Information Sheet prior to obtain Consent to act as a participant in a research study


A. Why is this research study being proposed?
A.1 - You have been asked to participate in a research study that investigates how your health related problems can be handled. It is collecting information like how the checkups are done, clinical tests are done or not done, what treatment is suggested; the level of relief you get through the existing health solutions and what needs to be improved.
A.2 – This scheme which is named “Health Account Scheme” is being implemented with collaboration of various Government Departments. Under the scheme one health diary will be given to you with instructions inside its cover. Instructions for writing in the diary correctly and completely will be explained. The design of the diary is such that it carries carbon sheets with every original sheet. Carbron copy will be retrieved from you and transported/sent for updating in computers. Periodic analysis will be done by Project Research Team to know the problems and health needs of the community for planning of services.
A.3 – In the above research study various Departments and stake holders are enlisted for coordination: Department of Health Research, National Institute of Health and Family Welfare, Department for Women and Child Development, Ministry of Human Resources Development, National Informatics Center, Ministry of Urban Development, Department of Rural Development and Department of Posts, in addition to District Administration, State Govt. besides NGOs, Self-Help Groups, Panchayats, Private Practitioners and Pharmacists in the study area.
A. 4 – Your district is selected for field-testing of this scheme. Therefore seek your co-operation and willingness for providing information during the survey. Information will be collected by study staff from your health diary and also in the questionnaire to assess your comfort level, Scheme’s efficacy in reflecting overall burden of diseases and needs for modifications in service delivery. The scheme envisages the following:
A.4 (1). Estimation and identification of the nature and extent of health problems in the study area.
A.4 (2). Collect information which can be utilized to address local needs.
A.4 (3). Assessment of improvement in awareness and health education level.
B. Who will know about my participation in this Study?
B.1 – The information obtained from you will be handled in confidential manner in which privacy is protected like other hospital medical records.
B.2 – Confidential Information obtained about you and your family will be encoded and kept confidential. Allocation of specific identity number and security of digital files will be ensured.
B.3 – The specific identify number on the carbon copies of the Diary collected from you will differentiate your records from others. Your name, address and other identification details will not be used in any transaction and analysis.
B.4 - The data and the outcome of the research will not be provided to relatives, personal physicians, Insurance Companies or third party unless your prior consent, in writing, has been obtained.
B.5 - Your identity or that of the members of your family will not be revealed in any description or publication emanating from the study. The research records of this research study may be summoned by an order of a Court of Law and may be inspected by regulatory authorities of the Government of India.
C. Who can take part in this Research study?
C.2 You can take part as you are permanent resident of the locality chosen for field evaluation of the scheme. Age and gender is no bar. For minors and those incapable of providing their own consent, consent will be obtained from parents and caretakers.
D:What procedures need to be performed for the purpose of the research?
After providing complete information of health accounting scheme to you, with your consent becoming available, following steps will be completed at your door/home/neighborhood or work place –
D.1-The Research officer will administer a questionnaire called the ‘ Health related Baseline Situation Analysis’. A short interview will be conducted to obtain basic information about your own health and physical conditions around you in the family, neighborhood/Mohalla. Assessment of facilities with regard to health care will be done.
D.2-Under the Health Account Scheme (HAS) all your relevant health information/diseases will be recorded/written in the diary. Staff/Officers working in the scheme and health volunteers will help you applying for and acquiring one diary and also to make you understand how you can write in it. You can fill the Diary yourself or get it filled by your health care provider.
D.3-H.A.S staff and the Department of Posts will together ensure transportation of the carbon copies of the Diary to its pre-determined destination after collecting it from you. You may also post it into the nearest Post-box. Postal stamps are not required.
D.4-You can ask as many questions as you desire or also suggest new ideas as and when it occurs to make the Scheme more beneficial. The diary will serve as primary source for keeping a comprehensive health record. It will give you information of health services (Govt. and Private) and counseling available within 5 Kilometer of your residence.
D.5-Relevant health information, educational material will be provided to you. Once satisfied, you can submit an application form to obtain the Diary. You will be provided application form that is called Health Accounting Scheme application form-(HASA). Monthly updating of the health status is to be done in the Diary. In case of NIL reporting of health problem, write OK in the column for that month. Monthly (HAS) camps in the first week of every month will be held for updating your Diary along with the facility to test Blood sugars, Haemoglobin, height, weight, pulse rate and general physical and symptomatic examination in addition to counseling & medications. This service will be avilable near you so that you need not to travel. HAS camps will be held in first week of every month from 5 to 8 am, which will not interfere with your work. You will be told the date and time beforehand.
D.6-Carbon copy of your Diaries will be collected every month and taken away for feeding data in computers that will update individual special account with your ID. You would also be able to update and see your account after you obtain password for your account. You can also make changes in your account data. At the end of one year of the scheme detailed evaluation of its benefits will be done by scheme staff.
D.7-What can be the possible side effects, risks and discomfort during the research study? Risk due to ‘Breach of Confidentiality’ –
D.8-Release or revelation by accident the information gathered about you is minimal at any stage during the research study. This information will not affect your employment, health insurance or relationships. Confidentiality of personal information about which you feel uncomfortable will be collected in a dignified and confidential manner in order to minimize embarrassment and inadvertent leakage to third party, including members of your family
F. What can be the possible benefits by participating in this research study?
F.1 – By participating in the study, you may take better care of your health. You will receive direct benefit by becoming more aware of issues relating to health and adequately informed about the status of your health and the facilities available to you. You will also be getting information about preventive measures, as well as health facilities available in the neighborhood. This diary entitles you to receive benefit of HAS screening camps for screening/ general checkups. Many health problems worsen in absence of right guidance and information. You can avail facilities like counseling and education of preventive methods to improve your health through health camps with Diary updating.
Your area will get customized health services, since it would be planned on the basis of information provided by persons like you and others from your area. The participation in the Scheme is free of cost.
G. Will I be told of any risks that might be detected/noticed during the course of the study?
G. 1 -Yes. If any serious health problem is anticipated from your health records provided by you then you will be informed in advance so that you can explore prevention.
H.Will my insurance provider or I be charged for the cost of any clinical procedures performed as part of this research study?
H.1 The Research Study will burden you neither financially nor will it have any conflict with the term and conditions of your insurance policy.
H.2 if I am ‘injured’ as a result of taking part in this study, will I be paid?
H.3 No, but your health problems will be addressed in nearest free Government hospital.
I.1 - This aspect will be dealt with as per the law of the land. And in case, any dispute arises, the jurisdiction for this purpose would be the Local/District Court.
J. Is my participation in this research study voluntary?
J.1 - Your participation in the research study is totally voluntary.
J.2 – If you do not agree to participate it will have no effect on your current or future relationship with the attending/consulting Health Care Providers in your area. You may refuse to participate or withdraw from participation at any time. If you refuse to participate in this study or withdraw from it, your decision will neither affect you nor become a cause of loss or benefits to which you are otherwise entitled.
L. Focus group discussion-
L.1-The focus group discussion will deal with the Health Account Scheme, its scope; benefits and suggestions for improving quality of care. (Details in annexure)