- Clinical Trials Guidance
- Federalwide Assurance
- Full Board Meeting Deadlines & Dates
- Investigator Handbook
- IRB Composition & Background
- Levels of Review
- UMD Policy
Video: UMD IRB Overview
NIH Clinical Trial Definition – Updated January 7, 2019
Clinical trials must be registered at clinicaltrials.gov prior to collecting data from human subjects if the researcher wants to submit a manuscript of their study to the journal. In addition, this is required by many peer-reviewed journals if an investigator is planning to submit a manuscript to that journal.
More information about the clinical trial requirements for grants and contracts can be found here:
The revised Common Rule also requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. More information about these requirements can be found here:
- Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h))
- NIH - Posting Clinical Trial Informed Consent Forms
In addition, informed consent documents for clinical trials are required to include a specific statement relating to the posting of clinical trial information at ClinicalTrials.gov. For more information please visit: NIH's Policy on the Dissemination of NIH-Funded Clinical Trial Information.
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.
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.
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.
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 eight (8) 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.
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.
For information regarding prisoner research, please visit the Office of Human Research Protections' (OHRP) webinars listed below:
An event that occurs during the course of a research protocol that either causes physical, social, economic, or psychological harm, or increases the risk of physical, social, economic, or psychological harm, or results in loss of privacy and/or confidentiality to a research participant or others (i.e. family members). Adverse events include expected and unexpected harmful effects and unexpected harms of an interaction or an intervention.
Unanticipated Problems (UPs) are defined as any incident, experience or outcome that meets all of the following criteria:
- Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied;
- Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants;
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.
The Office of Human Protections' (OHRP) has created an educational video describing the differences between Unanticipated Problems and Adverse Events. This video can be viewed at the link below:
Any difference in study conduct from the criteria or activities prescribed in the IRB approved protocol, which may or may not affect the participants' rights, safety, welfare, and/or the integrity of the study.
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".
|Meeting Dates||Application Submission Deadline|
|December 10, 2020||November 22, 2020|
|January 14, 2021||December 27, 2020|
|February 11, 2021||January 24, 2021|
|March 11, 2021||February 21, 2021|
|April 15, 2021||March 28, 2021|
|May 13, 2021||April 25, 2021|
|June 10, 2021||May 23, 2021|
|July 15, 2021||June 27, 2021|
|August 12, 2021||July 25, 2021|
|September 16, 2021||August 29, 2021|
|October 14, 2021||September 26, 2021|
|November 11, 2021||October 24, 2021|
|December 9, 2021||November 21, 2021|
IRB Investigator Handbook
Click below to Download/View IRB Investigator Handbook
IRB Investigator Handbook
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).
For additional information regarding the review committee, the Office for Human Research Protections' (OHRP) provides the webinars listed below:
- IRB Review Criteria
- Quorum and Voting in IRB Meetings
- Membership Requirements for Institutional Review Boards (IRB)
- Respect for Persons/Autonomy
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 complete the HSRD Form through IRBNet. You will receive an official determination confirming no IRB Approval is needed or additional information will be requested.
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