When do I need to submit a proposal to the IRB?

All proposed research that involves (1) intervention or interaction with human subjects, (2) the collection of identifiable private data on living individuals and/or (3) data analysis of identifiable private information on living individuals requires review and approval by the IRB prior to the initiation of the research. 

What is a Human subject?

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 (45 CFR 46)

What is Research?

Research is defined by the U.S. Department Health and Human Services as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46)

When in doubt, contact the IRB Manager to help determine whether a particular project is “research” as defined by the University of Maryland and by federal regulations.

Please note: Research that is limited to the collection of private information on individuals requires prior approval.  If the research is exempt, the application must be approved by the IRB Manager or the IRB Co-Chair before data collection begins.  If the research is non-exempt, the application must be approved by the IRB before data collection for exempt research begins.

When is IRB Request for Determination of Non-Human Subject or Non-Research form required ?

The Request for Determination of Non-Human Subject or Non-Research Form may be used by faculty, staff and students who are not sure whether their activity requires IRB review. You may mail the form to the IRB Office via campus mail or bring the form to the IRB office which is located in 2100 Lee Building.  Faculty and staff who submit a completed Request for Determination of Non-Human Subject or Non-Research Form to the IRB will receive written documentation on whether the activity requires IRB review.

What form(s) are needed to apply to do an experiment involving human subjects?

The IRB Initial Application Form (MS Word), which is available on IRB website

Is some research exempt from review?

No, all human subjects research must be reviewed.  There is a category of research called "exempt" which means that the IRB Manager or an IRB Co-Chair may review and approve the research research if it involves no more than minimal risk to the subjects and the only involvement of human subjects will be in one or more of the exemption categories. 

If my sponsored project proposal uses human subjects, how does ORAA find out that I am approved?

Once the research is approved by the IRB, the IRB Coordinator informs ORAA if you included the ORAA protocol number on your IRB application.  You should be aware that a sponsored program account cannot be set up unless approval has been granted.

What is Minimal Risk?

The Federal regulation for the protection of human subjects defines minimal risk as: 

"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 routing physical or psychological examinations or tests." 

For research involving prisoners, minimal risk is defined as “the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.”

When making a decision about minimal risk of research:

1. Consider both magnitude and likelihood of risk A more serious event may be permissible if its probability is extremely low;
Example: Airplane flight carries a risk of death, but it occurs only once in some millions of passenger miles.

2. Risks of ordinary, non-invasive diagnostic tests are OK
Examples: routine blood draws in adults, general physical exams, pen-and-paper tests, ultrasound exams(at accepted levels)

3. Minimal risk may be age- or context- dependent
Example: Blood draw may be minimal risk for someone old enough to give consent, but not for a small and needle-shy child

4. Remember that risks need not be "physical" in order to be "more than minimal"
Examples: A serious privacy risk, confidentiality risk, informational risk or risk of embarrassment may be enough to push a study into the "greater than minimal risk" category and thus to full committee reviewspan>

What is a Consent Form?

A consent form is used to provide information to prospective subjects to enable persons to voluntarily decide whether or not to participate as research subjects.  A consent form usually contains the basic elements of informed consent as identified in and required by the Federal regulations for the protection of human subjects (45 CFR 46). A

The University of Maryland, College Park IRB generally requires consent forms for both exempt research and nonexempt research.  If you would like the IRB to waive some or all of the consent form elements in the consent form template, please refer to the following waiver criteria.

(1) The research involves no more than minimal risk to the subjects;

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

 You may request a waiver of informed consent by including responses, in your IRB application, to the above listed waiver criteria.  The consent form document can be downloaded here (MS Word).

Who makes up the IRB?

The IRB includes members from diverse fields including criminal justice, education, exercise physiology, medicine, psychology, public health, and second language acquisition.  Members are drawn from within and outside the campus community. The IRB typically has 15-20 members with about 25% of those members from the community.

On what basis are proposals reviewed?

Human subjects research review is based on the IRB criteria of approval in the Federal regulations and the three ethical principles  in the Belmont Report which are: (1) Respect for Persons - to the degree that they are capable, subjects should be given the opportunity to choose what shall or shall not happen to them (informed consent) and persons with diminished autonomy should be protected; (2) Beneficence - research should be designed to maximize benefits and minimize possible harms to the subjects; and (3) Justice - the burdens and benefits of research should be fairly distributed, including the selection of research subjects.

What is the Turnaround Time for the Review of My Application?

The turnaround time for exempt and expedited transactions is approximately three weeks upon receipt of the application at the IRB office. Please note that the amount of time for an exempt review or an expedited review may be longer if the reviewers request changes or clarification. The turnaround time for Full Board reviews is at least one month as Full Board review meetings are held once a month. However, the turnaround time for applications reviewed by the Full Board may be longer than one month if the application is not submitted by the application deadline, the meeting agenda is full when the application is submitted, or the application is not approved as submitted when first reviewed by the Full Board. Please be sure to review the quality of your application prior to submitting to the IRB. Applications that are written well and include all documents pertaining to the project are typically approved in a shorter amount of time.

Why does the review process sometimes take so long?

Generally, the three different categories of review take different amounts of time. Research falling into the exempt category can be approved by the IRB Manager or the IRB Co-Chairs.  Exempt research is reviewed within approximately three weeks upon receipt.  Some non-exempt research that does not present greater than minimal risk can be reviewed by expedited review involving a subset of the IRB (EXPEDITED REVIEW CATEGORIES).  Expedited reviews generally take four weeks.  Research that presents greater than minimal risk requires Full Board review.  A full board review involves a convened meeting by a majority of the IRB.  Full board reviews are conducted monthly.  Revisions suggested by the full board, unless they are minor and very specific, must be brought back to a monthly full board meeting for final approval.

Who do I contact for further information?

For further information, about the IRB review process or the status of an IRB application please contact the IRB Staff or email at irb@umd.edu

For information about IRB policies (e.g. additional protections for research involving children, pregnant women, fetuses, neonates and prisoners) please contact the IRB Manager, Joseph Smith, 301-405-0678 or at jsmith@umresearch.umd.edu

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