CONSENT FORM - Web viewApplication Form. Application Form. Application Form. β-version....

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Application Ethical Review Committee (ERC) Punjab Medical College, Faisalabad Secretariat Pakistan Health Research Council Research Centre, Faisalabad Secretariat Ethical Review Committee Pakistan Health Research Council, Research Centre First Floor, Pathology Department, Punjab Medical College, Faisalabad, Pakistan Phone (92-41) 9210187 Fax: (92-41) 9210187 Email address: [email protected] Website: www.phrcfsd.wordpress.com

Transcript of CONSENT FORM - Web viewApplication Form. Application Form. Application Form. β-version....

Page 1: CONSENT FORM -    Web viewApplication Form. Application Form. Application Form. β-version. Secretariat Ethical Review Committee. Pakistan Health Research Council, Research Centre

Application Form

Ethical Review Committee (ERC)Punjab Medical College, Faisalabad

SecretariatPakistan Health Research Council

Research Centre, Faisalabad

Secretariat Ethical Review CommitteePakistan Health Research Council, Research Centre

First Floor, Pathology Department, Punjab Medical College, Faisalabad, PakistanPhone (92-41) 9210187 Fax: (92-41) 9210187 Email address: [email protected]

Website: www.phrcfsd.wordpress.com

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General Guidelines Researchers intended to work with human subjects are required to submit their research

studies for review by Ethical Review Committee (ERC). However, ERC will not, in any instance, entertain an application for a study that has already been started/completed.

Ethical Review Committee follows the Belmont Report and the Declaration of Helsinki as their baseline guidelines to review research proposals. Therefore, applicants are strongly encouraged to read both documents before applying for ethical review.

It is important that study expenses should not be borne by the study participants. Costs of drugs, laboratory investigations and any additional test should be paid from the study.

Studies unlikely to contribute significantly to the existing scientific knowledge are strongly discouraged and considered as waste of time and resources.

ERC application form can be downloaded from www.phrcfsd.wordpress.com/downloads/. An informal report, summarizing the whole research, might also be submitted to the

secretariat ERC at the end of research for record. Report must also include title of the study, name of the investigator and institutional affiliations. Report either could be submitted in hard form or could be sent electronically to: [email protected]

Non-duplication Certificate Only FCPS students are required to submit non-duplication certificate.

Informed Consent Informed consent is an essential part of research involving human subjects. It can be in

written, oral or audio-visual form. However, whenever non-written consent is obtained it should be documented and signed by the person obtaining informed consent and witnessed by another person. A prior approval must be taken from ERC for non-written informed consent. On the contrary, written informed consent is the preferred method and it should be prepared correctly and submitted along with the application form.

Informed consent is not just a signed document and it is not a one-time event. Rather it is a continuous process of shared decision-making between subject and the investigator.

Further guidelines related to informed consent are available at page 7 of this application form.

RESEARCH SYNOPSIS/PROPOSAL

It should start with the title page supplemented with following information: o Title of the synopsiso Name of the investigatoro Name of the supervisor (if any)/co-investigators (if any)o Details of the institute

Reference section should be correctly formatted according to standard guidelines.

RESEARCHER’S PRESENTATION

Every applicant has to deliver a 5-minutes PowerPoint presentation of his/her synopsis in front of Ethical Review Committee.

It is advised to keep notebook with you during your presentation to note down any suggestions/recommendations given by the ERC.

PowerPoint slides could be prepared according to guidelines “Key steps to an effective presentation” available at https://phrcfsd.wordpress.com/downloads/

~1~[Courtesy of PHRC, Faisalabad]

GUIDELINES

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RESEARCH PROPOSAL INFORMATION

1. Title of the study: Click here to enter text.

2. Details of Principal Investigator:

Name: Click here to enter text.

Designation: Click here to enter text.

Department: Click here to enter text.

Contact No.: Click here to enter text.

Email: Click here to enter text. Signatures of Principal Investigator

3. Details of the co-investigator(s)-if any:Name Designation Institutional Address

4. Details of Research Supervisor (if any):

Name: Click here to enter text.

Designation: Click here to enter text.

Department: Click here to enter text. Signatures of Research Supervisor

5. Details of Head of Department:

Name: Click here to enter text.

Designation: Click here to enter text.

Department: Click here to enter text. Signatures of Head of Department

~2~[Courtesy of PHRC, Faisalabad]

Please attach Curriculum Vitae (CV) of all the investigators with relevant publications (if any) in last 5 years.

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6. Proposed research study involves the use of: (Please fill the box with black color if macros does not work, as appropriate)

☐ Experimental Drug(s) ☐ Non-therapeutic research☐ Radioactive agents ☐ Experimental surgical procedure☐ Behavioral research ☐ Community research☐ Others (please specify) Click here to enter text.

7. Do your research study involve following subjects: Yes No(Please fill the box with black color if macros does not work, as appropriate)

☐ Pregnant women ☐ Children ☐ Elderly☐ Illiterate ☐ Fetus ☐ Handicapped☐ Terminally ill ☐ Poor ☐ Mentally challenged

8. Duration of the study: Click here to enter text.

9. Information about the sponsor(s)Name & Address: Click here to enter text.

Amount demanded/approved*: Click here to enter text.Amount PI will receive (p/m): Click here to enter text.Incentive for the participants: Click here to enter text.*Detailed budget must also be attached with the application in case of any sponsorship.

10. Is there any diagnostic test(s), part of your research study, which are not routinely done in the laboratory? If “yes”, please give detail. Please also mention who will bear the expenses.Click here to enter text.

11. How participants will benefit from this research?Click here to enter text.

12. How the institution will benefit from this research?Click here to enter text.

13. What are the risks/adverse effects possible to the research participants?Click here to enter text.

14. If adverse events happen, who would be responsible for managing them? Please give contact details.Click here to enter text.

~3~[Courtesy of PHRC, Faisalabad]

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Guidelines for the Informed Consent

1. Informed consent should be addressed to the research participants and not to the committee members.

2. The language of the informed consent should be kept simple, non-technical and understandable keeping in view the minimum literacy level of the study participants. Consent form in Urdu must be filled with utmost care. Rather than a word for word translation, the translation should capture the essence of the English version.

3. Informed consent could also be translated into other languages depending upon the language of the target population.

4. In case of minors (<16 years), informed consent should be obtained from their parents/legal guardians. A formal assent (child’s agreement) however could be obtained from children above the age of 9 years or as the threshold level set by ERC.

5. In case of mentally incapacitated patients, informed consent should be taken from their immediate relatives or legal guardians.

6. A sample Informed Consent is available at page number 6 and 7 of this application form to give an idea to the researcher about the layout of the informed consent. However, whenever required a separate informed consent could be prepared according to guidelines and attached with the application form.

Guidelines for drafting an informed consent

International bioethics guidelines requires that good informed consent should include following elements of information:

a. Project Informationi. Title of the study

ii. Name of the Investigatoriii. Name of the organizationiv. Source of Funding and complete breakdown of the budgetv. Duration of the study

b. Purpose of the studyBriefly explain the purpose of the research study

c. MethodologyDescribe any procedures involved in the research. Clearly identify the experimental procedures. If stored samples will be used further in different studies then it should be stated explicitly in the informed consent.

d. ConfidentialityDescribe how the confidentiality of the research subjects would be maintained. Especially in case of socially stigmatizing diseases like HIV-AIDS etc.

e. Possible benefits to the research participantsState any direct/indirect benefits to the research subject or to the society from your research. Benefits might include direct benefits like potential beneficial effects of an experimental drug or diagnostic test. Indirect benefits might include health related benefits, psychological benefits and kinship benefits.

~4~[Courtesy of PHRC, Faisalabad]

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f. Possible risks or discomforts to the research participantsState any physical, psychological, emotional, social and economic risks arising from research study.

g. Financial considerationsState any incentives offered, in addition to therapeutic and diagnostic costs, to the research participants.

h. Treatment alternativesExplain any alternative treatment options available. Compare both treatment options.

i. Right to Refuse to Participate and Withdrawal

j. For Further InformationGive contact details for further information.

k. Undertaking by the research participant

SUBMISSION CHECKLIST

Submission of Hard Copies

Hard copies of the following documents must be submitted to PHRC Research Centre, First Floor Pathology Department, Punjab Medical College, Faisalabad for review.

☐ ERC application☐ Informed consent in English (typewritten)☐ Informed consent in Urdu or any other local language (preferably composed in relevant

software, otherwise handwritten)☐ Research proposal/synopsis and/or Questionnaire☐ CV(s) of the investigator(s) with relevant publications (if any) in last 5 years

Submission of soft copies

Soft copies of the following documents must be mailed to: [email protected]

☐ ERC application + Informed consent in English (typewritten) ☐ Research proposal/synopsis and/or Questionnaire☐ PowerPoint presentation

~5~[Courtesy of PHRC, Faisalabad]

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Informed ConsentResearch DescriptionTitle of the Study Click here to enter text.Name of the Investigator Click here to enter text.Name of Organization Click here to enter text.Source of Funding Click here to enter text.Duration of the Study Click here to enter text.Purpose of the studyClick here to enter text.

MethodologyClick here to enter text.

ConfidentialityClick here to enter text.

Possible Benefits to the Research ParticipantsClick here to enter text.

Possible Risks to the Research ParticipantsClick here to enter text.

Right to Refuse to Participate and WithdrawalParticipation in this research study is voluntary and you may refuse to participate without any loss of benefits, which you are entitled. You have full right to withdraw anytime during the study. For Further InformationFor further details about the research study and the rights of the participants, please contact Name: Click here to enter text. Contact No.: Click here to enter text.

UNDERTAKING: I have read this consent form and fully understood it. I volunteer to participate in this research study. I understand that I will receive a copy of this form. I voluntarily choose to participate, but I understand that my consent does not take away any legal rights in the case of negligence or other legal fault of anyone who is involved in this study. I further understand that nothing in this consent form is intended to replace any applicable Federal/Provincial laws.

_______________________________ _________________________________Participant’s Name & Signatures/ Signatures of the witness in case of

thumb impression. thumb impression

______________________________Signatures of the Investigator and Date

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