IRB Review of Million Veteran Program Michael Linke, PhD, CIP Physical Scientist, Veterans Affairs Medical Center-Cincinnati Chair, University of Cincinnati Institutional Review Board Chair, NIH StrokeNET Central Institutional Review Board
CRITERIA FOR APPROVAL The IRB must determine that all of the following requirements listed in 45 CFR 46.111, 21 CFR.56.111 and VHA HANDBOOK 1200.05 are satisfied. 1. Risks to participants are minimized 2. Risks to participants are reasonable in relation to the anticipated benefits 3. Selection of participants is equitable 4. Scientific or Scholarly Review by qualified individuals(s) has demonstrated that (a) the research uses procedures which are consistent with sound research design 5. The IRB should determine if the investigator has sufficient time to conduct and complete the research and that the investigator has adequate staff and other resources, including facilities, to conduct the research. 6. For VAMC research, non-veterans will only be allowed to enter VA-approved research studies when there are insufficient veterans available to complete the study. 7. Informed consent will be sought from each prospective participant or the participant's legally authorized representative 8. Informed consent will be appropriately documented 9. When appropriate, the protocol makes adequate provision for monitoring the data collected to ensure the safety of participants 10. When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. 11. When some or all of the participants are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
CRITERIA FOR APPROVAL The IRB must determine that all of the following requirements listed in 45 CFR 46.111, 21 CFR.56.111 and VHA HANDBOOK 1200.05 are satisfied. 1. Risks to participants are minimized 2. Risks to participants are reasonable in relation to the anticipated benefits 3. Selection of participants is equitable 4. Scientific or Scholarly Review by qualified individuals(s) has demonstrated that (a) the research uses procedures which are consistent with sound research design 5. The IRB should determine if the investigator has sufficient time to conduct and complete the research and that the investigator has adequate staff and other resources, including facilities, to conduct the research. 6. For VAMC research, non-veterans will only be allowed to enter VA-approved research studies when there are insufficient veterans available to complete the study. 7. Informed consent will be sought from each prospective participant or the participant's legally authorized representative 8. Informed consent will be appropriately documented 9. When appropriate, the protocol makes adequate provision for monitoring the data collected to ensure the safety of participants 10. When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. 11. When some or all of the participants are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects.
(1) Risks to participants are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk; and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
Minimization of Risks • Physical risks – Blood draws will be performed per standard procedures – Blood leftover from clinical samples may be used – Lifestyle survey is optional
Minimization of Risks • Risks related to breach of security • Electronic data encrypted • Hard copy information stored in a locked file cabinet • GINA • Samples stored in secure VA central repository • Use of study codes • Key stored securely with limited access • Individual results will not be shared with anyone outside of the study • Certificate of Confidentiality
Minimization of Risks – Minimization of Risks related to published results • Any talks or papers will not identify you
(2) Risks to participants are reasonable in relation to the anticipated benefits • Direct benefit to subjects • Importance of the knowledge that may be expected to result. • The IRB should consider only those risks and benefits that may result from the research
MVP Benefits • No direct benefit • Results may help researchers understand diseases, illnesses, and conditions • May result in better ways to prevent, detect, and treat diseases and illnesses • Ultimate goal is to improve Veterans healthcare
(7) Informed consent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with, and to the extent required by Common Rule (45 CFR 46.116 and 21 CRF 50.20, and 38 CFR 16.116)
Circumstances Under Which Informed Consent May Be Sought. The Common Rule requires (1) The investigator to seek informed consent only under circumstances that: (a) Provide the prospective subject sufficient opportunity to read the informed consent document when applicable, (b) Provide the prospective subject sufficient opportunity to consider whether or not to participate, and (c) Minimize the possibility of coercion or undue influence. (2) The information that is given to the subject must be in language understandable to the subject or the subject’s LAR. (3) No informed consent, whether oral or written, may include any exculpatory language through which the subject : (a) Is made to waive, or appear to waive, any of the subject's legal rights; or (b) Releases, or appears to release, the investigator, the sponsor, the institution, or its agents from liability for negligence
REQUIRED ELEMENTS OF INFORMED CONSENT (1) A Statement That the Study Involves Research (2) An Explanation of the Purposes of the Research (3) The Expected Duration of the Subject's Participation (4) A Description of the Procedures to be Followed (5) Experimental Procedures (6) Risks or Discomforts (7) Benefits (8) Alternatives (9) Confidentiality (10) Research-Related Injury (11) Contact Information (12) Participation is Voluntary
REQUIRED ELEMENTS OF INFORMED CONSENT (1) A Statement That the Study Involves Research (2) An Explanation of the Purposes of the Research (3) The Expected Duration of the Subject's Participation (4) A Description of the Procedures to be Followed (5) Experimental Procedures (6) Risks or Discomforts (7) Benefits (8) Alternatives (9) Confidentiality (10) Research-Related Injury (11) Contact Information (12) Participation is Voluntary
Developing a simplified consent form for biobanking . Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP. PLoS One. 2010 Oct 8;5(10):e13302. • information conveyed during the consent process that can be complex or controversial. 1. future research that is unspecified at the time of consent 2. indefinite storage 3. ongoing medical record access 4. contact for future research 5. large-scale data sharing 6. development of commercial products 7. privacy and confidentiality protections 8. participants' access to research results 9. the ability to discontinue participation
1. Future research that is unspecified at the time of consent “The sample will be used for future studies related to characteristics of health or any disease, illness, or condition.”
2. Indefinite storage “The blood will be stored at the VA Central Biorepository until it is used up or until it is no longer of scientific value, at which time it will be destroyed”
3. Ongoing medical record access “…we will obtain information from your medical records on an ongoing basis…so that we can follow your health and care for as long as you are alive”
4. Contact for future research “You may be contacted again in the future to determine your interest in participating in additional research. Potential research may include phone calls, surveys, in-person visits and/or providing another specimen. Your decision to participate in additional research is entirely voluntary.”
5. Large-scale data sharing “I give the VA permission to continue to take information from my medical records and add it to the VA Central Research Database”
6. Development of commercial products “…use of your samples may lead to inventions or discoveries that could become the basis for new products or treatments. These inventions, discoveries or products could become commercially valuable and be patented and licensed. Commercially available products could also be developed directly from your blood or DNA. However, the VA has no plans to share with you any profits from these inventions, discoveries or products.”
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