Department of Psychology
Human Subjects Procedures
A set of procedures and hints
for preparing IRB submissions through the
Department of Psychology Departmental Review Committee
You may leave materials in the IRB TA mailbox in the yellow section in 1009 (first column to the right of
faculty mailboxes). Spare copies of the departmental cover sheets will be in
the mail room….
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Updated: |
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Amendments to research
(adding investigators) |
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Contact OPRS ( |
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Schedule of training sessions -- and Continuing Education; Training for undergrad assistants; your status |
Forms available for download |
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Consent Instructions
and TEMPLATE |
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All human subject research must receive
approval before work is begun. The procedure for obtaining approval begins when
investigators apply to the Department. The Chair signs, copies are made, and
the application and protocol are sent to OPRS for IRB review. No work may be
initiated before approval is received. Data obtained without prior approval are
“poisoned” and cannot be published in any form. Note that the IRB
is not allowed to grant ex post facto approvals.
Thesis and dissertation committee approval
When a graduate student proposes a thesis or dissertation, the proposal
approval form also requires the signature of the Chair of the
To obtain this signature, submit the thesis or dissertation approval form to the
Now, there’s a cute catch-22 here. The thesis or dissertation proposal should not be signed until IRB approval is in hand, but OPRS asks that IRB proposals for a thesis or dissertation be submitted after the thesis or dissertation committee has approved the project. This is to avoid the need for added paperwork in order to amend the project when the thesis or dissertation committee requests changes in the project design. In most cases, we can sign off while the IRB approval is still pending, so you can submit to the IRB at the same time you submit the thesis or dissertation prospectus approval form. In complicated cases, it may be necessary to wait for the IRB approval before the Department officially approves the thesis or dissertation proposal. On the other hand, the student may already have obtained IRB approval before proposing the thesis or dissertation in order to obtain pilot data before proposing. In that case, amendments may be needed to change the number of subjects and to accommodate any requests of the thesis or dissertation committee.
Some research is considered
“non-human subject research” – either because the
“subjects” are not considered human subjects according to
the definition in 45
ü Your
project is limited to accessing one or more of the following public use
datasets: Inter-University Consortium for Political and Social Research
(ICPSR), U.S Bureau of the Census, National Center for Health Statistics,
National Center for Educational Statistics, U.S. Bureau of Labor Statistics,
National Election Studies, National Crime Victimization Survey: School Crime
Supplement, 2003, National Epidemiologic Survey on Alcohol and Related
Conditions (NESARC), National Survey of America's Families (NSAF), and PRAMS.
ü Your
project is limited to course-related activities designed specifically for
educational or teaching purposes; where data is collected from and about human
subjects as part of a class exercise or assignment and is not intended for use outside
of the classroom. (Note
that this applies to undergraduate class assignments, next section.)
ü Your
activity is a case report involving the observation of a single patient whose
novel condition or response to treatment was guided by the care provider’s
judgment regarding the best interest of the individual.
ü Your
project involves research that is limited to death records, autopsy materials,
or cadaver specimens (provided that the cadaveric tissues/cells are not used
for clinical investigations).
If any of the above are true, your activity is in a category
that OPRS has determined not to
represent human subject research and waived
the requirement for submission to OPRS of an application for a human
subjects research determination.
However, it is recommended that investigators (faculty) document their
determination by placing a copy of this completed application in your files to
address any future queries about the project. This form may still be submitted
for an official determination by OPRS if required by the sponsor.
(From the form: Determination of Whether an Activity Represents
Human Subjects Research available on the OPRS site.) If your research is
not clearly within these guidelines, you should fill out the form: Determination
of Whether an Activity Represents Human Subjects Research which you can
download from http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/forms/index.shtml
along with a more detailed policy statement.
Graduate students should consider submitting this form even if their
research is within the guidelines to preclude any question from the
Psychology undergraduate class assignments
The “research” projects done by students as assignments in our regular, scheduled undergraduate classes do not require IRB approval (see previous section). They are considered instructional, and not research. No application need be made, although the instructor is expected to ensure that the same ethical procedures are adhered to as would be expected of a project approved by the IRB. This often includes obtaining consent from subjects who are not students in the class.
If the data collected should prove useful for further analysis or as the basis for further research or publication, IRB approval must be sought when this becomes evident. The pre-approval data can be considered “existing data collected for non-research purposes”.
Note that this exception does not apply to research under the 39x rubric, or to undergraduate laboratories in which animals are used. All animal use must be approved by the Animal Care Committee.
There are specific OPRS deadlines for submission for full (“convened”) reviews (either initial review or continuing review). In general, these deadlines fall two weeks before the meeting at which review will occur (a week to prepare the agenda and make and deliver packets, and a week for the IRB members to read it before the meeting). This schedule of meeting dates and deadlines is posted on the OPRS website.
However, you cannot hope to give us something the day of a deadline and have
it at OPRS in time for the next meeting. Even if the cover sheet indicates no
further processing,
Full initial reviews require the departmental committee to write reviews that are attached as Appendix F. This will not happen overnight! Please allow at least 5 days for these reviews (and, of course, it is those proposals that must meet specific deadlines at OPRS). If there are problems, obviously, it will take a bit longer for you to make the necessary corrections. (We can submit without corrections but the departmental reviews will indicate the problems, and it will take much longer to answer the problems if posed by the IRB than by us).
Exempt and expedited proposals (and expedited continuing reviews) are done on a rolling basis at OPRS, so there are no specific deadlines. The reminder letters do not distinguish these from full reviews, so you will be told a deadline that is really irrelevant.
What forms you must fill out, and how many copies are needed, depends on the
level of review. Please do not staple
your forms – use a clip!
Forms are available for download. Be sure you are using the current version of the forms.
The forms indicate all necessary attachments. In general, you will need to attach as many copies of any instruments or questionnaires as you must submit of the form itself. Please do not include the instruction pages with the application.
Level of review:
Registration: This is for research
projects that use people who are "not human subjects" according to 45
Submit directly to OPRS.
Exempt: Exempt studies meet the
requirements in 45
Expedited: Expedited review is accorded studies with no more than minimal risk within the specific categories listed in the OPRR Reports*. Use either the Social and Behavioral Sciences Application Form or the Health and Medical Sciences Application Form (Most Psychology projects will use the former, but if there are drugs or medical procedures, the latter must be used). You will have to indicate that your study is minimal risk, and check which of the categories apply (note that the entire project must fit within these categories for the project to qualify). You will write an extra paragraph or two justifying that it is qualified for expedited review. Do not write a full summary – just a verification of how it is minimal risk and fits within the categories you checked. Be sure to attach an Initial Review Cover Sheet – available in pdf format or as a Word document or in 1009.
Full review: All other studies require
full (or “convened”) review. The same forms are used as for
expedited review, but leave the expedited review sections blank. The department
committee will add two copies of Appendix F (one from each departmental
reviewer). Be sure to attach an Initial Review Cover Sheet – available in
pdf
format or as a Word
document or in 1009.
Standard instruments:
The following instruments have been reviewed by the IRB and are approved as
"standard". This means that if you will be using one (or more) of
them, you need attach only a single copy to your IRB application (for your file
at OPRS), but the reviewers will not need to see it (although a file copy will
be available should they wish to check it over). This is somewhat irrelevant to you, since the Department makes the
copies, but it saves us time and money.
If you do this, there are some procedures to follow:
· Be sure you are using the instrument and version
that was approved. If you make any modifications (either additions or deletions
of items) you will have to attach all the copies of the changes in a way that
is clear; if there are more than a small number of them, it will be simpler to
simply treat your instrument as non-standard and attach the normally requisite
copies.
· In your methods section (question 2 on the form),
be sure to say that the instrument is a standard instrument approved by the
IRB; list the name and version (if available), and copy the short descriptive
paragraph below so the reviewers know what it is.
The instruments approved are:
Profile of Mood States (POMS): (1971
copyright)
The POMS is a 65 item self-report questionnaire
containing adjectives that are rated on 5-point scales ranging from 1 (not at
all) to 5 (extremely). The POMS consists of 6 factor-analytically derived
subscales reflecting: vigor-activity, anger-hostility, depression-dejection,
confusion-bewilderment, fatigue-inertia, and tension-anxiety.
Beck Depression Inventory (BDI)
The BDI is a 21 item self-report questionnaire
that assesses an individual’s level of depressive symptoms. The inventory
is 83% accurate at discriminating depressed individuals from non-patient
controls.
The HDRS is a 21 item clinician-administered
rating scale designed to obtain a rating of depressive symptomology. The rating
scale assesses both cognitive and somatic symptoms of depression.
Structured Clinical Interview for DSM-IV (SCID) (Version 2.0, January 1995)
The SCID is a semi-structured interview designed
for members of the community who are not psychiatric patients. Questions
are asked about experiences and symptoms that make it possible to clinically
diagnose a variety of different mental disorders according to DSM-IV criteria,
using the American Psychiatric Association's Diagnostic and Statistical
Manual. Syndromes that can be discerned are schizophrenia, anxiety
disorders, mood disorders, somatoform syndromes, and disorders involving
substance use. The SCID-NP has satisfactory internal consistency for the
above-mentioned DSM-IV disorders and moderate construct validity, as shown by
its favorable comparison with other diagnostic assessment methods.
Montgomery-Asberg Depression Rating Scale (MADRS) (reference: Brit. J. Psychiat., 134, 382-9, 1979)
The MADRS is a clinician-administered rating
scale that assesses depressive symptoms. It is purported to be most
sensitive to change in depressive symptoms.
Positive and Negative Affect Schedule (PANAS)
The PANAS is a 20 item self-report questionnaire
that serves as a measure of current positive and negative mood. The items are
rated on a 5-point Likert scale where 1="not at all" and
5="extremely".
Marlowe-Crowne Scale
The Marlowe-Crowne scale is a 33 item
self-report inventory designed to assess an individual’s tendency to
answer in a manner that is socially desirable. Participants rate whether each
of the 33 statements are true or false.
Note also that OPRS will return any application that does not also have a research protocol attached. This means you must attach your grant application, whether pending, funded, or declined. Students must include the thesis proposal or prospectus. Unfortunately, OPRS still requires a "protocol" for all projects, even those that are simple projects that either require no funding or are funded through the Department. Since there is often no written proposal for such ad hoc projects, a "bogus" document must be created, typically by cutting and pasting from the lay summary, the scientific background and rationale, and the methods section of the application. We are trying to have this changed, but right now, OPRS will not accept an application that lacks such a supporting document.
A
clarification from
1. Provide background and the significance of the research
2. Describe the specific aims/objectives
3. List the performance sites and key personnel involved in the research (provide collaboration/support letters or institutional/organizational approvals where appropriate)
4. Describe the participants - population, # of participants, characteristics (i.e. rationale for subject selection)
5. Describe the methods and procedures including subject recruitment/ data procurement and consent (submit copies of all instruments, surveys, questionnaires, etc..)
6. Describe the outcome measures and analysis including “products” you plan to generate (i.e. manuscript, report to an agency, etc...)
New project: (except Registration).
Submit one (1) unstapled copy [original] of the
application to Pat or leave it in the IRB TA box in 1009. If you are requesting
an editorial review or have some special issues (boxes on the cover sheet that
should be initialed left un-initialed for some reason), please provide an
additional copy for the
Submit three (3) copies [original + 2
photocopies] of proposals that require full review. Also, please place
a Post-It with the word “
All new applications require an Initial Review Cover Sheet – available in pdf format or as a Word document or in 1009. Indicate the level of review requested by checking the appropriate box near the top of the form. Also check whether you wish an editorial review before the application is forwarded to OPRS (Departmental review is required for applications receiving full IRB review; the cover sheet will help guide these reviews). Note that each box on the form must be initialed by a faculty member (or an explanation attached explaining why it is not).
Level of Departmental Review:
Under the OPRS procedures
implemented
It is the investigator's option to have a regular review, in which the committee member advises of possible problems or difficulties so the investigator has a chance to revise the document before it is forwarded for review by the IRB. To request such a review, check the appropriate box near the top of the cover sheet. This is essentially what we have done in the past; we hope this review (editorial or in-depth review) assists investigators in having a smoother and faster IRB review.
The investigator may choose to request an application for exempt status
or expedited review be forwarded “as is”; the cover sheet
certifies that the application is acceptable for the Chair to sign. Only if
there are issues that might cause a reviewer to advise the Chair to decline
signing would the investigator be asked to make revisions. If there is a
serious disagreement, the full
Projects requiring full IRB review must be treated differently. Two reviewers are mandated, and each must write a review using Appendix F. Nevertheless, investigators will be offered the option of an editorial review or an ethical review. In this case, the ethical review will have to be somewhat more in-depth, as the reviewers must answer the 7 questions in Appendix F. If there are issues that would cause a reviewer to make a negative comment, the PI will be offered the opportunity to revise the application. Note that the investigator does not fill out Appendix F.
Be aware that if you submit for Exempt or Expedited review and the IRB determines that you require Full review, you will have to return to the Departmental Review Committee for 2 completed copies of Appendix F.
Note that the Departmental committee no longer has scheduled meetings; items are reviewed as they come in. However, this does not mean reviews occur instantaneously; we try to return comments or approvals in less than a week.
Continuing review: The
Continuing Review form is a more complicated than it should be, and will
require more time than you think to complete! Remember, it may have to go
through the Department Review Committee (and it MUST be signed by the Chair)
before it goes to OPRS. The IRB must then review it, and may request
changes. If it is not approved before your expiration date, work must stop
until it is approved! Therefore, it is wise to allow extra time for this
process; you can submit well in advance to guarantee there will be no lapse. If
it goes smoothly and gets to OPRS too far in advance, they will hold it until a
reasonable time so your next continuing review is not pushed too far forward.
Please
attach a departmental
Continuing Review cover sheet
(PDF file or
WORD version)
indicating whether there have been complaints or adverse events since the last
review. If you attest there were none, the CR will be signed without any
further departmental review.
The
form asks for all personnel (and any that have been added should already have
been reported as an Amendment), a review of changes in the literature, a report
of all subjects who refused participation or dropped out, and any adverse
events. Note that any adverse events must be reported directly to the
IRB as soon after they occur as possible. There is also a request for the
ethnic and gender composition of your subject population; if you did not
collect these data, you can state that the information was not a part of your
research and asking the additional questions would only have increased risks to
subjects. A breakdown of the
You
can attach an amendment to your Continuing Review form to change details or the
consent documents. Be aware that doing so, while somewhat easier than sending
an amendment separately, may slow the process of approval of the Continuing
Review. In some cases, the IRB may separate the amendment to prevent a lapse in
approval, so the project can remain active in its original form until the
amendment is approved.
The continuing review form is also used for the final report (when
you want to close out the project and seek no further approval). Be sure to say
FINAL REPORT boldly on the front, and submit as if it were a continuing review.
Remember that once you submit a final report, the project is closed forever.
You can’t do further analyses without first submitting an application
(for “existing data”). Don’t get caught closing a project and
then having a journal reviewer ask for some additional data!
Submit one unstapled copy [original] of the Continuing Review application
(with the departmental
Continuing Review cover sheet) to Pat Cushen or leave it in the IRB TA box in 1009.
If the project
requires a full review, please place a Post-It with the word “
Amendments: Any change
in what you are doing – from changes in number of subjects (including a
major decrease in anticipated subjects) to new personnel working in the
project, changes in recruiting procedures, changes in recruiting materials,
changes in instruments, or changes in procedures, must first be approved by the IRB. An Amendment Form asks for the new
materials and a brief justification of why the change is made. Note that any adverse
events must be reported directly to the IRB as soon after they occur as
possible. Don’t forget to add any students (graduate or undergraduate)
who are working on your research.
Submit the amendments form and materials directly
to OPRS.
Considerations
if you use the Subject Pool:
(click for Subject Pool rules)
Exemption: Few projects can be exempt if they use the subject pool. Obviously, projects under Federal agency heads, demonstration projects, or studies of existing data do not use the pool. Educational tests could, and there could possibly be a taste test. But the usual category of exemption -- surveys, interviews, etc. – cannot be invoked because minors (under 18) are excluded from this exemption, and you cannot exclude minors from subject pool experiments unless there is a valid scientific reason. If there is such a reason, be sure to make it explicit in your justification for exemption!
Special
requirements:
Even if your project is
exempt, you will need to supply a proper consent form (and parental
permission and assent if exempt for educational practices or taste tests),
using the same format as for any other project. It will not be stamped by OPRS,
but will be reviewed by the Departmental committee. The forms subjects see
should not vary as a function of the level of review given the project.
Rather than a “Consent” form, you should supply a single “Agreement to Participate” form that serves as both consent form (for those over 18) and assent form (for minors—parental permission will have been obtained through the blanket permission form). Other than the heading, this form should follow the template for a consent form. Note that no parental signatures or witness signatures are required, and the signature is of the subject, never a “legally authorized representative).
Note that the blanket permission is considered to meet the requirement that no one’s rights are abridged when permission is waived. The way this is handled (technically) is that each project using minors in the subject pool receives a waiver of parental permission, and part of the justification is that a blanket permission is on file. Please fill out initial review forms to ask for a waiver of permission on that basis. You should check that (1) the research is no more than minimal risk, (2) a waiver does not adversely affect rights (because of the blanket permission), (3) the research could not practically be carried out without the waiver, and (4) subjects are provided with information (the “agreement to participate” and the debriefing).
In
all cases, the debriefing for educational value must be supplied. It
need not be a verbatim script or handout; an outline can suffice. Exempt
proposals must attach a debriefing; others may either include it under
“what will be said to subjects to explain the research” (noting
explicitly what is to be said at the conclusion of the session), or attach a
debriefing sheet.
The
“inducement” for participants is a “Psychology Experience
Credit” or PEC. This is how it should be referred to throughout.
Remember, the alternatives include other experiments, practice clinical
interviews, and written reports. Consult the Subject Pool guide and procedures
if you are unclear about these alternatives. However, since you give a PEC (or
½ PEC if so advertised) to everyone who shows up, you don’t need to
indicate alternatives to being in this study.
Note
also that subjects will use a
Note
also that you do not have to include
Appendix S when using the subject pool (even though the form says you should).
- The sign-up procedure for
recruiting subjects is through an electronic system (PECOLSUS). Proposals
should reflect this change, and not refer to signing up on posted sheets.
- There is a blanket parental permission obtained from minors who will participate in the subject pool. This means no parental permission forms will be needed. Rather than a consent, you should have a single "Agreement to Participate" form that will serve as both a consent and an assent form
- No projects deemed to be greater than minimal risk will be allowed to use the subject pool unless minors are specifically excluded (for scientific reasons approved by the IRB). In most cases, this means the project received an expedited review. Some projects may have passed as exempt, but the most common exempt category excludes minors; if the project required full IRB review (perhaps because it didn’t fit the allowable categories), the IRB must have specifically determined that it is minimal risk. That will be stated at the top of the approval letter. Note that if your project received full review and the IRB does not determine that it is minimal risk, you will have to submit an amendment justifying the exclusion of minors.
What happens in
the Department:
The project will be reviewed by one (exempt or expedited
applications if editorial review was requested) or two (for full review)
members of the
About a day after review (if there is a review), the PI may receive a list
of suggested or required changes, or a note that the application is being
forwarded to OPRS.
If there are suggested changes, submit one (1) copy
of the corrected application to Pat Cushen or the IRB TA slot in 1009.
When the application is satisfactory, the committee will attach
the Appendix F (if it requires a full review) and
You can check your educational status on RISC, available from the OPRS website (menu on left of “Human Subjects” tab) or at https://riscweb.ovcr.uic.edu/phase1/. (You must be a PI of a protocol or authorized by a PI on Appendix P). Once you log in, you can list all the protocols you are on, and get details about any of them. On the left is a menu that includes “Educational Status”. It will list all your educational credits and experiences (with date and credit hours); your expiration date is at the top right (above the table).
Once your application is approved at the departmental level, it will be forwarded to OPRS for IRB review. Copying and forwarding will be done by the Department unless you specifically want to shepherd it yourself. Comments or requests for changes that you may receive from the IRB (through OPRS) should be responded to directly with OPRS -- the Department has no further responsibilities for the proposal (unless it is bumped to Full review and we must supply the two versions of Appendix F).
Continuing Review (annual re-review): Each investigator
should receive letters (90 day warning, 60 days, 30 days) from OPRS indicating
when renewal is due and what to submit. Note that some Re-Reviews are
scheduled sooner than one year. To renew your project, file a CONTINUING
REVIEW OF RESEARCH form (download it from
the OPRS page). Attach the departmental Continuing Review cover sheet and submit one copy to Pat.
The
Department committee no longer reviews Continuing Reviews – unless there were adverse events or
complaints. You should attach the departmental Continuing Review cover
sheet attesting to whether or not such things occurred. The cover sheet is
available in WORD or as a PDF
file.
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AFRICAN AMERICAN |
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CAUCASIAN |
UNKNOWN |
Males |
Females |
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0.7% |
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38% |
62% |
Ethnicity proportions are of the 90% who reported ethnicity
The freshman class that entered
Summer, 2000 had the following demographics:
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ASIAN |
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CAUCASIAN/WHITE |
OTHER and UNKNOWN |
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10.1% |
29.5% |
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(These data are from the Office of the Vice Chancellor
for Student Affairs and Enrollment Management
Submit the original (plus one copy if there’s a problem) of the CONTINUING REVIEW application with the departmental cover sheet to Pat Cushen or leave it in the IRB TA slot in 1009.
Note also that for Continuing Review,
investigators must have completed at least one session of continuing education. These sessions will be announced by UICprint e-mails. It is
hoped that there will be at least 20 possible sessions each semester. For
more information about continuing education, visit the OPRS web site and click Continuing Education.
Training and continuing education for undergraduate students: Anyone who interacts with subjects or handles their data must have
appropriate training/education. This includes undergrads who work in the lab.
There are two ways to handle this: First, you can list them as co-investigators
or add them by amendment (and they must appear in Appendix P in your continuing
reviews). Then OPRS will check their training. Alternatively, you can promise
to verify that any undergrads working for you have completed the necessary
training before engaging in research. You would not have to name the
individuals – but you must have promised (in your original application or
by amendment) that you will take responsibility for their training (both the
OPRS required training and any project specific training that may be relevant).
What happens after it leaves the
Department:
The department makes the necessary copies and delivers them to OPRS.
If the PI wants to make the deliveries him or herself, that can be arranged.
Deliveries can be made either to the OPRS office in AOB, or their satellite
office: 3108A,
Registration: That's it! Pat just files it.
Exempt or Expedited:
One or two IRB members review the application. This is done on a fairly
continuous basis – Vice-Chairs regularly “clear the shelf” of
proposals and amendments awaiting review (there is usually someone twice each
week). The convened meeting schedule and deadlines are therefore irrelevant for
these reviews. If everything is OK, you receive a letter of approval and can
begin work. If changes are required, you will receive a letter from OPRS. The
project cannot be disapproved, but it can be “bumped” to undergo
the next higher level of review. If it had been submitted as exempt, that means
filling out the Application Form. If it was expedited, it will have to
return to the department for review by the
Full
(convened): The full IRB
considers it at a convened meeting (after they have all read it). Be aware of
the meeting and submission deadlines, because if you just miss being
distributed in a packet you will have to wait at least two weeks longer to be
on the agenda for the next following meeting. If it is approved, you receive a
letter saying so, and begin work. But it is likely that changes will be
required. If the changes are explicit and simple ("check the box on
page-"; "add the following sentence to your consent form"), you
will receive a letter spelling out the required modifications. These are
reviewed by individual IRB Vice-Chairs, and so do not have to await the next
meeting, even if they received a full review. Work cannot begin until OPRS
certifies that the modifications are complete and satisfactory (you will
receive a letter of approval). In some cases, the application is
"deferred". That is, you are given a list of required modifications
and additional information or documentation that is required; after you
resubmit the corrected application, it must be brought to another convened
meeting of the IRB. Only if they are then satisfied can you receive a letter of
approval and begin work. In some cases, a project submitted for full review
will be determined to be minimal risk and the board will vote that continuing
reviews can be expedited (even though it may not fit the special categories).
It is also possible that you will be told the project is
disapproved, meaning it cannot be approved in this form. This should be very
rare, and you would receive further advice and information at that time.
When you get your response letter from OPRS, follow
their instructions and respond to them. Once we forward it out of the
Department, it doesn't have to come back through the
If you have questions about where a submitted application
is in the system, contact the Assistant Director for the board reviewing your
application (most Psychology protocols go to Board 2; some go to Board
3). It is a good idea to check the listing of
OPRS staff for whom to call, since there is sometimes turn-over. At
present:
IRB-2: Sandy Costello - - skamin1@uic.edu, Phone: 355-2908
IRB-3: Cynthia Tom-Klebba, MA
-- cklebba@uic.edu, Phone: 413-2053
Adverse or Unexpected Events: (AE)
OPRS requires an AE report within 5 days of any untoward occurrence in research. If a subject is hurt, mentally or physically, you must report it. (If the subject dies, a common occurrence with questionnaire studies, you have 48 hours to report it). You do not have to report grumpy complaints or drop-outs, or even distress that is within the range you predicted as a risk in your application (unless the proposed amelioration doesn't work).
In addition to reporting to OPRS, it would be best if the Department knows about it. For this, a complaining subject (who may file a grievance) would also be something to report. Please report such occurrences to Mike Levine < MikeL@uic.edu >, so the first hearing is not from the complainant. A simple e-mail indicating that someone might complain and why is all that is asked. The Department does not get a copy of AE reports – so please, remember to give the department a copy so we can be prepared (and proactive, if appropriate).
A list of common mistakes can be found by
clicking here.
- When you resubmit to Pat after Department editorial review, submit a clean copy. Do not highlight changes made in response to our review. This is presumably the copy that will go to the IRB, and they get confused by handwritten comments or out-of-place highlighting. One proposal was returned unreviewed because the IRB couldn’t figure out what all the extra stuff was about!
- Look carefully at the requirements for different levels of review. You may save time if you go for Expedited instead of Full, and a lot of effort filling out Exempt instead of the regular forms. But if you ask for too low a level, it will be sent back, and you will not only lose time, you may have to fill out a different set of forms.
- Be sure to address all the questions on the IRB forms. It is not acceptable to answer questions by saying "See answer to Question X above." The questions on the forms are redundant, yes, but the University IRB demands answers to each and every question.
- Note
that
- If you are using the Subject Pool, you cannot exclude minors except for acceptable scientific purposes. Since the blanket parental permission promises “minimal risk”, the project must either have been approved by exempt or expedited review, or the IRB have specifically determined that it is minimal risk.
- If you are using the Subject Pool, you must supply a debriefing that provides educational value for the students.
- If you are using the Subject Pool for subjects (including minors), your “consent” document should be headed “Agreement to Participate”. You can use this for subjects either older or younger than 18, as a consent or assent form. Parental permission will have been obtained through the blanket permission form. No parental signatures should be included on your “agreement” form. You should ask for a waiver of parental permission in the Appendix B, and justify it by the blanket parental permission.
- Be careful! Answer what was asked. Check all boxes, and put N/A for not applicable.
- Be careful not to include old information. At least one protocol was returned unreviewed because of a phrase in the consent hinting at a procedure not mentioned in the text. A silly error can cost you a month or more!
- The "Lay Summary" is really supposed to be in non-technical terms. Protocols are being returned ("deferred") for incomplete or incoherent lay summaries. This is the main part OHRP will read to be sure we are doing things right, so it has to be satisfactory. It is also a critical part of the annual Re-Reviews.
- Include as much detail about the methods as is reasonable, including attaching surveys or interview protocols, etc. These protocols must be very detailed and clear; they must assume nothing of the reader.
- Be wary of the "other reviews" box. Grant applications, master's or dissertation prospectus count as external reviews. Check "yes" and be sure to attach a copy.
- Consent
forms are a pitfall. See the
- The WORD template suffers all the pitfalls of WORD: silly question numbering, "page 20 of 18 footers", refusal to let you fit in the answer…. Do your best. However, do be sure that some form of pagination is somehow used.
- Remember that demographic information, particularly things like family income, arrest record, level of parents' education, drinking, drugs, etc. are sensitive information. Be sure to acknowledge these as risks!
- Be sure to list all student assistants as co-investigators. This is especially important for graduate students who may wish to use the fruits of this research for a thesis or dissertation. Students must be listed on an IRB application or their theses and dissertations will not be accepted by the Graduate College.
- Remember that all investigators must receive training. OPRS will not accept IRB applications without the investigator having been trained. So, all faculty and students who have not yet been trained need to attend sessions immediately. After initial training, re-training will be required. Note also that in signing the "Investigator's Assurance" (page 4 of the IRB application) you agreed "I will complete the required educational program on ethical principles and regulatory requirements in a timely manner." Previous approvals will not be considered valid if this obligation is not met! Click here for a Schedule of training sessions.
- The IRB will insist that you have consent forms available in other languages for non-English-speaking subjects, usually Spanish. You do not need translated consents if your subjects are English-speaking only -- either because of genetic differences that exclude even English-speaking ethnics because the diversity would swamp the results, or because the measurement instruments have not yet been validated in other languages, or the population you are sampling is English-speaking (e.g.: subject pool). You must list "English-speaking" in your inclusion or exclusion criteria, and you must have a scientific justification, not convenience. Be sure to justify that the burden is not therefore inequitably borne by one group while the benefits go to all groups. Also be clear that there are no benefits accruing to the subjects who are being denied to potential subjects because of their language (equity and justice). You must explicitly state these justifications -- the IRB is not allowed to assume reasons for you.
Note that when other language versions of consent are required, you should not translate your consent documents until they have been approved in English. When you supply your translations, OPRS can supply a back translation to verify the accuracy of your Spanish consent forms. You can avoid this by providing the credentials of the translator. It is common to add the translated versions by amendment.
- When using the Consent form template:
- Remove the instructions for use of the template at the upper left; remember to follow them (add the footer with a short title of your research, page # of #). A common reason for modifications is a missing or incomplete footer (or one that is different on the first and subsequent pages). If you have multiple forms (for different groups or phases, etc.) be sure the footers distinguish among them.
- Leave the "office use" box at the upper right. Remember to put the title of your project where it asks for "title of project" in the header.
- Be careful that the writing level is not too technical.
- Under
"What procedures are involved?", the suggested text includes
something like "I will be asked to do the following:" and there
is also a suggested "Approximately ## subjects will be involved at
- There may be some typos in the template. Do not replicate them.
- Be judicious in what you include. Do not talk about tape storage and disposal if you are not recording tapes. "New information" being provided is absurd during a single session. The statements about revealing information as required by law may not be applicable, and would only alarm subjects. Consent must be informed, but an overly legal and inclusive form scares subjects away.
- Injuries are not common in filling out a questionnaire, so don’t include what will be done if they get injured. For many of our studies, particularly minimal risk, you should not include the injury section – and remove the “if you are injured” part of the exceptions to confidentiality.
- If the subjects are all competent to give consent, remove “or authorized representative” from the heading “Signature of subject or authorized representative”. Unless blind or dyslexic subjects will be included, you can delete “(or someone has read to me)” under that heading.
- Only include the relevant signature lines. The over-18 consent does not need a parent signature. Subject pool forms do not need a witness. In fact, few forms need a withness.
- Some
common mistakes to avoid are posted in a separate list. Click here to see that
list.
* Note about expedited categories: In the
regulations, Category 5 (existing data) has a typographical error (a missing
“;”) that makes it seem only data collected for non-research
purposes are eligible. This is not so – any existing data
are eligible (assuming minimal risk). (This has been made clear in the current
version of the application). Here is a statement from M. Carome of OHRP:
OHRP
interprets expedited category (5) to mean that research involving materials
(data, documents, records, or specimens) that have been collected (i.e.,
already exist at the time the research is proposed), regardless of the original
purpose of the collection (research or nonresearch purpose), may be reviewed
under an expedited review procedure, provided the research involves no more
than minimal risk.