study’s review. Alternately, individual users can extend their personal rights to a researcher through signed consent. This consent should be obtained apart from the site.

Many research requests mention advertising on Facebook or MySpace. Researchers may use the pay functions of any site as the site's rules stipulate (i.e., flyer function in Facebook and the advertise feature in MySpace). They may also post the study on their own personal site (for a study which is not based on the site in use). Recruiting participants by messaging members of these sites is not covered under the terms of use and is therefore not permitted.

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Submission Process

ALL IUB investigators must submit an application detailing the involvement of human subjects in the research project. All documents must be typed or prepared legibly 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. Some applications will require a sponsor. See the "Researcher Responsibility" section for details and requirements. If the sponsor is from another campus, the review must take place on that campus. Projects submitted from the IUB Health Center must carry the signature of either the Administrative Director or the Medical Director. Projects from the National Institute for Fitness and Sport will not be reviewed by the IUB IRB unless an IUB approved rank employee serves as the principal investigator or sponsor of the project.

Requests for approval to use human subjects should be submitted to OHRPP, at Carmichael Center L03, 530 E. Kirkwood, on the appropriate forms. The forms must be completed according to the instructions provided.

The application for approval includes the required submission of a Summary Safeguard Statement in which the investigator sets forth answers to specific questions about his/her proposed research. Investigators may not submit a protocol or proposal in lieu of the Summary Safeguard Statement. The OHRPP will process only those applications that include a properly completed Summary Safeguard Statement; incomplete applications will be returned to the investigator. Applications must be submitted on versions of the forms that are current (3/06). If you have questions contact OHRPP by e-mail or by phone at 855-3067. The instructions for downloading forms are available by clicking here.

In order for applications to be reviewed in a timely manner OHRPP staff must be able to understand the purpose of the project, what the procedures are, and how human subjects are involved (i.e., what the subjects will be asked to do or have done to them). Investigators are cautioned to avoid using discipline-specific jargon, both in the description of the project and in the consent form. For projects being conducted where instruments and consent forms will be in a foreign language, two copies of the materials must be submitted for final approval; the foreign language version and an English translation. Investigators are urged to carefully follow the directions and to pay close attention to the quality of the consent statements and the clarity of the application in general. Consent forms must be in type no smaller than arial 11 or times new roman 12. Please leave space at the end of the form for OHRPP's approval stamp.

Investigators submitting applications subject for full board review must provide the necessary number of photocopies for the IRB. A single copy should be submitted initially for all levels of review. Investigators will be contacted by OHRPP staff as to the number needed, when additional copies of their application are required for full board review.
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Help With Process

The Committee maintains an office with four staff: Carey L. Conover, Director; Senta K. Baker, Assistant Director; Ryan T. Merckle, Research Risk Coordinator; Sharon Nejfelt, Offices Services Assistant Senior, in Carmichael Center L03, 530 E. Kirkwood Ave., 855-3067, iub_hsc@indiana.edu. Office hours are 8 am-12 noon and 1 pm-5 pm, Monday through Friday. Staff members are available to answer questions and help with completion of the forms. While investigators may drop by the office, those with appointments will receive priority.
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Approval Process

In its review of protocols, the IRB determines that the following requirements have been satisfied:

Risks to the subjects are minimized.
Risks to the subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Selection of subjects is equitable.
Informed consent meets the requirements of the federal regulations and provision is made to obtain an informed consent from each subject or the subject's legally authorized representative.
The research plan makes adequate provision to ensure the safety of subjects.
Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Studies are rarely disapproved by the IRB. However, many studies require additional information for adequate review. Occasionally, the IRB requests investigators to revise their procedures. Examples of common problems causing delays in the review and approval process are:

Failure to use a current application form.
Failure to complete the Documentation of Review and Approval page completely (dates, address, signatures, etc.).
Failure to complete each section of the Summary Safeguard Statement in a legible and comprehensible manner (making it impossible for the Committee to understand the research project and what subjects will be asked to do or have done to them).
Failure to provide additional materials as directed in the instructions.
Lack of acknowledgment of risk, although some element of risk is clearly present.
Lack of, or lack of an adequate, informed consent statement (containing all relevant information in language comprehensible to the prospective subject population).
Lack of screening of subjects to make certain they are not unduly at risk.
Need for the Committee to ascertain risk by consulting experts.
Unacceptable risk involved. (These are generally few in number and, typically, can be modified to meet concerns of the Committee.)

When approval is granted, the investigator will be sent a copy of the Documentation of Review and Approval with the Chairperson's signature and date. This page, along with a cover letter, will be sent to the address provided by the investigator. Notification of approval required for external funding will be forwarded to the appropriate agency, by OHRPP. The researcher is responsible for providing any other notifications.
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Amendments

The policy description below applies to all changes for studies reviewed at the Full Board and Expedited levels -or- any major change to a study reviewed at the Exempt level. For further detail regarding the change to the Emempt level review, please see Changes to the Oversight Process for Exempt Research Studies.

Investigators are required to report any proposed changes to their research study via a Study Amendment Form (submit one copy). Investigators must report any changes whatsoever, regardless of the level of the original review and regardless of their assessment of the importance of the change. Reference the original title of the study, the principal investigator, and the study 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 an expedited basis according to the weekly review schedule. Amendments involving more than minor changes or involving changes that pose more than minimal risk will be reviewed by the full board, at its next scheduled monthly meeting. Investigators are reminded that changes may not be implemented until final written approval is received from the Committee. A copy of this form may be obtained from the OHRPP at Carmichael Center L03, 530 E. Kirkwood Ave., 855-3067, or e-mail. The instructions for downloading this form are available by clicking here.
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Continuing Reviews

Approval will be granted for up to one year. Studies involving more than minimal risk may require continuing review at a shorter interval. Studies (except exempt level) that continue for longer than the approval period must apply for an updated approval before the end of the approval period. While OHRPP makes every effort to notify the PI of the need to renew the approval, ultimate responsibility lies with the researcher to make sure the approval does not expire for their projects that are ongoing. If the initial application indicates less than a one-year period, the investigator will receive a form to indicate whether the project has been completed or is continuing. Studies that initially received full board review will continue to receive full board review for the duration of the project, unless the scope of the study changes such that it would qualify for a lower level of review. Studies that continue to recruit subjects beyond the initial approval period will need to submit consent forms/information sheets for reapproval and updated stamps. A copy of the continuing review form may be obtained from OHRPP at Carmichael Center L03, 530 E. Kirkwood Ave., 855-3067, or e-mail. The instructions for downloading this form are available by clicking here.

Studies reviewed by the full board will have the next continuing review date determined by when the full board "approved" the study. For example, a study is reviewed on October 19, 2006. The IRB "approved" the study pending a number of minor changes to be made by the PI. The committee authorizes the chair of the committee to review the changes and when they are satisfactory give "final approval". The researcher takes awhile to provide the changes and the study is given "final approval" on January 3, 2007. In this case, the first continuing review for this study must take place by the full committtee no later than October 18, 2007, not January 2, 2008.

Investigators of exempt level projects are required to notify OHRPP when their project is completed. Shortly after the indicated ending date, OHRPP will send an e-mail notice to the investigator asking about the status of the project. The investigator should provide the requested information to the office for processing by the office staff. Studies that continue to recruit subjects beyond the initial approval period will need to submit consent forms/information sheets for reapproval and updated stamps.

If a study is terminated by the investigator, it may be reactivated within 30 days without having to submit a complete application to OHRPP as a new study. If it is beyond the 30 days, or a significant number of changes have been made, a new application will be required.

If the study is closed by OHRPP because the researcher has failed to renew their approval, the researcher will receive an e-mail notice of this and the same 30 day time period applies for reactivation without having to submit a complete application. This applies to all three levels of review.
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Unanticipated Events

Any unanticipated event associated with a study must be reported to OHRPP within 3 working days after the event. The report should be in letter format to the Office of Human Research Protection Programs at the main office email address (iub_hsc@indiana.edu). The report should contain the following:

study number and title to which the event relates
description of the event
principal investigator's assessment of the event, 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

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Record Keeping

OHRPP maintains the following files:

Federal regulations and communications, as well as University memoranda and letters of assurance.
Minutes of the IRB meetings.
Original protocols and copies of memoranda sent to, and received from, investigators.
Protocols not yet reviewed.
Protocols from which approval has been withheld and for which suitable remedial action has not yet been taken.
Correspondence between OHRPP staff and study personnel.

All protocols are kept for three years after completion of the research, and then are destroyed.

On this page:

Changes to the Oversight Process for Exempt Research Studies

Review Schedule

Commencement of Research

Information Mining from the Internet (including Facebook, MySpace and other social networking sites)

Submission Process

Help With Process

Approval Process

Amendments

Continuing Reviews

Unanticipated Events

Record Keeping