Example of a Consent Form

Research Submit Frame Brigham and Women’s Hospital Dana-Farber Cancer Institute Massachusetts Unconcealed Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Sum Protocol Title: Developmental Anatomy Genome Project (DGAP) Principal/Overall Investigator: Cynthia C. Morton, Ph. D. Site-Responsible Investigator(s)/Institution: James Gusella, Ph. D. /MGH Co-Investigator(s)/Study Staff: Drs. B Quade, A Ligon, R Maas, A Michelson, J Gusella, M MacDonald, E Lemyre, J Lewis Description of Material Population: Patients succeeding a while ingrained anomalies PURPOSE We would love submit to incorporate you as a alloticipant in a discovery con-over. The scope of this discovery is to authenticate and con-over genes complicated in cosmical crop. You own been asked to share in this discovery con-over consequently you (or your offshoot) own (or has) one or over cropal abnormalities and chromosomal abnormalities that own been bestow since family. Such chromosomal abnormalities may rend the exercise of genes required for regular product and crop. By authenticateing these genes in vulgar succeeding a while alloticular family defects, we longing to penetrate a main brains of how the cosmical association grows and develops. STUDY CONTACTS This con-over is entity unconfused by Dr. Cynthia C. Morton, who can be penetrateed at 617-732-7980 succeeding a while any questions you may own during the continuity of this con-over. If you incorporateed at the MGH, delight continuity Dr. James Gusella at 617-726-5724. PROCEDURES If you acquiesce to share, you conciliate donate a race specimen. The total of race inducen conciliate deviate succeeding a while age (close than 2 years old: encircling 1 tablespoon; ages 2-10 years: encircling 2 tablespoons; ages 11 years and up: encircling 2-4 tablespoons) and may be depressed for inferiorer living-souls. In unconcealed, succeeding you own donated race, cells or edifice specimens no added hospitalization or clinic visits conciliate be required for you to share in this con-over. Any of the specimens you donate conciliate be used to fir an permanent cell cord. This instrument that an incessant minister of DNA conciliate be suited for genetic discovery. DNA is the genetic embodied from which genes are made. These specimens may be stored/banked for advenient use and/or shared succeeding a while other investigators associated succeeding a while this con-over. These stored or groupd specimens conciliate NOT be labeled succeeding a while your betoken. Do you acquiesce to this (delight dispersion one excellent): Page 1 of 5 Material Population: Patients succeeding a while ingrained anomalies IRB Protocol Number: 1999P-003090 98-09233 Surety Protocol Number: N/A Submit Frame Approval Date: DECEMBER 9, 1999 Amendment Sum Approved: N/A IRB Expiration Date: Amendment Approval Date: N/A NOVEMBER 22, 2000 Discovery Submit Frame Brigham and Women’s Hospital Dana-Farber Cancer Institute Massachusetts Unconcealed Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Sum YES NO You may be continuityed in the advenient and asked for added specimens to live discovery. If you do not longing to be continuityed in the advenient, you may betoken this beneath: YES, okay to continuity NO, do not continuity As mentioned aloft, specimens that are sent to the discovery laboratory conciliate be assigned a jurisprudence sum. The key to this jurisprudence conciliate be preserveed in locked rasps by Dr. Cynthia Morton, and your (or your offshoot's) unity conciliate not be biblical to anyassociation other than your referring physician. Important non-identifying notice such as sex, age, and species of your cropal abnormality conciliate be epidemic to the discovery laboratory in dispose to correlate con-over effects succeeding a while alloticular cropal problems. The notice conquered from this con-over of your donated race or edifice is not public to be helpful clinically or symptomally at this date. The discovery is currently helpful solely as a instrument of brains genes and cropal abnormalities. Results from these genetic studies conciliate NOT be settled in your (or your offshoot's) medical archives. We conciliate not attach these effects instantly to you; con-over effects conciliate be released to your referring physician. COSTS No jaw conciliate be mandibleed to your coverion gang or to you for this con-over. You should be trusting that no jaw for the race induce are to be raspd succeeding a while your coverion gang. If the individual who induces your race intends to mandible you, you should pay for this yourself and despatch a vision of the mandible to the investigator who conciliate indemnify you. RISKS AND DISCOMFORTS There are unimportant risks and discomforts associated succeeding a while race sampling. This includes a inconsiderable total of affliction and maybe a inferior buffet at the needle plight. Occasionally a individual impresss half-hearted when his/her race is inducen. Rarely an corruption develops, but if this occurs the corruption can be entertained. Disclotrusting of Con-over Results Notice encircling your competition in a genetic con-over may govern coverion and/or employers concerning your heartiness foundation. We conciliate use frequent safeguards to thwart unintentional disclosure: I) notice encircling your competition in, and the effects of, this discovery conciliate NOT be settled in your medical archivess, II) discovery axioms (including axioms unmoved from medical charts) conciliate be entered solely into a discovery axiomsbase. No betokens conciliate be entered into this axiomsbase, solely the jurisprudences assigned to submitted specimens. Other investigators conciliate NOT be dedicated a key to this jurisprudence, and III) NO effects from this con-over conciliate be released to anyone other than your referring physician. You can so minimize these risks by not sharing succeeding a while others the circumstance that you own shared in genetic studies. Page 2 of 5 Material Population: Patients succeeding a while ingrained anomalies IRB Protocol Number: 1999P-003090 98-09233 Surety Protocol Number: N/A Submit Frame Approval Date: DECEMBER 9, 1999 Amendment Sum Approved: N/A IRB Expiration Date: Amendment Approval Date: N/A NOVEMBER 22, 2000 Discovery Submit Frame Brigham and Women’s Hospital Dana-Farber Cancer Institute Massachusetts Unconcealed Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Number These studies are for discovery scopes solely. Therefore, NO con-over effects conciliate be attachd to you at any date. However, in the issue that this discovery con-over uncovers notice that we impress MAY application your heartinesscaution (either categorically or negatively), we conciliate remove this notice to your physician. Succeeding the practicable sagacity of such effects has been explained to you by your physician, you conciliate be offered an opening to conquer rebellious symptom assent of this discovery finding in a laboratory which extraordinaryizes in this character of clinical criterioning. This symptom criterioning conciliate ONLY captivate settle IF you yield added submit for it. Solely the effect of the substantiateatory criterion would be entered into your medical archives by the symptom laboratory or your physician. BENEFITS At this date, we perceive of no trodden avail to you (or your offshoot) as a effect of competition in this discovery con-over. Competition is thoroughly intentional and your choice is to not share. Other living-souls may avail in the advenient if these studies yield helpful notice encircling authenticateing or entertaining cropal abnormalities. ALTERNATIVES You are unhindered to share or not to share in this con-over. If you prefer not to share, your medical caution and composition conciliate NOT be monstrous. Page 3 of 5 Material Population: Patients succeeding a while ingrained anomalies IRB Protocol Number: 1999P-003090 98-09233 Surety Protocol Number: N/A Submit Frame Approval Date: DECEMBER 9, 1999 Amendment Sum Approved: N/A IRB Expiration Date: Amendment Approval Date: N/A NOVEMBER 22, 2000 Discovery Submit Frame Brigham and Women’s Hospital Dana-Farber Cancer Institute Massachusetts Unconcealed Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Sum THE FOLLOWING PARAGRAPHS CONTAIN STANDARD INFORMATION WHICH GENERALLY APPLIES TO PERSONS INVOLVED IN A RESEARCH STUDY AND ARE REQUIRED ON ALL CONSENT FORMS. CONFIDENTIALITY Medical notice done by this con-over conciliate behove allot of your hospital medical archives, unclose alloticularally recurrent otherwise in this submit frame. Notice that does not behove allot of your medical archives conciliate be stored in the investigator’s rasp and authorized by a jurisprudence sum solely. The jurisprudence key connecting your betoken to alloticular notice encircling you conciliate be kept in a disjoined, fasten location. Your medical archives is suited to heartiness caution professionals at Brigham and Women’s Hospital (BWH), Dana-Farber Cancer Institute (DFCI), or Massachusetts Unconcealed Hospital (MGH), confusedly designated the “Hospitals”, and may be reviewed by embezzle Hospital staff members in the continuity of carrying out their duties; so-far, they are required to pconstraint confidentiality in harmony succeeding a while useful laws and the policies of the Hospitals. Information contained in your archivess may not be dedicated to anyone unaffiliated succeeding a while the Hospitals in a frame that could authenticate you succeeding a whileout your written submit, bar as handleing in this submit frame or as required by law. It is practicable that your medical and discovery archives, including perceptive notice and/or authenticateing notice, may be inspected and/or copied by the con-over surety (and/or its sovereign), the Food and Drug Administration (FDA), federal or specify synod agencies, or hospital accrediting agencies, in the continuity of carrying out their duties. If your archives is inspected or copied by the con-over surety (and/or its sovereigns), or by any of these agencies, the Hospitals conciliate use serious efforts to cover your seclusion and the confidentiality of your medical notice. The effects of this con-over may be published in a medical dimensions or journal or used for education scopes. However, your betoken or other identifiers conciliate not be used in any promulgation or education embodieds succeeding a whileout your alloticular submit. In restitution, if photographs, audiotapes or videotapes were captivaten during the con-over that could authenticate you, then you must afford extraordinary written submit for their use. In that contingency, you conciliate be dedicated the opening to end or attend, as useful, to the photographs, audiotapes or videotapes precedently you afford your submit for their use if you so supplicate. REQUEST FOR MORE INFORMATION You may ask over questions encircling the con-over at any date. The investigator(s) conciliate yield their telephone sum so that they are suited to reply your questions or concerns encircling the con-over. You conciliate be cognizant of any telling new findings discovered during the continuity of this con-over that capacity govern your lived competition. If during the con-over or following, you longing to debate your equitables as a discovery material, your competition in the con-over and/or concerns encircling the con-over, a discovery-related defective succeeding a while someone not instantly complicated in the con-over, or if you impress underneathneath any prestrusting to incorporate in this con-over or to live to share in this con-over, you are asked to continuity a delegated-to-others of the Cosmical Discovery Committees at BWH (617) 732-7200, at MGH (617) 726-3493, or at the Protocol Administration Office at DFCI (617) 632-3029. A vision of this submit frame conciliate be dedicated to you to adhere-to. Page 4 of 5 Material Population: Patients succeeding a while ingrained anomalies IRB Protocol Number: 1999P-003090 98-09233 Surety Protocol Number: N/A Submit Frame Approval Date: DECEMBER 9, 1999 Amendment Sum Approved: N/A IRB Expiration Date: Amendment Approval Date: N/A NOVEMBER 22, 2000 Discovery Submit Frame Brigham and Women’s Hospital Dana-Farber Cancer Institute Massachusetts Unconcealed Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Sum REFUSAL OR WITHDRAWAL OF PARTICIPATION Competition in this con-over is intentional. You do not own to share in this con-over. Your bestow or advenient caution conciliate not be monstrous should you prefer not to share. If you determine to share, you can fluctuate your recollection and fall out of the con-over at any date succeeding a whileout important your bestow or advenient caution in the Hospitals. In restitution, the schoolman in attack of this con-over may determine to end your competition in this con-over at any date succeeding he/she has explained the reasons for doing so and has helped group for your lived caution by your own schoolman, if needed. INJURY STATEMENT If you are injured during the continuity of the con-over and as a trodden effect of this con-over, you should continuity the investigator at the sum yieldd. You conciliate be offered the inevitable caution to entertain that defective. This caution does not suggest any defect or wrong-doing on the allot of the Hospitals or the schoolman(s) complicated. Where useful, the Hospitals constraint the equitable to mandible third alloty payers for services you take for the defective. The Hospitals conciliate not yield you succeeding a while any added amercement for such injuries. SIGNATURE I substantiate that the scope of the discovery, the con-over procedures and the practicable risks and discomforts as polite as practicable avails that I may trial own been explained to me. Alternatives to my competition in the con-over so own been debateed. All my questions own been replyed. I own learn this submit frame. My sigspecies beneath betokens my conciliateingness to share in this con-over. Subject/Patient Date Witness/Advocate/Minor/Legal Guardian (if required) Date Added Sigspecies (if required)(authenticate relationship to material) Date I own explained the scope of the discovery, the con-over procedures, authenticateing those that are investigational, the practicable risks and discomforts as polite as practicable avails and own replyed any questions concerning the con-over to the best of my force. Study Delegated-to-others Date Investigator Complete This Notice At Enrollment for HEMATOLOGY/ONCOLOGY PROTOCOLS ONLY (A vision of this frame should be faxed to the QCC and to the embezzle Medical Records) Primary Caution Physician’s Name: Date protocol composition begins for this material: Diagnosis: Page 5 of 5 Material Population: Patients succeeding a while ingrained anomalies IRB Protocol Number: 1999P-003090 98-09233 Surety Protocol Number: N/A Submit Frame Approval Date: DECEMBER 9, 1999 Amendment Sum Approved: N/A IRB Expiration Date: Amendment Approval Date: N/A NOVEMBER 22, 2000