permission permission both parents Individual exception may be sought requireda requireda requirede Assent Assent Witnessed assent suggested strongly required where suggested where possibleg reasonably where Individual possibleb reasonably exception may be possibleb sought >13 Committee Committee Minor increase HHS approval (IRB) (IRB) over minimum risk Committee (IRB) approval of project approval approval Committee (IRB) Witnessed parental permission of of project of project approval of project both parents requirede Parental Parental Witnessed parental Witnessed assent required apart (one) (one) permission from parents if necessaryh permission permission both parents requireda requireda required Assent Assent Witnessed assent required required required apart Individual Individual from parents if exceptions exceptions necessaryh may b may be soughtc soughtc General Procedural Requirements and Definitions 1. It is the responsibility of the investigator to advise the parent(s) of potential child subjects of the existence of and the provisions of this policy and procedure, and also that further information is available from the Committee of Protection of Human Subjects (IRB) through the Research Director's office. 2. Parental "permission" is always required for minors' participation in research. Overriding of parental objection to participation in a project which, in the investigator's opinion, may be harmful to the proposed subject by reason of lack of participation in the project requires action of the appropriate civil court. Social Service consultation, with the knowledge of the Research Director, should be sought should such a situation arise. 3. Witnesses: persons selected to witness assent activity, as required in this policy, must be qualified health professionals who are aware of: a) this policy and procedure; b) their professional responsibility to assure that assent is appropriately obtained; and c) their responsibility to seek the counsel of the Committee on Protection of Human Subjects (IRB) through the Research Director's office should any questions or concerns regarding propriety or procedure arise. It is the responsibility of the investigator to assure that the witness is advised of the above requirement. FOOTNOTES: a. Permission of either parent is sufficient. Legal guardian is accepted in lieu of parent. b. Determination of reasonableness may be made jointly by parent and investigator. Disagreements should be referred to Committee (IRB) for adjudication. Parent must be made aware of role and provision by investigator. c. Exceptions to assent requirement by reason of lack of maturity of judgment or psychological state of the proposed subject may be requested in specific
permission requireda Assent suggested where reasonably possibleb permission requireda Assent strongly suggested where reasonably possibleb both parents requirede Witnessed assent required where possibleg Individual exception may be sought Individual exception may be sought >13 Committee (IRB) approval of project Parental (one) permission requireda Assent required Individual exceptions may b soughtc Committee (IRB) approval of project Parental (one) permission requireda Assent required Individual exceptions may be soughtc Minor increase over minimum risk Committee (IRB) approval of project Witnessed parental permission both parents required Witnessed assent required apart from parents if necessaryh HHS approval Committee (IRB) approval of project Witnessed parental permission of both parents requirede Witnessed assent required apart from parents if necessaryh General Procedural Requirements and Definitions 1. It is the responsibility of the investigator to advise the parent(s) of potential child subjects of the existence of and the provisions of this policy and procedure, and also that further information is available from the Committee of Protection of Human Subjects (IRB) through the Research Director's office. 2. Parental "permission" is always required for minors' participation in research. Overriding of parental objection to participation in a project which, in the investigator's opinion, may be harmful to the proposed subject by reason of lack of participation in the project requires action of the appropriate civil court. Social Service consultation, with the knowledge of the Research Director, should be sought should such a situation arise. 3. Witnesses: persons selected to witness assent activity, as required in this policy, must be qualified health professionals who are aware of: a) this policy and procedure; b) their professional responsibility to assure that assent is appropriately obtained; and c) their responsibility to seek the counsel of the Committee on Protection of Human Subjects (IRB) through the Research Director's office should any questions or concerns regarding propriety or procedure arise. It is the responsibility of the investigator to assure that the witness is advised of the above requirement. FOOTNOTES: a. Permission of either parent is sufficient. Legal guardian is accepted in lieu of parent. b. Determination of reasonableness may be made jointly by parent and investigator. Disagreements should be referred to Committee (IRB) for adjudication. Parent must be made aware of role and provision by investigator. c. Exceptions to assent requirement by reason of lack of maturity of judgment or psychological state of the proposed subject may be requested in specific
2-G-PEDIATRIC-RESEARCH-assent-matrix-10-24-2011.docx