Research Patient

[Ernie]

Hi everyone,

Do any of you know if there is a law in the States that says that the researchers have to give the research patient their tests result?

I went to a research facility and I can't get the test result as they are saying that it is "Research". I would like to have the result in case there is new information about my case.

Thanks

[all4family]

Hi Ernie,

http://books.google.com/books?id=Ff-RPWd-J...1&ct=result

I found this article about clinical vs. research care. I didn't read the whole thing, but what I got was that they should give you the option to recieve your results. At the very least is says that the intrest of the patient should be foremost. I would think that if you could prove you wanted it for further health care they should give them to you. Good luck!

Hugs

Suzy

[masumeh]

Patient Rights laws and ethics include research participants, and we all have the right to our personal records and test results. However, it might be complicated for them to look it up, since they probably tried to mask your ID in the records for anonymity, assigning you a number that replaces your name. There is usually a list somewhere with the code-to-name matches...but you will have to find the right person to ask in that case.

Good luck.

[Poohbear]

I've had some dealings with this area several times as I have been a research patient multiple times at various different institutions.

The short answer to your question is "no". In general, researchers are not required to release data unless they are court ordered, required by the FDA to be released to them, members of congress, law enforcement.

They can CHOOSE to release information but are not required. I've never known a U.S. institutions or researcher not to release information if the information could potentially change your treatment options or if the information they gathered was important for you to know (for example, if they found a rare gene defect---they may offer you the option of knowing about it with the understanding it could negatively impact you if there was no other treatment option; like in the case where insurance could base decisions on that information).

This is a time to also strongly encourage people to carefully and thorougly read all consent forms to participate in the research before you sign and agree to be a research patient. Those papers will usually tell you if you will be given results or not; if they don't specify and it's a concern to you, then do not sign the consent form. Those consent forms are legally binding.

Ernie, go back and review the copy of "consent to research" paperwork. If what they are doing goes against what you consented to then you can try calling the patient representative at NIH. You will need the study title and IRB # before calling them (which will also be on the "consent to research" paperwork).

Most facilities that do research have two seperate files--your Medical file and your research file. You ARE legally entitled to your Medical file but not necessarily your research file.

[ajw4790]

Ernie,

Hi! I had wondered if you had heard anything yet from your Mayo adventures. I did not realize (or remember) that you were going as a research patient. That is awful that you are having such a hard time getting your results from all of the testing. I hope that soon you will get them to release the results. I am not familiar with the rules with all of this. It does make sense though that you have the right to your medical file. Not sure if that helps you though. Have you discussed the matter directly with the drs. you saw or the nurse of those drs. I have had a lot of difficulty with getting around receptionists at times, and they tend to have no clue! They just spit out the script of info that they are taught to say. I hope that someone soon will listen and understand how important this is and help you! Do they say that you will be able to get the info after the research is over? To travel all that way, and for this to happen... I am speechless... I am SOOO sorry!!!

[Sophia3]

In the mid 90's, I was in a government study with a nearby sleep doctor and was NOT given my results and as poohbear stated, that was in the paperwork I signed before the research. I was told I was getting the real drug, not a placebo, and did a diary. Mine was self explanatory whether the med had life changing improvements as it had for a small group (it did not)

Also the outcome did not compromise my health, thus nothing was released to my then doctor.

I have been in many researches since then, NOT medically related, but skin care and i did not get a report on that either. Nor could I talk about it with others in the research or even family. Some huge companies take getting skin creams to market VERY SERIOUSLY!

[Ernie]

Hi,

Thank you very much for all your advice. I will call the investigator next week to see if I can work out something.

I read my contract and it does not say that I am not allowed my research records. Before I entered the study I asked if I would get my result and they said yes. That's the reason I accepted to stop my meds again and get really sick.

[masumeh]

I couldn't find more research-specific ethical codes entitling patients to their records...but patient rights include the right to view and obtain a copy of their records. In psychology (APA, 2002), this goes for research participants as well. In fact, they are entitled to a report on the study's overall findings. I assumed that medical associations have even stiffer laws, but maybe they don't. Anyway, I think you should be able to get your records. And if you can't, you should contact the AMA and ask if this violates your patient rights. A participant is also a patient with rights (like do no harm, optimal treatment, etc.).

This is an excerpt from AMA's website:

Opinion 7.02 Records of Physician: Information and Patients

Notes made in treating a patient are primarily for the physician?s own use and constitute his or her personal property. However, on request of the patient, a physician should provide a copy or a summary of the record to the patient or to another physician, an attorney, or other person designated by the patient.

Most states have enacted statutes that authorize patient access to medical records. These statutes vary in scope and mechanism for permitting patients to review or copy medical records. Access to mental health records, particularly, may be limited by statute or regulation. A physician should become familiar with the applicable laws, rules, or regulations on patient access to medical records.

The record is a confidential document involving the patient-physician relationship and should not be communicated to a third party without the patient?s prior written consent, unless required by law or to protect the welfare of the individual or the community. Medical reports should not be withheld because of an unpaid bill for medical services. Physicians may charge a reasonable fee for copying medical records. (IV)

Report: Issued prior to April 1977; Updated June 1994

?2007 American Medical Association. All Rights Reserved

[Sophia3]

Research rules are different. Depending on exactly how records are kept, you could expose confidential information from a doctor, that is being done in a PRIVATE research. For example on illnesses or medications, or potential meds to bring to market.

Different research has different rules but I have NONE from my sleep research of several months in the 90's. It was government based but my doctor made up the rules to fit his criteria. He was trying his best to educate the MEDIA and medical profession and pharmaceutical companies if things were successful. He was even on CBS Evening News. Still, not a peep in my general record files history speaks about this UNLESS I bring it up.

I kind of like it that way because when you mentioned the drug to some people they flipped out and could not believe I was using it for a drug study. For a chance to IMPROVE my quality of life? Heck yes and the drug had years of safety under its belt when used properly in this country and others.

[Poohbear]

http://ohsr.od.nih.gov/info/sheet6.html

Note the below questions NIH has outlined.....including "will the results of the study be shared with you?". Obviously, the fact they even pose this question means researchers don't necessarily have to share results with you or even the results of the overall study.

AMA guidelines aren't the same in this case because the participant is giving consent to be a research patient. That doesn't mean patients don't have rights....they do, but it is per outlined under the "Office of Human Subjects Research" not AMA. Some studies are sensitive in such a way that patients names are never part of the research file---the record is given a number and the researcher may not even know what file number goes to a given patient. Some studies are "double blind" to deter bias from the researcher or the participant--how could a researcher release specific patient data in a truly double blind study? They can't.....thus in some cases, patients do not get the data that resulted in their participation in a study.

Why is this research being done?

Why are you being invited to participate?

How many people will take part in this research study?

How long will you take part in this research study?

What do we do to decide if you are eligible for this research study?

What procedures, drugs or other treatments are involved in this research study?

What are the risks and discomforts of this research study?

Are there any benefits to you if you take part in this research study?

What other choices do you have?

Are there reasons that your research participation may end early?

What will happen when the research study is over?

Will your clinical and other test results be shared with you?

Will the results of this research study be shared with you?

Will any of your blood, tissue or other samples be stored and used for research in the future?

Will you receive any compensation (money or other) for taking part in this Research study?

The following CC minimum language is part of the consent template and must be used: ?In general, patients are not paid for taking part in research studies at the NIH. The amount paid to research volunteers is guided by National Institutes of Health policies.?

Add appropriate language if compensation is to be paid, including the amount of compensation.

Do any of the researchers or the NIH have a financial interest related to this research study?

What privacy and confidentiality procedures apply to the information gathered about you in this study?

I hope this clarifies some of the confusion.

[Ernie]

Hi,

I checked my contract another time and it does not mention anything about giving me the information. It does talk about confidentiality but it is with government and insurance companies. They answered most of the questions you wrote Poohbear.

I called the secretary this afternoon and she told me that usually he does not give the documents but since I am asking him he might do so. I have to wait until next week to find out because he is unavailble.

[masumeh]

Well, I think this issue is very important, since many of the visitors to DINET.org do participate in medical studies. It is important to know your rights, which are not necessarily fully described in the consent forms you sign. You are fully entitled to benefits of the study, including knowing if a particular treatment is beneficial for you as an individual. Although you are a participant, you do not lose any rights to responsible physician care, especially when the research is care-oriented. Your patient-physician relationship remains entact, and you are still a patient with rights.

And of course, blind studies do not mean that every researcher is blind, or that it is not possible to uncover names which were replaced by codes. In fact, participants can withdraw at ANY time, even post-experiment. That means that researchers need to be able to go back into records and delete the person's information using only their name (since they are not informed of their recorded code).

Here is an except with some bold relevant areas. I don't know what the state-by-state statutes are, but I know that they usually need to conform with these internationally agreed upon declarations.

Policy

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI

Ethical Principles for Medical Research Involving Human Subjects Download the PDF file

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the:

29th WMA General Assembly, Tokyo, Japan, October 1975

35th WMA General Assembly, Venice, Italy, October 1983

41st WMA General Assembly, Hong Kong, September 1989

48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996

52nd WMA General Assembly, Edinburgh, Scotland, October 2000

53th WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly, Seoul, October 2008

INTRODUCTION

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs.

Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles.

It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.

The Declaration of Geneva of the WMA binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act in the patient's best interest when providing medical care."

Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research.

In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.

The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

In medical practice and in medical research, most interventions involve risks and burdens.

Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence.

Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH

It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

Appropriate caution must be exercised in the conduct of medical research that may harm the environment.

The design and performance of each research study involving human subjects must be clearly described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits.

The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee.

Medical research involving human subjects must be conducted only by individuals with the appropriate scientific training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional. The responsibility for the protection of research subjects must always rest with the physician or other health care professional and never the research subjects, even though they have given consent.

Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.

Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.

Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.

Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects.

Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no competent individual may be enrolled in a research study unless he or she freely agrees.

Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity.

In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse. There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee.

When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.

For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden.

When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject's dissent should be respected.

Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative.

Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE

The physician may combine medical research with medical care only to the extent that the research is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.

At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.

The physician must fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never interfere with the patient-physician relationship.

In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.

22.10.2008

[masumeh]

Poohbear,

I went to the site you quoted. NIH declares that it adheres to the Hellenski Declaration that I quoted above. The section you list is related to consent forms, and the questions are suggested subtitles for researcher use in developing the document. The answer to "Will I receive results?" should be Yes.

It's really sad to me that participants are routinely kept in the dark about their rights; and sadder still that they are denied their rights even when they explicitly request them.

I recently completed a grad paper about research ethics, so this is fresh in my mind. My field is psychology, but psychological, social, and biomedical research all depend on the same history of Belmont, Hellinski, and a few other landmark ethical declarations. It's known and discussed in professional and research ethics that clients often do not know their rights, and raising awareness about rights is an important yet neglected activity.

NIH has a document called 'Gray Booklet: Guildlines for the conduct of research involving human subjects at the NIH', which is also accessable at www.nih.gov

Bottom line for biomedical research is that you as the participant are suppose to benefit. You are not suppose to be simply used and forgotten. If you just remind the researchers you're dealing with of that, and how you suffered by leaving your medication in order to obtain some more knowledge of your disease for your treatment plan, then I think they should give you whatever info you are looking for. If they don't, it's really culpable, and you should contact the AMA to make a report of violated participant rights. That's my opinion anyway.

[flop]

My Grandad participated in a drug trial in the UK. He had heart failure and was part of a study looking to see if taking ACE inhibitors helped to treat heart failure.

He was allowed to know the results of his tests (lots of echo scans) but he wasn't allowed to know what medication he was taking (ie was he on an ACE inhibitor or was he on a sugar pill?). At the end of the trial he would have been allowed to get a special "patient's copy" of the study result - a paper saying if ACE inhibitors helped or not, he would not of got any individual results relating to himself just the overall findings of the research.

Ernie - if you had for example a tilt test off medication then another one on medication it would be reasonable to expect a copy of the baseline tilt results. They would not be able to tell you if you had a real med / what med you had and may not be able to give you results of the second tilt.

At least they are asking your doctor if you can have the results. If you get nowhere I would write to the doctor formally asking them to write a report about all the medical information from your trip to the hospital and any recommendations for treatments for you (it may be helpful to get them to write to your PCP and send you a copy).

Flop

[ajw4790]

Ernie,

I hope that next week you can get some answers! If they are not real cooperative maybe you can ask to see if they would be available after the study, if the results can be discussed verbally to you (if they won't give you a copy), why they said it would be available and now is not (which would be against your signed informed consent to be a subject-can make your results invalid, if you signed under other circumstances than the ones they are claiming). There are strict rules if they go against the informed consent/protocol you signed then your results are invalid and they could potentially lose the study, grant money, be fined etc...

Hopefully once you are able to talk to someone "in charge" things will be straightened out!!!

[Ernie]

Hi,

I received part of my Medical file and the doctor wrote: 'I let her know that she will receive a copy of all our records and all tests and consultation with good documentation of our impressions. She verbalised understanding.'

I don't know if that includes my Research file?