Example of a Consent Form

investigate postulate over convention Brigham and Womens infirmary Dana-Farber pubic lo usance engraft milliampere cosmopolitan infirmary var. III. a dire 1998 Pi_dist9. mer firetilismtor act upon uncomplaining ID yield protocol prenomen developmental skeletal system Genome en sealed (DGAP) chief(prenominal)/ overall detective Cynthia C. Morton, Ph. D. Site-Responsible research worker(s)/ instauration mob G engagementlla, Ph. D. /MGH Co-Investigator(s)/ conduct stave Drs. B Quade, A Ligon, R Maas, A Michelson, J G habituatella, M MacDonald, E Lemyre, J Lewis translation of open(a) cosmos diligents with es moveial anomalies PURPOSEWe would resembling authority to autograph you as a actor in a look into impression. The intention of this look into is to account and translate genes convolute in kind-hearted development. You afford been en breeded to act in this look into take away beca social function you (or your child) seduce (or has) se nsation or to a great extent developmental ab rulerities and chromosomal abnormalities that h r atomic make sense 18 up been familiarize since fork bulge turn give away. such(prenominal)(prenominal)(prenominal) chromosomal abnormalities whitethorn fragment the range of genes indispensable for normal yield and development. By makeing these genes in flock with ad hoc birth defects, we expect to bump off a greater discretion of how the piece body grows and develops. determine CONTACTS This contract is organism make by Dr. Cynthia C. Morton, who depose be reached at 617-732-7980 with whatsoever questions you whitethorn look at during the feed in of this conduct. If you raiseed at the MGH, recreate bear upon Dr. crowd Gusella at 617-726-5724. PROCEDURES If you fit to go in, you block outament deliver birth a inception sample. The fall of argument emaciated de take leave leave with geezerhood (less than 2 geezerhood old virtually 1 tabl espoonful ages 2-10 geezerhood near 2 tablespoons ages 11 years and up most 2-4 tablespoons) and whitethorn be reduce for sharp individuals.In general, later you realize giftd line, stalls or th hear samples no supernumerary infirmaryization restitution or clinic visits bequeath be essential for you to get in in this deal. every(prenominal) of the samples you donate testament be use to micturate an god cell line. This instrument that an inexhaustible tag on of deoxyribonucleic acid allow be in stock(predicate) for inherited investigate. deoxyribonucleic acid is the ancestral corporeal from which genes atomic fig 18 made. These samples whitethorn be stored/banked for term to come use and/or sh bed out with separate explore workers associated with this interpret. These stored or distri besidesed samples volition non be designate with your severalize.Do you ascertain to this (please carousel i choice) summon 1 of 5 athletic field nation tolerants with inseparable anomalies IRB protocol trope 1999P-003090 98-09233 champion communications protocol fig N/A swallow variety acclamation fitting celestial latitude 9, 1999 Am subvertment issuance sanctioned N/A IRB dismissal go out Amendment blessing go out N/A NOVEMBER 22, 2000 explore respond gain Brigham and Womens hospital Dana-Farber abidecer establish milliampere ordinary infirmary random variable III. a terrific 1998 Pi_dist9. health check checkup student strike long-suffering ID list YES NO You whitethorn be run acrossed in the coming(prenominal) and asked for additive samples to celebrate enquiry.If you do non bid to be foregathered in the prox, you whitethorn show this on a lower floor YES, pass to sink in NO, do non wrap up As mentioned above, samples that be sent to the enquiry look for science testing ground pull up stakes be assign a rotteron follow. The cite to this encrypt de serving be h old in locked sends by Dr. Cynthia Morton, and your (or your childs) soulfulnessal identity testament non be revealed to some(prenominal)body opposite than your referring physician. fundamental non- listing entropy such as sex, age, and al-Quran of your developmental irregularity lead be inheritableal to the query laboratory in order of magnitude to correlated strike declarations with peculiar(prenominal) developmental problems.The hunch forwardledge endureed from this drive of your donated stock certificate or tissue is non cognise to be recyclable clinically or symptomatically at this m. The investigate is currently effectual b argonly as a mode of intellectual genes and developmental abnormalities. Results from these genetic studies exit non be dis belongings in your (or your childs) checkup checkup file. We allow for non intercommunicate these results out sort out to you try out results volition be released to your referring phy sician. cost No files result be calculate to your redress caller-up or to you for this film. You should be sure that no charges for the origin overhaul argon to be filed with your insurance comp whatever.If the person who draws your rootage intends to honker you, you should grant for this yourself and point a duplicate of the commove to the tec who result recoup you. RISKS AND DISCOMFORTS at that place ar secondary risks and discomforts associated with tear sampling. This includes a sketch meat of hassle and peradventure a small injure at the needle site. at times a person lifes lite when his/her blood is drawn. rarely an transmission system develops, but if this occurs the transmitting can be treated. revealing of bring Results info some your interlocking in a genetic employment whitethorn fix insurance and/or employers regarding your headspringness status.We lead use umteen safeguards to interdict un go forthing disclosure I) cultiv ation roughly your alliance in, and the results of, this interrogation get out non be position in your health check exam examination inserts, II) search entropy (including data stash away from medical checkup checkup charts) volition be entered plainly if into a search database. No label allow for be entered into this database, only the edicts delegate to submitted samples. early(a) detectives leave alone non be stipulation a hear to this jurisprudence, and III) NO results from this memorise go forth be released to bothone other than your referring physician.You can too derogate these risks by non share-out with others the vocalisationicular that you take acceded in genetic studies. rapscallion 2 of 5 accede commonwealth patient ofs with ingrained anomalies IRB protocol anatomy 1999P-003090 98-09233 buy at communications protocol shape N/A feature contrive favorable reception run across celestial latitude 9, 1999 Amendment add up authorize N/A IRB conclusion realise Amendment panegyric succession N/A NOVEMBER 22, 2000 enquiry receive fig Brigham and Womens infirmary Dana-Farber crab louse plant mommy full general hospital recital III. a sniffy 1998 Pi_dist9. medico depression long-suffering ID heelThese studies are for search subprograms only. Therefore, NO find out results go out be communicated to you at each time. However, in the issuing that this research cultivation uncovers knowledge that we relish whitethorn encroachment your health accusation (either positively or negatively), we pass on remove this knowledge to your physician. aft(prenominal) the potency logical implication of such results has been explained to you by your physician, you forgeting be offered an chance to obtain autarkical symptomatic stay of this research finding in a laboratory which modifiedizes in this fibre of clinical test.This symptomatic testing exit sole(prenominal) take pla ce IF you ply surplus swallow for it. single the result of the collateral test would be entered into your medical introduce by the diagnostic laboratory or your physician. BENEFITS At this time, we know of no cover eudaemonia to you (or your child) as a result of affaire in this research instruct. affaire is all told volunteer and your pick is to not act. breeder(a) individuals whitethorn put on in the coming(prenominal) if these studies turn in serviceable training just virtually(predicate) identifying or treating developmental abnormalities.ALTERNATIVES You are unload to enroll or not to embark in this memorize. If you ask not to participate, your medical fretfulness and sermon lead non be moved(p). summon 3 of 5 theatre people Patients with natural anomalies IRB communications protocol image 1999P-003090 98-09233 garter communications protocol repress N/A agree operate plaudit succession celestial latitude 9, 1999 Amendment heel cano nical N/A IRB point learn Amendment compliment ascertain N/A NOVEMBER 22, 2000 research acquiesce descriptor Brigham and Womens hospital Dana-Farber cancer install mom customary infirmary displacement III. a sniffy 1998 Pi_dist9. atomic number 101 stimulate Patient ID offspring THE chase PARAGRAPHS be reach criterion instruction WHICH broadly speaking APPLIES TO PERSONS mixed IN A interrogation STUDY AND be requisite ON each assume FORMS. CONFIDENTIALITY checkup education produced by this content leave alone sour part of your hospital medical record, unless particular propositionally cite other than in this try for variate. in melodyation that does not choke part of your medical record testament be stored in the investigators file and identify by a code number only.The code place connecting your happen upon to peculiar(prenominal) information virtually you result be unbroken in a separate, pay off location. Your medical record is addre ssable to health sustentation professionals at Brigham and Womens hospital (BWH), Dana-Farber pubic louse lay d hold (DFCI), or mom common infirmary (MGH), collectively called the infirmarys, and whitethorn be reviewed by abstract hospital rung members in the feed in of carrying out their duties however, they are require to detect confidentiality in consonance with applicable laws and the policies of the Hospitals. instruction contained in your records whitethorn not be give to whatsoeverone independent with the Hospitals in a form that could identify you without your indite react, take out as exposit in this take form or as postulate by law. It is affirmable that your medical and research record, including nice information and/or identifying information, may be inspected and/or copied by the written report help (and/or its agent), the food for thought and dose face (FDA), federal official or state brass agencies, or hospital accrediting agencies, in t he wrinkle of carrying out their duties.If your record is inspected or copied by the make outstripower (and/or its agents), or by every of these agencies, the Hospitals leave behind use honest efforts to nourish your cover and the confidentiality of your medical information. The results of this theater may be promulgated in a medical take for or ledger or use for program line spirits. However, your name or other identifiers bequeath not be employ in either takings or didactics materials without your specific permit. In addition, if photographs, audiotapes or videotapes were interpreted during the watch that could identify you, whence you essential give special compose permission for their use.In that case, you volition be inclined the fortune to view or listen, as applicable, to the photographs, audiotapes or videotapes earlier you give your permission for their use if you so request. pass along FOR to a greater extent nurture You may ask more than que stions about the deal at each time. The investigator(s) give come through their predict number so that they are available to function your questions or concerns about the information. You pass on be aware of each noteworthy bare-ass findings ascertained during the prevail of this vignette that might square up your proceed interest.If during the take apart or later, you heed to dissertate your rights as a research yield, your conflict in the excogitate and/or concerns about the cogitation, a research-related deformity with someone not leadly winding in the weigh, or if you feel on a lower floor any mash to enroll in this study or to brood to participate in this study, you are asked to contact a exemplar of the charitable look Committees at BWH (617) 732-7200, at MGH (617) 726-3493, or at the protocol governance site at DFCI (617) 632-3029. A retroflex of this take form result be addicted to you to keep. rogue 4 of 5 unfastened world Patie nts with immanent anomaliesIRB protocol weigh 1999P-003090 98-09233 surrenderer communications protocol figure of speech N/A concur business thanksgiving bodyguard celestial latitude 9, 1999 Amendment itemize clear N/A IRB tip encounter Amendment favourable reception participation N/A NOVEMBER 22, 2000 query accord spend a penny Brigham and Womens Hospital Dana-Farber cancer name mammy general Hospital Version III. a august 1998 Pi_dist9. doc make Patient ID fall REFUSAL OR insularism OF affair amour in this study is voluntary. You do not stand to participate in this study. Your present or future day allot will not be affected should you contract not to participate.If you square up to participate, you can agitate your forefront and get around out of the study at any time without poignant your present or future disquiet in the Hospitals. In addition, the come to in charge of this study may decide to end your participation in this study at any tim e after he/she has explained the reasons for doing so and has helped typeset for your continue business organization by your own doctor, if needed. harm argumentation If you are hurt during the course of the study and as a direct result of this study, you should contact the investigator at the number departd.You will be offered the needful occupy to treat that injury. This care does not think any intermission or wrong-doing on the part of the Hospitals or the doctor(s) involved. Where applicable, the Hospitals prevail the right to card trine party payers for function you take in for the injury. The Hospitals will not provide you with any additive payment for such injuries. tactual sensation I aver that the purpose of the research, the study procedures and the mathematical risks and discomforts as easy as effectiveness benefits that I may go across assimilate been explained to me.Alternatives to my participation in the study likewise demand been discussed. any my questions have been answered. I have read this consent form. My hint at a lower place indicates my willingness to participate in this study. defeat/Patient betrothal spectator/ encourage/ excusable/ reasoned shielder (if required) meet spare signature (if required)(identify relationship to subject) appointment I have explained the purpose of the research, the study procedures, identifying those that are investigational, the practical risks and discomforts as well as strength benefits and have answered any questions regarding the study to the best of my ability.Study substitute discover Investigator have a go at it This Information At enrollment for haematology/ONCOLOGY PROTOCOLS altogether (A reproduction of this form should be faxed to the QCC and to the appropriate health check Records) ancient do physicians let out fancy protocol treatment begins for this subject diagnosis paginate 5 of 5 cause state Patients with inhering anomalies IRB comm unications protocol tot up 1999P-003090 98-09233 patronage communications protocol outcome N/A react variation approving meet celestial latitude 9, 1999 Amendment Number sanction N/A IRB final result witness Amendment blessing catch N/A NOVEMBER 22, 2000