Pacific University IRB # 1
INSTITUTIONAL REVIEW BOARD
FWA: 00007392 | IRB: 0004173
2043 College Way | UC Box A-133 | Forest Grove, OR 97116
P. 503-352-1478 | F. 503-352-1447 | www.pacificu.edu/research/irb
Proposal to Conduct Human Subjects Research
Autonomous, Protected Population
1 Instructions – Please read this information carefully and follow the instructions as precisely as
2 possible.
3
4 1. Use this form only if the intended participants will consist of incarcerated, but otherwise
5 autonomous, adults.
6
7 2. The objective of these templates is to provide a framework that focuses the investigators' and
8 reviewers' efforts in describing and verifying that the planned research meets all relevant
9 regulations and ethical considerations.
10 a. Answer every question in the templates carefully, completely, and directly. (You may
11 add/customize sections as appropriate to facilitate the explanation of unusual study features,
12 but you may not remove existing sections.)
13 b. Type answers to the questions directly into this form in the space indicated.
14 i. Delete explanatory text (embedded in red italics).
15 ii. Use boilerplate language as much as possible (embedded in blue).
16 iii. When complete, ensure the font color and styles are set to a uniform, readable standard.
17 c. For the project proposal, assume your audience is intelligent, but naive to the subject area.
18 Disciplinary jargon should not be used.
19 d. For the informed consent, write at an eighth grade reading level (or lower when appropriate) and
20 in the second person (e.g., you are invited to participate in a study, your records will be kept
21 private, etc.).
22 e. The informed consent should not include any identifying information beyond the participant’s
23 signature and printed name. This includes the addition of study protocol numbers, participant
24 numbers, birthdates, contact information, and so on. Use the participant contact information
25 form to gather identifying information from your participants or directly input contact information
26 into the master key (see below).
27 f. Develop a master key to enable the organization of identifying information and data (preferably
28 in an electronic format and vigorously protected with encryption and passwords). Investigators
29 and programs engaged in work where very sensitive and/or federally protected data are
30 gathered should be charged with identifying and implementing file encryption to convince the
31 IRB that robust safeguards are in use.
32 i. Enter the contact information you collect into the master key.
33 ii. Coded study identifiers are recorded in the master key. (Please note that study identifiers
34 should be random; never use initials.)
35 iii. Once the data are organized and collated, the master key (and participant contact
36 information forms, if used) should be destroyed. If it is important to your study to keep the
37 master key, please provide a detailed rationale to the IRB.
38 g. Data documents should have only the data and the study ID code; all other identifiers must be
39 eliminated.
40 h. Ideally, the informed consent, data, and the master key should be transported and stored
41 independently (compartmentalization), but reasonable alternatives can be proposed and
42 approved.
43 i. Your proposal and informed consent sections must be very consistent. Although these sections
44 are largely independent and serve different objectives, they must match precisely. Redundancy
45 between sections is expected.
Pacific University IRB # 2
46 j. Given the limited IRB human resources available at Pacific University, complete and
47 thoughtfully prepared proposals are expected. Prior to IRB submission, the faculty advisor(s) as
48 well as all key study personnel need to carefully review and edit the proposal documents for
49 comprehensiveness, clarity, and polish. It is extraordinarily rare for a proposal to be approved
50 by the IRB if it is incomplete or lacks clarity.
51
52 3. Include the following as appendices, whenever relevant. Please submit the proposal and informed
53 consent documentation in one Microsoft Office Word file. If some of your appendices are only
54 available in PDF format, it is acceptable to place these in a separate file from the rest of your
55 documentation. The IRB prefers Microsoft Office Word documents whenever possible but
56 understands that some documentation may only be available in PDF format.
57 a. Completion certificates of ethics training for investigators and research associates (if not already
58 on file with IRB).
59 b. Recruitment (e.g., flyers, email text, and the like) and data collection materials. It is not a
60 copyright violation to provide proprietary materials for IRB purposes. If materials are complex,
61 lengthy, or widely recognized standards (e.g., the Minnesota Multiphasic Personality Inventory,
62 the Wechsler Adult Intelligence Scale), you may elect to omit the materials but do provide a
63 statement about their validity/disciplinary acceptance. Please check with your college/school’s
64 IRB representative for help in making this determination.
65 c. Should the research involve collaborations with another institution or agency (e.g., clinics,
66 Department of Corrections), a formal letter of permission/support from that organization is
67 required.
68 d. If partnerships involve multiple IRBs, include copies of documentation submitted to the other
69 IRB(s) and any official approval letters; refer to the IRB webpage or contact one of the IRB co-
70 Chairs for advice.
71 e. If international research partnerships develop and involve subjects who are non-US citizens,
72 you must persuasively document that study procedures comply fully with both nations’ human
73 subject policies (consultation with foreign IRBs may be necessary) and demonstrate knowledge
74 of and sensitivity to the foreign cultural norms. Refer to the international research form on the
75 IRB website and http://www.hhs.gov/ohrp/international/index.html for more information.
76 f. If English fluency/literacy is equivocal for any subjects in your intended sample, all materials,
77 release forms, and consent forms must be translated appropriately. It is the investigators'
78 responsibility to procure validated translation services. Copies of the English and translated
79 materials must be included in the submission along with the verified translation form available
80 on the IRB website.
81 g. Other forms, if needed (e.g., HIPAA or FERPA).
82
83 4. Fill out and sign the study personnel and contact information form and submit it as a separate file
84 from the proposal, informed consent, and appendices. It may be submitted via email (as a PDF file),
85 fax, or as a hard copy through campus mail.
86
87 5. Please submit your proposal in the following manner.
88 a. Refer to http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartc for especially
89 relevant guidance.
90 b. Before submission, review the guidelines for compliance and then delete the instructions (this
91 page and embedded ones).
92 c. Send an electronic copy of the complete proposal and accompanying documents to the IRB
93 office at irb@pacificu.edu. (The only exceptions to this are the study personnel and contact
94 information form and any other forms that require signatures (HIPAA forms, letters of support,
95 etc.). They may be submitted via fax or campus mail if necessary. All other documentation must
96 be paperless.)
97 d. Proposals cannot be processed for review until the IRB office has received all required
98 materials.
99
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100 6. Once your submission is received, a project number will be assigned. Use this number in all future
101 dealings with the IRB regarding the project. Note that the IRB office normally will communicate only
102 with the faculty advisor for student projects.
103
104 7. Once your project is approved, you must complete the following (when applicable).
105 a. Submit a project closure request when your project is completed.
106 b. Complete a project extension request if your research extends beyond the approved study
107 dates.
108 c. Undergo mandated periodic/continuing reviews if the study presents more than minimal risk.
109 Additional documentation will be required.
Pacific University IRB # 4
INSTITUTIONAL REVIEW BOARD
FWA: 00007392 | IRB: 0004173
2043 College Way | UC Box A-133 | Forest Grove, OR 97116
P. 503-352-1478 | F. 503-352-1447 | www.pacificu.edu/research/irb
Proposal to Conduct Human Subjects Research
Autonomous, Protected Population
110 1. What is the title of this study?
111 Enter information here.
112
113 2. What is the purpose of this study and how is a prisoner sample justified?
114 For biomedical and/or behavioral research involving prisoners, federal regulations (45 CFR 46.301-306)
115 allow for only the following types of research questions: (a) a study of causes, effects, and processes
116 of incarceration and of criminal behavior; (b) a study of prisons as institutional structures or of prisoners
117 as incarcerated persons; (c) research on conditions affecting prisoners as a class; or (d) research with
118 intent and probability to improve health or well-being of the subjects. No other types of studies can
119 be approved.
120
121 If your study involves prisoners, you must specifically and explicitly identify which of these categories
122 applies for your study and persuasively explain how the project is likely to achieve the aim(s).
123
124 Provide enough relevant information to allow the IRB reviewers to understand the rationale/justification
125 for the study and its merits (basic and/or applied), including any relevant study hypotheses and
126 dissemination plans.
127
128 3. What are the relevant characteristics of the intended sample and the recruitment plan?
129 a. Intended sample size and relevant demographics
130 Some considerations include: age range, sex/gender, ethnic/minority status, and health status.
131 Please include a brief rationale for the proposed sample size (e.g., a priori power calculation,
132 amount for a counterbalanced design, etc.).
133
134 b. Eligibility criteria
135 List and describe key characteristics necessary for participation in the study.
136
137 c. Exclusionary criteria
138 List and describe criteria that would exclude subject participation in the study, e.g., pregnancy,
139 specific medical condition, English language fluency, age, etc.
140
141 d. Recruiting plan
142 Explain proposed recruiting plan/methods; include copies of flyers, notices, etc. in appendices.
143
144 Note that for prisoner samples, procedures for the selection of subjects must be fair to all
145 prisoners and immune from arbitrary intervention by prison authorities or other prisoners; be
146 sure to describe how your methodology achieves this. Unless the principal investigator provides
147 to the Board justification in writing for following some other procedures, control subjects must be
148 selected randomly from the group of available prisoners who meet the characteristics needed
149 for that particular research project. Explain these features well!
150
151 4. What is the study methodology?
152 a. Location of the study
153 Identify where the data will be gathered, stored, and analyzed.
154
Pacific University IRB # 5
155 b. Materials, measures, and/or apparatus to be applied
156 Name and explain each element so that its purpose is clear. Address validity of instruments not
157 widely recognized outside of the discipline, and provide references, if possible. If relevant,
158 include appendices that describe and/or depict proposed study tools. If possible, identify the
159 independent and dependent variables, as well as the proposed statistical analysis. Including
160 these elements will smooth the progress of the review.
161
162 c. Procedures
163 Denote study design as appropriate. List in a step-by-step fashion how the study will unfold. In
164 reading this, the IRB reviewers should be able to imagine exactly what it would be like to be a
165 participant in every condition of the proposed research. Include the expected duration/time
166 commitment of the subject's participation and identify any additional costs to the subject.
167
168 d. Time frame for recruitment, data collection, analysis and dissemination
169 Recruiting will begin once IRB approval has been obtained. Data collection will begin…continue
170 as appropriate, include an ending date. Investigators are strongly encouraged to describe the
171 planned outlets for study findings (e.g., A&S Senior Project Day; publication of formal
172 thesis/dissertation available in library; local, regional, national or international
173 scientific/professional meetings) in the proposal (here or in Part 3).
174
175 5. What risk(s) accompany participation in this study?
176 Federal regulations also require that study procedures present no more than minimal risk and no
177 more than inconvenience to participants when a prisoner sample is involved.
178
179 a. Specifically identify and briefly describe the various risks to which participants may be
180 exposed
181 Risks can be physical, social, emotional, legal or economic.
182
183 b. Describe the likelihood of these risks occurring, how they can/will be minimized, and
184 how they will be handled should they occur
185 Enter information here. Note that each identified risk should have an associated minimization
186 strategy.
187
188 For prisoner samples, investigators must anticipate and identify in the proposal when there may
189 be a need for follow-up examination or care of participants after the end of their participation
190 and provide adequate provisions for such, taking into account the varying lengths of individual
191 prisoners' sentences, and for informing participants of this fact in the Consent materials.
192
193 c. Describe any element(s) of deception or meaningful withholding of information
194 associated with the study methodology
195 Address this issue explicitly. If deception or information withholding is involved, a debriefing is
196 usually required; explain the debriefing process (if already provided in Part 5, state so here),
197 being sure to offer participants a chance to withdraw their data explicitly once all the elements
198 have been disclosed.
199
200 d. Describe any treatment alternatives that may be advantageous to subjects, if clinical
201 trials are involved
202 This section is relevant for studies involving clinical trials. The purpose is to clearly identify any
203 clinical procedures that are experimental and disclose the existence of appropriate alternative
204 procedures or courses of treatment, if any, which might be advantageous to the subject. If you
205 are collecting normative data or are NOT conducting clinical trials, then you may simply state,
206 “This study does not involve clinical trial(s).”
207
Pacific University IRB # 6
208 6. Does participation in this study provide direct benefit or compensation?
209 Benefit and compensation are different notions not to be used interchangeably. Claiming that
210 participants will benefit means that they will gain a clear and demonstrable advantage that could not
211 obtained unless they participated in the study. Many studies are simply non-beneficial.
212 Compensation is an outright payment or some form of material reward given to subjects in
213 acknowledgment of their participation.
214
215 Note also that for prisoner samples, investigators must offer adequate assurance that parole boards
216 will not take into account a prisoner's participation in the research in making decisions regarding
217 parole, and clearly inform prisoners in advance that participation in the research will have no effect
218 on parole decisions.
219
220 a. Describe the specific unique benefits subjects will realize via their participation in this
221 study, if any
222 Enter information here.
223
224 b. Describe the payment or other reward participants will receive, if any
225 Enter information here.
226
227 7. How will adverse events be handled and reported?
228 The IRB must be notified promptly when an unexpected adverse reaction occurs. Explicitly state
229 that you will notify the IRB promptly and explain how you will manage the event. Keep in mind that
230 adverse research events can cover a wide spectrum of possibilities. They may include, but are not
231 limited to just those potential risks that have already been identified, but also consist of unexpected
232 events as well. The IRB considers adverse event reporting as mandatory, and crucial for clinical
233 studies. Medical/clinical research examples are given below. Review and integrate those that are
234 relevant to your particular study.
235 A serious adverse event is any unfavorable and unintended sign (including an abnormal
236 laboratory finding), symptom, or disease temporally associated with the use of a medical
237 treatment or procedure that may or may not be considered related to the medical treatment or
238 procedure. Serious adverse events include those that
239 o are fatal or life threatening;
240 o result in significant or persistent disability;
241 o require or prolong hospitalization;
242 o result in a congenital anomaly/birth defect; or
243 o represent other significant hazards or potentially serious harm to research subjects or
244 others, in the opinion of the investigators.
245 Unexpected serious adverse events are those that have not been described in the
246 o package insert for a given drug or investigator's brochure (for FDA investigational agents);
247 o approved protocol; or
248 o informed consent document.
249 Adverse research events include, but are not limited to
250 o physical or psychological/emotional harm or injury (e.g., emotional distress triggered by
251 study questions about emotionally charged life events);
252 o threats to privacy or safety;
253 o unusual amount of participant withdrawal or drop-out;
254 o breaches of confidentiality; or
255 o subject complaints about the experimental procedures or the conduct of the investigators.
256 Use as much of the boilerplate language provided as possible; modify as necessary while
257 maintaining intent and compliance requirements.
258
259 8. How will you protect the privacy of your participants?
Pacific University IRB # 7
260 Explain specific steps you will take to protect the personal information your participants provide.
261 Make it clear whether the results will be kept in a confidential or an anonymous manner, keeping in
262 mind that it cannot be both. A promise of confidentiality means that although names can be
263 associated with corresponding data (such as a master key of names and study ID numbers), steps
264 will be taken to minimize the possibility that someone other than the PI could do so. A claim of
265 anonymity indicates that no one, not even the PI, actually knows the identities of any participants,
266 regardless of the ability or inability to link participant identities to data.
267
268 Investigators must consider, anticipate and have plans for situations where it may be necessary to
269 break confidentiality. If child abuse is known or strongly suspected, investigators are required to
270 notify the appropriate authorities. If a participant is believed to be a threat to oneself or others, the
271 investigator should notify the appropriate authorities. The conditions under which the investigator
272 may break confidentiality must be described in the proposal and the informed consent.
273
274 9. Is there a grant or contract supporting this study and/or any potential conflicts of interest?
275 a. Describe any grant or contract funding support for this study, if any
276 Enter information here.
277
278 b. Describe any potential or apparent conflict(s) of interest that may exist
279 Enter information here.
280
281 10. How will informed consent be obtained and documented?
282 There are specific requirements for obtaining and documenting informed consent; this step must be
283 prepared clearly. In all cases, the duties and rights of the participants must be clearly explained.
284 The primary way to do this is explicitly (i.e., via reading and signing the form). The required
285 elements include
286 a statement that the study involves research;
287 an explanation of the purpose(s) of the research;
288 identification of the expected duration of the subject's participation;
289 identification of the approximate number of participants;
290 a description of the procedures to be followed;
291 identification of any experimental clinical/treatment procedures and a complete disclosure of
292 appropriate alternative procedures or courses of treatment, if any, that might be advantageous
293 to the subject;
294 identification of any additional costs to the subject that may result;
295 explanation of anticipated circumstances under which a participant may be removed by the
296 investigator from further participation without regard to the subject's consent;
297 a description of any reasonably foreseeable risks or discomforts to the subject plus a statement
298 that the particular treatment or procedure may involve currently unforeseeable risks to the
299 subject (or to the embryo or fetus, if the subject is or may become pregnant);
300 a description of any benefits to the subject or to others which may reasonably be expected from
301 the research;
302 a statement describing the extent, if any, to which confidentiality of records identifying the
303 subject will be maintained;
304 for research involving more than minimal risk, an explanation as to whether any compensation
305 and an explanation as to whether any medical treatments are available if injury occurs, and, if
306 so, what they consist of, or where further information may be obtained;
307 an explanation of whom to contact for answers to pertinent questions about the research and
308 research subjects' rights and whom to contact in the event of a research-related injury to the
309 subject; and
310 a statement that participation is voluntary and that refusal to participate will involve no penalty or
311 loss of benefits to which the subject is otherwise entitled, and the subject may discontinue
Pacific University IRB # 8
312 participation at any time without penalty or loss of benefits to which the subject is otherwise
313 entitled.
314 o This also must explain the consequences of a subject's decision to withdraw from the
315 research and the procedures for orderly termination of participation by the subject.
316 o A statement that significant new findings developed during the course of the research which
317 may relate to the subject's willingness to continue participation will be provided to the
318 subject.
319
320 There are circumstances where modified consent procedures can be used, but these must be
321 requested and justified in detail. A partial list of examples includes: (a) anonymous survey methods
322 (anonymity reduces many types of risk and returning the survey can be interpreted as implied
323 consent when warranted), (b) deception studies may obtain consent post-study as part of the
324 required debriefing (with this situation be sure to offer participants the option to withdraw their data
325 after all the disclosures have been made), and (c) archival studies may warrant consent waivers
326 (HIPAA and FERPA regulations allow for this under select circumstances).
327
328 It is the investigators' responsibility to understand these regulations and then prepare compelling,
329 detailed justification for any requested modifications to the standard informed consent process.
Pacific University IRB # 9
INSTITUTIONAL REVIEW BOARD
FWA: 00007392 | IRB: 0004173
2043 College Way | UC Box A-133 | Forest Grove, OR 97116
P. 503-352-1478 | F. 503-352-1447 | www.pacificu.edu/research/irb
Proposal to Conduct Human Subjects Research
Autonomous, Protected Population
330 1. Study title
331 Enter information here. Include the IRB project number in () following your title.
332
333 2. Study personnel
334 Modify the columns in the table below to fit the number of personnel involved in the study; identify
335 the role of each as indicated (e.g., principal investigator, faculty advisor, student investigator,
336 research assistant). Dissertation readers need not be named.
Name
Role Principal Investigator Faculty Advisor
Institution Pacific University Pacific University
Program
Email
Telephone
337
338 3. Study invitation, purpose, location, and dates
339 Federal regulations require a statement that the study involves research and an explanation of the
340 purpose(s) of the research. For example: “You are invited to participate in a research study on the
341 potential relationship between… The project has been approved by the Pacific University IRB and
342 will be completed by… The study will take place in the… The results of this study will be used to
343 inform…”
344
345 4. Participant characteristics and exclusionary criteria
346 Disclose all relevant eligibility requirements and exclusionary factors. Also explain circumstances
347 under which a subject may be removed by the investigator from further participation without regard
348 to the subject's consent.
349
350 5. Study materials and procedures
351 The purpose of this section is to enable a potential participant to imagine what it will be like to be in
352 this study. Be sure to address all of the following explicitly: (1) the approximate number of
353 participants, (2) a description of the procedures to be applied, (3) the expected duration/time
354 commitment of the subject's participation, and (4) identification of any additional costs to the
355 subject.
356
357 6. Risks, risk reduction steps and clinical alternatives
358 a. Unknown risks
359 It is possible that participation in this study may expose you (or an embryo or fetus, if you are or
360 become pregnant) to currently unforeseeable risks.
361
362 b. Anticipated risks and strategies to minimize/avoid
Pacific University IRB # 10
363 Ensure risks described here and in the proposal are an exact match! Give an avoidance
364 strategy for each risk.
365
366 c. Need for follow-up examination or care after the end of study participation
367 Identify whether or not there exists a potential need for follow-up examinations or care after the
368 end of participation and explain how this will be provided/available, taking into account the
369 varying lengths of individual prisoners' sentences.
370
371 d. Advantageous clinical alternatives
372 If the study involves clinical trials, the consent form must clearly identify and explain the clinical
373 procedures that are experimental and disclose appropriate alternative procedures or courses of
374 treatment, if any, which might be advantageous to the subjects. If this issue is not relevant,
375 state, “This study does not involve experimental clinical trial(s).”
376
377 7. Adverse event handling and reporting plan
378 Boilerplate language example - generic
379 The IRB office will be notified by the next normal business day if minor adverse events occur (e.g.,
380 a, b, c) and will be handled as follows: …
381
382 The IRB office will be notified within 24 hours if major adverse events occur (e.g., a, b, c) and will be
383 handled as follows:
384
385 Boilerplate language example - clinical study
386 In the case of any unfavorable and unintended sign (including an abnormal laboratory finding),
387 symptom, or disease temporally associated with the use of a medical treatment or procedure that
388 may or may not be considered related to the medical treatment or procedure being investigated, the
389 IRB will be notified within 24 hours. These may include, but are not limited to events that
390 are fatal or life threatening;
391 result in significant or persistent disability;
392 require or prolong hospitalization;
393 result in a congenital anomaly/birth defect; or
394 represent other significant hazards or potentially serious harm to research subjects or others.
395
396 8. Direct benefits and/or payment to participants
397 This is a required statement. It is important for you to understand that parole boards will not take
398 into account your participation in this project in making decisions regarding your parole in any way.
399
400 a. Benefit(s)
401 Remember, if there are no clear benefits, state, “There is no direct benefit to you as a study
402 participant.”
403
404 b. Payment(s) or reward(s)
405 If there is no payment or reward planned, state, "Participants will not be paid for their
406 participation."
407
408 Be sure the benefits/payments (or lack thereof) described here and in the proposal match. In
409 considering benefits, remember that in this setting, “benefits” refer to unique consequences
410 available only to those who participate.
411
412 9. Promise of privacy
413 Make it clear whether the results will be kept in a confidential or an anonymous manner, keeping in
414 mind that it cannot be both. A promise of confidentiality means that though names can be
415 associated with data, steps will be taken to minimize the possibility that someone other than the PI
Pacific University IRB # 11
416 could do so. A promise of anonymity means that no one, not even the PI, can associate names with
417 data.
418
419 Investigators must consider, anticipate and have plans for situations where it may be necessary to
420 break confidentiality. If child abuse is known or strongly suspected, investigators are required to
421 notify the appropriate authorities. If a participant is believed to be a threat to oneself or others, the
422 investigator should notify the appropriate authorities. The conditions under which the investigator
423 may break confidentiality must be described in the proposal and the informed consent.
424
425 10. Medical care and compensation in the event of accidental injury
426 This section is a legal statement that must remain primarily as is. Use the provided language, plus
427 additional study-specific material, as needed. The purpose of this statement is to make it perfectly
428 clear that if a subject is injured while participating and it is not Pacific’s fault, then Pacific will not pay
429 for treatment or a penalty.
430
431 During your participation in this project it is important to understand that you are not a Pacific
432 University clinic patient or client, nor will you be receiving complete …medical care (or state the
433 appropriate kind of care, e.g., eye, mental health, physical therapy) care as a result of your
434 participation in this study. If you are injured during your participation in this study and it is not due to
435 negligence by Pacific University, the researchers, or any organization associated with the research,
436 you should not expect to receive compensation or medical care from Pacific University, the
437 researchers, or any organization associated with the study.
438
439 11. Voluntary nature of the study
440 Your decision whether or not to participate will not affect your current or future relations with Pacific
441 University and other collaborating agencies, if relevant. If you decide to participate, you are free to
442 not answer any question or withdraw at any time without prejudice or negative consequences. If you
443 choose to withdraw after beginning the study …explain how that will be managed, e.g., subject
444 compensation, what will happen to the subject’s data collected prior to withdrawal, etc.. If
445 investigators elect to deviate from the suggested language, it is essential that to clearly and fully
446 communicate the plan(s) to potential participants.
447
448 12. Contacts and questions
449 The researcher(s) will be happy to answer any questions you may have at any time during the
450 course of the study. If you are not satisfied with the answers you receive, please call Pacific
451 University’s Institutional Review Board, at (503) 352-1478 to discuss your questions or concerns
452 further. If you become injured in some way and feel it is related to your participation in this study,
453 please contact the investigators and/or the IRB office. All concerns and questions will be kept in
454 confidence.
455
456 13. Statement of consent
457 Modify as appropriate for your study. To add custom content, copy a line, paste into the appropriate
458 order and retype the needed text. Delete items as necessary. Blue text is mandatory. Red text is
459 meant to be illustrative.
460
Yes No
I am 18 years of age or over.
All my questions have been answered.
I have read and understand the description of my participation duties.
I have been offered a copy of this form to keep for my records.
I agree to participate in this study and understand that I may withdraw at any time
without consequence.
I give permission for the researcher(s) to gather photo/video data for analysis,
Pacific University IRB # 12
understanding that any published reports will not use my image(s) in any form.
I give permission for the researcher(s) to use (un/altered) images in published reports
that (do/do not) allow others to ascertain my identity.
I give permission for the researcher(s) to gather and use my genetic information only
for the purposes specifically delimited in this consent form.
I give permission for the researcher(s) to examine my case file, but to use only the
information specifically described above.
461
462
Participant’s signature Date
463
464
Principal investigator’s signature Date