| What you take | What it costs them |
|---|---|
| An hour of time | An hour of earning, cooking or rest |
| An account of a difficult event | The distress of retelling it |
| Identifying details | Exposure risk they cannot control |
| A photograph | How they appear to strangers, indefinitely |
| Ethics is | Ethics is not |
|---|---|
| A set of judgements you make continuously | A form signed once |
| Applied in the field, under pressure | A committee’s responsibility |
| Tested by what you do when nobody checks | A compliance step |
| Improved by naming dilemmas openly | A record of having no problems |
| You hold | They often hold |
|---|---|
| Institutional backing | No route to complain |
| Control of the questions | No say in what is asked |
| The power to publish | No sight of the output |
| A link to a programme | A reason not to refuse |
| Participant as author means | Not |
|---|---|
| They shape what is asked | They answer what was decided |
| They see what was found | They read about it later, or never |
| They can withdraw | Their data is fixed once given |
| They retain a stake | The institution owns it entirely |
| Why ethics fails | What it looks like |
|---|---|
| Convenience | The same basti surveyed again |
| Deadline pressure | Consent read at speed |
| Distance | The analyst never met anyone |
| Habit | "The form we always use" |
| Optimism | "They will not mind" |
| Failure damages | Concretely |
|---|---|
| People | Distress, stigma, danger |
| Truth | Coerced answers are unreliable answers |
| Trust | The next study is refused |
| Your organisation | Access lost, reputation with it |
| Code | Written after |
|---|---|
| Nuremberg, 1947 | Experiments on prisoners without consent |
| Helsinki, 1964 | Continuing abuses in medical research |
| Belmont, 1979 | Tuskegee |
| CIOMS | Concerns about research in poor countries |
| Nuremberg established | Which had not been |
|---|---|
| Voluntary consent is essential | Required at all |
| The participant may withdraw | Recognised |
| Risk must be justified | Weighed |
| Research must have social value | Assessed |
| Helsinki added | Beyond Nuremberg |
|---|---|
| Independent ethics review | Consent alone |
| Wellbeing over scientific interest | A researcher’s judgement |
| Provisions for those who cannot consent | An absolute consent rule |
| Registration and reporting of trials | Private results |
| What Tuskegee did | Which principle it broke |
|---|---|
| Enrolled without informed consent | Respect for persons |
| Withheld a known cure | Beneficence |
| Targeted poor Black men | Justice |
| Continued for forty years | All three, knowingly |
| Tuskegee lesson | Development analogue |
|---|---|
| The marginalised are easy to study | The same bastis, surveyed repeatedly |
| "Just observing" can harm | Withholding a known benefit |
| Withholding information is a breach | Not returning findings |
| Trust, once broken, does not return | Communities refusing access |
| Belmont principle | Operationalised as |
|---|---|
| Respect for persons | Informed consent |
| Beneficence | Risk-benefit assessment |
| Justice | Fair selection of participants |
| Year | Milestone | What it added |
|---|---|---|
| 1947 | Nuremberg Code | Voluntary consent is essential |
| 1964 | Declaration of Helsinki | Ethics review; wellbeing over science |
| 1972 | Tuskegee exposed | Catalyst for modern oversight |
| 1979 | Belmont Report | Three guiding principles |
| 1982/93 | CIOMS guidelines | Ethics for low-resource & global settings |
| 2017 | ICMR National Guidelines | India’s comprehensive framework |
| 2023 | DPDP Act (India) | Personal data protection in law |
| Year | What changed in practice |
|---|---|
| 1947 | Consent became a requirement |
| 1964 | Review by others became expected |
| 1972 | Public exposure forced reform |
| 1979 | Principles became procedures |
| 2017 | India codified its own standard |
| Imported codes assume | South Asian reality |
|---|---|
| Written consent is meaningful | Many participants cannot read |
| Individual autonomy decides | Household and community decide |
| Refusal carries no cost | It often carries a perceived one |
| A regulator can be reached | Rarely, in practice |
| Principle | The question it forces |
|---|---|
| Respect for persons | Did they genuinely choose? |
| Beneficence | Have we minimised harm, and is there benefit? |
| Justice | Who bears the burden, who gains? |
| Respect for persons has two halves | Which means |
|---|---|
| Honour the choices of the autonomous | Do not override a competent refusal |
| Protect those with reduced autonomy | Extra safeguards, not exclusion |
| Ask | Not just |
|---|---|
| What harms could this cause? | Is it physical? |
| Who benefits, and when? | Is knowledge produced? |
| Do the benefits reach the risk-bearers? | Does someone benefit? |
| What would make it safer? | Is it within the rules? |
| Injustice appears as | Example |
|---|---|
| Convenient populations | The same slum, repeatedly |
| Benefits flowing elsewhere | A paper, a career, a funding round |
| Burden without feedback | No results returned |
| Exclusion from the useful research | Women omitted from trials |
| Over-researched | Under-researched |
|---|---|
| Urban slums near institutions | Remote and inaccessible areas |
| NGO programme areas | Places with no programme |
| The poor | The powerful and the intermediaries |
| Beneficiaries | Those excluded from the scheme |
| Conflict | Which principles collide |
|---|---|
| A survivor discloses ongoing abuse | Confidentiality vs. preventing harm |
| Interviewing a woman privately is impossible | Autonomy vs. safety |
| A gatekeeper wants to select participants | Access vs. voluntariness |
| Publishing a finding may stigmatise a group | Truth vs. non-maleficence |
| Beyond Belmont | Because Belmont assumed |
|---|---|
| Respect for communities | The individual is the unit of harm |
| Reciprocity | Knowledge is benefit enough |
| Transparency about funding | Research is disinterested |
| Cultural humility | The researcher’s categories fit |
| Question | Failing answer |
|---|---|
| Does each person genuinely choose? | "They all agreed" |
| Have I minimised avoidable harm? | "There is no physical risk" |
| Is there real benefit, to whom? | "It advances knowledge" |
| Are burden and benefit shared? | "They are the target group" |
| Could this harm a group? | Not considered |
| Consent requires | It is not established by |
|---|---|
| Understanding | A signature |
| Voluntariness | Attendance |
| Disclosure | A form having been read out |
| The right to stop | Silence |
| Element | How it fails in the field |
|---|---|
| Voluntary | Officials present; a benefit implied |
| Informed | Read at speed, in the wrong language |
| Comprehended | Heard, not understood; never checked |
| Disclose | Commonly omitted |
|---|---|
| Who funds it, and why | Almost always |
| What participation involves | The real time it takes |
| Foreseeable risks | Social and legal ones |
| How data is stored and shared | Onward sharing |
| The right to refuse or stop | Stated once, quickly |
| Where reading is not assumed | Do |
|---|---|
| Read the form aloud, in their language | Slowly, with pauses |
| Check comprehension | Ask them to say it back |
| Use an impartial witness | Not a gatekeeper or a relative |
| Record oral consent | Audio, or witnessed note |
| Leave an information sheet | Even if unreadable, it can be shown to others |
| Pressure source | Counter |
|---|---|
| Officials accompanying you | Interview without them |
| Fear of losing a benefit | State the separation, clearly |
| Refusing a visitor feels rude | Offer refusal actively, twice |
| A gatekeeper has instructed them | Confirm privately |
| Situation | Who consents | Extra safeguard |
|---|---|---|
| Minor (child) | Guardian + child’s assent | Age-appropriate explanation |
| Cognitive impairment | Legally authorised representative | Assent where possible |
| Acute distress / crisis | Defer or seek surrogate | Re-consent when stable |
| Group / community study | Individuals + community gatekeepers | Avoid coercive leaders |
| Illiterate participant | The person (orally) | Impartial literate witness |
| Situation | Who consents | Safeguard |
|---|---|---|
| Minor | Guardian, plus child’s assent | Age-appropriate explanation |
| Cognitive impairment | Legal representative | Assent where possible |
| Acute distress | Defer | Return later, or not at all |
| Detained or institutionalised | The person, independently | No staff present |
| Consent as a process means | In practice |
|---|---|
| It can be withdrawn any time | Say so more than once |
| Long studies need re-consent | At each major change |
| New uses need new consent | Repositories, secondary analysis |
| Silence is not agreement | Ask explicitly |
| Vulnerability comes from | Not from |
|---|---|
| Dependence on the researcher or a benefit | Being uneducated |
| Restricted ability to refuse | Being poor as such |
| Stigma attached to the topic | Being a member of a group |
| Legal or physical exposure | Any inherent weakness |
| Group | Source of vulnerability | Heightened risk |
|---|---|---|
| People in poverty | Economic dependence | Undue inducement; can't refuse |
| Children | Limited autonomy | Cannot fully consent; easily led |
| Women (in some settings) | Gendered power | Coerced consent; safety after |
| Dalit / Adivasi | Caste & social exclusion | Stigma; extractive study |
| Persons with disability | Access & capacity barriers | Exclusion or paternalism |
| Refugees / migrants | Precarious legal status | Fear; deportation; reprisal |
| Group | Source of vulnerability | Safeguard |
|---|---|---|
| People in poverty | Economic dependence | Modest, explained compensation |
| Children | Limited autonomy | Guardian consent plus assent |
| Women, in some settings | Household authority | Private interview; women interviewers |
| Stigmatised groups | Disclosure risk | Minimal identifiers |
| Detained or dependent | Cannot freely refuse | Independent consent, no staff present |
| Inducement size | Effect |
|---|---|
| Below the value of the time | Under-compensation |
| Roughly the value of the time | Fair, and usually right |
| Well above local daily earnings | Consent is compromised |
| Risk to a woman participant | Mitigation |
|---|---|
| A household decides her answer | Interview privately |
| Others listen in at home | Neutral location, or a walk |
| Repercussions after you leave | Do not disclose what she said |
| Male interviewer on sensitive topics | Women interviewers, trained |
| Group-level harm | How it happens |
|---|---|
| A finding brands a community | Reported by caste or village |
| Stigma is entrenched | A statistic quoted without context |
| A place becomes shorthand | Named in a headline |
| People never surveyed are affected | They share the label |
| Data point | Risk if it leaks |
|---|---|
| Immigration status | Detention or deportation |
| Location of a settlement | Eviction |
| Names and photographs | Targeted violence |
| Movement patterns | Interception |
| Over-researching costs | Which shows as |
|---|---|
| Participant time, repeatedly | Declining cooperation |
| Raised and disappointed expectations | Open cynicism |
| Safeguard | Rather than |
|---|---|
| Stronger consent process | Excluding the group |
| Impartial witness | A gatekeeper’s word |
| Community consultation | Individual consent alone |
| Referral routes ready | Asking and leaving |
| Data minimisation | Collecting all you might need |
| Concept | Belongs to | Fails when |
|---|---|---|
| Privacy | The participant | You question them in public |
| Confidentiality | You | You share or gossip |
| Anonymity | The data | Quasi-identifiers combine |
| Privacy violation | Looks like |
|---|---|
| Entering without invitation | Arriving with officials |
| Questioning in front of others | A crowd at the doorstep |
| Probing beyond what was agreed | "While I am here..." |
| Observing without saying so | Notes taken unannounced |
| Practice | Why |
|---|---|
| Names stored separately from responses | A leak of one is not a leak of both |
| Linked only by a code | The key can be locked separately |
| Need-to-know access only | Fewer holders, less risk |
| No informal discussion of answers | Villages are small |
| State the limits up front | Do not promise what you cannot hold |
| Quasi-identifier | Combined with |
|---|---|
| Village | Age |
| Caste | Occupation |
| Number of children | Household composition |
| Disability | Anything else |
| Step | What is still exposed |
|---|---|
| Remove names and IDs | Everything else |
| Keep village, age, caste, job | A unique combination |
| Small geographic unit | One matching person |
| Publish | They are identifiable |
| Geographic unit | Re-identification risk |
|---|---|
| National | Low |
| Village or ward | High |
| Security step | Frequently skipped |
|---|---|
| Encrypt devices and files | On personal phones |
| Unique passwords, access control | Shared logins |
| Keep the name-code key separate | Stored in the same folder |
| Delete identifiers when done | Kept indefinitely |
| Secure paper forms | Left in a field office |
| Sensitive category | Consequence of disclosure |
|---|---|
| HIV status | Stigma, exclusion, violence |
| Mental illness | Stigma; loss of standing |
| Caste | Discrimination |
| Sexuality | Violence; legal exposure in some settings |
| Experience of violence | Retaliation |
| Do not promise | Say instead |
|---|---|
| "This is completely confidential" | "We will protect this, and here are the limits" |
| "Nobody will ever know" | "Your name will not appear" |
| "It is fully anonymous" | "We remove names and check for identifiability" |
| "Nothing bad can happen" | "Here is the risk as we see it" |
| Assumed harmless because | But |
|---|---|
| No needles or drugs | Questions can retraumatise |
| "Only a survey" | Time is a real cost |
| "We just observed" | Tuskegee was observation |
| "Nothing was published locally" | Data travels |
| Type | Example in development research |
|---|---|
| Physical | Fieldwork that exposes a participant to danger or reprisal |
| Psychological | Re-traumatising a survivor by probing painful memories |
| Social | Stigma, gossip or exclusion if answers become known |
| Legal | Recording undocumented status or illegal work that can be used against them |
| Economic | Lost wages for time given; a job lost if an employer learns what was said |
| Harm type | Example | Occurs |
|---|---|---|
| Physical | Reprisal after speaking | After you leave |
| Psychological | Retraumatising a survivor | During |
| Social | Gossip; exclusion | After |
| Economic | Lost work; a lost benefit | Immediately |
| Legal | Status exposed | Later, possibly |
| Harm type | Visible to you? |
|---|---|
| Physical | Rarely — occurs later |
| Psychological | Sometimes, during |
| Likelihood x severity | Action |
|---|---|
| High x High | Redesign; do not proceed as planned |
| Low x High | Mitigate; have a response ready |
| "Daily life" risk differs by | So minimal risk is |
|---|---|
| Wealth | Not a fixed threshold |
| Gender | Higher for some to speak |
| Legal status | Not minimal at all |
| Topic | Relative to the question |
| Step | What people skip |
|---|---|
| Identify harms | The non-physical ones |
| Estimate likelihood and severity | Doing it explicitly |
| Minimise by design | Dropping a question |
| Judge the residual | Concluding no |
| Redesign or stop | The stop option |
| Field team exposure | Response |
|---|---|
| Hearing accounts of violence daily | Debriefing, routinely |
| No outlet or supervision | A named person to talk to |
| Pressure to complete quotas | Realistic targets |
| No option to stop | Rotation off difficult modules |
| Mitigation | Cost |
|---|---|
| Drop a high-risk question | A variable |
| Offer referral | A list, and follow-up |
| Let people skip or pause | Some missing data |
| Private, safe settings | Time and logistics |
| Tighten data handling | Process discipline |
| Self-review fails because | Which is why |
|---|---|
| You are invested in proceeding | The reviewer must be independent |
| You cannot see your own blind spots | Composition matters |
| Deadline pressure is on you | Review sits outside the timeline |
| You wrote the consent form | Someone else must read it |
| Ethics review has expanded | What still varies |
|---|---|
| More institutions have committees | Whether they meet regularly |
| ICMR 2017 set a national standard | How consistently it is applied |
| Clinical trials are registered | Social research often is not reviewed |
| IEC requirement | Purpose |
|---|---|
| Independent members | No stake in the outcome |
| A lay or community member | A non-researcher perspective |
| A legal member | Rights and law |
| Gender balance | Whose risks are recognised |
| Documented procedures | Decisions can be reviewed |
| ICMR 2017 covers | Applies to |
|---|---|
| Biomedical and health research | Clinical and community studies |
| Social and behavioural research in health | Much development research |
| Consent, privacy, vulnerable groups | All of it |
| Committee composition and function | Institutions |
| ICMR principle | What it asks of you |
|---|---|
| Essentiality | Is this research necessary at all? |
| Voluntariness | Is agreement genuinely free? |
| Non-exploitation | Fair compensation, no undue inducement |
| Privacy and confidentiality | Protect identity and data |
| Accountability and transparency | Be answerable for conduct |
| Clinical trials carry | Beyond ordinary review |
|---|---|
| DCGI regulation, under CDSCO | A statutory approval |
| Registered committee oversight | Not just any IEC |
| Compensation rules for injury | Defined in law |
| Area | The committee asks |
|---|---|
| Value & design | Is the research worth doing and methodologically sound? |
| Consent | Is the process genuinely free, informed and understood? |
| Risk–benefit | Are harms minimised and justified by benefit? |
| Vulnerable groups | Are extra safeguards in place and appropriate? |
| Privacy & data | How will identity and data be protected? |
| Justice | Is participant selection and benefit-sharing fair? |
| The committee asks | Prepare |
|---|---|
| Is it worth doing, and sound? | The design rationale |
| Is consent genuinely free? | The process, not just the form |
| Are harms minimised and justified? | The risk assessment |
| Is selection fair? | Why these participants |
| How is data protected? | Storage, access, deletion |
| Do | Do not |
|---|---|
| Submit before collecting anything | Seek retrospective approval |
| Include local-language materials | Submit English only |
| Report changes and adverse events | Amend quietly |
| Treat questions as help | Treat review as an obstacle |
| The protocol says | The field gives you |
|---|---|
| Private interview | A crowd around the chair |
| Voluntary participation | A sarpanch who has selected people |
| Neutral questions | A participant in tears |
| A defined sample | People who want to be included |
| Gatekeeper permission gives you | It does not give you |
|---|---|
| Access to the community | Any individual’s consent |
| Local legitimacy | Freedom from their influence |
| A list of people | A representative sample |
| Cooperation | Voluntariness |
| Field consequence of payment | Manage by |
|---|---|
| A crowd gathers | Do not announce amounts publicly |
| People answer to qualify | Screen before mentioning payment |
| A gatekeeper expects a share | Pay participants directly |
| Refusal becomes costly | Keep the amount modest |
| Before fieldwork, decide | Because in the moment |
|---|---|
| What triggers disclosure | You will not want to |
| To whom you would report | You will not know |
| What you tell the participant first | It is too late afterwards |
| Who in the team decides | It should not be one person alone |
| A photograph | Consequence |
|---|---|
| Is identifiable data | Consent must cover it separately |
| Travels beyond your intent | Reports, websites, donor decks |
| Attaches a face to a story | Stigma follows the person |
| Cannot be withdrawn once circulated | Consent has to precede use |
| Ask of every image | If the answer is no |
|---|---|
| Would I accept this of my own family? | Do not use it |
| Would they recognise themselves in it? | Show them first |
| Does it show agency, not only need? | Choose another |
| Is the caption theirs or mine? | Quote them |
| Sign in a field team | Response |
|---|---|
| Emotional flatness or irritability | Rotate off the module |
| Avoiding certain interviews | Take it seriously, not as slacking |
| Sleep and appetite changes | Time off; professional support |
| Cynicism about participants | A supervision conversation |
| Step | What it produces |
|---|---|
| Name the conflict | Which principles clash |
| Who is affected, how badly | A ranking of stakes |
| Realistic options | Not just the two obvious ones |
| Decide for the most vulnerable | A defensible rule |
| Document it | A record you can be held to |
| Stage after the field | Ethical question |
|---|---|
| Storage | Who can reach it, for how long? |
| Analysis | Are we reading people fairly? |
| Ownership | Whose data is this? |
| Sharing | Could release harm anyone? |
| Reporting | Are we over-claiming? |
| Ask | Usual answer | Better |
|---|---|---|
| Who owns the data? | The institution | Shared, with agreed terms |
| Who can use it? | The researchers | The community too |
| Who benefits? | The publisher | Both |
| Who holds a copy? | The institution | Leave one behind |
| Return findings as | Not as |
|---|---|
| A meeting, in their language | A 60-page English PDF |
| A poster or a one-page summary | A link nobody can open |
| A radio spot or a community screening | A journal article |
| A conversation, with questions | A one-way presentation |
| Accountability means | Which requires |
|---|---|
| Naming the funder | Saying so up front |
| Letting participants challenge findings | A forum to do it in |
| Reporting uncomfortable findings | A funder who tolerates them |
| Acknowledging limits | Writing them down |
| DPDP Act duty | What it means for a researcher |
|---|---|
| Collect only what is needed | Justify every field |
| A clear, stated purpose | Consent notice in plain terms |
| Security safeguards | Encryption and access control |
| Erasure when the purpose ends | A deletion date |
| Notify breaches | A process, in advance |
| FAIR | CARE | |
|---|---|---|
| Centres | The data | The people in it |
| Asks | Is it usable by science? | Who controls and benefits? |
| Risk if used alone | Extraction at scale | Data that helps nobody |
| Before releasing micro-data, check | If in doubt |
|---|---|
| Smallest cell sizes | Aggregate or suppress |
| Combinations of quasi-identifiers | Coarsen them |
| Whether consent covered sharing | Do not release |
| Who could misuse it, and how | Restrict access |
| Writing failure | What it costs |
|---|---|
| Over-claiming | Credibility, and future access |
| Cherry-picking | Truth |
| Stripping dignity | The people described |
| Not crediting communities | The relationship |
| Planning check | Failing answer |
|---|---|
| Is this research necessary? | "It would be interesting" |
| Could existing data answer it? | Not checked |
| Who bears risk, who gains? | Not asked |
| Has a committee reviewed it? | "We will do it later" |
| Are materials in the local language? | English only |
| Fieldwork check | Watch for |
|---|---|
| Consent genuinely understood | Speed; no comprehension check |
| Refusal costs nothing | A benefit implied |
| Interviews private and safe | A crowd; a gatekeeper |
| Limits of confidentiality stated | Blanket promises |
| Referral routes ready | Asking and leaving |
| After fieldwork | Concretely |
|---|---|
| Store securely | Encrypted; key separate |
| Guard against re-identification | Check smallest cells |
| Meet DPDP obligations | Purpose, security, erasure |
| Return findings | Budgeted, with a date |
| Delete identifiers | On the date you set |
| Red flag | What it actually means |
|---|---|
| "They are poor, they will not mind" | You have not asked |
| "No time for ethics review" | The timeline is the problem |
| "The incentive is large, everyone will agree" | That is the concern |
| "Just remove the names" | Anonymity has not been checked |
| "We will share results eventually" | You will not |
| Source | Use it for |
|---|---|
| ICMR 2017 guidelines | The Indian standard, in full |
| Declaration of Helsinki | The foundational principles |
| Belmont Report | The three principles, briefly |
| CIOMS guidelines | Low-resource and cross-country research |
| DPDP Act, 2023 | Legal duties on personal data |
| Takeaway | The habit |
|---|---|
| Every row is a person | Ask what this costs them |
| Consent is a process | Check comprehension, every time |
| Vulnerability means more protection | Safeguards, not exclusion |
| Anonymising is hard | Check the smallest cells |
| Ethics does not end at collection | Return the findings |