1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
US MILITARY ACADEMY AT WEST POINT
WEST POINT, NY
This consent form is valid only if it contains the IRB stamped date
Consent for Voluntary Participation in a Non-Clinical Research Study Entitled:
“_______________________”.
Principal Investigator: Rank, Name, Corps, Service/Department, Phone number
Study site: __USMA __ OTHER (specify):
1. INTRODUCTION OF THE STUDY
You are being asked to be in this research study because…(Explain succinctly and simply
why the prospective subject is eligible to participate. Example: Because you are taking part in
the ShipShape Weight Management Program at USMA). Your participation is voluntary.
Refusal to participate will not result in any punishment or loss of benefits to which you are
otherwise permitted. Please read the information below, and ask questions about anything you
do not understand, before deciding whether to take part in the study.
2. PURPOSE OF THE STUDY
The purpose of the study is to learn about …. (State what the project is designed to discover
or establish).
Other studies have shown …. (Provide a brief explanation to support the need of conducting
this study).
3. PROCEDURES TO BE FOLLOWED
If you agree to be in this study, you will be asked to:
(Describe step-by-step everything the subjects will be asked to do or undergo as part of
the research study. Use lay language, short sentences and short paragraphs. Example: You
will be asked to complete a survey. State how long the survey will take to complete. Clearly
explain what procedures will be taken if a subject becomes upset. Define and explain medical
and scientific terms in ordinary language. For example, describe the amount of blood to be
drawn in terms of teaspoons or tablespoons.)
4. AMOUNT OF TIME FOR YOU TO COMPLETE THE STUDY
Study title:
Date:
PI Initials:
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
You will be part of this study for ___ (State the period of time the subject will participate
in the project (days, weeks, months or years). During this time you will be asked to visit x
times. Each visit will last approximately ____ (minutes, hours).
5. NUMBER OF PEOPLE WHO WILL TAKE PART IN THIS STUDY
A total of __ subjects are expected to take part in this study.
OR (If a multi-site study:)
This study is called a multi-site study because participants from several institutions will be in
the study. There will be up to ___ people taking part in this study at (e.g., ___USMA, at ____
Natick, at ____ Picatinny, etc.). A total of ____ people will be in the study from all of the
institutions involved.
6. POSSIBLE RISKS OR DISCOMFORTS FROM BEING IN THIS STUDY
The possible risks and discomforts from being in this research study include: (Identify each
intervention with a subheading and then describe any reasonable foreseeable risks, discomforts,
inconveniences, and how these will be managed. In addition to physiological risks/discomfort,
describe any psychological, social, legal, or financial risks that might result from participating
in the research.)
Model for protocols involving no risks:
There are no expected risks or discomforts from being in this study.
Model statement for protocols that include blood drawing as part of the research:
There will be some discomfort from having your blood drawn, and you may have swelling,
bruising or infection at the site of the needle stick. Some people feel dizzy or light-headed for a
few minutes after their blood is drawn.
Model language for protocols that may cause the potential for counseling:
If something in this research makes you uncomfortable or upset, you may choose to stop
taking part in this research at any time without loss of benefits; you may contact the investigator
for referral. If the investigator notes any distress or anxiety associated with the research, you
will be referred to ___________ (e.g., your primary care physician for help or professional
counselor)
Model statement for protocols that may affect a military career:
Study title:
Date:
PI Initials:
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
Divulgence of any illegal activities or sensitive information, such as drug use, is required to
be reported to your Commanding Officer, which may affect your military career.
7. POSSIBLE BENEFITS FROM BEING IN THIS STUDY
(If your study involves minors or use of surrogate consent, 10 USC 980 requires that the intent to
benefit each subject be addressed.)
You may benefit from this study because ________. The information we learn may help us
learn about _______________. (Add specific information; describe the anticipated benefits, if
any, to science or society, expected from the research.)
However, no benefit can be guaranteed.
OR
You will not benefit from taking part in this study, but the information we learn may help us
learn about
(Add specific information; describe the anticipated benefits, if any,
to science or society, expected from the research.)
8. CONFIDENTIALITY/PRIVACY OF YOUR IDENTITY AND YOUR RESEARCH
RECORDS
The principal investigator will keep your research records. These records may be looked at by
staff from [specify the name of the entities as appropriate for your study site. For example, state:
the KACH Institutional Review Board (IRB), the Army Human Protections Office, the US Military
Academy Human Protections Administrator, and other government agencies as part of their duties.
These duties include making sure that the research participants are protected. Confidentiality of
your records will be protected to the extent possible under existing regulations and laws but can not
be guaranteed. Complete confidentiality cannot be promised, particularly for military personnel,
because information bearing on your health may be required to be reported to appropriate medical or
command authorities. Your name will not appear in any published paper or presentation related to
this study.
(Unless a HIPAA Authorization is not required or waived by the institution review board, you
must include the following sentence and the Section 15 for HIPAA Authorization:)
This research study meets the confidentiality requirements of the Health Insurance
Portability and Accountability Act (HIPAA).
(If a Certificate of Confidentiality is required for an NIH study, use the following model
statement as appropriate for non-active duty participants only)
For this research study a Department of Health and Human Services (DHHS) Certificate of
Study title:
Date:
PI Initials:
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
Confidentiality is in place to protect your privacy such as your name or other identifying
information from being disclosed in any civil, criminal, administrative, legislative or other
proceedings, whether at the federal, state or local level. However, the researcher is not prevented
from the voluntary disclosure of matters such as child abuse, reportable communicable diseases
or a participant’s threatened violence to self or others. However, the Certificate of
Confidentiality does not apply to active duty subjects as it pertains to military command
authorities.
9. CONDITIONS UNDER WHICH YOUR PARTICIPATION IN THIS STUDY MAY BE
STOPPED WITHOUT YOUR CONSENT
Your taking part in this study may be stopped without your consent if remaining in the study
might be dangerous or harmful to you. Your taking part in this study may also be stopped
without your consent if the military mission requires it, or if you lose your right to receive
medical care at a military hospital. (Also include specific information that may cause a
subject’s participation to be stopped without their consent.)
10. ELIGIBILITY AND PAYMENT FOR BEING IN THIS STUDY
Please note that active duty may not be reimbursed for participating in the study except for
having blood drawn.
If subjects will not be paid for being in this study, please state:
You will not receive any payment for being in this study.
Otherwise, use one of the following model statements, as appropriate:
Models:
If you are eligible for care at military hospitals, but are not an active duty member of the
military, you will receive $__________ for being in this study.
AND/OR
If you are a Federal Government employee eligible for care at military hospitals, and you are
taking part in this study outside your normal duty hours, you will receive $__________ for being
in this study.
AND/OR
If you are an active duty member of the military and are having blood drawn outside of your
duty, you will receive _____ (up to $50.00) per blood draw for being in this study not to exceed
$250.00 (note: the maximum is required by NNMC)
Study title:
Date:
PI Initials:
178
179
180
181
182
183
184
11. COMPENSATION IF INJURED AND LIMITS TO MEDICAL CARE
Model:
You will not receive any compensation (payment) if you are injured as a direct result of
being in this study. You should discuss this issue thoroughly with the principal investigator
before you enroll in this study.
185
186
187
Should you be injured as a result of your participation in this study, you will be given
medical care for that injury at no cost to you.
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
Medical care is limited to the care normally allowed for Department of Defense health
care beneficiaries (patients eligible for care at military hospitals and clinics). Necessary medical
care does not include in-home care or nursing home care.
If at any time you believe you have suffered an injury or illness as a result of
participating in this research project, you should contact the Department of Clinical Investigation
at ___ (specify the name of the study institution) at ___________ (list the phone number).
12. COSTS THAT MAY RESULT FROM TAKING PART IN THIS STUDY
For USMA studies use the following sentence:
There is no charge to you for taking part in this study.
13. IF YOU DECIDE TO STOP TAKING PART IN THIS STUDY AND THE
INSTRUCTIONS FOR STOPPING EARLY
Model:
You have the right to withdraw from this study at any time. If you decide to stop taking
part in this study, you should tell the principal investigator as soon as possible; by leaving this
study at any time, you in no way risk losing your right to medical care.
14. YOUR RIGHTS IF YOU TAKE PART IN THIS STUDY
Taking part in this study is your choice. You may choose either to take part or not to take
part in the study. If you decide to take part in this study, you may leave the study at any time.
No matter what decision you make, there will be no penalty to you and you will not lose any of
your regular benefits. Leaving the study will not affect your medical care.
15. AUTHORIZATION FOR RESEARCH USE
It is possible that the results of this study will raise additional result questions. The deidentified data may be used for subsequent studies that have met the standards of the appropriate
Study title:
Date:
PI Initials:
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
institutional review board.
16. AUTHORIZATION FOR RESEARCH USE OF PROTECTED HEALTH
INFORMATION
The Federal Health Insurance Portability and Accountability Act (HIPAA) includes a
Privacy Rule that gives special safeguards to Protected Health Information (PHI) that is
identifiable, in other words, can be directly linked to you (for example, by your name, Social
Security Number, birth date, etc.). We are required to advise you how your PHI will be used.
(1). What information will be collected?
For this research study, we will be collecting information about… Example: your overall
health status, any side effects that you are experiencing, and how the medicines are affecting the
size of the tumors. List the PHI you will be collecting.
(2). Who may use your PHI within the Military Healthcare System?
The members of the research team will have access to your health information in order to
find out if you qualify to participate in this study, to administer research treatments, to monitor
your progress, and to analyze the research data. Additionally, your PHI may be made available
to health oversight groups such as the and the Keller Army Community Hospital (KACH)
Institutional Review Board (IRB) and the US Military Academy Human Protections
Administrator.
(Add other institution that is applicable.)
(3). What persons outside of the Military Healthcare System who are under the HIPAA
requirements will receive your PHI?
Examples: The Principal Investigator or designee will send your PHI to the CALGB Data
Coordinating Center at Duke University (or its successors) to be analyzed. The study sponsor
may need to do an audit of the research records. If you experience a complication, we may need
to send a copy of your medical record (with your name and other personal identifying
information blacked out) to the study sponsor.
(4). What is the purpose for using or disclosing your PHI?
a. The members of the research team need to use your PHI in order to analyze the
information to find out whether the drug we are testing is effective and to monitor your
safety.
b. For disclosures outside the DoD: Your blood sample, which will be labeled with your
initials, will be sent to the Tissue Bank at Ohio State University (or its successors) for
testing in accordance with the approved study.
Study title:
Date:
PI Initials:
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
(5). How long will the researchers keep your PHI?
The research team in the Cardiology Service will keep the research data for up to three
years after the end of the study. Then all the information will be destroyed. The master code will
be destroyed as soon as all data collection is completed. For a database or tissue banking study:
There is no expiration date.
(6). Can you review your own research information?
Examples:
a. If the research includes blinding research participants to their study group: You will not
be able to look at your research information until the study has ended.
b. If the research data was obtained from persons other than a health care provider under a
promise of confidentiality, and access to the data would likely reveal the source of the
information: You will not be able to look at your research information.
c. Other studies: You may look at your personal research information at any time.
(7). Can you cancel this Authorization?
Yes. If you cancel this Authorization, however, you will no longer be included in the
research study. The information we collected from you can be destroyed at your request.
If you want to cancel your Authorization, please contact the Principal Investigator in writing.
(8). What will happen if you decide not to grant this Authorization?
If you decide not to grant this Authorization, you will not be able to participate in this
research study. Refusal to grant this Authorization will not result in any loss of medical benefits
to which you are otherwise entitled.
(9). Can your PHI be disclosed to parties not included in this Authorization who are not
under the HIPAA requirements?
There is a potential that your research information will be shared with another party not
listed in this Authorization in order to meet legal or regulatory requirements. Examples of
persons who may access your PHI include representatives of the Army Human Protection Office.
Department of Health and Human Services (DHHS) Office for Human Research Protections
(OHRP), and the DHHS Office for Civil Rights. This disclosure is unlikely to occur, but in that
case, your health information would no longer be protected by the HIPAA Privacy Rule.
(10). Who should you contact if you have any complaints?
If you believe your privacy rights have been violated, you may file a written complaint
with the Human Protections Administrator, West Point, NY. Telephone: 845-938-7985.
.
Study title:
Date:
PI Initials:
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
Your signature at the end of this document acknowledges that you authorize USMA
personnel to use and disclose your Protected Health Information (PHI) collected about you for
research purposes as described above.
17. CONTACTS FOR QUESTIONS ABOUT THE STUDY
If you have questions about the study, or if you think you have a study-related injury you
should contact _____________ at _____________. For questions about your rights as a research
participant, contact the Human Protections Administrator, West Point, NY at (845)938-7385.
A copy of this consent form will be provided to you.
Study title:
Date:
PI Initials:
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
SIGNATURE OF RESEARCH PARTICIPANT OR LEGAL RESPRESENTATIVE
You have read (or someone has read to you) the information in this consent form. You
have been given a chance to ask questions and all of your questions have been answered to your
satisfaction.
BY SIGNING THIS CONSENT FORM, YOU FREELY AGREE TO TAKE PART IN
THE RESEARCH IT DESCRIBES.
________________________________
Subject’s Signature
______________
Date
________________________________
Subject’s Printed Name
SIGNATURE OF INVESTIGATOR
You have explained the research to the participant, or his/her legal representative, and
answered all of his/her questions. You believe that the volunteer subject understands the
information described in this document and freely consents to participate.
____________________________________________________________________
Investigator’s Signature
Date (must be the same as the participant’s)
_______________________________________
Investigator’s Printed Name
SIGNATURE OF WITNESS
Your signature as witness is intended to attest that the information in the consent document and
any other information was explained to and apparently understood by the participant, or the
participant’s legal representative, that questions and concerns were addressed and that informed
consent was freely given.
___________________________________________________________________
Witness’ Signature
Date (must be the same as the participant’s)
__________________________________
Witness’ Printed Name
Version 1 – USMA Biomedical July 2015
Study title:
Date:
PI Initials: