1 NOTE: A) Use this consent form template for a tissue/blood/bone marrow banking
2 study. B) Use lay terms (6th to 8th grade language). C) Add a participant initial and
3 date line on the bottom of each page. D) Delete this „Note‟ and italicized examples.
4 E) Submit one consent form with the line numbers and one without the line numbers.
5 (*“Until WRNMMC” exists and a unified DCI and standard operating procedures are
6 established, refer to each PI‟s site institution. Modify “WRNMMC” to your institution‟s name
7 and follow its policies that govern the review and approval process and the appropriate consent
8 form required by the institution. For example, for WRAMC, you will need to cut and paste the
9 text, starting at “Introduction”, onto DA FORM 5303-R, May 89 for the official copy.)
11 WALTER REED NATIONAL MILITARY MEDICAL CENTER
12 BETHESDA, MARYLAND
14 This Specimen banking consent form is valid only if it contains the IRB stamped
17 Consent for Voluntary Participation in a Specimen Banking Study Entitled:
21 Principal Investigator: Rank, Name, Corps, Service/Department, Phone number
24 Study site: __ NNMC, __ MGMC, __WRAMC, __USUHS
26 1. INTRODUCTION OF THE STUDY
27 You are being asked to be in this specimen banking study because you have been
28 diagnosed with _________________ and we would like to store some of your (blood
29 and/or tissue; specifically identify what you are collecting) for future research. Your
30 participation is voluntary. Refusal to participate will not result in any penalty or loss of
31 benefits to which you are otherwise entitled.
33 Please read the information below, and ask questions about anything you do not
34 understand, before deciding whether to take part in the study.
36 2. PURPOSE OF THE STUDY
38 The purpose of the study is to collect and store (blood and/or tissue/bone marrow
39 samples, specifically identify what you are collecting) from people who have
40 _______________ for future research studies.
42 (Provide the scope of the future research here as appropriate.)
44 3. PROCEDURES TO BE FOLLOWED
47 If the blood/tissue banking request will store the left over specimens from a primary
48 research study or during the routine clinical procedure:
50 The (blood and/or tissue) samples that will be stored are left over from specimens
51 that will be taken as part of your routine medical care or as part of your treatment study.
52 At this time, it is impossible to name all the kinds of research studies for which
53 researchers may want to use your (blood and/or tissue).
57 If the blood/tissue banking request will procure additional blood/tissue specimens from a
58 primary research study or during the routine clinical procedure:
60 The (blood and/or tissue) samples that will be stored are taken for the purpose of
61 this study. (Please note that since blood/tissue that will be stored is obtained for the
62 purpose of research, any procedures that involve procuring the blood/tissue specimens
63 must be explained, and any associated risks must be listed in section 7.)
65 (As appropriate, describe the amount of blood in teaspoon and/or the size of
66 tissue to be collected.)
68 Any future research done on your stored (blood and/or tissue) must be approved
69 by a committee called an Institutional Review Board (IRB). The IRB is a group of
70 people who review research studies in order to protect the rights and welfare of research
71 subjects like you. The IRB of (specify the institution of the IRB as appropriate) will
72 determine that the research is done according to acceptable standards. They will also
73 determine if we need to contact you and ask your permission for specific future research
74 studies using your stored specimens.
76 The choice to let the researchers keep the (blood and/or tissue) samples for future
77 research is up to you. No matter what you decide to do, it will not affect your medical
78 care. If you decide now that your (blood and/or tissue) samples can be kept for research,
79 you can change your mind at any time.
81 Your (blood and/or tissue) samples will only be used for research and will not be
82 sold. The research done with your samples may help to develop new products in the
83 future, or may be used to establish a cell line that could be patented and licensed. There
84 are no plans to pay you should this occur.
86 4. IDENTIFICATION OF YOUR BLOOD AND/OR TISSUE SAMPLES, HOW
87 AND WHERE THEY WILL BE STORED AND WHO WILL HAVE ACCESS TO
88 YOUR SAMPLES
90 Your (blood and/or tissue) samples will be identified by ___________ (clearly
91 state how sample containers will be identified; e.g. by a code, not by your name or social
92 security number, or sponsor’s social security number; if maintaining a link to the patient,
93 clearly state) and stored in a “blood and/or tissue bank” in the _____________ (e.g.
94 Department of Pathology at the WRNMMC).
96 No third party, including relatives and personal physicians, will have access to the
97 stored samples without written consent from you. Only the principal investigator and
98 associate investigator(s) will have access to the stored samples. However, your de-
99 identified samples may be shared and used by other researchers who are collaborating
100 with the primary investigator in an IRB approved research. Any remaining blood/tissue
101 will be (returned to the principal investigator for re-banking, or be destroyed at the
102 collaborator site, or ….).
104 5. AMOUNT OF TIME FOR YOU TO COMPLETE THIS STUDY
106 You will actively take part in this study whenever your samples are being
107 collected (specify the time line). Your samples will be stored in the bank until they are no
108 longer needed for research, or until you request removal of your samples from the (blood
109 and/or tissue) bank. Removal of your samples from the bank must be requested in
110 writing to the researcher at the address at the end of this consent form.
112 6. NUMBER OF PEOPLE THAT WILL TAKE PART IN THIS STUDY
114 A total of up to _________ subjects are expected to take part in this study.
118 (If a multi-site study)
120 This study is called a multi-site study because participants from several hospitals
121 will be in the study. There will be up to ___ people taking part in this study at (e.g., ____
122 WRAMC, at ____ NNMC, at ____ MGMC, etc.). A total of ____ people will be in the
123 study from all of the hospitals involved.
126 7. POSSIBLE RISKS OR DISCOMFORTS FROM BEING IN THIS STUDY
128 If you procure additional blood specimens from a primary research study or from the
129 routine clinical procedure, specify any additional risks.
132 There may be some discomfort from drawing blood, and you may have pain,
133 swelling and a bruise at the site of the needle stick. Some people feel dizzy or light-
134 headed for a few minutes after blood is drawn.
138 Donating your (blood and/or tissue) for future research may have no risk.
139 However, a possible risk is that your confidentiality may be broken resulting in the
140 release of information that links your name with the results obtained from research
141 performed on your (blood and/or tissue) samples. Although the chances of this
142 happening are very small, several adverse events could occur as a consequence of this.
143 These include denial of insurance or employment, higher insurance rates, mental stress to
144 you or your family members, and other social discomforts and inconveniences. These
145 risks can impact the mental state of both you and your family members, which could
146 require counseling.
148 8. POSSIBLE BENEFITS FROM BEING IN THIS STUDY
150 You will not benefit directly from being in this (blood and/or tissue) banking
151 study, but the possible benefits of future research from your (blood/and or tissue) include
152 learning more about what causes ____________ and other diseases, how to prevent them
153 and how to treat them.
155 9. CONFIDENTIALITY/PRIVACY OF YOUR IDENTITY AND YOUR
156 RESEARCH RECORDS
158 The principal investigator will keep your research records in a secured and locked place.
159 These records may be looked at by staff from [specify the name of the entities as appropriate
160 for your study site. For example, if WRAMC studies, state: the Walter Reed Department of
161 Clinical Investigation, the Walter Reed Human Use Committee (HUC), the Army Clinical
162 Investigation Regulatory Office (CIRO)], Department of Clinical Investigation, and the
163 Institutional Review Board (IRB), and other government agencies as part of their duties.
164 These duties include making sure that the research participants are protected. Confidentiality
165 of your records will be protected to the extent possible under existing regulations and laws
166 but can not be guaranteed. Complete confidentiality cannot be promised, particularly for
167 military personnel, because information bearing on your health may be required to be
168 reported to appropriate medical or command authorities. Your name will not appear in any
169 published paper or presentation related to this study.
172 Your (blood/and or tissue) will be identified by _________________ (clearly
173 state how samples will be identified; e.g. by a code, not by your name or social security
174 number, or sponsor’s social security number; if maintaining a link to the patient, clearly
175 state how confidentiality will be maintained).
177 This research study meets the confidentiality requirements of the Health Insurance
178 Portability and Accountability Act (HIPAA). A HIPAA Authorization form for this
179 study will be provided to you separately, and you will be asked to sign that form.
181 (If a Certificate of Confidentiality is required for an NIH study, use the following model
182 statement as appropriate for non-active duty participants only:)
184 For this research study a Department of Health and Human Services (DHHS)
185 Certificate of Confidentiality is in place to protect your privacy by not disclosing your
186 name or other identifying information from being disclosed in any civil, criminal,
187 administrative, legislative or other proceedings, whether at the federal, state or local
188 level. However, the researcher is not prevented from the voluntary disclosure of matters
189 such as child abuse, reportable communicable diseases or a participant’s threatened
190 violence to self or others. The Certificate of Confidentiality does not apply to active duty
191 subjects as it pertains to military command authorities.
193 10. CONDITIONS UNDER WHICH YOUR PARTICIPATION IN THIS STUDY
194 MAY BE STOPPED WITHOUT YOUR CONSENT
196 Your taking part in this study may be stopped without your consent if remaining
197 in the study might be dangerous or harmful to you. Your taking part in this study may
198 also be stopped without your consent if the military mission requires it, or if you lose
199 your right to receive medical care at a military hospital.
201 11. ELIGIBILITY AND PAYMENT FOR BEING IN THIS STUDY
203 You will not receive any payment for being in this study.
205 12. COMPENSATION TO YOU IF INJURED AND LIMITS TO YOUR
206 MEDICAL CARE
208 You will not receive any compensation (payment) should you be injured as a direct
209 result of being in this study. You should understand that this is not a waiver or release of
210 your legal rights. You should discuss this issue thoroughly with the principal investigator
211 before you enroll in this study.
212 Medical care is limited to the care normally allowed for Department of Defense
213 health care beneficiaries (patients eligible for care at military hospitals and clinics).
214 Necessary medical care does not include in-home care or nursing home care.
217 13. COSTS THAT MAY RESULT FROM TAKING PART IN THIS STUDY
221 For WRAMC and NNMC studies use the following sentence:
223 There is no charge to you for taking part in this study.
227 The additional cost to you for taking part in this study is $____________
228 for _________.
232 14. IF YOU DECIDE TO STOP TAKING PART IN THIS STUDY AND THE
233 INSTRUCTIONS FOR STOPPING EARLY
235 You have the right to withdraw from this study at any time. This can be done by
236 contacting the principal investigator, or the principal investigator’s designee, at the phone
237 number in section 17 of this consent form. You may request that your sample be
238 destroyed or that your identification be removed without destroying the sample. This
239 request should be done in writing to the address at the end of this consent form; by
240 leaving the study at any time, you in no way risk losing your right to medical care.
242 15. RESEARCH RESULTS
243 (If the results will not be provided to the participant state this and explain why):
245 The results from tests that may be done on the (blood and/or tissue) that you
246 donate for future research will not be given to your or to your doctor, even if you ask that
247 this be done and the results will not become part of your hospital medical record because
248 these tests will be done for research purposes only. (If the subject or his or her doctor will
249 have access to research results, then describe the circumstances of this access and the
250 potential implications, benefits and risks. When applicable, discuss the need for genetic
251 or psychological counseling before or after the study.)
255 Your individual testing results that may be done on the (blood and/or tissue) that
256 you donate for future research will not be released to any third party, including family
257 members, personal physicians, insurers or employers, under any circumstance unless
258 required by law.
260 (If the results are to be disclosed, indicate at what point in the research that the findings
261 will be disclosed, who will disseminate the information, and what supports are available
262 after the subject is provided this information, especially when the results may cause
263 adverse effects.)
265 16. YOUR RIGHTS IF YOU TAKE PART IN THIS STUDY
267 Taking part in this study is your choice. You may choose either to take part or not to
268 take part in the study. If you decide to take part in this study, you may leave the study at
269 any time. No matter what decision you make, there will be no penalty to you and you
270 will not lose any of your regular benefits. Leaving the study will not affect your medical
276 17. CONTACTS FOR QUESTIONS ABOUT THE STUDY
278 If you have questions about the study, or if you think you have a study-related
279 injury you should contact _____________ at _____________. For questions about your
280 rights as a research participant, contact the Department of Clinical Investigation at
281 __________________________ (location and phone #) or Staff Judge Advocate Office
282 at ____________________________________ (location and phone #).
286 18. OTHER RESEARCH FOR WHICH YOUR BLOOD AND/OR TISSUE
287 SAMPLES TAKEN DURING THIS STUDY COULD BE USED
289 Please read carefully each sentence below and think about your choices. After
290 reading each sentence, circle “yes” or “no”, include the date and your initials. If you
291 have any questions please talk to your doctor
293 Model (Add the model below if tissue and/or blood collection are research procedures
294 that are part of an add-on study within a primary study):
296 Remember, no matter what you decide to do about the storage and future use of
297 your (blood and/or tissue) samples, you may still take part in ____________________
298 (provide the protocol number and title of the primary research study).
300 BY SIGNING THIS FORM, YOU ARE AGREEING THAT:
302 a. Your following human biological samples may be kept in a bank for use in future
303 research to learn about, prevent, detect, or treat ________________. (Specify as many
304 options as you are collecting.)
306 (1) Blood: YES NO Participant’s Initials _____ Date _______
310 (2) Tissue: YES NO Participant’s Initials _____ Date _______
314 (3) Bone marrow: YES NO Participant’s Initials _____ Date _______
317 b. Your following human biological samples may be used for research about other health
318 problems (for example: causes of heart disease, cancer, diabetes).
320 (1) Blood: YES NO Participant’s Initials _____ Date _______
324 (2) Tissue: YES NO Participant’s Initials _____ Date _______
328 (3) Bone marrow: YES NO Participant’s Initials _____ Date _______
331 (Use only for studies involving genetic testing)
332 c. Your following human biological samples may be used for research involving genetic
333 studies to learn about whether certain genes relate to ____ (name the type of disease that
334 you are interested in researching.)
336 (1) Blood: YES NO Participant’s Initials _____ Date _______
340 (2) Tissue: YES NO Participant’s Initials _____ Date _______
344 (3) Bone marrow: YES NO Participant’s Initials _____ Date _______
347 d. The principal investigator (or someone he or she chooses) may contact you in the
348 future to ask you to take part in future research.
350 YES NO Participant’s Initials ______ Date ________
353 End the consent form with the following:
355 A copy of this consent form will be provided to you.
358 SIGNATURE OF RESEARCH SUBJECT OR LEGAL RESPRESENTATIVE
359 You have read (or someone has read to you) the information in this consent form. You
360 have been given a chance to ask questions and all of your questions have been answered
361 to your satisfaction.
363 BY SIGNING THIS CONSENT FORM, YOU FREELY AGREE TO TAKE PART
364 IN THE RESEARCH IT DESCRIBES.
367 ________________________________ ______________
368 Participant’s Signature Date
371 Participant’s Printed Name
375 SIGNATURE OF INVESTIGATOR
376 You have explained the research to the volunteer, or his/her legal representative, and
377 answered all of his/her questions. You believe that the volunteer subject understands the
378 information described in this document and freely consents to participate.
382 Investigator’s Signature Date (must be the same as the participant’s)
386 Investigator’s Printed Name
389 SIGNATURE OF WITNESS
390 Your signature as witness is intended to attest that the information in the consent
391 document and any other information was explained to and apparently understood by the
392 participant, or the participant’s legal representative, that questions and concerns were
393 addressed and that informed consent was freely given.
397 Witness’ Signature Date (must be the same as the participant’s)
401 Witness’ Printed Name
406 Version - WRNMMC Specimen banking CF 26 Nov 07.doc