| 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 |
| 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 |
| 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 |
| 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 |
| 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? |