Autotext Resources
The purpose of this document is to list standard text ("boilerplate" or "autotext") that addresses recurrent issues, that can be copied to your own word processor (or directly copied from this page), and that expresses the necessary information consistently over time.  In many cases, the text covers a variety of circumstances, and needs to be edited to address the specific circumstance.  In text that refers to one of the official forms, a page number is often given as well as a form section; this is for convenience only, since the page number often changes depending on the amount of text entered in the form.

The entries are alphabetical, follow the same format:  a general summary, a possible tag to use if the text is added to one's autotext , followed by the actual standardized text.  Sometimes a usage note is added below the text itself.

The alphabetical listing is not always intuitively obvious; if you can't find what you're looking for, try searching of relevant terms on the page.

access by FDA	access
Page 4, VII.G.3. of the application, will the FDA, the manufacturers and the sponsor have access to identifiable information?  If so, specify and include this information in the consent form (see ., below).
adverse effects queries	viif
Page 3, , VII.F. of the Human Subjects Application, asks about how possible adverse effects from the study will be handled.  Please answer each item in accordance with the guidelines below. 
advisor copied on review letter	adv
cc:  faculty sponsor ( )
alcohol screening	alcohol
Page 3, VII.D.3. of the application, states that you will exclude subjects who abuse alcohol.  Please provide the screening interview you will use to exclude subjects who abuse alcohol.  The Committee suggests that these data not be recorded for subjects who are excluded from the study.  Please confirm.
anonymity and confidentiality	anoncon
.  Your responses to page 5, VII.G.1. and 2. of the Human Subjects Application seem to be contradictory.  Please note that items 1. and 2. are, in most situations, logically disjunct; please clarify whether data will be anonymous (no possible link to subjects' identities) or confidential (data coded, and links to identities kept separate from data).  If this distinction does not apply, please clarify. 
approach call features	appcall
Please submit a protocol or script for the approach call.  This should include (a) a check to make sure that the person answering the phone is the right person, (b) an introduction identifying the caller and the study, and their departmental and University of Washington affiliation, (c) a statement or reminder about how the prospective subject's name was obtained, (d) a question that allows the prospective subject to opt out of the telephone interview, or set a more convenient time ("Are you interested in hearing more about this study?  Is this a good time to talk?"), (e) a general description of the study, (f) if any screening questions will be asked, a description of the questions, especially of the most personal and sensitive a subject can expect to be asked, accompanied by the statement, "You are free not to answer any questions you do not wish to answer"; (g) a request for verbal consent before proceeding with the questions, and a statement about what will be done with the screening data if prospective subjects are screened out; (h)the screening questions that will be asked, and what will be said to subjects if they are screened out; (i) the arrangement of an appointment or next step for those eligible prospective subjects who wish to, continue;  (j) and a closing that includes a contact name and telephone number if the person should have any further questions about the study. 
approach issues	approach
In order to protect the privacy of a prospective subject, the initial approach should be made by someone whom prospective subjects will recognize as having ordinary access to their names and other information about them.  This individual would obtain permission from the potential subject to release his or her name to the investigator.  Is the trauma nurse coordinator someone prospective subjects would recognize as having normal access to their names and to confidential medical information about them?  If not, please explain how the initial contact with prospective subjects will be made. 
approval alert	approved
Please note that no procedures, instruments or forms are approved in general or at large:  they are approved only in the context of a specific Human Subjects Application.  Only materials and procedures that have actually (a) been submitted for review in connection with a specific application, (b) been reviewed in connection with that application and (c) approved in connection with that application, are actually approved for use in connection with the study covered by that application - and only in connection with that application.  Materials or procedures that are not provided cannot be reviewed, and cannot be considered approved.
approval in principle	aip
Approval in Principle
assent form heading explanation	af-head
(since minors are by definition not able to give legal consent, their agreement to participate is called assent)
assent requirements	assent
Assent must be obtained from the minors who will be subjects in the study.  Please submit an assent form, written in simplified language to be signed by the children who would not understand the consent form for adults.  Please submit the approximate text of a statement to be presented orally to those subjects who cannot sign their names (such as subjects who are five years old or who are physically handicapped) asking for their oral assent to participate.  The statement should be presented in simplified language and should describe what you are asking the children to do; how long it will take to do it; that participation is voluntary; and that the children can stop participating at any time by telling the experimenter that they want to quit.  You may also want to explain the presence of the video cameras, if they are visible to the children..  The children should be given an opportunity to ask questions before deciding whether to participate and should be informed that they may withdraw at any time without penalty. 
audiotape information point	aud1
aud1.  Page 5, VII.H.3. of the application, indicates that audio recordings of subjects will be used in the study.  Please explain what recordings will be made and how they will be used.  If identifiable recordings will be heard by anyone but the investigators, subjects should be given the opportunity to review and delete any portions.  This information should be included in the consent form (see point tape2., below). 
audiotape revision point	aud2
aud2.  Under "Other Information," please add a statement describing how the audiotapes will be used, how they will be stored, how long they will be kept, and whether they are to be listened to by anyone not on the study staff.  If the tapes are to be kept indefinitely, or if they are to be heard by people not on the study staff, add the further statement that subjects will have the right to review their tapes and delete any portions they may wish to delete. 
blood draw (risks section)	blood
 .  Paragraph , following sentence , add:  "The insertion of the needle to draw blood may cause discomfort and a bruise may form where the needle enters the vein." 
child abuse query	cabuse1.
Is it possible that the study procedures could reveal recent or ongoing child abuse?  If this should happen, what would you do?  (See point cabuse2., below.) 
child abuse statement	cabuse2.
In accordance with your response to point cabuse1., above, if study procedures may reveal child abuse, under "Other Information" add:  "All of the information that you provide will be confidential.  The only exceptions would be incidents of child abuse that you might report and risks of imminent harm to others or to yourself." 
confidentiality agreement procedure	conaghow
The correct procedure is to submit one proposed Confidentiality Agreement, on a current Confidentiality Agreement form, bearing original signatures of all relevant parties.  Because a Confidentiality Agreement is an instrument that must be executed with the original signatures of all parties, it is unnecessary to provide copies of incomplete Confidentiality Agreements, since they cannot validly be completed, lacking as they do original signatures of some of the parties.  If approvable, this will be completed by the signature of the relevant Human Subjects Division administrator.  The original will then be returned for you, to function as formal certification of authorization for use of records.  A copy of the executed Agreement will be retained in the application file.  This copy is not itself an executed Confidentiality Agreement, because it does not bear original signatures; it is simply evidence that such an Agreement has been executed and issued.  It is the responsibility of the principal investigator to retain the Confidentiality Agreement as evidence of authorization for use of records.  
consent form advisor listing	cf-adv
At the top of the first page, in the investigator information section, add the name of your advisor, and your advisor's University of Washington and departmental affiliation, and contact telephone number.
consent form link	seeuwcf
(See sample standard University of Washington consent form at http://www.washington.edu/research/hsd/forms/samplecf.doc )
consent form not in record	cfnot
IRB has determined that the consent form should not be placed in the medical record.
consent form: presigned	cf-presign
The consent form[s] submitted with the [Human Subjects Application/ modification proposal / Status Report] was pre-signed by the investigator.  Except in very specific circumstances, approved on a case-by-case basis by the Committee, consent forms should not be pre-signed.  Consent Forms should be signed by the person actually administering consent, at the time consent is administered.  The person who administers consent, if not the principal investigator, is acting as the agent of the principal investigator and must be able to represent the study with full knowledge and authority to prospective subjects; this person should be listed as an investigator in the Investigators' Information section of the consent form.  (The principal investigator is ultimately responsible for any defects in the consent process, and the chain of responsibility must be clear.)  Please confirm the Committee's understanding that you have not been using a pre-signed consent form, and that the investigator's signature line has been signed by a listed investigator at the time consent is administered.  If this is not the case, please explain. 
consent form:  typed name lines	typesig
Under the signature lines of investigator and subject, insert lines labeled "Typed or printed name of investigator" and " Typed or printed name of subject", respectively. 
consent form: addressing subjects	you
Since all the material in the "Investigator's Statement" section of the consent form is addressed to the subject, please revised the text to address subjects directly (as "you"), rather than in the third person. 
consent/assent form heading	cafhead
Substitute for the heading "Consent Form" the heading "Consent/Assent Form" (since minors are by definition not able to give legal consent, their agreement to participate is called assent).
deception debriefing point	db1.
  In accordance with the criteria specified in decep1., above, please submit for Committee review the debriefing protocol and statement that you will use with the subjects who have been deceived.  The protocol should indicate how you will review and explain the nature of, and reasons for, the deception with the subjects, should express regret for the necessity of deceiving the subjects, and should offer the subjects a chance to ask questions or work through any confusion they might have.  The written debriefing statement should present the same information in summary form, and should include a contact telephone number and name for subjects to call if they should have further questions or concerns.  When students have served as subjects, it is important to present this material in a way that introduces the subjects to the broader conceptual and research issues involved.  This may include providing specific references to relevant literature.
deception	decep
decep1.  The Committee takes any use of deception in research seriously, not only because it puts subjects at risk in ways to which they have not been able to give fully informed consent, but also because it undermines the credibility of the research endeavor itself.  The Committee finds deception acceptable when, and to the extent which, it is unavoidably required by the research to be done, and when the benefits outweigh the risks.  To ameliorate the effects of unavoidable deception, the Committee almost always requires debriefing of the deceived subjects.  Debriefing after deception has several goals:  to repair the breach of informed consent entailed by the deception, to remove any confusions or defuse any tensions that might have been generated by the deception, to make it clear especially to younger subjects that deception is permissible only in exceptional circumstances, and to repair (as much as possible) the breach of trust that has occurred not only between the investigator and the subject, but (potentially) between all researchers and all subjects.  The written debriefing statement should express regret for the necessity of deceiving the subjects, should explain what the deception was and why it was necessary, should offer the subjects a chance to ask questions or work through any confusion they might have, and should (if there is a significant risk of such reactions) offer information about sources of further support, counseling, or other assistance subjects may need as a result of the deception.  It is also important, especially when students have served as subjects, to present this material in a way that introduces the subjects to the broader conceptual and research issues involved.  (See point db1., below.)
electrical equipment testing	zap
In order to assure the protection of human subjects in research involving electrical equipment, that equipment is to be tested by institutional personnel responsible for electrical safety.  This responsibility is borne by the Scientific Instrument Division at the University Hospital and by the Medical Instrument Shop at Harborview Medical Center.  Investigators who cannot arrange for this testing shall submit a statement of their own regarding electrical safety, indicating both the testing done to assure safety of the original equipment and the plan for periodic retesting. 
eligibility language	screenout
The Committee feels that it is better not to give prospective subjects who have been screened out the impression that they have been screened out because of some defect on their part, but rather to put the burden on the study (by saying, e.g., "whether the study is a good fit for you").  Another benefit of avoiding talk of "eligibility" is that one also avoids encouraging prospective subjects to stretch a point to try to qualify for interesting or desirable studies or study conditions.  Please review the recruitment and screening materials and revise them as necessary to indicate that exclusion from the study is a matter of study design and not of a defect, or a failure to perform, on the part of the prospective subject. 
identifier removal	name2
 .  To protect the confidentiality of the study data, delete the section for subject's name and other identifying information from the instruments and replace with a section for study code. 
Item 1 asks whether the investigators will handle such effects, whether they will refer subjects to appropriate care, or whether they have some other definite agency that will handle such effects.  The default option here is "by investigators"; if neither of the other two choices is checked, this one should be.  If the third is checked, an explanation of the agency that will handle the effects must be added.
Item 2. asks whether facilities or equipment are adequate to handle possible adverse effects.  If they are not, please explain why they are not adequate, and what will be done to make up for this inadequacy.
Item 3. asks whether the subjects are to be financially responsible for costs arising from adverse effects, or whether some other agency has assumed that responsibility.  Please note that the UW Compensation Plan handles only adverse effects resulting from surgical or medical procedures performed in the course of research studies.  If this is the case, the first choice is appropriate.  If there is a sponsoring agency that has assumed responsibility through its own insurance plan, the second choice should be checked.  Otherwise, the third choice should be checked unless some other definite arrangement has been made.  If that is the case, the fourth choice should be checked, and the arrangement should be explained.
modification copies needed	modcop
Please re-submit the modification proposal in three copies, one of which is a signed original  It might be helpful to clarify why, and under what circumstances, the Human Subjects Division needs three copies of material.  The HSD is required to keep two file copies of all applications and related materials, so that they can be sent to reviewers at the mandated annual review which each Human Subjects Application undergoes.  Thus modification proposals should be sent in triplicate, so that one copy can be put with each file copy, and one copy returned to the investigator (this is the "Investigator' Copy", usually indicated as such by a box checked on the front page of the modification proposal).  It is therefore usually unnecessary to make additional copies of material already in the Investigator's Copy when referring to it, since we already have two copies (Master and Committee) on file.  On the other hand, if a modification proposal itself is sent without the requisite number of copies, it must either be copied by us or await the arrival of the remaining number of copies from the investigator – either of which means that there is a delay between the time it is received and the time it can be reviewed.
physical injury 	viif3
Page 7, , VII.F.3. of the Human Subjects Application, asks whether the subjects are to be financially responsible for costs arising from physical injury caused by study procedures, or whether some other agency has assumed that responsibility.  This question applies only to physical injuries.  You have answered this question, but have not discussed in the Human Subjects Application, or in the consent or consent/assent forms, what physical injuries subjects might expect from participating in the study.  Please confirm or correct the Committee's understanding that no physical risks can be expected from study procedures.  If this is not the case, please explain the risks, and modify the consent material accordingly. 
radiation safety committee	rsc
Submit a current letter of approval from the Radiation Safety Committee (RSC). 
sharing of information	share
Under "Other Information", in the appropriate place, state whether information provided by one subject would be shared with another and, if so, under what circumstances. 
social security information point	socsec1
ssn1.  According to the Federal Privacy Act of 1974, requests for disclosure of Social Security numbers must be accompanied by an explanation as to whether disclosure is mandatory (and if so, under what statutory or other authority the number is requested) or voluntary, and as to what uses the number will be put.  Please either delete the request for subjects' Social Security numbers or revise the consent form as outlined in point ssn2., below. 
social security revision point	socsec2
ssn2.  Under "Other Information", in the appropriate place, if, in accordance with your response to point ssn1., above, you wish to request subjects's Social Security numbers, please give an explanation as to whether disclosure is mandatory or voluntary, as to what statutory or other authority requested the number, and as to what uses the number will be put. 
subject's signature line	subsig
After the subject's statement, insert an signature and date line for the subject. 
subject's statement heading	substhead
Page 3, after the investigator's signature and date line, insert flush left the heading "Subject's Statement".
subject's statement	substate
Replace the Subject's Statement text with the current standard University of Washington consent form Subject's Statement, as below.
This study has been explained to me.  I volunteer to take part in this research.  I have had a chance to ask questions.  If I have questions later about the research, I can ask one of the researchers listed above.  If I have questions about my rights as a research subject, I can call the Human Subjects Division at (206) 543-0098.  [If relevant, add:  I give permission to the researchers to use my medical records as described in this consent form.]  I will receive a copy of this consent form. 
suicidality	si
Answers to some of the questions in the instruments may reveal a subject's intention to commit suicide.  Please explain how you will respond if a subject conveys this intention. 
UWise confidentiality agreement	uwconag
A Confidentiality Agreement was attached in the UWise application.  Unfortunately, a Confidentiality Agreement is a document that requires original signatures both of investigators and of the appropriate Human Subjects Division administrator.  Please send one copy of a signed Confidentiality Agreement, with original investigator signatures, to the Human Subjects Division; attach a cover memo identifying the study to which it belongs by name of principal investigator, application number, and application title.  When the application is approved, this will be signed and scanned; the scanned version will be uploaded to the UWise system, and the original, with original signatures, will be returned to you for your records. 
UWise investigator letter closing	uwinv
Please respond to this letter within the UWise system, at your earliest convenience, in order to expedite final approval.  Submit all revised or new materials as attachments within UWise.  Please do not alter the application text itself unless specifically requested to do so.  If you have any questions about how to perform UWise functions, please contact the UWise training staff.  If approval is granted based on your response to this letter, you will be notified within the UWise system.  If additional information is needed, we will contact you.  Please note that you may not conduct this activity until you have received notification of final approval. 
videotaping information point	vid1
vid1.  Page 5, VII.H.3. of the application, indicates that video recordings of subjects will be used in the study.  Please explain what recordings will be made and how they will be used.  If videotapes will be kept indefinitely, or be seen by anyone but the investigators, subjects should be given the opportunity to review and delete any portions.  This information should be included in the consent form (see point tape2., below).
videotaping revision point	vid2
vid2.  Under "Other Information," please add a statement describing how the videotapes will be used, how they will be stored, how long they will be kept, and whether they are to be seen by anyone not on the study staff.  If the tapes are to be kept indefinitely, or if they are to be seen by people not on the study staff, add the further statement that subjects will have the right to review their tapes and delete any portions they may wish to delete. 
vote:  approval in principle	vote-aip
By a vote of ____ the application was approved/was deferred
vote:  approval report	vote-app
By a vote of ____ the Committee accepted/questioned the approval report
See attached document 
vote:  modification	votem
By a vote of ____ the modification was/will be approved/was deferred
See attached document 
vote:  new application	vote
By a vote of ____ the application was/will be approved/was deferred
See attached document  
vote:  non-compliance	votenc
By a vote of ____ the Committee approved a determination with respect to the non-compliance.  See attached documents 
vote:  status report	vote2
By a vote of ____ the renewal was approved/was deferred
See attached document 
vote:  subcommittee report	votesc
By a vote of ____ the Committee accepted/rejected the report of the Subcommittee
waiving written consent (screening)	waivcon
For the Committee to consider a request to waive the usual requirement for written documentation of informed consent, please clarify whether and how the screening meets the criteria for such a waiver.  (See pages B12 and B14 of the University of Washington Human Subjects Manual.)  To receive such a waiver, the activity covered should involve no more than minimal risk to subjects, involve no procedures for which written consent is required outside a research context, and should require such a waiver in order to be practicable. 
witness not needed	witness
A signature line for a witness is not necessary in the case of competent subjects and may be deleted at your discretion.