Purpose The purpose of this Standard Operating Procedure (SOP) is to define the scope of the Human Research Protection Program (HRPP).

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1 MISSISSIPPI STATE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM Scpe f the Human Research Prtectin Prgram (01-28) Apprved Purpse The purpse f this Standard Operating Prcedure (SOP) is t define the scpe f the Human Research Prtectin Prgram (HRPP). Materials 45 CFR CFR CFR CFR 26 Subparts C and D OHRP guidance entitled Guidance n Engagement f Institutins in Human Subjects Research Belmnt Reprt MSU OP Definitins Researcher any MSU affiliated individual (faculty, staff, r student (undergraduate r graduate) cnducting research. Missin The Mississippi State University (MSU) Human Research Prtectin Prgram (HRPP) will strive tward the highest prtectin f human research participants and t cultivate thrugh educatin an atmsphere f such prtectin thrughut the entire University research cmmunity. We will prmte the highest ethical standards fr the cnduct f human subjects research, and we will make nging effrts t identify and implement best practices fr thse effrts. The HRPP will endeavr t be a chesive team t prvide effective and efficient service t the University research cmmunity, and t d s in a supprtive and pleasant envirnment. Plicy The IRB is the nly entity delegated the authrity t review all prpsed research invlving human subjects perfrmed under the auspices f MSU. Therefre, individuals with questins pertaining t human subjects prtectins issues may cntact the HRPP, HRPP Officer, IRB Chair, r Directr f Research Cmpliance. The MSU HRPP fllws the ethical principles f the Belmnt Reprt t gvern the cnduct f all research invlving human participants. MSU cnducts research f bth a Scial/Behaviral nature, as well as Bimedical research. As such, the rganizatin fllws the DHHS regulatins (the Cmmn Rule), as well as the FDA regulatins regarding human subjects research. The HRPP agrees t cmply with the prvisins f 38 CFR 16. In accrdance with the Cmmn Rule, the fllwing definitins are the basis fr the criteria used t determine if the research meets the federal definitin f research and human subjects (45 CFR ): Research means a systematic investigatin*, including research develpment, testing and evaluatin, designed t develp r cntribute t generalizable** knwledge. Activities which meet this definitin cnstitute research fr purpses f this plicy, Scpe f the Human Research Prtectin Prgram Page 1 f 5

2 whether r nt they are cnducted r supprted under a prgram which is cnsidered research fr ther purpses. Fr example, sme demnstratin and service prgrams may include research activities. *The term systematic investigatin refers t a study in which there is a research prtcl t be fllwed in its cnduct, specific research questins t be answered, r a hypthesis t be addressed. **The term generalizable refers t a study designed t draw cnclusins beynd the specific instances being studied, infrm public plicy, r generalize findings. (Michael Carme, OHRP, and Jeffrey Chen, HRP Assciates, Inc.) Human subject means a living individual abut whm an investigatr (whether prfessinal r student) cnducting research btains (1) Data thrugh interventin r interactin with the individual, r (2) Identifiable private infrmatin. Interventin includes bth physical prcedures by which data are gathered (fr example, venipuncture) and manipulatins f the subject r the subject's envirnment that are perfrmed fr research purpses. Interactin includes cmmunicatin r interpersnal cntact between investigatr and subject. Private infrmatin includes infrmatin abut behavir that ccurs in a cntext in which an individual can reasnably expect that n bservatin r recrding is taking place, and infrmatin which has been prvided fr specific purpses by an individual and which the individual can reasnably expect will nt be made public (fr example, a medical recrd). Private infrmatin must be individually identifiable (i.e., the identity f the subject is r may readily be ascertained by the investigatr r assciated with the infrmatin) in rder fr btaining the infrmatin t cnstitute research invlving human subjects. Additinally, when the FDA regulatins apply t research, the fllwing definitins f clinical investigatins and human subjects are used (21 CFR 50): Clinical investigatin means any experiment that invlves a test article and ne r mre human subjects and that either is subject t requirements fr prir submissin t the Fd and Drug Administratin under sectin 505(i) r 520(g) f the act, r is nt subject t requirements fr prir submissin t the Fd and Drug Administratin under these sectins f the act, but the results f which are intended t be submitted later t, r held fr inspectin by, the Fd and Drug Administratin as part f an applicatin fr a research r marketing permit. The term des nt include experiments that are subject t the prvisins f part 58 f this chapter, regarding nnclinical labratry studies. Human subject means an individual wh is r becmes a participant in research, either as a recipient f the test article r as a cntrl. A subject may be either a healthy human r a patient. When medical device research invlves in vitr diagnstics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects. Scpe f the Human Research Prtectin Prgram Page 2 f 5

3 When fllwing Department f Justice (DOJ) regulatins, MSU, the HRPP, investigatrs and research staff must fllw the requirements f 28 CFR 512, including: Fr research cnducted within the Bureau f Prisns Implementatin f Bureau prgrammatic r peratinal initiatives made thrugh pilt prjects is nt cnsidered t be research. The researcher must assume respnsibility fr actins f any persn engaged t participate in the research prject as an assciate, assistant, r subcntractr t the researcher. The researcher must have academic preparatin r experience in the area f study f the prpsed research. When submitting a research prpsal, the applicant shall prvide the fllwing infrmatin: A summary statement, which include: Names and current affiliatins f the researchers Title, purpse, lcatin and duratin f the study Methds t be emplyed Anticipated results Number f participants (staff r inmates) required and amunt f time required frm each Indicatin f risk r discmfrt invlved as a result f participatin. A cmprehensive statement, which includes: Review f related literature Detailed descriptin f the research methd Significance f the anticipated results and their cntributin t the advancement f knwledge Specific resurces required frm the Bureau f Prisns Descriptin f all pssible risks, discmfrts, and benefits t individual participants r a class f participants, and a discussin f the likelihd that the risks and discmfrts will actually ccur Descriptin f steps taken t minimize any risks. Descriptin f physical r administrative prcedures t be fllwed t: Ensure the security f any individually identifiable data that are cllected fr the study. Destry research recrds r remve individual identifiers frm thse recrds when the research has been cmpleted. Descriptin f any anticipated effects f the research study n rganizatinal prgrams and peratins. Relevant research materials such as vitae, endrsements, sample cnsent statements, questinnaires, and interview schedules. A statement regarding assurances and certificatin required by 28 CFR 46, if applicable. The prject must nt invlve medical experimentatin, csmetic research, r pharmaceutical testing. The research design must be cmpatible with bth the peratin f prisn facilities and prtectin f human subjects. The researcher must bserve the rules f the institutin r ffice in which research is cnducted. Any researcher wh is a nn-emplyee f the Bureau must sign a statement in which the researcher agrees t adhere t the prvisins f 28 CFR 512. All research prpsals will be reviewed by the Bureau Research Review Bard. Scpe f the Human Research Prtectin Prgram Page 3 f 5

4 When fllwing Envirnmental Prtectin Agency (EPA) regulatins: EPA prhibits research invlving the intentinal expsure f pregnant wmen, nursing wmen, r children t any substance. The EPA requires applicatin f 40 CFR 26 Subparts C and D t prvide additinal prtectins t pregnant wmen and children as participants in bservatinal research, i.e., research des nt invlve intentinal expsure t any substance. EPA plicy requires submissin f HRPP determinatins and apprval t the EPA human subjects research review fficial fr final review and apprval befre the research can begin. Fr research nt cnducted r supprted by any federal agency that has regulatins fr prtecting human research participants, and fr which the intentin f the research is submissin t the EPA, the EPA regulatins prtecting human research participants apply, including: EPA extends the prvisins f the 40 CFR 26 t human research invlving the intentinal expsure t nn-pregnant, nn-nursing adults t any substance. EPA prhibits the intentinal expsure f pregnant wmen, nursing wmen, r children t any substance. Any and all activities that meet these definitins require submissin t and review by the HRPP t determine the apprpriate level f review in accrdance with the applicable regulatins regardless f whether the research is cnducted within r utside the State f Mississippi. All student lead research must be cnducted under the versight f a faculty r staff advisr. Any mdificatins f an apprved study cannt be initiated withut HRPP apprval in accrdance with MSU HRPP SOP n Mdificatin f Apprved Applicatins (01-08). Engagement in Research The MSU HRPP fllws the OHRP guidance entitled Guidance n Engagement f Institutins in Human Subjects Research t determine when the rganizatin is engaged in research. Individuals cnsidered as agents f MSU include all faculty, staff, and students acting in the capacity f an affiliate f the University. MSU faculty and staff engaging in emplyment (practice f prfessin, cnsulting r business) utside f Mississippi State University in accrdance with HRM plicy , Outside Emplyment, are nt cnsidered agents f the rganizatin during such utside emplyment. MSU HRPP expects that all investigatrs, IRB members, HRPP staff as well as the Institutinal Official verseeing r cnducting research under the auspices f MSU will adhere t the basic ethical principles f respect fr persns, beneficence, and justice as utlined in the Belmnt Reprt. The rganizatin will include nn-emplyees listed in the MSU Human Resurces Hiring Tl Kit ( - such as adjunct faculty, visiting faculty, and visiting schlars - as agents f the rganizatin (and thereby cvered under the auspices f the MSU HRPP) nly when they are acting in a capacity directly related t the University s business (such as service n a graduate student s cmmittee). Unaffiliated entities r individuals may visit ur website at fr resurces pertaining t their rights as a participant and questins t ask befre and after the study. Thse individuals affiliated with anther institutin will be asked t prvide dcumentatin f IRB apprval frm their hme institutin r an indicatin that their institutin s HRPP des nt require review and apprval since their activities will be reviewed and apprved by the MSU HRPP. Scpe f the Human Research Prtectin Prgram Page 4 f 5

5 Categries f participants MSU cnducts research invlving the fllwing categries f participants: 1. Adults with and withut decisin-making impairment 2. Children with and withut decisin-making impairment 3. Pregnant wmen 4. Prisners 5. Nn-English Speaking peple 6. Emplyees f the institutin 7. Students f the institutin MSU des nt by plicy exclude any types f research r research invlving any specific categries f participants. Ensuring cmpliance The MSU HRPP wrks with ther rganizatinal entities t ensure all required apprvals are in place prir t the cnduct f human subjects research. Spnsred Prgrams Administratin will nt release funding fr human subjects research prir t apprval f the prject by the HRPP. The HRPP will ntify all investigatrs, in writing, f their apprval status. Additinally, the HRPP prvides guidance t investigatrs and CIRB cncerning activities that smetimes are r are nt verseen by the HRPP at MSU, such as classrm research, quality imprvement, case reprts, prgram evaluatin, and surveillance activities, rutine training regarding required apprvals t the campus cmmunity, including new faculty rientatin and guest lectures in classes. When cntacted by research participants, the MSU HRPP prvides infrmatin such as but nt limited t, participant rights, any prblems, cncerns r questins pertaining t the participants invlvement in the research study. The HRPP maintains Cmpliant and Participant Call Lgs wherein calls frm ptential participants are dcumented. Mst calls are then frwarded t the PI f the study r apprpriate rganizatinal entity t address. The HRPP cmmunicates with the MSU research cmmunity in a variety f methds. Changes in plicy and prcedures, training pprtunities as well as pertinent infrmatin regarding human subjects research are highlighted in s r Dear Clleagues Letter, n the website, r in face-t-face interactins. The HRPP als cnducts audits and pst-apprval mnitring in accrdance with the plicy n Cmpliance and Quality Assurance Prgram (01-45). Cmpnents f the rganizatin MSU has n cmpnents f the institutin that are viewed as separate rganizatins. Reviewed IRB Chair Date HRPP Officer Date Scpe f the Human Research Prtectin Prgram Page 5 f 5