- What is a “human subject”?
- What is research?
- If no publication or presentation will result from a project, does it still qualify as “research”?
- Can you give me some examples that are not human subjects research?
- What is a Federalwide Assurance (FWA)?
- What is an Institutional Review Board (IRB)?
- Does Mines have an IRB?
- What type of projects may qualify for exempt approval?
- What type of projects may require an expedited or full IRB board approval?
- Can I use a student CWID as a code to protect privacy?
- Is it OK to let someone from another institution survey our students for their research project?
- Is it OK to give my students some extra credit points for participating in my survey?
- I’m the instructor of my class, and it’s my research project with my students. Why can’t I know which students are participating in my study? What do I do?
- Do I need training?
- When should I send in an application for approval?
- What is the average length of time for an application to be approved?
- My proposal involves some research that might need to be considered human subjects but it is due to NSF today at 5pm. What do I do?
- Who do I contact if my question isn’t answered here?
“Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains
- Data through intervention or interaction with the individual, or
- Identifiable private information
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Perhaps. Publication or presentation is generally a benchmark of generalizable knowledge. However, activity that results in generalizable knowledge whether published or not is considered by some to be research since human subjects are involved and they are to be protected.
Some examples that do not qualify as human subjects research include the following:
- Surveys for evaluating the performance of faculty, staff, and students, or other studies for internal institutional use only
- This type of activity does not meet the definition of “research”
- Analysis of publicly availably data, such as reviewing US Census data
- This type of de-identified data does not meet the definition of “human subjects”
- Oral history of New Orleans jazz artists and memories of post-WWII era
- This type of activity does not meet the definition of “research.”
- Video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum.
- This type of activity does not meet the definition of “research.” The creation of the videotape is not intended to prove a hypothesis, inform policy, or draw conclusions
An FWA is an agreement between Mines and the United States Department of Health and Human Services (DHHS) where Mines assures that all of its activities related to human subjects research, regardless of the source of support, will comply with federal regulations concerning the protection of human subjects, including the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46 . Mines’ FWA is 00006893.
An IRB is a federally-regulated committee charged with ensuring that research involving human subjects is ethical, equitable, and humane. To this end, an IRB conducts both an initial review of a proposed research protocol as well as ongoing reviews of an approved research project. During the initial review, an IRB will consider whether a proposed research protocol meets established criteria for minimizing risks to human subjects. Based on this consideration, an IRB may approve or deny the protocol, or may alternatively condition approval upon certain changes to the protocol.
Mines is not registered with Office of Human Research Protection (OHRP) for a full internal IRB. Under our current registration, Mines can only provide exempt approvals. Research projects requiring an expedited approval or full IRB board approval must be sent to an IRB in good standing with OHRP. Mines currently has an agreement with COMIRB.
Projects that qualify for exempt approval include, but are not limited to, the following:
- research conducted in established or commonly accepted educational settings, involving normal educational practices.
- research involving educational tests, survey procedures, interview procedures, or observations of public behavior.
- research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.
- taste and food quality evaluation and consumer acceptance studies.
Examples of projects that require an expedited or full IRB board approval, include, but are not limited to, the:
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings in a nondisfiguring manner
No! These identifiers are used so frequently on campus that anonymity is not assured. Consider using a random number generator.
Maybe, if the following criteria are satisfied. These requests are often denied because they are burdensome with minimal benefit to our students.
(1) The research has been reviewed and approved by the principal investigator’s home institution
(2) Mines can determine that the research has benefit to our students, the school, and is not an undue burden
(3) A Mines co-investigator is added to the research project
(4) We can establish a reciprocity agreement with the home institution’s IRB or the research is exempt
(5) We independently review the research and, if necessary, make amendments to protect our students
Not Regularly. Extra credit as an incentive for participating creates an unfair situation for others in your class and is an unfair inducement into the research. There could be situations when extra credit could be approved if there are alternative ways for students to earn the same level of credit while not participating in the research project.
Due to the inherent risk of bias in an Instructor and his/her treatment of the participants/nonparticipants when grading assignments, this is not allowed Adding a co-investigator to administer the project activities or to do the grading of the students may sufficiently reduce the risk.
All researchers, including student researchers, engaged in research are required to complete the CITI training modules prior to the commencement of the project. Confirmation of training should then be emailed to the human subjects team, and retained for your file.
Submit your application 4-6 weeks before approval is needed. Don’t wait until you have a project pending to start the approval process.
The Mines human subjects team meets once every two weeks. COMIRB panel meetings can be found posted online. Note: COMIRB requires applications to be submitted 14 days prior to a scheduled meeting. Please plan accordingly and allow 4-6 weeks for application review. Often there are several iterations of an application before approval is granted.
The Office of Research Administration (ORA) will mark your proposal cover sheet as “IRB Pending.” As soon as you are notified that you will be funded, you should start the application submission process. You cannot be given access to your funds until ORA receives a copy of your approval letter. Some sponsors require a copy of the approval letter before releasing the funding. If you are in this situation, please notify the human subjects team of any required deadline imposed by the sponsor as soon as possible.
Please contact firstname.lastname@example.org with further questions.