Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
US. OErARTMENT OF HEALTH. EDUCATION. AND WELFARE Vol. 3, No. 12, August 26, 1974 n e purpose of this notice is to provide clarification of that portion of the Instruction Sheet (Rev. 2-73) for Form NIB 398 pertaining to Research Involving DHEU regulations define "subject a t risk" as "MY individual vho may be Exposed to. the possibility of injury, including physical. psychological, or social injury, as 8 consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary t o meet his needs, o r which increase r the ordinary risks of daily life, including the recognized risks inherent ina chosen occupation or field of service." DHEU is concerned vith the protection of tba rights and welfare of human subjects in all research, development, and related activities. The Department's regulations (45 C.F.R., Part46)are coccerned vith protection of rights to privacy, the need for informed consent, protection of confidentiality of data, and protection against physical, psychological, sociological. or legal risk. rights and vel far emd protection against risk a to the individual is not limited t o activities involving children and adults but also includes the fetus. the abortus and the dead. The uses of organs, tissues. body fluids,or graphic, written or recorded info zz ation, while they present no physical risks to the subjects, nay create medico-legal risks,or expose the subject to public embarrassment or humiliation through break of confidentiality and invasion of privacy. The major focus of a project(for exanple, on a ned ical procedure) is not the sole determinant of the need for protections. The safeguarding and confidentiality of medical records and other forms of data Collected on individuals and groups and the use of such data either by the investigator conducting the original research. concurrent use of. the data by other investigators,or use of the data at a later time are considered within the scope of concern of this policy. The need for protection of While safeguarding the rights and welfare of subjects at risk is primarily the responsibility of the organization conducting grant activities, the responsibility f o r determining the adequacy of proposed procedures is shared by organizational re vie v corn it tees and DHrV staff and advisory committees. Therefore, ifthe proposal involves hman subjects. the principal investigators hall, under the heading HUEUN SUBJECTS a t the end of the Nethods of Procedure section of the The' GUIDE i e published a t irregulm into mah to pmide policy, prcgm, and add nist rat ive infomation to indi3iduah and olr~anixationeoh0 need to be kept informed of requirmmta and chcmges ing nmt a and contracts activities adninistered by the National Institutes of Boalth. HUMAN SUBJECTS II
Page 2
1)' Descrfbe the requirements for a subject population and explain the rationale for wing in this population apec i al groupa auch aa prisoners, children.the mentally disabled or groups whose ability to give voluntary informed consent h y be i n queation. legdl or other--and assess the likelihood and aeriouanesa of auch riaka. methods of rue arch create potential riaka, describe other methods, ifMY, that were considered and vhy they will not beued. 3) Deacribe consent procedurea tobe followed, Including h w and whore informed consent vlll b e obtained. ag dns tor minimizing potential risks and an assessment of their likely Describe and aasess any potent fal risks--physical, psychological, social, 6) Analyze the risk-benefit ratio. ks esa the potencfal benefit. to b e gained by the individual subject. as .well as benefits which may ~ CCN( ! to aoc iet yin general as a result of the The statements are subject to review, approval, and modification by your local your application and any additional materials requeated by the corn it tee should be aubmitted for local review vel1 in advance of Public Health Sew ice deadllnos. If this revlev i a not completed in adv mu of the deadline, it will be your torpunsibil it y to aee that MY modificationr of the Method8 of Procedure or H W SUATLCIS 8ect ion u area ul t of the reviev are forwarded t o the PHS. These should bo sonc directly to the Division of Research Grants, NIB, Bechesda, Maryland 20014, and ahould be ident if io d by principal in ve at i gator ' a nmna. project title, and name of or gads arion precisely aa entered on the receipt of application card recurnod vlrh the original application. The regulationa concerned vith the protection of human aubjecta effect iv a July 1, 1974, require that organ i racion d review and approval be completad m d certified prior to subdisaion of prop o aab LO MIEV. the DW will provide that for a period of one year fr m the cCfective data of these regulations. organizations may aubmit e ert if i cation a no later than 30 day0 f oll wing the deadline for which the proposal via submitted. or,if no deadllne is specified. 33 days fol loving the submiaaion of the proposal. not received within the 30 diya, u provided above, the application will be administratively vithdrawn by the Division o f Research Grants and returned LO tho Mter July 1. 1975, organizational revlev m d approval muat be completed and certified prior to submission of proposal8 t o DEW. To in aure timely completion of this rev iw. Hovever, by s epr rats noclca.