79C3C34C52B45572883A05D425EB0F82
http://nbcpakistan.org.pk/assets/nbc-erc-application-form-.pdf
http://leaux.net/URLS/ConvertAPI Text Files/55D33D40918803D0F038C5AE8E840E69.en.txt
Examining the file media/Synopses/55D33D40918803D0F038C5AE8E840E69.html:
This file was generated: 2020-12-01 07:44:45
| Indicators in focus are typically shown highlighted in yellow; | Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; | "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; | Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|---|---|---|
| Political | Criminal Convictions | prisoners | 1 |
| Political | political affiliation | political | 1 |
| Health | Drug Usage | drug | 2 |
| Health | Drug Usage | influence | 1 |
| Health | Mentally Disabled | mentally | 2 |
| Health | Physically Disabled | physically | 1 |
| Health | Pregnant | pregnant | 1 |
| Health | injured | injured | 1 |
| Social | Age | age | 2 |
| Social | Child | child | 1 |
| Social | Child | children | 4 |
| Social | Fetus/Neonate | fetus | 2 |
| Social | Linguistic Proficiency | language | 7 |
| Social | Religion | religious | 1 |
| Social | Student | student | 1 |
| Social | Women | women | 3 |
| Social | embryo | embryo | 1 |
| Social | gender | gender | 1 |
| Social | parents | parents | 1 |
| General/Other | Incapacitated | incapacitated | 1 |
| General/Other | Public Emergency | emergency | 4 |
| General/Other | Relationship to Authority | authority | 1 |
Searching for indicator prisoners:
(return to top) Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 2. The objectives of the study p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q3 Brief description of methods used in protocol. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 4. a) Expected duration of the study period (to completion). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Expected duration of study on each individual subject. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 5. a) Please indicate source of funding. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Has funding been approved? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 6 Subject information. p.9204559: a) Group: Patients Students p.9204559: Others p.9204559: b) Records: Children & women p.9204559: c) Age range: One year and above p.9204559: p.9204559: p.9204559: p.9204559: d) Gender: p.9204559: Male p.9204559: Female p.9204559: Both p.9204559: p.9204559: e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it includes foetal research, give p.9204559: brief explanation of need to use this group. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-5/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 7. Criteria for inclusion and exclusion of patients and controls (type separate). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 8. a) Compensation (to research subject): p.9204559: Monetary: No Yes Amount: p.9204559: Other: No Yes Specify: p.9204559: p.9204559: Reimbursement of No expenses: p.9204559: Yes p.9204559: Type & amount: p.9204559: p.9204559: b) Compensation (to Investigators): p.9204559: Yes No p.9204559: p.9204559: If yes then p.9204559: Monetary: Travel: Gifts: Amount: As per govt. Rules Other p.9204559: Specify: -NA- p.9204559: p.9204559: Q 9. Adverse effects: p.9204559: a) Describe adverse effects/risks expected to the subjects during the study? p.9204559: p.9204559: p.9204559: p.9204559: b) What is the provision for managing these effects? p.9204559: p.9204559: p.9204559: p.9204559: c) Who will pay for them? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 10. In cases where therapeutic need of the research subject is identified during the course of the study: p.9204559: a) What is the provision for managing these cases? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Who will pay for them? p.9204559Searching for indicator political:
(return to top) are given here in order to help and p.9204559: facilitate the researchers in drafting a proper, acceptable consent form. p.9204559: p.9204559: 1. All studies involving human subjects should have a properly drafted consent form. No study should be done on p.9204559: human subjects without obtaining informed consent and sufficiently before the start of the study, at an appropriate p.9204559: time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand p.9204559: the study. p.9204559: 2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the p.9204559: person taking the consent and witnessed by a second person. p.9204559: 3. In case of children, an assent form from children and consent from guardian / parents is needed. p.9204559: 4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian p.9204559: or close relative p.9204559: 5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in p.9204559: certain cases), and governmental officials should be taken into confidence, and a written consent should p.9204559: be obtained. p.9204559: 6. In case of doing a study in other locations such as other hospitals and clinics, permission p.9204559: from appropriate authority or physicians should also be obtained. p.9204559: 7. The consent form should be in English and Urdu with translation into other local language if needed. These p.9204559: should be identical in such a way that the translation of one into other is similar. The language should be easy which p.9204559: can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided. p.9204559: 8. It should be written in “second or third person” and not in “first person”. For example, “You will be asked p.9204559: to give 10 cc blood” or “you will be asked few questions” etc. p.9204559: 9. A properly drafted consent form should contain the following important points. p.9204559: p.9204559: a) Information sheet. There should be one paragraph or page giving information about the nature of p.9204559: study, its purpose and need, possible benefits of the study, and procedures to be carried out on the study subjects. p.9204559: b) Possible risks and benefits to the study subjects p.9204559: c) Availability of alternate treatment in case of therapeutic trials p.9204559: d) Voluntary participation without aSearching for indicator influence:
(return to top) treatment, indicate whether other non-experimental (conventional) p.9204559: treatments are available and compare the relative risks (if known) of each. p.9204559: p.9204559: 7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES p.9204559: o “This study involves (minimal risk) (greater than minimal risk).” In the event that greater than p.9204559: minimal risk is involved, provide the subject with the following information. p.9204559: o If you are injured as a direct result of taking part in this research study, emergency medical care will be p.9204559: provided by [name] medical staff or by transporting you to your personal doctor or medical center. Indicate who will p.9204559: pay for this treatment. p.9204559: p.9204559: 8. CONFIDENTIALITY p.9204559: o Describe the extent to which confidentiality of records identifying the subject will be maintained. p.9204559: “Your identity in this study will be treated as confidential. The results of the study, including laboratory or any p.9204559: other data, may be published for scientific purposes but will not give your name or include any identifiable references p.9204559: to you.” p.9204559: p.9204559: 9. TERMINATION OF RESEARCH STUDY p.9204559: You are free to choose whether or not to participate in this study. There will be no penalty or loss of benefits to p.9204559: which you are otherwise entitled if you choose not to participate. You will be provided with any significant new p.9204559: findings developed during the course of this study that may relate to or influence your willingness to p.9204559: continue participation. In the event you decide to discontinue your participation in the study, p.9204559: o These are the potential consequences that may result: (list) p.9204559: o Please notify (name, telephone no., etc.) of your decision or follow this procedure (describe), so that your p.9204559: participation can be orderly terminated. p.9204559: In addition, your participation in the study may be terminated by the investigator without your consent p.9204559: under the following circumstances. (Describe) It may be necessary for the sponsor of the study to terminate the p.9204559: study without prior notice to, or consent of, the participants in the event that (Describe circumstances, such as loss p.9204559: of funding.) p.9204559: p.9204559: Page-12/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: 10. AVAILABLE SOURCES OF INFORMATION p.9204559: o Any further questions you have about this study will be answered by : Name: p.9204559: Phone Number: p.9204559: o Any questions you may have will be answered by: Name: p.9204559: Phone Number: p.9204559: o In case of a research-related emergency, call: Day Emergency Number: p.9204559: Night Emergency Number: p.9204559: p.9204559: 11. AUTHORIZATION p.9204559: I have read and understood the consent form, aSearching for indicator mentally:
(return to top) 59: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 2. The objectives of the study p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q3 Brief description of methods used in protocol. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 4. a) Expected duration of the study period (to completion). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Expected duration of study on each individual subject. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 5. a) Please indicate source of funding. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Has funding been approved? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 6 Subject information. p.9204559: a) Group: Patients Students p.9204559: Others p.9204559: b) Records: Children & women p.9204559: c) Age range: One year and above p.9204559: p.9204559: p.9204559: p.9204559: d) Gender: p.9204559: Male p.9204559: Female p.9204559: Both p.9204559: p.9204559: e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it includes foetal research, give p.9204559: brief explanation of need to use this group. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-5/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 7. Criteria for inclusion and exclusion of patients and controls (type separate). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 8. a) Compensation (to research subject): p.9204559: Monetary: No Yes Amount: p.9204559: Other: No Yes Specify: p.9204559: p.9204559: Reimbursement of No expenses: p.9204559: Yes p.9204559: Type & amount: p.9204559: p.9204559: b) Compensation (to Investigators): p.9204559: Yes No p.9204559: p.9204559: If yes then p.9204559: Monetary: Travel: Gifts: Amount: As per govt. Rules Other p.9204559: Specify: -NA- p.9204559: p.9204559: Q 9. Adverse effects: p.9204559: a) Describe adverse effects/risks expected to the subjects during the study? p.9204559: p.9204559: p.9204559: p.9204559: b) What is the provision for managing these effects? p.9204559: p.9204559: p.9204559: p.9204559: c) Who will pay for them? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 10. In cases where therapeutic need of the research subject is identified during the course of the study: p.9204559: a) What is the provision for managing these cases? p.9204559: p.9204559: p.920455Searching for indicator physically:
(return to top) sb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Guidelines for drafting an informed consent form p.9204559: Although a sample of informed consent form is attached, additional guidelines are given here in order to help and p.9204559: facilitate the researchers in drafting a proper, acceptable consent form. p.9204559: p.9204559: 1. All studies involving human subjects should have a properly drafted consent form. No study should be done on p.9204559: human subjects without obtaining informed consent and sufficiently before the start of the study, at an appropriate p.9204559: time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand p.9204559: the study. p.9204559: 2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the p.9204559: person taking the consent and witnessed by a second person. p.9204559: 3. In case of children, an assent form from children and consent from guardian / parents is needed. p.9204559: 4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian p.9204559: or close relative p.9204559: 5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in p.9204559: certain cases), and governmental officials should be taken into confidence, and a written consent should p.9204559: be obtained. p.9204559: 6. In case of doing a study in other locations such as other hospitals and clinics, permission p.9204559: from appropriate authority or physicians should also be obtained. p.9204559: 7. The consent form should be in English and Urdu with translation into other local language if needed. These p.9204559: should be identical in such a way that the translation of one into other is similar. The language should be easy which p.9204559: can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided. p.9204559: 8. It should be written in “second or third person” and not in “first person”. For example, “You will be asked p.9204559: to give 10 cc blood” or “you will be asked few questions” etc. p.9204559: 9. A properly drafted consent form should contain the following important points. p.9204559: p.9204559: a) Information sheet. There should be one paragraph or page giving information aboSearching for indicator pregnant:
(return to top) he study) p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-4/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 2. The objectives of the study p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q3 Brief description of methods used in protocol. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 4. a) Expected duration of the study period (to completion). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Expected duration of study on each individual subject. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 5. a) Please indicate source of funding. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Has funding been approved? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 6 Subject information. p.9204559: a) Group: Patients Students p.9204559: Others p.9204559: b) Records: Children & women p.9204559: c) Age range: One year and above p.9204559: p.9204559: p.9204559: p.9204559: d) Gender: p.9204559: Male p.9204559: Female p.9204559: Both p.9204559: p.9204559: e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it includes foetal research, give p.9204559: brief explanation of need to use this group. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-5/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 7. Criteria for inclusion and exclusion of patients and controls (type separate). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 8. a) Compensation (to research subject): p.9204559: Monetary: No Yes Amount: p.9204559: Other: No Yes Specify: p.9204559: p.9204559: Reimbursement of No expenses: p.9204559: Yes p.9204559: Type & amount: p.9204559: p.9204559: b) Compensation (to Investigators): p.9204559: Yes No p.9204559: p.9204559: If yes then p.9204559: Monetary: Travel: Gifts: Amount: As per govt. Rules Other p.9204559: Specify: -NA- p.9204559: p.9204559: Q 9. Adverse effects: p.9204559: a) Describe adverse effects/risks expected to the subjects during the study? p.9204559: p.9204559: p.9204559: p.9204559: b) What is the provision for managing these effects? p.9204559: p.9204559: p.9204559: p.9204559: c) Who will pay for them? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 10. In cases where therapeutic need of the research subject is identified dSearching for indicator injured:
(return to top) e participation will be p.9204559: communicated to you.” p.9204559: o If applicable, state that a particular treatment or procedure may involve risks that are currently p.9204559: unforeseeable (to the subject, embryo or fetus, for example.) p.9204559: p.9204559: 4. POSSIBLE BENEFITS p.9204559: o Describe any benefits to the subject that may be reasonably expected. If the research is not of direct benefit to p.9204559: the participant, explain possible benefits to others. p.9204559: p.9204559: 5. FINANCIAL CONSIDERATIONS p.9204559: o Explain any financial compensation involved or state: “There is no financial compensation for your participation p.9204559: in this research.” p.9204559: o Describe any additional costs to the subject that might result from participation in this study. p.9204559: o Please indicate any financial benefits to the subjects including therapeutic or diagnostic costs being covered by p.9204559: the study. p.9204559: p.9204559: 6. AVAILABLE TREATMENT ALTERNATIVES p.9204559: o If the procedure involves an experimental treatment, indicate whether other non-experimental (conventional) p.9204559: treatments are available and compare the relative risks (if known) of each. p.9204559: p.9204559: 7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES p.9204559: o “This study involves (minimal risk) (greater than minimal risk).” In the event that greater than p.9204559: minimal risk is involved, provide the subject with the following information. p.9204559: o If you are injured as a direct result of taking part in this research study, emergency medical care will be p.9204559: provided by [name] medical staff or by transporting you to your personal doctor or medical center. Indicate who will p.9204559: pay for this treatment. p.9204559: p.9204559: 8. CONFIDENTIALITY p.9204559: o Describe the extent to which confidentiality of records identifying the subject will be maintained. p.9204559: “Your identity in this study will be treated as confidential. The results of the study, including laboratory or any p.9204559: other data, may be published for scientific purposes but will not give your name or include any identifiable references p.9204559: to you.” p.9204559: p.9204559: 9. TERMINATION OF RESEARCH STUDY p.9204559: You are free to choose whether or not to participate in this study. There will be no penalty or loss of benefits to p.9204559: which you are otherwise entitled if you choose not to participate. You will be provided with any significant new p.9204559: findings developed during the course of this study that may relate to or influence your willingness to p.9204559: continue participation. In the event you decide to discontinue your participation in the study, p.9204559: o These are the potential consequences that may result: (list) p.9204559: o Please notify (name, telephone no., etc.) of your decision or follow this procedure (describe), so that your p.9204559: participation can be orderly terminated. p.9204559: In addition, your participation in the study may be terminated by the investigator without your consent p.9204559: under the following circumstances. (Describe) It may be necessary for the sponsor of the study to terminate the p.920455Searching for indicator child:
(return to top) ghtGray">Consent document must be clearly written and understandable to subjects. The language must be p.9204559: nontechnical (comparable to the language in a newspapers or general circulation magazine), and scientific, technical or p.9204559: medical terms must be plainly defined. p.9204559: p.9204559: Informed Consent, whether oral or written, may not include language that appears to waive subjects’ legal rights or p.9204559: appears to release the investigators or anyone else from liability for negligence. p.9204559: p.9204559: 1. PURPOSE OF THIS RESEARCH STUDY p.9204559: o Include 3-5 sentences written in nontechnical language. “You are being asked to participate in a research study p.9204559: designed to...” p.9204559: p.9204559: 2. PROCEDURES p.9204559: o Describe procedures: “You will be asked to do...” p.9204559: o Identify any procedures that are experimental/investigational/non-therapeutic. p.9204559: o Define expected duration of subject's participation. p.9204559: o Indicate type and frequency of monitoring during and after the study. p.9204559: p.9204559: 3. POSSIBLE RISKS OR DISCOMFORT p.9204559: Note that these include not only physical injury, but also possible psychological, social or economic harm, discomfort, p.9204559: or inconvenience. p.9204559: o Describe known or possible risks. If unknown, state so. p.9204559: o Indicate if there are special risks to women of child bearing age; if relevant, state that study may involve p.9204559: risks that are currently unforeseeable, e.g., to developing fetus p.9204559: o If subject's participation will continue over time, state: “any new information developed p.9204559: Page-11/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: during the study that may affect your willingness to continue participation will be p.9204559: communicated to you.” p.9204559: o If applicable, state that a particular treatment or procedure may involve risks that are currently p.9204559: unforeseeable (to the subject, embryo or fetus, for example.) p.9204559: p.9204559: 4. POSSIBLE BENEFITS p.9204559: o Describe any benefits to the subject that may be reasonably expected. If the research is not of direct benefit to p.9204559: the participant, explain possible benefits to others. p.9204559: p.9204559: 5. FINANCIAL CONSIDERATIONS p.9204559: o Explain any financial compensation involved or state: “There is no financial compensation for your participation p.9204559: in this research.” p.9204559: o Describe any additional costs to the subject that might result from participation in this study. p.9204559: o Please indicate any financial benefits to the subjects including therapeutic or diagnostic costs being covered by p.9204559: the study. p.9204559: p.9204559: 6.Searching for indicator children:
(return to top) 9: d) Non-approved use or non-approved dose for approved drugs p.9204559: e) Experimental surgical procedures p.9204559: f) Fetal research p.9204559: g) Behavioral research p.9204559: h) Gene molecular cloning p.9204559: i) Community research Other (please specify): p.9204559: p.9204559: Please provide details in case a or d is checked p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 1. What is the purpose of the study? (Please give a brief background of the study) p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-4/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 2. The objectives of the study p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q3 Brief description of methods used in protocol. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 4. a) Expected duration of the study period (to completion). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Expected duration of study on each individual subject. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 5. a) Please indicate source of funding. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Has funding been approved? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 6 Subject information. p.9204559: a) Group: Patients Students p.9204559: Others p.9204559: b) Records: Children & women p.9204559: c) Age range: One year and above p.9204559: p.9204559: p.9204559: p.9204559: d) Gender: p.9204559: Male p.9204559: Female p.9204559: Both p.9204559: p.9204559: e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it includes foetal research, give p.9204559: brief explanation of need to use this group. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-5/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 7. Criteria for inclusion and exclusion of patients and controls (type separate). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 8. a) Compensation (to research subject): p.9204559: Monetary: No Yes Amount: p.9204559: Other: No Yes Specify: p.9204559: p.9204559: Reimbursement of No expenses: p.9204559: Yes p.9204559: Type & amount: p.9204559: p.9204559: b) Compensation (to Investigators): p.9204559: Yes No p.9204559: p.9204559: If yes then p.9204559: Monetary: Travel: Gifts: Amount: As per govt. Rules Other p.9204559: Specify: -NA- p.9204559: p.9204559: Q 9. Adverse effects: p.9204559: a) Describe adverse effects/risks expected to the subjects during the study? p.9204559: p.9204559: p.9204559: p.9204559: b) What is the provision for managing these effects? p.9204559: p.9204559: p.9204559: p.9204559: c) Who will pay for them? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 10. In cSearching for indicator fetus:
(return to top) a newspapers or general circulation magazine), and scientific, technical or p.9204559: medical terms must be plainly defined. p.9204559: p.9204559: Informed Consent, whether oral or written, may not include language that appears to waive subjects’ legal rights or p.9204559: appears to release the investigators or anyone else from liability for negligence. p.9204559: p.9204559: 1. PURPOSE OF THIS RESEARCH STUDY p.9204559: o Include 3-5 sentences written in nontechnical language. “You are being asked to participate in a research study p.9204559: designed to...” p.9204559: p.9204559: 2. PROCEDURES p.9204559: o Describe procedures: “You will be asked to do...” p.9204559: o Identify any procedures that are experimental/investigational/non-therapeutic. p.9204559: o Define expected duration of subject's participation. p.9204559: o Indicate type and frequency of monitoring during and after the study. p.9204559: p.9204559: 3. POSSIBLE RISKS OR DISCOMFORT p.9204559: Note that these include not only physical injury, but also possible psychological, social or economic harm, discomfort, p.9204559: or inconvenience. p.9204559: o Describe known or possible risks. If unknown, state so. p.9204559: o Indicate if there are special risks to women of child bearing age; if relevant, state that study may involve p.9204559: risks that are currently unforeseeable, e.g., to developing fetus p.9204559: o If subject's participation will continue over time, state: “any new information developed p.9204559: Page-11/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: during the study that may affect your willingness to continue participation will be p.9204559: communicated to you.” p.9204559: o If applicable, state that a particular treatment or procedure may involve risks that are currently p.9204559: unforeseeable (to the subject, embryo or fetus, for example.) p.9204559: p.9204559: 4. POSSIBLE BENEFITS p.9204559: o Describe any benefits to the subject that may be reasonably expected. If the research is not of direct benefit to p.9204559: the participant, explain possible benefits to others. p.9204559: p.9204559: 5. FINANCIAL CONSIDERATIONS p.9204559: o Explain any financial compensation involved or state: “There is no financial compensation for your participation p.9204559: in this research.” p.9204559: o Describe any additional costs to the subject that might result from participation in this study. p.9204559: o Please indicate any financial benefits to the subjects including therapeutic or diagnostic costs being covered by p.9204559: the study. p.9204559: p.9204559: 6. AVAILABLE TREATMENT ALTERNATIVES p.9204559: o If the procedure involves an experimental treatment, indicate whether other non-experimental (conventional) p.9204559: treatments are available and compare the relative risks (if known) of each. p.9204559: p.9204559: 7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES p.9204559: o “This study involves (minimal risk) (greater than minimal risk).” In the event that greater than p.9204559: minimal risk is involved, provide the subject with the following information. p.9204559: o If you are injured as a direct result of taking part in this research study, emergency medical care will be p.9204559: provided by [name] medical staff or by transporting you to your personal doctor or medical center. Indicate who will p.9204559: pay for this treatment. p.9204559: p.9204559: 8. CONFIDENTIALITY p.9Searching for indicator language:
(return to top) p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Secretariat p.9204559: Pakistan Medical Research Council Shahrah-e-Jamhuriat, off Constitution Avenue p.9204559: Sector G-5/ 2 Islamabad p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-1/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: National Bioethics Committee Government of Pakistan p.9204559: Ministry of National Health Services, Regulations and Coordination p.9204559: p.9204559: ETHICAL REVIEW APPLICATION FORM p.9204559: p.9204559: Note: (All research projects must be submitted to NBC secretariat, located at Shahrah-e-Jamhuriat off Constitution. p.9204559: Avenue, Sector G-5/ 2 Islamabad) p.9204559: Checklist p.9204559: p.9204559: This checklist is prepared in order to facilitate an investigator in preparing a complete application and to help p.9204559: Research Ethical Committee of National Bioethics Committee for expedited review. Your cooperation in completing it p.9204559: will be highly appreciated. p.9204559: p.9204559: PRINCIPAL INVESTIGATOR’S NAME: p.9204559: p.9204559: DESIGNATION: p.9204559: p.9204559: DEPARTMENT: p.9204559: p.9204559: One copy of ERC Application form with checklist One copy of Research Protocol in standard format p.9204559: A copy of Drug Brochure or any supplementary information enclosed (if applicable). p.9204559: p.9204559: One copy of informed consent in English and Urdu or any other local language of the population study. p.9204559: p.9204559: One copy of Questionnaire in English and Urdu administered during the study (if applicable). Please make a copy of this p.9204559: entire application for your files. p.9204559: I have submitted the application form, research protocol and informed consent with Urdu translation by e-mail. p.9204559: p.9204559: p.9204559: Signature: Principal Investigator Date p.9204559: p.9204559: p.9204559: Signature of supervisor (if applicable) Date p.9204559: p.9204559: p.9204559: Signature of Chairman of the Department Date p.9204559: p.9204559: p.9204559: Page-2/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: National Bioethics Committee Government of Pakistan p.9204559: Ministry of National Health Services, Regulations and Coordination p.9204559: p.9204559: Instructions / guidelines for researchers: p.9204559: p.9204559: 1. Please answer all questions. It is the responsibility of researcher to fill the application p.9204559: form appropriately. Incompletely and inappropriately filled form will not be accepted/ considered for review p.9204559: and discussion in the meeting. This may result in delay in approval of the proposal. p.9204559: p.9204559: 2. In case of urgency, a strong justification should be provided for an extra expedited review p.9204559: and approval such as meeting a dead line for funding etc. Even in case of expedited, review it may take 6 weeks in p.9204559:Searching for indicator religious:
(return to top) in drafting a proper, acceptable consent form. p.9204559: p.9204559: 1. All studies involving human subjects should have a properly drafted consent form. No study should be done on p.9204559: human subjects without obtaining informed consent and sufficiently before the start of the study, at an appropriate p.9204559: time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand p.9204559: the study. p.9204559: 2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the p.9204559: person taking the consent and witnessed by a second person. p.9204559: 3. In case of children, an assent form from children and consent from guardian / parents is needed. p.9204559: 4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian p.9204559: or close relative p.9204559: 5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in p.9204559: certain cases), and governmental officials should be taken into confidence, and a written consent should p.9204559: be obtained. p.9204559: 6. In case of doing a study in other locations such as other hospitals and clinics, permission p.9204559: from appropriate authority or physicians should also be obtained. p.9204559: 7. The consent form should be in English and Urdu with translation into other local language if needed. These p.9204559: should be identical in such a way that the translation of one into other is similar. The language should be easy which p.9204559: can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided. p.9204559: 8. It should be written in “second or third person” and not in “first person”. For example, “You will be asked p.9204559: to give 10 cc blood” or “you will be asked few questions” etc. p.9204559: 9. A properly drafted consent form should contain the following important points. p.9204559: p.9204559: a) Information sheet. There should be one paragraph or page giving information about the nature of p.9204559: study, its purpose and need, possible benefits of the study, and procedures to be carried out on the study subjects. p.9204559: b) Possible risks and benefits to the study subjects p.9204559: c) Availability of alternate treatment in case of therapeutic trials p.9204559: d) Voluntary participation without any compulsion, moral or otherwise and without any financial p.9204559Searching for indicator student:
(return to top) 4559: entire application for your files. p.9204559: I have submitted the application form, research protocol and informed consent with Urdu translation by e-mail. p.9204559: p.9204559: p.9204559: Signature: Principal Investigator Date p.9204559: p.9204559: p.9204559: Signature of supervisor (if applicable) Date p.9204559: p.9204559: p.9204559: Signature of Chairman of the Department Date p.9204559: p.9204559: p.9204559: Page-2/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: National Bioethics Committee Government of Pakistan p.9204559: Ministry of National Health Services, Regulations and Coordination p.9204559: p.9204559: Instructions / guidelines for researchers: p.9204559: p.9204559: 1. Please answer all questions. It is the responsibility of researcher to fill the application p.9204559: form appropriately. Incompletely and inappropriately filled form will not be accepted/ considered for review p.9204559: and discussion in the meeting. This may result in delay in approval of the proposal. p.9204559: p.9204559: 2. In case of urgency, a strong justification should be provided for an extra expedited review p.9204559: and approval such as meeting a dead line for funding etc. Even in case of expedited, review it may take 6 weeks in p.9204559: granting approval. p.9204559: p.9204559: 3. Application must be signed by PI. In case of student’s/ resident’s application, it should also p.9204559: be signed by supervisor. p.9204559: p.9204559: 4. For Q.1, please give a brief background of the study indicating the need for this study. p.9204559: p.9204559: 5. For Q.3, please do not give details of laboratory or scientific procedures. Only mention the p.9204559: procedures to be carried out on human subjects such as blood, body fluid collection or biopsy and storage of these p.9204559: samples, treatment to be provided to study subjects, observations, interviews, focus group discussions etc. p.9204559: p.9204559: 6. For Q.8, only direct compensations should be mentioned. Traveling in connection of studies and p.9204559: presentation should not be included here. p.9204559: p.9204559: 7. For Q.9, All possible adverse events that are likely to occur as a result of the study p.9204559: should be included, with a plan to help the patient get appropriate treatment. p.9204559: p.9204559: 8. Consent form must be attached. Separate guidelines are given for drafting consent form which p.9204559: should be strictly followed. In case of improperly drafted consent form or its absence on preliminary scrutiny, no p.9204559: application will be considered for discussion in the meeting. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-3/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51Searching for indicator women:
(return to top) ugs p.9204559: e) Experimental surgical procedures p.9204559: f) Fetal research p.9204559: g) Behavioral research p.9204559: h) Gene molecular cloning p.9204559: i) Community research Other (please specify): p.9204559: p.9204559: Please provide details in case a or d is checked p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 1. What is the purpose of the study? (Please give a brief background of the study) p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-4/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 2. The objectives of the study p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q3 Brief description of methods used in protocol. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 4. a) Expected duration of the study period (to completion). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Expected duration of study on each individual subject. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 5. a) Please indicate source of funding. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Has funding been approved? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 6 Subject information. p.9204559: a) Group: Patients Students p.9204559: Others p.9204559: b) Records: Children & women p.9204559: c) Age range: One year and above p.9204559: p.9204559: p.9204559: p.9204559: d) Gender: p.9204559: Male p.9204559: Female p.9204559: Both p.9204559: p.9204559: e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it includes foetal research, give p.9204559: brief explanation of need to use this group. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-5/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 7. Criteria for inclusion and exclusion of patients and controls (type separate). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 8. a) Compensation (to research subject): p.9204559: Monetary: No Yes Amount: p.9204559: Other: No Yes Specify: p.9204559: p.9204559: Reimbursement of No expenses: p.9204559: Yes p.9204559: Type & amount: p.9204559: p.9204559: b) Compensation (to Investigators): p.9204559: Yes No p.9204559: p.9204559: If yes then p.9204559: Monetary: Travel: Gifts: Amount: As per govt. Rules Other p.9204559: Specify: -NA- p.9204559: p.9204559: Q 9. Adverse effects: p.9204559: a) Describe adverse effects/risks expected to the subjects during the study? p.9204559: p.9204559: p.9204559: p.9204559: b) What is the provision for managing these effects? p.9204559: p.9204559: p.9204559: p.9204559: c) Who will pay for them? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 10. In cases where therapeutic need of the research subject is identified during the course of the study: p.9204559: a) What is the proSearching for indicator embryo:
(return to top) Describe procedures: “You will be asked to do...” p.9204559: o Identify any procedures that are experimental/investigational/non-therapeutic. p.9204559: o Define expected duration of subject's participation. p.9204559: o Indicate type and frequency of monitoring during and after the study. p.9204559: p.9204559: 3. POSSIBLE RISKS OR DISCOMFORT p.9204559: Note that these include not only physical injury, but also possible psychological, social or economic harm, discomfort, p.9204559: or inconvenience. p.9204559: o Describe known or possible risks. If unknown, state so. p.9204559: o Indicate if there are special risks to women of child bearing age; if relevant, state that study may involve p.9204559: risks that are currently unforeseeable, e.g., to developing fetus p.9204559: o If subject's participation will continue over time, state: “any new information developed p.9204559: Page-11/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: during the study that may affect your willingness to continue participation will be p.9204559: communicated to you.” p.9204559: o If applicable, state that a particular treatment or procedure may involve risks that are currently p.9204559: unforeseeable (to the subject, embryo or fetus, for example.) p.9204559: p.9204559: 4. POSSIBLE BENEFITS p.9204559: o Describe any benefits to the subject that may be reasonably expected. If the research is not of direct benefit to p.9204559: the participant, explain possible benefits to others. p.9204559: p.9204559: 5. FINANCIAL CONSIDERATIONS p.9204559: o Explain any financial compensation involved or state: “There is no financial compensation for your participation p.9204559: in this research.” p.9204559: o Describe any additional costs to the subject that might result from participation in this study. p.9204559: o Please indicate any financial benefits to the subjects including therapeutic or diagnostic costs being covered by p.9204559: the study. p.9204559: p.9204559: 6. AVAILABLE TREATMENT ALTERNATIVES p.9204559: o If the procedure involves an experimental treatment, indicate whether other non-experimental (conventional) p.9204559: treatments are available and compare the relative risks (if known) of each. p.9204559: p.9204559: 7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES p.9204559: o “This study involves (minimal risk) (greater than minimal risk).” In the event that greater than p.9204559: minimal risk is involved, provide the subject with the following information. p.9204559: o If you are injured as a direct result of taking part in this research study, emergency medical care will be p.9204559: provided by [name] medical staff or by transporting you to your personal doctor or medical center. Indicate who will p.9204559: pay for thisSearching for indicator gender:
(return to top) e specify): p.9204559: p.9204559: Please provide details in case a or d is checked p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 1. What is the purpose of the study? (Please give a brief background of the study) p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-4/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 2. The objectives of the study p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q3 Brief description of methods used in protocol. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 4. a) Expected duration of the study period (to completion). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Expected duration of study on each individual subject. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 5. a) Please indicate source of funding. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: b) Has funding been approved? p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 6 Subject information. p.9204559: a) Group: Patients Students p.9204559: Others p.9204559: b) Records: Children & women p.9204559: c) Age range: One year and above p.9204559: p.9204559: p.9204559: p.9204559: d) Gender: p.9204559: Male p.9204559: Female p.9204559: Both p.9204559: p.9204559: e) If subjects are children, pregnant women, mentally retarded, or prisoners, or if it includes foetal research, give p.9204559: brief explanation of need to use this group. p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Page-5/13 p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Q 7. Criteria for inclusion and exclusion of patients and controls (type separate). p.9204559: p.9204559: p.9204559: p.9204559: p.9204559: Q 8. a) Compensation (to research subject): p.9204559: Monetary: No Yes Amount: p.9204559: Other: No Yes Specify: p.9204559: p.9204559: Reimbursement of No expenses: p.9204559: Yes p.9204559: Type & amount: p.9204559: p.9204559: b) Compensation (to Investigators): p.9204559: Yes No p.9204559: p.9204559: If yes then p.9204559: Monetary: Travel: Gifts: Amount: As per govt. Rules Other p.9204559: Specify: -NA- p.9204559: p.9204559: Q 9. Adverse effects: p.9204559: a) Describe adverse effects/risks expected to the subjects during the study? p.9204559: p.9204559: p.9204559: p.9204559: b) What is the provision for managing these effects? p.92Searching for indicator parents:
(return to top) p.9204559: NBC Secretariat: Pakistan Medical Research Council, Shahrah-e- Jamhuriat, Off Constitution Avenue, Sector G-5/2, p.9204559: Islamabad. www.pmrc.org.pk, email: pmrc@isb.comsats.net.pk, Tel: +92-51-9207386, 9216793, 9205480, Fax: 051-9216774, p.9204559: 9204559 p.9204559: p.9204559: Guidelines for drafting an informed consent form p.9204559: Although a sample of informed consent form is attached, additional guidelines are given here in order to help and p.9204559: facilitate the researchers in drafting a proper, acceptable consent form. p.9204559: p.9204559: 1. All studies involving human subjects should have a properly drafted consent form. No study should be done on p.9204559: human subjects without obtaining informed consent and sufficiently before the start of the study, at an appropriate p.9204559: time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand p.9204559: the study. p.9204559: 2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the p.9204559: person taking the consent and witnessed by a second person. p.9204559: 3. In case of children, an assent form from children and consent from guardian / parents is needed. p.9204559: 4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian p.9204559: or close relative p.9204559: 5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in p.9204559: certain cases), and governmental officials should be taken into confidence, and a written consent should p.9204559: be obtained. p.9204559: 6. In case of doing a study in other locations such as other hospitals and clinics, permission p.9204559: from appropriate authority or physicians should also be obtained. p.9204559: 7. The consent form should be in English and Urdu with translation into other local language if needed. These p.9204559: should be identical in such a way that the translation of one into other is similar. The language should be easy which p.9204559: can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided. p.9204559: 8. It should be written in “second or third person” and not in “first person”. For example, “You will be asked p.9204559: to give 10 cc blood” or “you will be asked few questions” etc. p.9204559: 9. A properly drafted consent ...Searching for indicator incapacitated:
(return to top) 216774, p.9204559: 9204559 p.9204559: p.9204559: Guidelines for drafting an informed consent form p.9204559: Although a sample of informed consent form is attached, additional guidelines are given here in order to help and p.9204559: facilitate the researchers in drafting a proper, acceptable consent form. p.9204559: p.9204559: 1. All studies involving human subjects should have a properly drafted consent form. No study should be done on p.9204559: human subjects without obtaining informed consent and sufficiently before the start of the study, at an appropriate p.9204559: time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand p.9204559: the study. p.9204559: 2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the p.9204559: person taking the consent and witnessed by a second person. p.9204559: 3. In case of children, an assent form from children and consent from guardian / parents is needed. p.9204559: 4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian p.9204559: or close relative p.9204559: 5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in p.9204559: certain cases), and governmental officials should be taken into confidence, and a written consent should p.9204559: be obtained. p.9204559: 6. In case of doing a study in other locations such as other hospitals and clinics, permission p.9204559: from appropriate authority or physicians should also be obtained. p.9204559: 7. The consent form should be in English and Urdu with translation into other local language if needed. These p.9204559: should be identical in such a way that the translation of one into other is similar. The language should be easy which p.9204559: can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided. p.9204559: 8. It should be written in “second or third person” and not in “first person”. For example, “You will be asked p.9204559: to give 10 cc blood” or “you will be asked few questions” etc. p.9204559: 9. A properly drafted consent form should contain the following important points. p.9204559: p.9204559: a) Information sheet. There should be one paragraph or page giving information about the nature of p.9204559: study, its purpose and need, possible beSearching for indicator emergency:
(return to top) ar treatment or procedure may involve risks that are currently p.9204559: unforeseeable (to the subject, embryo or fetus, for example.) p.9204559: p.9204559: 4. POSSIBLE BENEFITS p.9204559: o Describe any benefits to the subject that may be reasonably expected. If the research is not of direct benefit to p.9204559: the participant, explain possible benefits to others. p.9204559: p.9204559: 5. FINANCIAL CONSIDERATIONS p.9204559: o Explain any financial compensation involved or state: “There is no financial compensation for your participation p.9204559: in this research.” p.9204559: o Describe any additional costs to the subject that might result from participation in this study. p.9204559: o Please indicate any financial benefits to the subjects including therapeutic or diagnostic costs being covered by p.9204559: the study. p.9204559: p.9204559: 6. AVAILABLE TREATMENT ALTERNATIVES p.9204559: o If the procedure involves an experimental treatment, indicate whether other non-experimental (conventional) p.9204559: treatments are available and compare the relative risks (if known) of each. p.9204559: p.9204559: 7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES p.9204559: o “This study involves (minimal risk) (greater than minimal risk).” In the event that greater than p.9204559: minimal risk is involved, provide the subject with the following information. p.9204559: o If you are injured as a direct result of taking part in this research study, emergency medical care will be p.9204559: provided by [name] medical staff or by transporting you to your personal doctor or medical center. Indicate who will p.9204559: pay for this treatment. p.9204559: p.9204559: 8. CONFIDENTIALITY p.9204559: o Describe the extent to which confidentiality of records identifying the subject will be maintained. p.9204559: “Your identity in this study will be treated as confidential. The results of the study, including laboratory or any p.9204559: other data, may be published for scientific purposes but will not give your name or include any identifiable references p.9204559: to you.” p.9204559: p.9204559: 9. TERMINATION OF RESEARCH STUDY p.9204559: You are free to choose whether or not to participate in this study. There will be no penalty or loss of benefits to p.9204559: which you are otherwise entitled if you choose not to participaSearching for indicator authority:
(return to top) e start of the study, at an appropriate p.9204559: time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand p.9204559: the study. p.9204559: 2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the p.9204559: person taking the consent and witnessed by a second person. p.9204559: 3. In case of children, an assent form from children and consent from guardian / parents is needed. p.9204559: 4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian p.9204559: or close relative p.9204559: 5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in p.9204559: certain cases), and governmental officials should be taken into confidence, and a written consent should p.9204559: be obtained. p.9204559: 6. In case of doing a study in other locations such as other hospitals and clinics, permission p.9204559: from appropriate authority or physicians should also be obtained. p.9204559: 7. The consent form should be in English and Urdu with translation into other local language if needed. These p.9204559: should be identical in such a way that the translation of one into other is similar. The language should be easy which p.9204559: can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided. p.9204559: 8. It should be written in “second or third person” and not in “first person”. For example, “You will be asked p.9204559: to give 10 cc blood” or “you will be asked few questions” etc. p.9204559: 9. A properly drafted consent form should contain the following important points. p.9204559: p.9204559: a) Information sheet. There should be one paragraph or page giving information about the nature of p.9204559: study, its purpose and need, possible benefits of the study, and procedures to be carried out on the study subjects. p.9204559: b) Possible risks and benefits to the study subjects p.9204559: c) Availability of alternate treatment in case of therapeutic trials p.9204559: d) Voluntary participation without any compulsion, moral or otherwise and without any financial p.9204559: incentive or coercion. However, financial assistance or reimbursement for time and traveling may/should be provided p.9204559: to study subjects; which should commensurate with the time spent, and should not be too high. p.9204559: e) Right to withdraw from the study at any time without affecting their rights and treatment. p.9204559: f) Confidentiality p.920| Indicator | Vulnerability |
|---|---|
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| drug | Drug Usage |
| embryo | embryo |
| emergency | Public Emergency |
| fetus | Fetus/Neonate |
| gender | gender |
| incapacitated | Incapacitated |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| parents | parents |
| physically | Physically Disabled |
| political | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| religious | Religion |
| student | Student |
| women | Women |
| Indicator | Peers |
|---|---|
| child | ['children'] |
| children | ['child'] |
| drug | ['influence'] |
| influence | ['drug'] |
coercion
consent
developing
harm
risk
volunteer
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|---|---|---|
| Political | Criminal Convictions | prisoners | 1 |
| Political | political affiliation | political | 1 |
| Health | Drug Usage | drug | 2 |
| Health | Drug Usage | influence | 1 |
| Health | Mentally Disabled | mentally | 2 |
| Health | Physically Disabled | physically | 1 |
| Health | Pregnant | pregnant | 1 |
| Health | injured | injured | 1 |
| Social | Age | age | 2 |
| Social | Child | child | 1 |
| Social | Child | children | 4 |
| Social | Fetus/Neonate | fetus | 2 |
| Social | Linguistic Proficiency | language | 7 |
| Social | Religion | religious | 1 |
| Social | Student | student | 1 |
| Social | Women | women | 3 |
| Social | embryo | embryo | 1 |
| Social | gender | gender | 1 |
| Social | parents | parents | 1 |
| General/Other | Incapacitated | incapacitated | 1 |
| General/Other | Public Emergency | emergency | 4 |
| General/Other | Relationship to Authority | authority | 1 |