Useful Research Terms:
Children give assent when they agree to take part in research. Children who are old enough (usually age 7 or older) to express that they want to be in a study sign an assent form. For this study children will provide assent once they are no longer on a breathing machine.
Banking or storing samples
Sometimes biological samples (like blood or saliva) from study participants are stored for researchers to use in future studies. The lab where these samples are stored is called a biobank. Samples in these labs are always coded with a research number.
An individual or group of individuals responsible for oversight and management of the conduct of a multi-center study of al collaborating institutions. For this study we have two, the Clinical Coordinating Center (CCC) & the Data Coordinating Center (DCC).
Each study has a list of requirements of who can and cannot participate. The items that allow someone to participate in a study are called inclusion criteria. The factors that do not allow someone to participate are called exclusion criteria.
Institutional review board (IRB)
A group of people that might include doctors, researchers, community members, pharmacists and other experts who review and approve research studies before they begin.
The individual with primary responsibility for oversight and management of the conduct of the study at all participating research sites.
Parents/guardians give permission when they agree their child can take part in research. Parents/guardians sign a consent form to confirm that they understand the study and give permission for their child to participate.
A carefully designed plan to keep study participants safe and answer specific research questions.
Site Principal investigator (PI)
The individual at each site who agreed to participle in the multi-center study and is responsible for the oversight of the conduct of the study at their center.
The process by which study participants are assigned to different study groups by random chance (like flipping a coin or pulling a name out of a hat).
Maneno Yenye manufaa kwa Utafiti: Watoto hutoa idhini wanapokubali kushiriki katika utafiti. Watoto ambao ni wazima wa kutosha (kwa kawaida umri wa miaka 7 au zaidi) kueleza kwamba wanataka kuwa katika utafiti saini fomu ya idhini. Kwa ajili ya utafiti huu watoto kutoa idhini mara moja wao si tena juu ya mashine ya kupumua. Wakati mwingine sampuli za kibiolojia (kama damu au mate) kutoka kwa washiriki wa utafiti huhifadhiwa kwa watafiti kutumia katika masomo ya baadaye. Maabara ambako sampuli hizo huhifadhiwa inaitwa benki ya viumbe. Sampuli katika maabara haya daima huandikwa nambari ya utafiti. Mtu binafsi au kundi la watu wanaohusika na usimamizi wa usimamizi wa utafiti wa kituo cha vituo vya ushirikiano. Kwa ajili ya utafiti huu tuna mbili, Kituo cha Uratibu wa Kliniki (CCC) na Kituo cha Uratibu wa Takwimu (DCC). Kila utafiti una orodha ya matakwa ya nani anayeweza na asiyeweza kushiriki. Vitu vinavyowezesha mtu kushiriki katika utafiti huitwa vigezo vya kuingizwa. Sababu ambazo haziruhusu mtu kushiriki huitwa vigezo vya kutengwa. Bodi ya ukaguzi wa taasisi (IRB) ni kikundi cha watu ambao wanaweza kujumuisha madaktari, watafiti, wanachama wa jamii, wauzaji wa dawa na wataalamu wengine ambao hukagua na kuidhinisha masomo ya utafiti kabla ya kuanza. Mtu binafsi na wajibu wa msingi kwa ajili ya usimamizi na usimamizi wa mwenendo wa utafiti katika maeneo yote ya utafiti kushiriki. Wazazi au walezi wanaweza kutoa idhini yao kwa mtoto wao kushiriki katika utafiti. Wazazi au walezi wanaweza kusaini fomu ya idhini ya mtoto wao ili kuthibitisha kwamba wanaelewa utafiti na kutoa ruhusa kwa mtoto wao kushiriki. Mpango ulioundwa kwa uangalifu ili kuwaweka washiriki wa utafiti salama na kujibu maswali maalum ya utafiti. Mtafiti Mkuu (PI) ni mtu binafsi katika kila kituo ambaye alikubali kushiriki katika utafiti wa kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo cha kituo. Utaratibu ambao washiriki wa utafiti huwekwa katika vikundi tofauti vya utafiti kwa bahati mbaya (kama kurusha sarafu au kuvuta jina kutoka kofia).