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First things first: If you're sick or hurt, think you might be, or are otherwise concerned about your health during or after a study, you should tell the study doctor and contact your licensed primary care physician or specialist without delay. Your health is the most important thing. You won't loose the opportunity to complain by taking the time to see your doctor.
There are different ways to complain or ask questions about what happened to you during research, or in research recruitment, e.g., being asked to participate in research. You can complain directly to the researcher, the study coordinator, the institutional review board (IRB) that reviewed and approved the research, senior officials at the institution where you enrolled in research (institution = study site, a hospital, university, clinic, physician's office, etc.), the sponsor (drug and device manufacturers, private organizations), the U.S. Food and Drug Administration (FDA), or the Office for Human Research Protections (OHRP).
The choice of who to complain to will depend on several things. There are no hard and fast rules and the choice is ultimately your own. You should understand that not all research is subject to federal (FDA or OHRP) regulations and there may not be any agency outside the institution with oversight. You should also keep in mind the possibility that you've misunderstood something. If this is the case, you should receive a polite explanation in response to your concern. If you're uncertain about what was supposed to happen in a study, don't hesitate to ask for information. Follow this link to see a list of Frequently Asked Questions About Research.
If you decide to complain to the researcher: Write, email, or telephone the principal investigator identified in your consent form. Putting your concerns in writing is helpful to prevent misunderstanding and confusion. Remember to keep copies of your correspondence. You should tell the study doctor about serious problems (injury or suspected injury) immediately. Conscientious researchers will be grateful you complained and often do their best to correct problems. In an ideal world this would be all you'd need to do. Unfortunately the world is not always ideal. An extremely busy researcher, a researcher who simply doesn't care what you think, or a researcher who doesn't care to comply with ethical principles or federal regulations (where applicable) may toss your complaint in the trash or may answer your complaint in a way that doesn't satisfy you. If you've complained to the investigator you should receive a response in a reasonable amount of time. If you don't, or if the response troubles you, you can consider complaining to the IRB that reviewed and approved the research, the institution, FDA, or OHRP.
Sometimes people are afraid to complain directly to the researcher. There are any number of reasons why this might be the case, but if you feel uncomfortable at the thought of complaining to the researcher, don't do it. Complain elsewhere instead.
If you decide to complain to the institutional review board (IRB) that reviewed and approved the research: Write, email, or telephone the individual or organization identified in the section of the study consent form that tells you whom to contact for more information about your rights as a research subject. If there is no contact information in the consent form, use Google to find the web site of the IRB, or the hospital (clinic or study site), and then locate the contact person for the IRB. Often this information can be found by looking for the
Research Office or in the personnel listing for
Research Administration. Another option is to call the general information number and ask for the name and contact information for the chair of the IRB. Complaining to the IRB is roughly like complaining to the researcher's
boss. You should receive a response to your complaint in a reasonable amount of time. If you don't receive a response or if the response troubles you, you have the option to complain to FDA or OHRP; if the IRB is part of a hospital, university, or clinic, you can also complain to senior administrators at the institution.
If you decide to complain to FDA or OHRP: FDA or OHRP can be your initial choice or your last choice. It's up to you to decide. There are several issues to consider and there are often no easy or right answers. Complaining to the investigator, the IRB, or the institution trusts them to do the right thing. They may or may not merit this trust. On the one hand, a hospital IRB may bend over backwards to correct problems of which they were unaware and may make changes so the same problems don't happen again. In this (ideal) situation the institution would report the incident about which you complained to OHRP or FDA as required. On the other hand, if an IRB or institution routinely bends, breaks, or ignores regulations, FDA or OHRP authority might be required, both to address your complaint as well as to prevent future problems. If you complain to FDA or OHRP after receiving an unsatisfactory response from an investigator, IRB, or institution, it's helpful to include copies of previous correspondence with complaints to FDA or OHRP.
Trust yourself: complain when you think you should. If you feel like you're being harassed or pressured to enroll in research, you are. If something happens that nobody warned you about, you're entitled to ask why. If the study is nothing like what was described to you, you're entitled to ask questions. Obvious problems merit complaint. While it goes without saying that complaints should be factual, you shouldn't be afraid to complain for fear of getting an investigator, institution, or IRB into trouble. There are a number of reasons why this is so, but the most important reason is that a complaint is not the same as a judgment of noncompliance or wrongdoing. Authority to make judgments following investigation of complaints is limited to federal agencies with the legal authority to do so, like FDA or OHRP.
Reporting Complaints About Research Regulated by FDA: Complaints, concerns, and questions about FDA-regulated research should be sent to the appropriate FDA center. Remember: you will not
get somebody into trouble by complaining or asking questions. Properly speaking, complaints are
allegations. FDA evaluates allegations and decides which ones merit investigation. Investigations are generally prioritized on the basis of several factors (potential for harm, for example). Providing as much information as possible assists FDA in evaluating allegations. If FDA investigates your complaint, the agency will not (generally) inform you of the outcome; often the agency will tell you this in advance, but not always. In some cases the reason for this is that agency rules prohibit communication about investigations once underway. Keep in mind that not all research with drugs, medical devices, or dietary supplements is covered by FDA regulations.
How do you know if research is subject to FDA regulation? Studies conducted under an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) are subject to FDA regulation, as are bioequivalency studies for new generic drugs. If a drug isn't on the market yet (e.g., isn't sold in the U.S.), the research would likely be done under an IND or IDE. The best way to figure out whether or not a study is subject to FDA regulation is to check the study consent form: if it mentions FDA, or if it says that FDA may examine your medical records, the study is subject to FDA regulation. Studies that are exempt from IND or IDE regulations are still required to follow FDA regulations for IRB review and approval and informed consent. If you don't know whether or not FDA has authority, you loose nothing by complaining to FDA. It might also be the case that the sponsor is required to file an IND or IDE but neglected to do so.
Biologics studies (including gene therapy and vaccine studies):
(Division of Communication and Consumer Affairs, CBER)
(Division of Scientific Investigations, Office of Compliance, CDER)
Medical Device studies:
(Division of Bioresearch Monitoring, Office of Compliance, CDRH)
Source: Food and Drug Administration. Reporting Complaints Related to FDA-Regulated Clinical Trials. Accessed on 2009-11-10 at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplaintsrelatingtoClinicaltrials/default.htm
Reporting Complaints to OHRP and Complaints About Research Funded by the U.S. Government: OHRP has jurisdiction over studies funded by the U.S. government and specifically studies conducted by the National Institutes of Health (NIH). OHRP also has jurisdiction over research subject a Federal Wide Assurance (FWA). Institutions (whether a hospital, academic institution, university, clinic, corporation, or physician practice) that receive federal funds for research must file an FWA. The FWA is essentially a pledge to comply with the Common Rule (45 CFR 46). Institutions are required to indicate whether they will apply the Common Rule to federally funded research only or extend the Common Rule to all research at the institution. Roughly 60% of institutions with an FWA choose to extend the Common Rule to cover all research conducted at the institution. OHRP jurisdiction is limited to research with federal funding or to research covered by an FWA. How can you tell if OHRP has jurisdiction over a study? Unless it's sponsored by NIH, you often can't. Fortunately, unlike FDA, if you identify yourself in your complaint, OHRP will tell you whether or not they have jurisdiction and if they do, you'll receive a final response with the agency's findings. OHRP's findings are sent to the institution in a determination letter which is subsequently posted on the OHRP web site.
To complain to OHRP about federally funded research, or research conducted under a Federal Wide Assurance (FWA), send your complaint to:
Kristina Borror Ph.D., Director, Division of Compliance Oversight
Office for Human Research Protections
Department of Health and Human Services
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Phone: OHRP main telephone number (240) 453-6900
Phone: OHRP toll free number: (866) 447-4777
Fax: (240) 453-6909, (301) 402-2071
OHRP Directory / Staff Telephone Numbers and E-Mail Addresses: http://www.hhs.gov/ohrp/about/staff.html
OHRP accepts complaints in writing, via email, or by telephone. OHRP also accepts anonymous complaints. In the case of signed complaints, if OHRP determines the agency has jurisdiction, they will ask whether or not they may disclose the identity of the complainant to the institution named in the allegation. In some cases OHRP may forward complaints to FDA. For additional information see:
OHRP Compliance Oversight. Accessed on 2009-11-10 at: http://www.hhs.gov/ohrp/compliance/
Federally funded research testing drugs, dietary supplements, and medical devices may be subject to both FDA and OHRP regulations. If you complain to FDA and OHRP, you should indicate this as a courtesy to prevent reduplication of efforts.
No matter what the outcome of your complaint, like all citizens, research subjects have the option to sue under civil law (for negligence or medical malpractice, for example). You should discuss this promptly with an experienced attorney. Research subjects can file complaints about the conduct of licensed health care providers with state professional licensing boards. Follow this link to our List of State Medical and Osteopathic Boards.
Please contact CIRCARE if you think we can help, if you have questions, or if you'd simply like to share your experience with us. Follow this link to our Contact Page for details.
Research subjects are often confused about was supposed to happen during a clinical trial, or what obligations sponsors, IRBs, and researchers have. FDA guidance and information for sponsors, IRBs, and clinical investigators may provide useful information. Keep in mind this only applies to research regulated by FDA unless otherwise noted. We intend to expand this list.
Can I be charged for participating in research? FDA IRB Information Sheets — Investigational Studies. September, 1998. Charging for Investigational Products. Accessed on 2006-03-02 at: http://www.fda.gov/oc/ohrt/irbs/toc4.html#products
What are the rules about recruiting subjects for research? FDA IRB Information Sheets — Investigational Studies. September, 1998. Recruiting Study Subjects. Accessed on 2006-03-02 at: http://www.fda.gov/oc/ohrt/irbs/toc4.html#recruiting. See also: FDA IRB Information Sheets — Investigational Studies. September, 1998. Payment to Research Subjects. Accessed on 2006-03-02 at: http://www.fda.gov/oc/ohrt/irbs/toc4.html#payment
What information is supposed to be in the consent form? FDA IRB Information Sheets — Investigational Studies. September, 1998. A Guide to Informed Consent. Accessed on 2006-03-02 at: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
Is this a waiver in the consent form? FDA IRB Information Sheets — Investigational Studies. September, 1998. Compensation vs. Waiver of Subject's Rights. Accessed on 2006-03-02 at: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html#waiver
For information about informed consent in research under the jurisdiction of OHRP (e.g., federally funded research or research conducted under a Federal Wide Assurance), see:
- OHRP Policy Guidance on Exculpatory Language in Informed Consent. 1996-11-15. Accessed on 2006-03-02 at: http://www.hhs.gov/ohrp/humansubjects/guidance/exculp.htm
- OHRP Policy Guidance. Informed Consent Tips. Revised 1993-03-16. Accessed on 2006-03-02 at: http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm
- OHRP Policy Guidance. Informed Consent Checklist. 1998-09-30. Accessed on 2006-03-02 at: http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm
- OHRP Policy Guidance on Informed Consent, Legally Effective and Prospectively Obtained. 1993-08-12. Accessed on 2006-03-02 at: http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-03.htm
FDA Regulated Research: FDA Information Sheet Guidances, Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Index). 1998. Accessed on 2006-03-02 at: http://www.fda.gov/oc/ohrt/irbs/default.htm
Federally Funded Research or Research Conducted under a Federal Wide Assurance: Office for Human Research Protections Policy Guidance by Topic (Index). Accessed on 2006-03-02 at: http://www.hhs.gov/ohrp/policy/index.html
Last Updated: 2009-11-10
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