|
|
|
Human Subjects Review Board |
|
Applications (Word Format) Applications (PDF) Other Links |
|
The Human Subjects Review Board (HSRB) is the administrative and decision-making body having responsibility for review and approval of research involving human subjects. Before any research involving human subjects can be initiated it must have received HSRB review and approval. All Proposals should be sent
directly to Steve Quackenbush, Chair of HSRB, via campus mail or e-mail (steven.quackenbush@maine.edu
). Investigator Guidelines for Research that Includes Human Subjects I. Where Do I Begin? UMF
faculty, staff, and students who intend to conduct projects involving human
participants must seek prospective approval (or an exemption) from the Human
Subjects Review Board (HSRB).
Depending on the nature of your project, one of three scenarios will
unfold: 1)
Your
project is EXEMPT FROM FURTHER HSRB
OVERSIGHT. Exempt categories
include (but are not limited to): (a) research conducted in established or
commonly accepted educational settings, involving normal educational
practices (such as the systematic analysis of the efficacy of various
instructional strategies) and (b) research involving surveys and interviews
(unless the research is conducted in such a manner that human subjects can be
identified or the survey/interview responses can potentially damage a
participants financial standing, employability or reputation). Additional exemptions are detailed on page
1 of the Request for Exemption
form (Microsoft Word; PDF).
Only the HSRB can determine if
a research project is exempt from further HSRB oversight. ·
If
you believe that your project is exempt from further oversight, simply
complete a Request for Exemption form (Microsoft
Word; PDF). As indicated on this form, your request
should include (a) a brief description of your project, (b) a clear account
of your “informed consent” procedures (including relevant documents), and (c)
all survey and interview questions.
Note that the HSRB website includes sample
“informed consent” forms that you can modify for use in your own study. ·
You
will receive feedback within 10 days regarding the status of your
proposal. If your project is indeed
exempt, no further HSRB oversight is required. If your project is not exempt, the review
process may take longer (and the HSRB Chair may ask the investigator to
submit a Request for HSRB Review
form) ·
Note
that any project dealing with sensitive information or special populations
(as defined below), or presenting greater than minimal risk to participants,
will require a full HSRB review.
2)
Your
students are conducting a classroom
project involving human subjects (where the purpose of the project is the
education of individual students).
If you believe that your classroom project is exempt from monitoring
by the HSRB, you should complete a Course
Required Research form (Microsoft
Word; PDF) Such submissions will require review at a
full HSRB meeting, so it is important to submit this form the semester prior
to the initiation of the classroom project.
Once the project is approved, no subsequent review is required (unless
there are changes in the course, the instructor, or the nature of the
project). [NOTE: ONLY THE HSRB CAN DETERMINE WHETHER STUDENT RESEARCH IS INDEED
EXEMPT FROM HSRB MONITORING, The following are examples of student
research that may justify the submission of a Course Required Research
form:
i. Student research that is not intended
to produce "generalizable" information
shared beyond the research class, and that does not include sensitive
information, pose greater than minimal risk, or study a special population.
ii. Data collected in connection with a class
that is undertaken for the purpose of learning research techniques, or
professional skills (e.g., patient evaluations for nursing students, law
student research techniques, student counseling
techniques).
iii. Observation of students performed in
commonly accepted educational settings provided the evaluator does not
interact with the student (including observation of minors). Studies that
focus on normal educational practices, curriculum, instructional techniques,
or management strategies are exempt provided that the information is not
shared beyond the UMF class or the research context.
iv. Analysis of existing data files in
which subjects cannot be identified. ·
Note:
If the results of the research will be
disseminated to the general public, or if the project deals with sensitive information, involves interactions with “special populations” (defined
below), or constitutes “risk” (of any sort) to the participants, the
individual project requires HSRB oversight (and it is the instructor’s
responsibility to bring the project to the attention of the HSRB Chair). 3) Your project requires HSRB oversight.
If your project does not clearly fall into one of the categories noted
above, you should submit a Request for
HSRB Review (Microsoft
Word; PDF). Such research will be reviewed at the next
full HSRB meeting. All student submissions require the
signature of a faculty sponsor. II. What is the Process of
HSRB Review? A. Initial HSRB Review Material for HSRB review (or request for exemptions)
should be delivered to the chair of the Internal Review Board (Steve
Quackenbush) via campus mail or e-mail (steven.quackenbush@maine.edu). If the submission is made via e-mail, the
form can be signed by the principal investigator (or faculty sponsor) at the
time the project is approved. The
HSRB chair will screen all applications to see if the project qualifies as EXEMPT FROM FULL
REVIEW (as defined above). If the
project does indeed require review, the HSRB may: 1.
Approve
the research as submitted. 2.
Approve
the research contingent upon specific revisions. 3.
Table
the protocol for substantive changes. 4.
Disapprove
the research. 5.
Suspend
or terminate research that has not followed HSRB conditions of approval. 6.
Monitor the research for compliance with
HSRB recommendations. If the protocol is approved contingent upon minor revisions,
the investigator must send a copy of the revised protocol to the HSRB Chair.
Federal Regulations require review of research at least
annually, consequently the date of approval always begins form the date of
review and extends at the maximum one year from the review date. Protocol approval automatically expires at the end of the
HSRB approval period. If a researcher
would like to continue research activities past the approval period, the
research must submit a Request for
Continuing Review (Microsoft
Word; PDF) C. Report of Unforeseen and Adverse Events IV. Definitions Research: Research is defined as a systematic
investigation designed to contribute to or develop "generalizable"
knowledge (intended to be shared with the general public). This includes
research obtained by an investigator through interaction or intervention with
a human subject or any research on human subjects that includes identifiable
private information. This does not include research in commonly accepted
educational settings that does not generate information used beyond the
institution (such as course evaluations) unless the subjects can be
identified and the information obtained poses a risk to the subject greater
than that encountered in daily life.
[Note: Only the HSRB can determine whether a given project is
appropriately classified as “research”] Minimal Risk:
Risk that is not greater than that encountered in every-day life. Sensitive Information: Includes information that may pose a risk to the subject:
psychological, social, medical, legal, economic or quality of life. The
following categories exemplify these risks. Categories of Sensitive Information: 1. Information relating to sexual attitudes,
preferences, or practices. 2. Information relating to the use of
alcohol, drugs or other addictive products. 3. Information pertaining to illegal
conduct. 4. Information that if released could reasonably
damage an individual's financial standing, employability, or reputation
within the community. 5. Information that would normally be
recorded in a patient's medical record and the disclosure of which could
reasonably lead to social stigmatization or discrimination. 6. Information pertaining to an
individual's psychological well-being or mental health. 7. Genetic information Special subject populations: Certain populations have additional protections under the
Common Rule. Studies that include special subject populations must follow a
more rigorous review by the HSRB. (Researchers are reminded that Subject populations with added protections: 1. Minors (under 18 years) 2. Pregnant women 3. Fetuses or products of labor and
delivery 4. Prisoners
For more information visit the Office for Human Subjects Research Protection Website at www.hhs.gov/ohrp/
|