Rural Access Improvement and Decentralization Project (RAIDP)

Rural Access Improvement and Decentralization Project (RAIDP)

IMPLEMENTING PARTNER: SKY-Samaj Nepal
YEARS: 2012-2013
GRANT AMOUNT: $150,000
THEMES: Infrastructure

The Rural Access Improvement and Decentralization Project (RAIDP) aims to improve services related to health, education, agriculture and good governance in Nepal. Over the project period (2005 to 2013), over 2 million Nepalis have utilized improved rural transport infrastructures and services produced by the program, in turn enhancing their access to economic opportunities.

Despite the project’s success, there are known accountability and capacity issues that prevented the effectiveness of community based organizations (CBOs), including:

  • Inconsistent monitoring processes without clear responsibilities delegated to CBO members
  • Lack of CBO knowledge on the Environmental and Social Management Framework (ESMF)
  • No formal mechanism for grievance submission and redress; few (verbally submitted) grievances resolved
  • Insufficient training and ill defined CBO responsibilities in ensuring quality road construction
  • Lack of standard tools to measure road construction quality

Strategy
The objective of the CARTA sub-project was to strengthen the capacity of community based organizations (CBOs) to monitor the civil work and contract processes under RAIDP and to facilitate access to relevant agencies for grievances redress. The specific goals were to:

  • Support 80 CBOs to understand the policy and principles in the Environmental and Social Management Framework (ESMF), and their roles and responsibilities;
  • Capacitate CBOs for understanding quality of construction work by providing training based on specific training manual;
  • Capacitate the CBOs for monitoring the labor contract process and payment of the contractors;
  • Support the CBOs to collect and report grievances and to assist them in understanding any malpractice.

Results
The overall results of the sub-project were positive. Two surveys conducted provided comparison data that demonstrated increased knowledge and skill levels after training interventions. For instance, 97% of CBO members had knowledge of the Environmental and Social Management Framework (ESMF), compared to the 28% prior the sub-project implementation. Likewise, 92% of community based organization (CBO) members had knowledge of the quality of civil work and community monitoring methods, compared to 26% at the baseline. All CBOs received and discussed contract documents by the end of the sub-project, in contrast to 27% before CARTA. Prior to CARTA, CBOs were not assigned roles to monitor civil work and only 60% of road projects were displayed on the information boards. By the end of the sub-project, 84% of CBOs were assigned monitoring roles and 96% of the road projects were displayed on the boards.

In addition, there was major improvement on the number of recorded and redressed grievances. For example, before the intervention, all grievances were verbal and hardly ever addressed. At the end of the sub-project, 187 grievances were recorded, 89% of them being addressed. As a result of the increased number of valid filed grievances, the Local Development Officer and the District Technical Office chief carried out additional monitoring visits at the district level.

Lessons
Media mobilization and awareness raising activities created the demand for tools used in CARTA. For example, many community based organizations (CBOs) in non sub-project locations requested trainings on the Environmental and Social Management Framework (ESMF) and on the use of a Labor Based Toolkit (LBT). Responding to the demand, LBT activities were replicated in other RAIDP road projects. This newly created demand for capacity building activities reflects the intrinsic and extrinsic values of citizen empowerment that allows for communities to demand and contribute to better governance and service delivery.

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Combating Corruption and Unethical Behavior in Clinical Drug Trials in Kerala, India

IMPLEMENTING PARTNERS: JANANEETHI
YEARS: 2009-2010
GRANT AMOUNT: $17,000
THEMES: Health

Inadequate rules and regulations and poor or no government enforcement of these rules within the sector of clinical drug trials in Kerala State, India, have led a local CSO, JANANEETHI, to start investigating the field and research structural flaws that violate human rights and result in poor delivery of public health services. Through its actions, JANANEETHI has successfully engaged authorities to take up the issue and create awareness among stakeholders. Closing loopholes, eliciting an ethics debate and prompting government agencies to enforce and oversee drug trials have rendered JANANEETHI’s intervention highly successful. A second phase of the project is underway.

Corruption Problem Addressed
India has become a global hub for clinical drug trials on human subjects, reportedly worth $400 million USD and growing by over 30% per year. Until the 1990s, most clinical research was carried out in academic medical centers and financed by the Government. Recently, commercial interests have started dominating the drug trial scene in which the financial bottom-line can override ethical and human rights concerns. A number of factors are responsible for the current increase in drug trials conducted in India. These include the low cost of experiments, almost 60% less than comparable trials in Europe or the US, and access to a large pool of illiterate and relatively less educated patients with a wide variety of diseases. Trials became easier after the 2005 amendment of the Drugs and Cosmetics Act of 1940 permitting concurrent trials. These factors and the absence of specific laws to protect patients have lead to widespread corruption in clinical drug trials.

Rampant corruption has been alleged from the highest policy level down to local institutions. The regulatory mechanism is steered from the drug controller’s office at the center with little involvement and control at the local levels. Bioequivalence trials offer participants large payments in violation of existing ethical guidelines inducing poor people to risk their lives. At present, sound and ethical clinical trials depends mostly on personal integrity and honesty of the investigator concerned.  While corruption is so widespread, there are no specific laws to prosecute illegal or unethical activities.

Actions Taken by JANANEETHI
During the first phase of the project, JANANEETHI focused on identifying the problems in drug trials and the underlying structural weaknesses in the regulatory system. It identified five participants of drug trials and recorded their experience. In continuation, the CSO identified the weaknesses in the regulatory mechanism through personal interviews conducted with members of a variety of institutions, including medical colleges; ethics review boards, hospitals, staff and doctors responsible for the trials and others working on ethical standards of drug trials. The research exposed serious shortcomings and loopholes.

JANANEETHI felt that the Government of India had aggressively encouraged foreign drug trials without establishing necessary protective measures and without guaranteeing inadequate effective regulatory mechanisms.  JANANEETHI also felt that the Central Drugs Standard Control Organization (CDSCO), the principal regulatory agency, lacked capacity and/or the will to carry out its functions including the scientific review of trial protocols and monitoring the conduct of trials. Ethics committees were not adequately equipped or trained nor were they held accountable for their decisions. The confidentiality clause in the Indian Council for Medical Research (ICMR) guidelines indemnified the researchers who violated ethical norms and good practices while not protecting the privacy of trial participants. Physicians received huge incentives and payments to recruit trial subjects. Often patients would not know they were being used as test cases. Simultaneously, necessary medical treatments and compensations were denied or withheld for a growing number of trial related injuries and deaths occurring among the test population.

JANANEETHI has published a handbook on ethical standards of clinical trials for capacity-building purposes and undertook awareness raising activities with the full range of stakeholders involved, including briefing media representatives aiming to launch a state wide campaign on appropriate practices and ethical standards for drug trials reaching out to the public through radio programs, television and other media.

The CSO also reinforced existent outreach to medical professionals and members of various ethics committees, awareness raising classes for medical students and other affected parties. Project activities furthermore included: advocacy through presentations to government officials, Members of Parliament, the State Legislative Assembly and heads of medical institutions; select monitoring of drug trial activities; and coalition building among concerned institutions.

All these activities will be reinforced and strengthened in a follow-up to the first project phase to ensure sustainable results and make use of the successfully created momentum.

Impact and Results Achieved
JANANEETHI has successfully carried out an extensive investigation and has brought to surface the serious shortcomings, malpractices and violations of guidelines in the fast growing business of clinical drug trials in India. Its research has also shown that while there were a few guidelines, no specific law existed to enforce them and punish violators.

JANANEETHI has been highly successful in elevating the issue of corruption in drug trials to the national level. As a result, JANANEETHI was contacted and has submitted a report to the Human Rights Commission which is investigating rights violations in drug trials. JANANEETHI also participated in the first ever national consultation on the regulation of clinical trials which was held in collaboration with representatives from ICMR, World Health Organization, CDSCO, international medical research organizations and members of a Parliamentary Committee. While there was initial resistance on behalf of the authorities at first, constant pursuance and endurance on behalf of JANANEETHI has prompted officials as well as doctors and other stakeholders to constructively engage with the project and start furthering its objectives of realizing safe and ethical drug-testing.

JANANEETHI has succeeded as a whistleblower in Kerala, publicly challenging and protesting corrupt practices in drug trials.  JANANEETHI was promised by the Health Secretary of Kerala that strict measures would be taken to respect ethical practices in drug trials.  The second phase is expected to create further results in awareness building through campaigning for sound ethical practices under international accepted norms in clinical drug trials.

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Improving Public Health Service Delivery: Citizen Monitoring in Nepal

IMPLEMENTING PARTNER: SAMUHIK ABHIYAN (SA)
YEARS: 2010-2011
GRANT AMOUNT: $18,348
THEMES: Health

Poor service delivery or no service delivery at all in the area of public health have led a local CSO, SAMUHIK ABHIYAN (SA), to increase citizen awareness and participation in one municipality and two Village Development Committees (VDCs) in the Nuwakot District in Nepal. SA conducted surveys, mobilized the community and installed Corruption Monitoring Committees (CMCs) to increase transparency and hold authorities accountable. Through its actions, SA has successfully implemented the “Combating Corruption through Citizen Participation” project and is currently building on that success conducting a second phase with the objective to further institutionalize citizen oversight, ensuring that the existing government policies and regulations are implemented effectively.

Corruption Problem Addressed
Access to health and the quality of services delivered by hospitals, health posts and health sub-posts have been identified as serious impediments to human development in many parts of Nepal. Major problems include wide-spread malpractices and theft in the distribution of free medicines, causing shortages, and poor human resource management resulting in the absence of health workers and staff. Others include corruption in the delivery and distribution of travel allowances to expecting mothers, and a lack of development in health infrastructure, including the unavailability and poor maintenance of medical equipment. Furthermore, administrators of public health services frequently re-route citizens to avail of private healthcare services.

Actions Taken by SA
At the outset of the project’s first phase, SA organized a program to orient political leaders, media, civil society, and government departments to secure buy-in and ensure commitment to the project’s objectives. Following this coalition-building exercise, SA conducted a baseline survey with a sample of 625 respondents within the target community to identify the type of corruption observed and the resulting problems.

The survey revealed important information and documented that most citizens were not aware of their right to entitlements in public health services. Knowledge about the provisions for the distribution of free medicines as well as other incentives to avail of health services provided and paid for by the government had not reached the target populations. Local authorities had financial incentives to keep the citizenry uninformed as they were able to augment their income. The evaluation furthermore documented that the quality of healthcare services provided was poor. As a result, seventy-five percent of the respondents had been using private providers instead of public health facilities. SA facilitated the installation and training of CMCs and organized a meeting to discuss the survey results. SA furthermore developed materials for information, education and communication and kept a discussion alive, coordinating and communicating with stakeholders on a constant basis.

In collaboration with the CMCs, SA also conducted Right-to-Information (RTI) Act trainings, and provided citizens with the tools to demand greater accountability. These activities were bolstered through another awareness campaign and involved citizens as well as district community organizations. The district hospital as well as other health posts agreed to display citizen charters in appropriate places and the CMCs set out to monitor actual service delivery.

Impact and Results Achieved
In its evaluation, SA observed the following results:

  • Hospital intake has increased from about 40-50 patients/day to about 60-70 patients/day.
  • The attendance rate in sub health posts has increased from 5-10 patients/day to 15-20 patients/day.
  • CMCs are now monitoring health service delivery and file complaints in cases of suspected corruption. The same CMCs have started monitoring government service delivery beyond health.
  • Instances of corruption in health services are mapped and reforms advocated by citizen coalitions.
  • CMCs filed ten corruption-related RTI applications; five were successfully addressed. The remaining five cases were submitted to the appropriate authorities.
  • Most service units are considered to be working in a corruption-free manner.
  • A significantly larger number of poor and old patients receive their prescribed medicines for free. The stock of medicine is maintained as per government regulation.
  • Due to the Citizen Charters placed, citizens have greater access to information and were empowered to request services based on the information provided. If they do not receive the advertised services they now inform the CMCs.
  • Community interest has increased significantly. Citizen Coalitions have started to contribute time and effort to advocating and lobbying for better management practices in their respective community health posts.
  • The project has attracted media coverage from district to national level in a variety of outlets
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Controlling Corruption to Improve Health Services for the Poor in Odisha State, India

IMPLEMENTING PARTNER: AYAUSKAM
YEARS: 2009-2010
GRANT AMOUNT: $21,000
THEMES: Health

Corruption and a lack of transparency in government administered health services has led a local CSO, Ayauskam, to mobilize and educate citizens and citizen organizations to engage in coalition-building and hold health service providers to a higher standard of accountability across 10 Panchayats of Khariar block in Nuapada district, Odisha. The project has been successful; sustainability however depends on the continued constructive engagement between community organizations, citizen monitors and service providers, as well as the right balance of public pressure versus collaboration between the different stakeholders. Continued funding for Ayauskam to moderate and balance this important consensus-building process toward achieving sustainable results is a priority.

Corruption Problem Addressed
Ayauskam in collaboration with Vikash, another NGO in Odisha state, tackled corruption in 10 Gram Panchayats (local governments) in Khariar block, Nuapada district of Odisha State. The health sector was targeted as initial discussions with citizens revealed that they were not receiving basic health services despite significant government spending on health. A detailed survey in 64 villages was conducted and the findings were startling: It revealed rampant corruption in the health sector.

People in the survey area paid more than $11,000 USD annually in “corruption taxes” to government health service providers. For example, the effective hospital charge for delivering a child was around $55 USD when it was supposed to be free. Health service delivery became a business of exploitation rather than an entitlement as foreseen by the applicable law. Medicine was not available free of cost, doctors and the other health service providers were not available during their hours of duty, and payments to patients were delayed (e.g., for the program to encourage child delivery in hospitals). Hospital staff demonstrated condescending and inhumane behavior toward patients and their relatives and oversight authorities were complacent and not exerting the necessary control and accountability mechanisms.

Actions Taken by Ayauskam
The first step for Ayauskam was to increase media awareness about corruption. During a media consultation workshop, survey findings were discussed with reporters and journalists working in both print and electronic outlets. This generated a lot of enthusiasm. The then sensitized journalists subsequently covered stories on health right violations including service provider behavior, lack of provisions of free medicines and other symptoms of a non-functional service delivery scheme.

The next step was to establish and strengthen community based organizations (CBOs) through targeted training and village meetings. Every village formed a “Durnity Birodhy Manch” (DBM, Citizens against Corruption) forum to protest corruption issues at the village level. These formed a network at the Panchayat, at both block and district levels.

Capacity development programs were organized to train women change agents, members of Panchayati Raj Institutions, CBOs, youth clubs, government officials and service providers.

Campaigns against corruption were initiated in the villages. Social audits were conducted to discuss the problems of each village followed by public hearings with district level officials including the District Collector and the head of the district health department. Villages obtained information about services which enabled them to become more articulate. An impact monitoring tool was developed for community volunteers and self-help group members to monitor health service delivery and corrupt practices. Rallies and demonstrations were conducted to show the strength of the CBOs and the community.

Ayauskam and the communities had to overcome many challenges. Service providers and officials at the block and district levels initially reacted negatively: They influenced people to not cooperate with the project team and doctors tried to influence the leaders of political parties to subvert the effort. Their strategies included making threats to file criminal and false claims against DBM members and withholding vital information to carry out the vigilance needed. Without the relevant information, it was not possible to organize people and create results. In all cases, information was however provided after the applicants filed appeals according to the Right to Information (RTI) Act.

DBM members persisted, wrote letters, and conducted regular discussions with higher authorities and local politicians. This forced authorities and politicians to involve the people in the quest to improve health services. Gradually the situation improved. Increased awareness and greater participation of communities forced the service providers to take their questions and concerns seriously. DBM members started discussions with service providers. DBM made it clear that it was fighting against corruption and not against individuals. Cooperation between the community and service providers evolved as problems were shared and solved.

Many local groups helped support the DBM efforts. The involvement of Panchayat Raj Institutions (PRI) members helped tremendously. Grassroots service providers started cooperating and participated in project activities. Cooperation between community organizers and local level health functionaries is improving. Social audits strengthened cooperation between the health care administration and the DBM forum at the local level. The training and capacity building provided for CBOs encouraged CBOs to support the efforts to demand better services. Self-help groups in every village have become active tackling corrupt practices observed.

Impact and Results Achieved
The administration now recognizes the strength of the community. It instructed the health department and the Integrated Child Development Scheme (ICDS) to involve CBOs and the community in village health planning. The Gram Kalyan Samity (a village level institution created under the National Rural Health Mission [NRHM] for village health planning and monitoring) gained real power.

Not only within the target areas, but also other Gram Panchayats of Khariar block benefited from the project intervention. Village level service providers started attending the social audits and related programs.

The rallies conducted against corruption increased the people’s ability and propensity to demand their entitlements and hold authorities and service providers responsible.

The impact study shows that there has been a reduction of corrupt practices in government hospitals: 80 percent of participants surveyed are not paying fees for hospital delivery. Payment of the service tax to other service providers has been reduced by 50 percent. Expenditures on medical services during pregnancy and delivery have been reduced 82 percent. Village health committees have been formed, free medicines are available at the village level, and countersigning of checks for financial support to mothers after hospital delivery is done immediately. There is an effective distribution of the full quota of Take Home Rations under the ICDS, medicine lists are displayed at government hospitals, and malnourished children receive special care. Anti-natal and post-natal health services have improved also.

Every household is now able to save more than $55 USD per year due to the project intervention. People’s participation increased in the decision making process, implementation and monitoring of programs. The process is community-owned and can be sustained by village level leadership, CBOs, and the block level DBM.

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Combatting Corruption in Clinical Drug Trials (Phase II)

IMPLEMENTING PARTNER: Jananeethi
YEARS: 2011-2012
GRANT AMOUNT: $35,000
THEME: Health

This phase was an extension of an earlier project commenced by Jananeethi. The design and implementation of the project would not have materialized but for the strong belief and support from PTF. The flexibility that PTF allowed in pursuing emerging pathways and recalibrating activities and timelines gave a rare bandwidth to the project to explore out-of-the box options and innovative collaborations.

The nature of the issue being explored makes it extremely difficult to track and study. It is only because of Jananeethi’s long standing track record in the state and its extensive linkages with multiple stakeholders that the key actors in the issue – actual patients – were identified and agreed to share their experiences. The emphasis on constructive engagement also worked in the project’s favor. Instead of sensationalizing the issue and creating political rhetoric, Jananeethi pursued a path of discussions and informed briefings and played the role of a convener in getting key stakeholders to come to the table and discuss the issues.

The issue of unethical drug testing has opened up many other fronts to look at accountability mechanisms and their status in the health sector in Kerala. The Kerala Health Watch Group is perfectly poised to take on the role of a watchdog to support victims of corruption and abuses at very local levels.

Finally, long lasting impacts are only possible through sustained actions on many fronts. The seed grant provided through this project gave the critical opportunity to build evidences, coalesce stakeholders and create broad based people’s organizations. This momentum needs to be sustained, nurtured and capacitated to create lasting and meaningful changes. Jananeethi is committed to meet these challenges and leverage the learnings and insights from this project to its broader mandate of human rights work in Kerala.

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Combatting Corruption in Clinical Drug Trials in Kerala

IMPLEMENTING PARTNER: Jananeethi
YEARS: 2009-2010
GRANT AMOUNT: $35,000
THEME: Health

The primary objectives of Jananeethi project were to regulate clinical drug trials under law, and to ensure ethical standards and best practices; to ensure transparency and accountability; to approve the rights of human participants in clinical trials; to check instances of corruption and unethical practices and to enlighten the civil society and other stakeholders with regard to mandatory norms and rules to be complied with in a clinical trial.

The baseline information we gathered from our initial contacts with researchers, clinical practitioners, medical and Para-medical staff, institutional heads and members of institutional review committees were quite disheartening and embarrassing. What surfaced most was blissful ignorance among all concerned of the statutory norms and universal ethical standards to be strictly followed in any clinical drug trial. There was apparently no interest in the concerned departments and institutions to rectify or to make good of the situation. Further, the emergence of the contract research organizations that have sprouted in almost all cities and towns were pushing themselves into hospitals, laboratories and even clinics of private practitioners. Thus the overall scenarios were gruesome.

Our attempts to identify human participants in clinical trials were repeatedly foiled by concerned investigators/institutions on a reason that the matter was ‘confidential’. We have used Right to Information Act as tool for the collection of data’s. Though we got information on clinical trials from institutions approached, all of them denied the details of trial participants on the ground of privacy and confidentiality. All offenders went scot-free and nothing was left on paper to prove against them. No record was maintained, no consent form was properly signed, and not even a single evidentiary document was traceable in any institution. This delay in identification of participants caused some problem initially but we were able to identify them and record their experiences. Constructive engagement with government and other stakeholders was one of the major activities of our project. Meeting with Dr. Usha Titas IAS, Secretary, Health and Family Welfare, State of Kerala was quite useful.  Meeting with Institutional Review Boards of various institutions helped its inherent weakness and us to know the way IRB’S are working. Engagements with doctors working in field of clinical trials helped us to collect vital information on clinical trials and its loopholes. Constructive engagements with government officials, Heads of medical institutions are still in progress for various purposes like conducting awareness programmes, installation of display boards etc.

In the circumstances, the primary requisite was to create general awareness on the mandatory norms and statutory guidelines among all concerned. Jananeethi published a handbook on the guidelines and circulated it among all. It generated a discussion across the State among medical practitioners and researchers. We also held press conferences and had press releases on the matter. In the meantime, we interviewed several medical personnel who have been involved in trials. We also had extensive consultations across the country with eminent medical practitioners regarding the ethical standards in clinical trials. Knowledge generation among authorities, doctors, and members of ethics committees and among general public regarding the issues and concerns involved in the conduction of clinical trials plays a crucial role in elimination of unethical practices and for the protection of rights guaranteed to the participants of clinical trial.  To achieve this goal we have designed different activities. For example publication of handbook on ethical standards of clinical trials, press meetings, personal discussions with doctors and members of ethics committees, awareness classes for medical students and affected parties with the help of other stakeholders. We have collected various national and international guidelines on clinical trials and codified the same through handbook in Malayalam. We have prepared rights of human participants in Malayalam for display at various centers. We have also prepared a draft Charter of rights of human participants for distribution among authorities and public in general. From our experience it is crystal clear that ignorance about the ethical guidelines and rights of human participants among the doctors who are involved in the drug trials, ethics committee members, and most importantly among the government officials and general public leads to corruption and gross violation of rights of human participants.

In the second half of the first year of our struggle against the engulfing unethical practices leading to corruption, we were able to identify five human participants in a clinical drug trial. Each participant was visited at his/her residence, detailed discussions were held based on a scheduled questionnaire. Innocent patients were not aware of the corruptions implied; they had taken in good spirit. But what emerged from our discussions was that every norm of a good practice was flouted. To prove our stand that the conduction of clinical trials are not in accordance with ethical standards we have interviewed and Recorded the opinions of experts in the field like Dr. Amar Jesani of Centre of Studies in Ethics and Rights, Mumbai, Dr. C.R.Soman, Chairman, Health Action by people, Thiruvananthapuram, Dr. P.V. Gangadharan oncologist, Lakeshore hospital Kochi, Dr.K.G.Radhakrishnan.Hence we started with constructive engagements of the government departments, institutional heads, media and other stake holders. We are building up a critical mass in the society with regard to the clinical trials; we have been successful in few hospitals and research institutes so far. We propose to engage the media and communication strategies on large scale in the second phase of the project.

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