Human Subjects Information		[Home]
	Institutional Review Board Approval Process Before you begin a new research project involving human subjects, you must receive approval from the UMD Division of Research Institutional Review Board (IRB) before you begin collecting data or running analysis. A “human subject” is defined for this purpose as 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. Effective April 20, 2005, the two IRB initial application forms were replaced with one IRB Initial Application Form which you can print or download (into MS Word) from http://www.umresearch.umd.edu/IRB. This new form requires the signature of the Principal Investigator, Co-Principal Investigator (if applicable), Student Investigator (if applicable) and the Departmental Human Subjects Review Committee Chairperson or Designee OR the Department Head (Chairperson) or Designee or Unit Head (Director) or Designee for Departments and Units without an HSRC.  Frequently Asked Questions (FAQs) about the IRB Process – What You Need To Know About Human Subjects Research All research involving human subjects must be reviewed before data collection or analysis takes place. Some research involves only the use of archival data and may not be considered “human subjects research.” If you suspect your research may fall into this category, you may submit a Request for Determination of Non-Human Subject or Non-Research Form to the IRB. This 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. If you have any questions regarding this form, please contact Roslyn Edson, the IRB Manager, at 301-405-0678. If your project is considered research on human subjects, it must be approved by the IRB. Your application for human subjects research is approved through a two-step process. The first is that the human subjects research advisor in our department will review your application and if approved, will sign the Application Form and return it to you for submission to the campus-level Institutional Review Board (IRB) at 2100 Lee Building, College Park. The following FAQs should help you guide you through the human subjects research process. What research must be reviewed? In accordance with federal regulations and legal memoranda signed by the University, ALL RESEARCH involving the collection of data from human subjects conducted by any member of the University community (faculty, staff, or students) must be approved by the Institutional Review Board (an all-campus group), or one of its sanctioned, designated review groups, prior to data collection. The Graduate School monitors this process for theses and dissertations, and will not clear a candidate for graduation unless documentation of approval is provided. Yes, but what about obviously no-risk research, like an anonymous survey sent out in the mail? No exceptions. None. But wait! I've heard about theses categories of "exempt" research. Federal regulations define some categories of research "exempt" from prior review by the full IRB board. The UMD IRB Manager or an IRB Co-Chair may use exempt review procedures to review and approve an IRB application when the research 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.  See below for where you can find these exemption reasons. If you determine that your application meets one of the exempt categories, you should write the category number(s) on your IRB Initial Application cover sheet and explain why your proposal is exempt.  However, YOU can NOT be the person to decide if your own research is "exempt" - your notation for exemption is a recommendation to the IRB - the IRB Manager or an IRB Co-Chair must decide whether the research is exempt and by which category(s). Exemption Categories The following exemption categories do not apply to research involving prisoners, fetuses, or pregnant women, but to all other research with human subjects. 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness or the comparison among instructional techniques, curricula, or classroom management methods.  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.  This exemption category for research involving survey or interview procedures or observation of public behavior does not apply to research with children, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed. 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) the research is conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National Center for Education Statistics under Federal statute 20 U.S.C. 12213-1, which provide certain legal protections and requirements for confidentiality. 4. Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.  5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.  6. Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome foods without additives are consumed or (b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. Are there any typical problem areas? Yes. The most common risks associated with research done in our department involve either risk of subjects' loss of privacy rights (i.e., confidentiality of information), or the possible distress caused by filling out instruments about personally sensitive topics. Often, applicants forget to describe in their application exactly what these potential risks are and how they will minimize these risks. Instead, they simply state that "there are no risks." Given enough careful thought and preplanning, almost all research can be structured so as to minimize any risk. Be sure to describe how this will be accomplished. What about this Informed Consent business? Essentially, all research subjects must be afforded the opportunity to make an informed judgment about whether they want to participate in the research or not. In most cases it is a good idea to obtain written consent on a form that clearly describes the research. This may not be required in some cases such as anonymously collected data or mail surveys. However, some anonymously collected data, such as surveys collected in a class, may still require written consent because of possible perceived peer or instructor pressure to participate. If a signed informed consent form is not used in this case, you should provide a written handout for all subjects clearly stating that their participation in your study is not mandatory, and stating what it is you are asking of the subjects. Consent Form Guidance Documents Sample consent forms and additional consent form guidance documents can be found on the IRB website http://www.umresearch.umd.edu/IRB.  These guidance documents include a consent form template and an appendix with additional guidance for specific issues such as research involving minors and research involving audio taping, videotaping, digital recordings or photographs.  The consent form guidance documents are attached to the IRB Initial Application Form and Renewal application.  What do I have to do, and how long will this all take? Human subjects review applications (complete with instructions) are available from the website of the UMD Division of Research (see below). The human subjects research advisor in our department, Doris MacKenzie will review your application and if approved, will sign the Application Form and return it to you for submission to the IRB Department, where the IRB Manager will review and approve exempt research.  Exempt research is usually reviewed by the IRB department within one week upon receipt of the application. In some cases, your IRB application may be eligible for “expedited” review, which is conducted about two to three weeks upon receipt of the application. Please note that the amount of time for an expedited review may be longer if the reviewers request changes or clarification. Non‑Exempt applications require a full board review, which are conducted monthly. 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. Notification of IRB approval Approval letters are mailed to the Principal Investigator at the location cited on the IRB application cover page. For applications reviewed by the full board, Principal Investigators are notified of the IRB's decision within approximately one week of the meeting. If you would like to know the status of an application, you should send an e-mail to Roxanne Freedman at rfreedman@umresearch.umd.edu or irb@deans.umd.edu Is there anything else I need to know? YES!! There is an Important New Procedure... New guidelines for the protection of human subjects have recently been established by the Public Health Service (PHS) and the National Institutes of Health (NIH). The newly created Office of Human Subjects Research (OHSR) has pronounced its first initiative to be the education of scientists who do research with human subjects. The new policy of the PHS is that "all staff engaged in research or research training who receive PHS support shall successfully complete a program of instruction in the responsible conduct of research dealing with human subjects." The IRB at University of Maryland has just instituted a training program to help UM researchers meet this certification requirement. Information about this can be found at www.umresearch.umd.edu by clicking on "NIH Certification." This web site will connect you with tutorials and then take you to the UMCP certification exam. While this certification is not yet required for all investigators, our Departmental Human Subjects Review Committee encourages every investigator to familiarize themselves with these procedures to protect the rights of human subjects. Where can I find all the forms and more information about human subjects? The Institutional Review Board forms and instructions are available from the UMD Institutional Review Board website at http://www.umresearch.umd.edu/IRB.