IRB Process


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Definitions
Federalwide Assurance
Full Board Meeting Deadlines & Dates
Investigator Handbook
IRB Composition & Background
Levels of Review
UMD Policy

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Definitions

Human Subject Research
45CFR46.102(f)-Human Subject means a living individual about whom an investigator conducting research obtains:

(1) data through interaction or intervention with the individual, or
(2) identifiable private information

45CFR46.102(d)-Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Informed Consent
Written informed consent must be obtained from all participants when possible. If not possible, a waiver or alteration of informed consent may be requested with proper justification. Consent is not just a form, it is a process. Participation is always voluntary. Participants may ask questions before signing, during the study and after the study has been completed.

Minimal Risk
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

Exempt Review
Although this category is called "exempt," this type of research does require IRB review. The exempt review process is less rigorous than an Expedited or Full Board review. To qualify, research must fall into one or more of six (6) federally-defined exempt categories. These categories present the lowest amount of risk to potential participants because, generally speaking, they involve either collection of anonymous or publicly-available data. Some examples of Exempt research are: anonymous surveys/interviews, passive observation of public behavior without collection of identifiable information, retrospective chart/record/data reviews, analysis of discarded pathological specimens without identifiers, etc.

Vulnerable Populations
They are a group of individuals with diminished autonomy who require additional protections. For example, minors must have parental consent to participate. Examples of vulnerable populations: Children, Pregnant women, prisoners, cognitively impaired, illiterate, etc.

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Federalwide Assurance

FWA: 00005856
IRB Registration: IRB00000474
IRB Organization: 0000281

To check the expiration dates for these Assurances, please refer to the Department of Health and Human Services website for the Office for Human Research Protections(OHRP) database.

The UMCP Federal Wide Assurance and the IRB registration are listed under "U of Maryland Coll Park Campus".

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Full Board Meeting Deadlines & Dates

Application Submission Deadline Meeting Dates
October 25, 2015November 12, 2015
November 22, 2015December 10, 2015
December 27, 2015January 14, 2016
January 24, 2016February 11, 2016
February 21, 2016March 10, 2016
March 27, 2016April 14, 2016
April 24, 2016May 12, 2016
May 22, 2016June 9, 2016
June 26, 2016July 14, 2016
July 31, 2016August 18, 2016
August 21, 2016September 8, 2016
September 28, 2016October 13, 2016
October 23, 2016November 10, 2016
November 20, 2016December 8, 2016






















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IRB Investigator Handbook

Click below to Download/View IRB Investigator Handbook
IRB Investigator Handbook

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IRB Composition & Background

It is a review committee consisting of faculty, students, staff, and outside members that has been established to help protect the rights and welfare of human participants participating in research. It is established to evaluate the ethical implications and conduct a risk-benefit analysis of research involving human participants through the application of 45CFR46 (Code of Federal Regulations governing human subject research).

History Lesson:
(1) Nuremburg Code
(2) Tuskegee Syphilis Study
(3) STD Inoculation Study

Belmont Report:
(1) Respect for Persons/Autonomy
(2) Beneficence
(2) Justice

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Levels of Review

Review Path Flowchart
Review Path Flowchart

Human Subject Research Determination
If you are unsure if your project requires IRB review and approval, please download and subject the HSRD Form through IRBNet. You will receive an official determination confirming no IRB Approval is needed or additional information will be requested.

Expedited Review
To qualify for an Expedited Review, research should fall into one or more of nine (9) federally-defined Expedited categories. These categories involve collection of samples/data in a matter that is not anonymous and involves no more than minimal risk to participants. Some examples of expedited research include: collection of blood samples, analysis of existing, identifiable pathological specimens, behavioral interventions, surveys/interviews/focus groups, etc.
Expedited Review Guidance and Categories
Expedited Review Flowchart

Full Board Review
Proposed human participant research which does not fall into either Exempt or Expedited review categories will be added to the next available agenda for Full Board Review. Projects presenting greater than minimal risk or transactions increasing the potential risk, will always be reviewed at the Full Board.
Submission Deadline and Meeting Dates

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UMD Policy

IRB Office - Standard Operating Procedures
IV-2.10- UNIVERSITY OF MARYLAND SYSTEM POLICY ON HUMAN SUBJECTS OF RESEARCH: Please read the official policy here.