Sponsored Programs and Research Services

IRB-Human Subjects in Research

Frequently Asked Questions

What is the procedure for getting IRB approval at CSU?

After a primary investigator completes the proposal
application and submits it, along with applicable consent forms and
letters of permission, the IRB staff will do an initial review to
determine whether the protocol is exempt from further review. Please
note that only the IRB staff have the authority to ascertain which
level of review will be necessary for your particular proposal. If it
is exempt, the protocol is immediately approved and the investigator is
authorized to move forward with data collection. Also if it is exempt,
it is not necessary to use an informed consent
If the protocol is determined to qualify for an expedited review, then it will be
forwarded to two of the IRB committee members, who will review the
proposal and then communicate with the investigator about any necessary
revisions and ultimately, authorization to go forward with data
collection.
If the protocol requires a regular
review, that means it must be reviewed by the entire IRB committee at a
regularly adjourned meeting, and then a representative of the IRB will
communicate with the primary investigator following the meeting.

What are the criteria for “exempt”?

The Federal law (45 CFR 46) established specific criteria that
must be met in order for review to occur at a particular level. First
of all, if the research proposes data collection that falls into one of
several categories, it may qualify as “exempt”. These activities are:

1.
Educational research on children that focuses on regular or special
educational instructional strategies, or on the effectiveness of
instructional techniques, curricula, or classroom management
strategies.
2. Non-controversial
research with adults, meaning use of educational tests, surveys,
interviews, or observations of public behavior IF there is no risk for
the subjects (the term “risk” is somewhat subjective)
3. Research on elected or
public officials
4. Use of existing data,
e.g. accessing data that were collected for a different project or part
of an agency’s regular record keeping. In order for this category to be
applicable, the data must either be publicly available (e.g. court
records), or completely de-identified so the researcher has no means of
associating a set of data with a particular subject.

What are the criteria for “expedited” reviews to be a
feasible option?

The Federal law (45 CFR 46) established specific criteria that
must be met in order for review to occur at a particular level. First
of all, the research must be minimal risk. Then, if the research
proposes data collection that falls into one of several categories, it
may qualify for “expedited” review. Following are the categories:

Category
1: Clinical studies of drugs and medical devices only when
condition (a) or (b) is met.
(a) Research on drugs for
which an investigational new drug application (21 CFR Part 312) is not
required.
(b) Research on medical
devices for which (i) an investigational device exemption application
(21 CFR Part 812) is not required; or (ii) the medical device is
cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.

Category 2: Collection of
blood samples by finger stick, heel stick, ear stick, or venipuncture
as follows:
(a) From healthy,
nonpregnant adults who weigh at least 110 pounds. For these subjects,
the amounts drawn may not exceed 550 ml in an 8 week period and
collection may not occur more frequently than 2 times per week; or
(b) from other adults and
children2, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the
frequency with which it will be collected. For these subjects, the
amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8
week period and collection may not occur more frequently than 2 times
per week.

Category 3: Prospective
collection of biological specimens for research purposes by noninvasive
means.

Category 4: Collection of
data through noninvasive procedures (not involving general anesthesia
or sedation) routinely employed in clinical practice, excluding
procedures involving x-rays or microwaves. Where medical devices are
employed, they must be cleared/approved for marketing.

Category 5: Research
involving materials (data, documents, records, or specimens) that have
been collected, or will be collected solely for nonresearch purposes
(such as medical treatment or diagnosis).

Category 6: Collection of
data from voice, video, digital, or image recordings made for research
purposes.

Category 7: 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.

Category 8: Continuing
review of research previously approved by the convened IRB as follows:
(a)where (i) the research
is permanently closed to the enrollment of new subjects; (ii) all
subjects have completed all research-related interventions; and (iii)
the research remains active only for long-term follow-up of subjects; or
(b)where no subjects have
been enrolled and no additional risks have been identified; or
(c)where the remaining
research activities are limited to data analysis.

Category 9: Continuing
review of research, not conducted under an investigational new drug
application or investigational device exemption where categories two
(2) through eight (8) do not apply but the IRB has determined and
documented at a convened meeting that the research involves no greater
than minimal risk and no additional risks have been identified.

When is a regular review necessary?

1. Research in which
there is more than minimal risk. “Minimal risk” is usually defined as
risk not exceeding that of normal daily activities.
2. Research involving
prisoners.
3. Research involving
mentally disabled individuals.
4. Research using
pregnant women (This is almost never relevant to us; it’s in the
regulation because the same regulation governs biomedical research.)
5. Most research with
minors.

How does the Institutional Review Board at Cleveland State
University review research proposals?

After a research proposal is received, it is processed and
entered into our database of research projects. The proposal is then
distributed to two members of the Board, who review it within the
context of standards set forth in the Code of Federal Regulations 45
CFR 46. The reviewers can request revisions, approve or deny the
proposal, or forward it on to full Board review, as described in
§46.109 of the regulations

What is the process to decide whether or not research has
to undergo full-board review?

Research that is described, by the reviewers, as controversial
or potentially harmful to anyone involved will undergo full-board
review, as likely will any research involving protected classes of
human subjects.

How long will it take for my research protocol to receive
approval?

If everything is submitted correctly and the research is not
controversial or conducted with protected classes, a minimum of ten
(10) working days is required for the initial review. This can
substantially vary depending on revision requirements, etc. Plan ahead!!

What are the most common revisions that reviewers request
from primary investigators and how can those common errors be avoided?

  • Inadequate information about the rationale for the study
    question
    .

    Often graduate students identify the purpose of the
    research as being a degree requirement for their Masters or Doctoral
    degree. While the research requirement may be a main reason for the
    research, there needs to be an additional, compelling reason to involve
    participants in a research project. Often, then IRB reviewers ask for
    more information about the need for the given project. By clearly
    stating the need and purpose for the research on Item IIIa of the
    proposal form, it alleviates the extra turnaround time needed when
    reviewers must ask researchers to further clarify the research purpose.

  • Inappropriate use of the terms "anonymous" and
    "confidential"
    .

    These two terms are often confused and improperly used
    interchangeably. Such inaccurate uses occur on both the proposal forms
    as well as on the Informed Consents. If the researcher will have any
    means of tracing a set of responses back to a specific individual, then
    the data is confidential. If data is being collected without
    any identifying information associated with the recording of the data,
    then the data is anonymous. NOTE: Data CANNOT be both
    anonymous and confidential; it is one or the other.

Do I have to keep my data confidential or anonymous?

No, researchers are permitted to credit participant responses
with the people who generated those responses, as long as participants
have been clearly notified, in the Informed Consent, that their
responses are NOT confidential.

Who do I contact if I have any questions about submitting
research?

Questions about anything related to institutional review can
be directed to Barbara Bryant, the Institutional Review Board
Coordinator, at the Sponsored Programs and Research Services
(216)687-3630. Board members can answer questions as well.

Where is the Institutional Review Board located?

The IRB is administered through the Sponsored Programs and Research Services located in Parker Hannifin Hall, 2258 Euclid Avenue. The Board members are spread throughout the campus and beyond.

What are some general requirements for consent forms?

In every consent form, there should be some form of personal
introduction and a description of the research. A statement needs to
specifically state that the participant can withdraw at any time
without penalty.

For those conducting research during class time, consent forms
MUST present an option for the student should they choose not to
participate OTHER THAN missing class

The requirements for the consent forms are confusing. Is
there a sample consent form that can be used as a guide?

Yes, sample
consent forms
are available to be used as guides when assembling
your own forms.

How will CSU IRB know that I have registered and taken the
CITI certification tests?

CSU has a server that enables us to store, and track, all
individuals
who have taken and passed the CITI modules that are required. Also,
you will be assigned a completion number that you will be asked to
record when you complete your IRB Proposal Form.

How often do I need to update my Researcher Certification?

The IRB requires continuing education and updating of the
certification
every three years.