Protection of Human Subjects In Research Sam Houston State University 2005

Belmont Principles The report of the Commission created by the National Research Act (1974) that identified the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and that developed guidelines which should be followed to assure that such research is conducted in accordance with those principles.The report of the Commission created by the National Research Act (1974) that identified the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and that developed guidelines which should be followed to assure that such research is conducted in accordance with those principles.

Belmont Principles Respect for personsRespect for persons –Informed consent –Protect privacy –Maintain confidentiality

Belmont Principles BeneficenceBeneficence –Sound research design –Favorable risk-benefit analysis JusticeJustice –Equitable selection

What Comes Under Committee Review Research means a systematic investigation designed to develop or contribute to generalizable knowledge.Research means a systematic investigation designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtainsHuman subject means a living individual about whom an investigator (whether professional or student) conducting research obtains –(1) data through intervention or interaction with the individual, or (2) identifiable private information.

What Comes Under Committee Review PHSC approval means the determination of the Committee that the research has been reviewed and may be conducted at SHSU within the constraints set forth by the PHSC and by other institutional and Federal requirements.PHSC approval means the determination of the Committee that the research has been reviewed and may be conducted at SHSU within the constraints set forth by the PHSC and by other institutional and Federal requirements.

What Comes Under Committee Review The PHSC shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.The PHSC shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. The PHSC shall require that information given to subjects as part of informed consent is in accordance with HSS § The PHSC shall require that information given to subjects as part of informed consent is in accordance with HSS § §46.116

What Comes Under Committee Review The PHSC shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure approval of the research activity.The PHSC shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure approval of the research activity.

Types of Review Exempt (by Chair or his/her designate)Exempt (by Chair or his/her designate) Expedited (by Chair or his/her designate)Expedited (by Chair or his/her designate) Full Committee ReviewFull Committee Review Only the PHSC has the authority to decide which type of review is appropriateOnly the PHSC has the authority to decide which type of review is appropriate

Criteria for Approval of Research Risks to subjects are minimizedRisks to subjects are minimized –by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and –whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. –risks include physical, emotional, legal, financial, reputation

Criteria for Approval of Research Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Selection of subjects is equitable.Selection of subjects is equitable. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by HSS § Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by HSS § §46.116

Criteria for Approval of Research When appropriate, there are adequate provisions to protect the privacy (anonymity) of subjects and to maintain the confidentiality of data.When appropriate, there are adequate provisions to protect the privacy (anonymity) of subjects and to maintain the confidentiality of data.

Criteria for Approval of Research Proposals requiring more scrutinyProposals requiring more scrutiny ParticipantsParticipants ChildrenChildren PrisonersPrisoners Pregnant womenPregnant women Mentally disabled personsMentally disabled persons Economically disadvantaged personsEconomically disadvantaged persons Educationally disadvantaged personsEducationally disadvantaged persons

Criteria for Approval of Research Proposals requiring more scrutinyProposals requiring more scrutiny Settings TopicsSettings Topics Prisons Alcohol/DrugsPrisons Alcohol/Drugs Nursing Homes Depression/SuicideNursing Homes Depression/Suicide Hospitals Learning DisabilitiesHospitals Learning Disabilities Schools Abortion/AIDS/HIV/Sex Schools Abortion/AIDS/HIV/Sex Web Surveys /Chat Sexually Transmitted DiseasesWeb Surveys /Chat Sexually Transmitted Diseases Telephone Surveys Body Image/Eating DisordersTelephone Surveys Body Image/Eating Disorders Outside the Classroom Criminal ActivityOutside the Classroom Criminal Activity Psychological Inventories Psychological Inventories